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flexibele endoscopes

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1. cceeeeeeeeeeeeeeeeenees 71 Appendix 6 System specifications of the washer disinfector c ccceeeeeeeeeeeeeeeeeeeeeeeeeeeeanees 72 Appendix 7 Determination of microbiological quality ccceecccecsseeeeeeeeeeeeeeseeseeeeesaaeeeeesanees 76 Appendix 8 Flow chart for microbiology tests on flexible endoscopes eseeeeeeeeeeeeeeeeeees 79 Appendix 9 Flow chart for microbiology tests on the post disinfection rinse water 0 80 Appendix 10 Estimation sheet on microbiology in endoscopes and or washer disinfectors 81 Appendix 11 Ninhydrine swab test ccccccssseeceesseeeceseseeceseeaeceecsuseeeesseauseesseseueeeesseeeeesaaaess 82 Appendix 11 Ninhydrine swab test cccccccseececeseeeeeeeseeeeeeeseaeeeeesaeeeeeesasauseeeeeseaaeeeesaaeeeesaenees 82 Appendix 12 Hemoglobin swab teSt ccccceseeeececeeeeeeeceeeeeseeeeeeeeeesseaeeeeeeeeeseeseaaaaeeeeesaneaeeees 83 Appendix 13 Release form flexible endoscopes cccccceceseeeeeceeeeeeeeaneeeeeseeeseeeeesaaaeeeesaaees 85 Appendix 14 Schedule of requirements for Washer CISINfECtOF cccccseeeeeeeceeeeeeeeeaeeeeeeeeees 86 Appendix 15 Requirements for flexible ENdOSCOPES ccesecceeceseeeeeeaeeeeeeesseseeeesaeaaeeeeeanees 88 Appendix 16 Schedule of requirements for drying Cabinet cccccceceeeeeeeeeeeeeeeeeeeeeeeeeeeeanees 89 Appendix 17 Audit form endosco
2. disinfectant solution to the disinfection temperature pel o TT disinfection phase erene ee d T during the disinfection phase The time of the actual disinfection phase which is the a o time after the disinfection temperature is reached Pea TT Or The flow generated by the pump s at a given ee ee ee pressure Rotation speed wash arms S S S speed wash arms m ae eee V Final rinse O oo o o S y oO The number of rinsing step s CT o S y O The amount of water that is taken The quay ofthe water thats taken see Wi ft The temperature of the incoming water o Z O T o The time the machine needs for the water to heat up D to the rinse temperature The temperature of the water during the rinsing phase The time of the actual rinsing phase which is the time a a after the rinse temperature is reached Eae or The flow generated by the pump s at a given ee ee pressure Rotation speed wash arms oS d S E l l Vi Quality of the water used in the disinfector Temperature o SSS S S S Hardness oo d S S Content of other minerals S S Amount and type of micro organisms o o T o To o Details on integrated softeners ion exchangers RO Z d Version 2 1 2011 73 Parameter Specitied Measured Correct values and values N membranes etc S membranes ete ana a O o o oO Disinfection thereof S S S Integrated filters o ooo S S S Mamenanceteret e l Disinfection ther
3. 2 1 Organisation cleaning amp disinfection Safety management is only successful if responsibilities are clearly designated Both the VMS report and the abovementioned IGZ reports demand the assignment of responsibilities Commitment of Executive Board or Boards of Directors is explicitly mentioned Furthermore the involvement of all healthcare providers and medical specialists is essential for successful implementation of the VMS The IGZ recommends the appointment of an Expert on Scope Cleaning and Disinfection DSRD to ensure a successful endoscopes management plan In practice this responsibility is assigned to the infection prevention advisers Experts Sterile Hospital Supplies DSMH or heads of the Central Sterilization Department or the Endoscopy Department The Executive Board or Board of Directors is at all times responsible for quality and continuity of the provided care in accordance with the Dutch Care Institutions Quality Act The operational responsibility is delegated at a managerial level to the appointed organisational managers or management teams These can be management teams of scope disinfecting and or scope utilizing departments decentralised If endoscopes are disinfected centrally the management can be part of the Central Sterilization Department CSA or Facility Services support services Intermediate forms with pre cleaning at an outpatient department followed by adequate logistics and central automated dis
4. ESGE ESGENA guideline Cleaning and disinfection in gastrointestinal endoscopy update 2008 Endoscopy 2008 40 939 957 23 Clean is not clean enough microbiological safety around endoscopy can be improved J Kovaleva et al Medisch Contact 64 No 23 June 4 2009 1041 1043 24 Letter Report 360050013 2008 quality of cleaning and disinfection of flexible endoscopes Reprise Adrie de Bruijn Arjan van Drongelen RIVM July 2008 25 State Supervision Public Health Health Care Inspectorate report Risks of medical technology underestimated The Hague October 2008 26 CEN TC102 N784 NWIP STORAGE CABINETS heat sensitive endoscopes Version 1 september 2004 27 Directive 93 42 EEC European Council of 14 June 1993 concerning medical accessories 28 Willis C Bacteria free endoscopy rinse water A realistic aim Epidemiology and Infection 2005 134 2 p 279 284 29 Performance Indicators Quality Assurance Medical Systems Dutch Society of Clinical Physics May 2007 30 Guideline Responsibility medical specialist in maintenance and management of medical equipment Order of Medical Specialists October 17 2008 31 Pidduck D Cross infection and the laryngoscope Br J Perioper Nurs 2002 May 12 5 170 5 32 Lo Passo C Pernice et al Transmission of Trichosporon asahii oesophagitis by a contaminated endoscope Mycoses 2001 44 1 2 13 21 33 Wenzel RP Edmond MB Tuberculosis
5. o detergent dosing system technical validation see section 10 5 validation Assemble logbook per washer disinfector note oprocess counter o Inventory information of the machine Version 2 1 2011 37 INANSSDVNVIA sSd00dd INSANSSDVNVIA 9Sd00dd opreventive and corrective maintenance oprocess faults oreplacement of parts oprocess cancels oreplacing of the detergent and disinfectant containers o validation reference to validation report orelease declaration Microbiologically Microbiological validation see section 10 7 3 The reporting of the abovementioned items is carried out by the responsible department to the DSRD The assessment and functional release of the washer disinfector is done by the DSRD see appendix 5 release form The filing of the installation report technical and microbiological occurs under the responsibility of the DSRD 5 5 Risk inventory and evaluation The cleaning and disinfection of endoscopes is performed to prevent risks for patients However these procedures possibly involve other risks Both the supplier of the detergent and disinfectant and the heads of the involved departments are obliged to consider this Risks can be divided in the following categories Risk for employees Risk for endoscopes and washer disinfectors Risk for the environment Risk regarding chemical safety Risk regarding microbiological safety Risks can be minimised by using gene
6. ARBO a ban on working with open containers glutaraldehyde was enforced which accelerated the conversion to machine disinfection The GZ reports from 2000 and 2004 ref 3 4 show an insufficient compliance of the existing guidelines in the field of cleaning and disinfection such as the guideline of the Dutch Workingparty on Infection Prevention WIP ref 5 Based on frequent reports of incidents in this field the IGZ was obliged to further tighten the supervision by keeping on showing the hospitals their responsibilities regarding patient safety One of the recommendations by the IGZ was the appointment of a flexible endoscopes decontamination expert DSRD These experts sought each other through various communication channels to discuss problems This led to frequent meetings of these professionals nationwide These meetings resulted in a profitable collaboration of four professional associations with involvement of this field gt The Sterilization Association of the Netherlands CSC gt The Dutch Nurse Association division Gastroenterology and Hepatology V amp VN SEVA gt The Dutch Society of Experts on Sterile Medical Devices VDSMH gt The Dutch Society of Infection Prevention and Control in the Health Care Setting VHIG From this collaboration the Advisory Board Cleaning and Disinfection Flexible Endoscopes SFERD was established mid 2006 In accordance with the formulated project plan this advisory board has started with t
7. Is the connection tubing still intact Are all fittings still intact Are the channels actually purged Are all suspension clips still intact Is maintenance carried out according to protocols Is the drying storage cabinet cleaned according to protocols Does the drying storage cabinet function according to the specification are the critical eS parameters set by the manufacturer within tolerances Does the drying cabinet provide a signal for a faulty drying process Does the drying cabinet provide a signal when the maximum storage time has expired Does the drying cabinet provide a signal if the door is not closed properly Does the drying cabinet provide a signal if the power supply fails Have the environmental conditions changed Automation It is desirable that the drying cabinets can be connected to a trace system of flexible endoscopes as is used in the hospital 10 11 Control Flexible Endoscopes It is possible that an endoscope underwent a validated cleaning and disinfection process but due to damage malfunction of the endoscope e g a tear in the biopsy channel or the cardan rubber disinfection has been insufficient so it can still be contaminated These damages defects are not always detected by a leak test To ensure an effective cleaning and disinfection it is also important that the connectors which connect the endoscope to the washer disinfector or the drying cabinet are connected and that the ch
8. Letter to Hospital Managements Hygienists departments hospital hygiene pulmonologists medical microbiologists and hospital pharmacists about brochoscopes GHI JK DV 93557 Rijswijk February 1993 2 State Supervision Public Health Letter to Pulmonologists directors of hospitals medical microbiologists hospital hygienist Hospital Pharmacists and Experts sterilised medical accessories GHI INFZ 93647 Rijswijk November 1993 3 State Supervision Public Health Health Care Inspectorate report Scope Disinfection in Dutch hospitals The Hague April 2000 4 State Supervision Public Health Health Care Inspectorate report Follow up research scope Disinfection The Hague June 2004 5 Workgroup Infection Prevention directive Cleaning and disinfection of endoscopes Leiden April 2009 www wip nl 6 State Supervision Public Health Letter to Hospital managements or Board of Directors of hospitals medical microbiologists and hospital hygienist 1997 1905 IGZ Rijswijk March 1997 7 Bronchoscopy related Infections and Pseudoinfections in New York 1996 and 1998 MMWR Weekly July 9 1999 48 26 557 560 8 Agerton et al Transmission of a highly Drug Resistant Strain Strain W1 of Mycobacterium tuberculosis JAMA October 1 1997 vol 278 No 13 9 Michele et al Transmission of Mycobacterium tuberculosis by a fiberoptic brochoscope JAMA October 1 1997 vol 278 No 13 10 N
9. hardware and software or mechanical components S A A Fe aera et EPP For software and hardware problems the maximum downtime is 24 hours ae SE 11 8 Software licenses should be valid for the lifetime cycle of the device a ee Lia al and hardware updates and features for software and hardware updates can be performed on behalf of modalities and control for at least 10 years 90 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 17 Audit form endoscopy Questionnaire on behalf of endoscopy Appendix 17 Dep GE urology pulmonologist ENT Department location Audited Auditor s Date describe departement amount en type of endoscopes en endo washerdesinfector Comments answ er the questions by entering yes no or partly in the appropriate column The The endoscope policy is established at departmental level policy is established at SEE GE level _ yes ee E are disinfected by machine S ecseited TT aay are sterilised artly nd a endoscopes are divided es 1 5 These are recorded in These are recorded in writing Used biopteurs loops etc are sterilised or disposables are used i Work takes place according to correct principles as follows manual eak Tea an a a pe peceat E process steps in disinfector ro e A A o enn o psm a E C Version 2 1 2011 91 answ er the questions by ent
10. the institution should decide to refrain from buying the endoscope concerned Most manufacturers have a list of endoscopes that can be cleaned and disinfected in the washer disinfector It is recommended to verify that all endoscopes used in the institution are mentioned on the list before the purchase of the washer disinfector The same advice can be given if one intends to purchase a new type of endoscope or if planning to use a loan endoscope In that case the connectors should be purchased to properly connect the endoscope in the machine Part of the initial validation is to ensure that the endoscopes used in the hospital are on the list of the manufacturer the right connectors are present preparatory activities such as brushing of the channels which the manufacturer describes in the work instructions are included Part of the revalidation is to verify in advance whether endoscopes or loan endoscopes are on the list of manufacturer of the washer disinfector If not the manufacturer or the manufacturer of endoscopes should 19 After the entire process in the WD the endoscope shall be free from vegetative bacteria but not necessarily spores and other contamination The combination of the cleaning process and the disinfection process shall be designed to achieve this condition recognising the high level of bacterial contamination that may exist It shall be necessary to take into account other factors such as the design of
11. 24 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author gt STEP 1 Get released endoscope from drying cabinet y STEP 2 Transport of disinfected dry endoscope Registration of patient doctor and endoscope ID Yy Performing endoscopy F y STEP 3 After use flush the ducts of the endoscope and wipe off the exterior Release return to departement STEP 4 Transport of an used endoscope delivery of the used endoscope and information in desinfection room y Repair performed P A STEP 5 Preperations before cleaning and disinfecting endoscope dissamble and ultrasoniccaly treat spare parts e g valves STE P13 loan endoscope STEP 6 Manually leak testing of the endoscope Send endoscope in for repair and arrange loan Repair by MT Leakage of INSANSSDVNVIA sSd00dd endoscope if possible lt n possible See eee ayes endoscope A i E no y Repair performed gt STEP 8 Manually brush channels r y STEP 8 Suck out and or flush channels y STEP 8 Disconnect leak tester y STE
12. amp Policy DO Leaders Strategy Ue aoe Employees policy Resources Processes In addition to this four fields of results are defined CHECK Customer satisfaction Employee satisfaction a Wares Impact on society a m check Final results l action amp Testing and improving of processes i a is shown in the last field ACT Figure 1 The EFQM model with the Plan Do Check Innovation amp learnin Act cycle as applied in this SFERD handbook g The SFERD has made good use of this model while striving for the development of a guaranteed quality system The PDCA cycle of the EFQM model is addressed in the following chapters PLAN chapter 1 Leadership Vision and Organisation chapter 2 Strategy amp Policy DO chapter 3 Human Resource Management chapter 4 Resource Management chapter 5 Process Management CHECK chapter 6 Appreciation by Customers chapter 7 Appreciation by Healthcare staff chapter 8 Appreciation by Society chapter 9 Results ACT chapter 10 Improvement and Innovation by Audit amp Control The EFQM is an independent foundation established in 1991 at the initiative of the Ministry of Economic Affairs under the name Dutch Quality Institute 8 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 1 LEADERSHIP
13. below shows how the results of microbiological tests should be interpreted and what actions could be necessary Table 4 Acceptance Criteria of Willes in a microbiological test of the post disinfection rinse water ref 28 Aerobic colonies Interpretation en possible action per 100ml 0 Acceptable 1 9 Acceptable Consistently low numbers of bacteria indicates the water treatment is under control 10 100 Doubttul Find the cause of the problem see Appendix 9 and 10 gt 100 Unacceptable Discard the washer disinfector until water quality has improved PART 5 Control of the efficacy of the self disinfection cycle The self disinfection cycle of the washer disinfector is designed to prevent contamination of the washer disinfectors themselves The self disinfection is carried out according to the instructions by the manufacturer While performing a self disinfection parts of the washer disinfector are disinfected that would not be disinfected during a normal process in most systems These can be parts of the water supply or water treatment systems filters The microbiological quality of post disinfection rinse water is actually also an indication of whether the machine is bacteria free Indeed if the machine is contaminated with a bio film organisms can be detected during the check of the post disinfection rinse water If bacteria are found during the check of the post disinfection rinse water then a water sample should be t
14. cabinet and flexible endoscope after purchase installation and maintenance Manager Endoscopy department is responsible for the daily affairs at the endoscopy room s is responsible for the introduction and testing of new equipment is responsible for providing re training and updating knowledge of employees is responsible for reporting and documenting deviations is the manager of the quality documents is responsible for monitoring and recording of the cleaning and disinfection process is responsible for training and supervising new employees Manager cleaning and disinfection unit is responsible for the entire process procedures work instructions and protocols in accordance with laws and regulations concerning cleaning and disinfection of flexible endoscopes is responsible for the updating of procedures work instructions and protocols is responsible for circumstances in which working conditions are created Version 2 1 2011 15 INSANSSVNVA JodNOSJH NVANH INSANSASVNVA 4A0EdNOSsAY NVANH is responsible for the establishment and adherence to enforced agreements is responsible for the purchase and introduction of new cleaning and disinfection equipment for flexible endoscopes is responsible for providing training on behalf of the expertise of the employee Medical Practitioner is responsible that he she is adequately informed about prevailing procedures regarding an endoscopy and acts in accordance should
15. ccccsssssseecssnsssesesseeseeesseesssonees 42 6 1 PAGE SANCUY E A hed danmcwantantdiaddn E A E E 42 6 2 Turn over availability endoscopes cccceceeeeeeeceeeeeeeeaeeeeeessueceeeeeseseeeesaseeeeees 42 7 APPRECIATION BY HEALTH CARE STAFF cccccsseecessesseneescensenees 43 8 APPRECIATION BY SOCIETY sensnnnnnnonnnnnnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnennnennnnnnnne 44 8 1 incidem managements oriasi aE E AE ESERE E ER 44 8 2 Aspects on the application of incident management ccceseeeeeeeceeeeeeeeeeeeeeeeeaes 45 8 3 Phases in the incident procedure cccccccccseeeecneeeeececeaueeeeceaeueeeceseeeeeeessneeeesssaes 46 8 4 Amplification on phases in the incident ProCe dure cccccceeeccceeeeeceeeeeeseeeeeseees 47 8 5 Image damage on the INStItUTION ccceeceecceceeeeeeeeeeeeeeeaeeeeeesseeeseeeeseaeeeeeseaeseeeees 49 o RESULT aA E AAA 50 10 IMPROVEMENT AND INNOVATION BY AUDIT amp CONTROL 51 10 1 Perornmng AUIS idnicacenscnauutnbinddsasagercrsinidtanGumeratdeaausnicasweneuedipinidectauenduaniiaiedeiauiwias 51 10 2 Risk inventory and EVAIUALION ccccceeeeeeeeeeeeeeeecaeeeeeeseaeseeeeeseeeeeeeseeaeeeessaaeeeeeeeaes 51 10 3 Agreements on management cccceecceceesceceeeeeecssececeueeenseceeeeseeceseeeessaeeeenseeeeetes 51 10 4 Assessment Of management ccceccceseseeeeeceeeeeecceeseeeecsueeeessuaueeesessgeeeeesenseeeeees 52 10 5 Co
16. disinfector and processes The user should be able to recognise simple faults and failures and resolve these If failures cannot be resolved by the user one needs to inform the Medical Technology Clinical Physics Accordingly the Medical Technology Clinical Physics registers the notification and subsequent actions in the logbook and informs the DSRD about this The user and technicians should be able to identify abnormalities in the functioning Version 2 1 2011 55 LIGNVY Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOdd WI 10 6 Validation of the washer disinfector The following are STEPs in the validation The DSRD ensures that all STEPs are performed The validation of the washer disinfector should be performed at least once a year Measurements tests and checks should be performed after any maintenance or repair depending on the nature of the changes to or activities on the machine In any case a release test should be performed The manufacturer should indicate whether maintenance or repair has influenced the process the Medical Technology Clinical Physics evaluates the arguments of the manufacturer together with the DSRD In consultation it is decided which release tests are necessary Section 10 4 schematically shows the overview of the management measures that make up the validation and which should be performed periodically or if indicated 10 6 1 Logbook In the logbook all data regarding the use of
17. disinfector for use Approval release is done by the Medical Technology Clinical Physics in agreement with the DSRD if all conditions of chapter 10 6 10 8 are met Taking out of service occurs when one or more conditions are not met The DSRD weighs the severity of the deviation and decides whether the washer disinfector should be taken out of service in consultation with Medical Technology Clinical Physics Indication approval If it turns out that the washer disinfector is safe to use after validation a clear mark should be placed on the washer disinfector by means of an approval sticker issued by Version 2 1 2011 61 LIGNV Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOdd WI the Medical Technology Clinical Physics In addition the validity best before date should be indicated on the sticker Indication out of service lf the validation indicates that the washer disinfector is not safe to be used a clear mark should be placed on the washer disinfector with the out of service sticker This mark must always be red and provided with a date Reason for taking out of service can be that the washer disinfector is damaged so that safe operation is not possible maintenance repair is no longer possible or if this is a logical conclusion based on the validation results This information should be included in the logbook including the conclusion disqualified A washer disinfector that does not meet the r
18. for a duration of minimally 5 minutes The ultrasonic bath is closed because due to the vibrations aerosols can develop which are potentially contaminated with micro organisms The materials are removed from the bath rinsed under the tap and placed in the basked after termination of the ultrasonic treatment Cleaned materials are washed and disinfected in the washer disinfector or for mechanical cleaning and thermal disinfection transported to the CSA Ultrasonic fluid should be refreshed minimally once per shift and in case of visible contamination 5 3 Disinfection of TEE transducers The currently used TEE transducers are not suitable for cleaning and disinfection Therefore a manual cleaning and disinfection is necessary while care should be taken of a universal clear and verifiable approach The transducer is a very fragile instrument that is particularly susceptible to buckling and bending Proceed as follows ATTENTION NEVER IMMERSE THE ELECTRONIC PARTS THE CONTROL STATION OF THE TRANSDUCER Registration Register the number of the transducer the patient number the date and time of the endoscopy the name of the doctor and the disinfection employee Cleaning Note In case the transducer is used with an intact sheath and is not visually contaminated the cleaning step can be omitted Perform adequate hand hygiene Wear gloves Check the entire transducer for contamination and irregularities Ma
19. inventory and analysis the risk assessment can be limited to one individual In this case the procedure is continued b There is a structural risk which affected several patients and or staff In this case the procedure is continued c It is concluded that there is was no risk for patient and or staff The procedure is stopped here the notification is reported Version 2 1 2011 47 ALAIOOS Ad NOILVIOSdddV ALAIOOS Ad NOILVIOSdddV STEP 5 Notififying the Board of Directors The DSRD reports the findings to the BoD and advises the president of the BoD to assign an expert team STEP 6 Board of Directors assigns expert team The representative of the BoD assigns an expert team the team members are determined by the DSRD and medical microbiologist Depending on the individual risk Step 4a or group risk step 4b the size of the team can be established In case the employees have been at stake the occupational physician will be part of the team STEP 7 Deciding on the policy The expert team decides about the policy to be implemented and advises the BoD on this The following issues need to be addressed can endoscopic examinations proceed without an increased risk for the patient and or employee should patients be recalled for examination if the risk of hepatitis B hepatitis C and or HIV cannot be ruled out should the incident be reported to the IGZ should there be a press release In case t
20. is not entirely completed S 5 4 The process consists of at least the phases pre cleaning cleaning flushing disinfecting de E E He E K a de E E Indicate the consumption of detergents specify costs per run PP po 5 10 Indicate the consumption of disinfectant specify costs per run 6 Cleaning and disinfection es SSS Ra Detergent and disinfectant should be provided with a CE qualification Pf fo 6 2 The washer disinfector is suitable for all brands of CE approved detergents and disinfectants The washer disinfector is suitable for disinfection with per acetic acid 6 4 The product information of the washer disinfector product contains information on cleaning and disinfection temperatures provide product information The machine has a self disinfection process The washer disinfector makes a notification if the disinfectant container is empty The washer disinfector makes a notification if the detergent container is empty There is a check on the dosage of disinfectant detergent 6 5 7 Dosage exposure time and temperature of the detergent and disinfectant should be established in the programs It is indicated in the documentation which programs are available provide documentation The equipment operates with a rinse cycle with bacteria free water to prevent residues of detergent and disinfectant BS standard R4101 7 Requirements regarding suppor education TT 7 1 There is an Engli
21. largely determined by the rinsing principle the method of connecting of the endoscope and the parameters of the cleaning and disinfection process in addition to using the chemicals validated by the manufacturer For the purpose of validation checks are performed on the process parameters The effectiveness of the cleaning disinfection and rinsing to remove disinfectant from the endoscope are part of the type test and are therefore not again determined during the validation by the hospital This document provides assistances to arrange the validation of the washer disinfector drying cabinets and monitoring of flexible endoscopes within the institution For the purpose of this handbook validation is defined as the evaluation of the results of all measurements tests and inspections performed in a period to obtain assurance that the washer disinfector complies with the specifications established by the manufacturer 52 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Table 3 Overview of the management measures Measure Check if new and loan endoscopes can be placed in disinfector and drying cabinet Microbiological control endoscopes Microbiological control loan endoscopes Inspection endoscopes Check the cleanliness of the exterior of the endoscopes Process control test with dummy endoscope Check the registration on replacement of chemic
22. located in the vicinity of the ultrasonic bath and easily accessible for everyone 7 The load regulation contains the following actions 3 6 l The products are at least 5 minutes in the ultrasonic bath 3 7 DE 37 fme products are spread as much as possible with minimum shading E Small products that can float go into a closed basket L ae The bath is closed with a lid when it is operating a o 92 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column el load regulation is present Em disinfector type 4 2 This is located in the vicinity of the machine and is easily date regulation accessible for everyone The load regulation includes the following actions 4 3 Ring caps and any other loose parts are placed in a basket in Eo de washing machine EHR 4 4 The scope is placed into the machine in such a way that the A Pe lea distal part is located free e g disappears in the mouth of E a E E 4 6 The load regulation describes which tubes should be connected e T A answ er the questions by entering yes no or partly in the appropriate column The outlines of the technical function are clear to the staff Pf An operation regulation is located in the vicinity of the machine a date regulation and easily accessible for everyone A procedure is established in wri
23. may decide to suspend the use of the washer disinfector In this case it is likely that the changes to the washer disinfector is such that the type tests as once performed by the manufacturer The manufacturer should repeat a part of type tests and make the results available to the DSRD 10 7 Periodical inspections verification specifications and other controls The following inspections verifications and controls are typically performed ona predetermined annually schedule In the event of an incident it will be necessary to carry out research to determine the cause of the incident After correcting of the problem it should be verified whether the washer disinfector functions within the predetermined specifications again The nature and extent of the activities that are required will depend on the nature of the incident and the underlying problem The DSRD should put together and perform a dedicated inspection program verifications and controls in these cases 58 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 10 7 1 Daily inspection washer disinfector Before first use on any working day the washer disinfector should be visually inspected The visual inspection consists of enough chemicals in the cans right can at the right place inspection for defects and other deviations that are visible at first sight inspection for leaks inspection for corro
24. of disinfectants area for storage of transportation containers and transportation trolleys area for a possible container washer disinfector area for manoeuvring an washer disinfector for repair When using separate areas clean and contaminated passing of empty transport containers from contaminated to clean should be taken into account where plastic sleeves in the container liners are used and or pass through container washer disinfectors Sufficient surface area for spatial separation of clean and contaminated goods Take into account the future developments in technique data processing necessary equipment and possible extension of services Back flow of water from the washer disinfector to the water distribution system should not be possible The required water quality depends on the type of disinfector and the cleaning agent and disinfectant Take the area for any water filters into account Comply with the NEN 1010 class 0 technical quality requirements ref 14 The building commission recommends in the building construction standard Consultation department outpatient treatment and general organ function studies a cleaning and disinfection area of 9m per two endoscopy rooms Version 2 1 2011 19 4AOQDEdNOSAY INSANSASVNVA 4AOQDEGNOSAY Air conditioning Extraction Disposal of disinfectants Wall and floor coverings Doors and windows Lighting Receiving area for contaminated endosc
25. of endoscopes cleaning and disinfection equipment and process chemicals in the context of EN ISO 15883 for the organization with the suppliers 12 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 2 2 Centrally located versus local disinfections units For a proper cleaning and disinfection of flexible endoscopes one should provide appropriate facilities and equipment and one should ensure that the staff is competent in the field of cleaning and disinfection of endoscopes The extend and design of the cleaning and disinfecting area should include physical separation between the clean and contaminated area Considering the above a central cleaning and disinfection area is preferred over a local facilities SCENARIO 1 Central endoscopy units and cleaning disinfection Endoscopy units of various specialties adjacent to or near the cleaning and disinfection unit Advantages Disadvantages Spatial facilities and the expertise are Difficult to realize in existing buildings better used as the activities carried out by a smaller group Personnel and equipment are available Depending on the location in the hospital more efficiently Stock material can be more costs for transportation and logistics reduced problems More uniformity The quality assurance is more manageable so less risks for the patient N B There must be consultation between the various user
26. of tubes containers etc contamination of the post disinfection rinse water bio film in pipes containers etc washer disinfector used incorrectly e g wrong programs technical failure detected during the validation or maintenance Design limitations and or damages to the endoscope lumens too small and or not accessible channels not accessible for brushes damage to endoscopes with possible accumulation of organic material Insufficient execution of the cleaning and disinfection process omissions in the process by lack of expertise of staff incomplete process due to too high turnover rate workload Version 2 1 2011 45 ALAIOOS Ad NOILVIOSdddV ALAIOOS Ad NOILVIOSdddV 8 3 Phases in the incident procedure The following flowchart describes the different steps that are taken It is possible that different steps are started and executed in parallel 1 notification identification incident 2 INVENTORY and ANALYSIS Expert Endoscope Disinfection assesses the risk of process based on information RISK INVENTORY Is there has there been an increased risk of contamination of a patient and or staff member 3a 3b 11 RISK PROCESS RISK NO RISK no risk patient staff patient staff end of process report 4b 4c individual incidental risk group structural risk Estimation risk patient staff is performed by medical microbiologist 5 11 notifying Board of Directors BoD end of process report Team memb
27. only to guarantee the validity of the CE marking and the related product liability of the manufacturer In case the manufacturer indicates that a temporary modification is necessary to perform certain measurements he must provide a procedure for this The results of measurements tests and inspections are documented If corrections are made in sensors and measurement systems the condition before the correction is also reported E g if a temperature sensor shows a value that is too low the sensor should be adjusted so that it shows the correct value again Any deviation should be recorded in the report as well The DSRD should verify whether this deviation adversely affected the effectiveness of the process and whether the patient safety has been at stake due to this deviation In severe cases a look back of the patients should be considered 10 8 Other controls washer disinfector Verification of the efficacy of the disinfection process If in doubt about the effectiveness of the disinfection process it must be verified whether the disinfectant prescribed by the manufacturer is used Also the process parameters that can influence the effectiveness of the disinfection process should be verified Additionally the concentration of the active ingredient in the disinfectant can be determined Perhaps the concentration of the active ingredient in the disinfectant is not consistent with the concentration indicated on label 10 9 Release washer
28. otherwise protected against damage due to movement Clearly indicate on the container that the endoscope is used and potentially contaminated For example the lack of seals on the container characterises the endoscope as contaminated Transport the container to the decontamination room Directly present the container for the manual pre cleaning and machine disinfection STEP 5 Preparations before cleaning and disinfecting of the endoscope Requisites For personal protection apron not water permeable gloves mouth nose mask safety goggles or splash shield For the cleaning process e A suitable detergent for manual pre cleaning compatible with the detergent and disinfectant that are used in the washer disinfector Exposure time concentration and temperature are applied according to the instructions of the manufacturer e Gauzes or fibre cloths Various channel brushes compatible to the diameter work channel preferably single use e Tools to rinse blow channels such as e Air water pistol e Luer lock syringes e Tube water jet channel depending on type and brand of scope e Tube elevation channel depending on type and brand scoop e Leak tester e Transport containers clearly labelled contaminated or clean e Detergents and disinfectants for transportation containers or a container washer disinfector Execution Fill up the clean sink with detergent concentrat
29. per test at least 100 ml of water in a sterile container If the water for the post disinfection rinse is disinfected by adding a small amount of disinfectant in the washer disinfector a neutralizing agent must immediately be added to the sample The manufacturer of the washer disinfector can identify the appropriate neutralizing agents 3 NEN EN ISO15883 4 2008 8 Information to be supplied by the manufacturer 76 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author The microbiological investigation takes place as follows Filter the rinse water over a 0 22 0 45 um membrane and subsequently lay the membrane on an R2A agar plate Warning the technique of spread plating of the water sample is not suited for the detection of very small numbers of bacteria Incubate at 28 32 C for at least 5 days Assess growth and possibly determine germ counts Growth should consist of less than 10 cfu 100 mL see Appendix 9 In case of growth gt 10 cfu 100 mL carry out determination lf the washer disinfector is used for cleaning and disinfection of bronchoscopes the test if indicated should be repeated on Mycobacteria and or Legionellae in the event of growth This requires specific culture media and incubation times The water should be free of these microorganisms Standard See Willes acceptance criteria section 10 7 2 See Appendix 9 flow chart post
30. report suspected abnormalities and or failure of prevailing procedures to the manager of the department is responsible to use only well functioning and decontaminated equipment If in doubt about the status both cleaning and technical maintenance the equipment shall not be used is responsible for reporting any malfunction of the equipment and or flexible endoscope to the manager of the department Medical microbiologist is responsible for proper processing of microbiological cultures of rinse water and the endoscope is responsible for interpreting results of microbiological tests is responsible for risk assessment of blood borne diseases caused by incidents Disinfection and or Endoscopy assistant is responsible for performing the applicable cleaning and disinfection procedures of flexible endoscopes the use of washer disinfectors drying cabinet and peripheral equipment is responsible for completing the logbook and checklists regarding the use of flexible endoscopes and peripheral equipment is aware of the procedure in case of deviations and or failure of prevailing procedures is responsible for the registration of patients endoscope and washer disinfector information patient tracking system is responsible for updating his her own knowledge and training Manager department Medical Technology Clinical Physics is responsible for ensuring the quality and safety of medical equipment is responsible for the e
31. system that enables control of the rae dosage of detergent and disinfectant The washer disinfector is equipped with connections which prevent change of detergent and disinfectant Pf a a a Version 2 1 2011 101 answ er the questions by entering yes no or partly in the appropriate column The water softener is frequently regenerated Pf 3 1 al coarse filter of the drying unit is replaced every xxx operating Pf frequency Hours 3 2 hours 33 Te fine filter sterile filter is replaced every xxx operating hours oo frequency Hours The washer disinfector features pressure monitoring of the 3 4 channels by which obstructions are detected bee UV unit is maintained according to the Maintenance Manual Le frequency Hours The filters in the wash room are cleaned frequently Loe SEE 37 Te filters in the water supply are frequently monitored a frequency The nozzles on the spray arm are frequently checked for patency ls The sealing rings of the leak detector are frequently checked and 3 9 replaced if necessary i ar The nozzles and tubes of the inset trolley are examined and 10 cleaned frequently 4 4 the drying cabinets have preset minimum drying time M drying time The suction channel of the drying cabinet is drained to the 4 5 outside An up to date technical logbook is present for each drying 4 6 cabinet Maintenance of the ultrasonic bath takes regularly place pt be ee up to date techn
32. tests and inspections Demonstrably competent and specially trained individuals who are familiar with the design construction use and maintenance of washer disinfector are responsible for performing measurements tests and checks The starting points for validation are always specified by the manufacturer Companies that carry out measurements tests and checks should operate under a quality assurance system e g ISO 9000 To ensure integrity of the technician all activities should be performed and reported in accordance with written procedures The DSRD monitors the execution and reporting of the activities Measurements tests and checks requiring a modification of the washer e g for placement of measurement sensors in liquid pipelines or modifications to the washer disinfector programming should be avoided If a modification is required to perform a measurement test or check this can only be carried out following a protocol provided by the manufacturer User The user should use the washer disinfector according to the instructions of the manufacturer as outlined in the work instruction and for the purpose for which the washer disinfector is designed The user should be qualified to perform the function and must be instructed in the use of the washer disinfector It involves an instruction from the manufacturer supplier that also focuses on the technical operation of the washer disinfector with emphasis on the limitations of the washer
33. the availability of the washer disinfectors Moreover it is generally not useful to perform the measurements tests and inspections that are carried out during maintenance again by another party The expert is responsible for making agreements with the relevant parties about the work that is carried out Obvious parties here are the supplier the medical technology department the advisor infection prevention validation companies etc 10 5 1 Normative references The functional requirements and test methods for washer disinfectors are described in the following international standards ref 10 NEN EN ISO 15883 1 2006 Washer disinfectors Part 1 General requirements terms and definitions and tests NEN EN ISO 15883 4 2008 Washer disinfectors Part 4 Requirements and tests for washer disinfectors employing chemical disinfection for thermolabile endoscopes NPR CEN ISO TS 15883 5 2005 Washer disinfectors Part 5 Test soils and methods for demonstrating cleaning efficacy Wherever this document refers to the standard the interaction of the standards referred to above is meant 10 5 2 Requirements and responsibilities In this part the actors which are relevant in washer disinfectors validation are mentioned These actors have certain responsibilities and must meet certain requirements 54 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Contact
34. the channels of the endoscope with dry HEPA filtered air Therefore endoscopes without channels do not require a drying cabinet 10 10 2 Documentation A digital logbook has to be created directly at purchase of a drying storage cabinet This logbook should contain the following information and documents date of placement on site product specification according to the Schedule of Requirements process specification according to manufacturer s specifications safety features type test declaration wiring diagrams of piping automation etc technical manual declaration of conformity for endoscopes that can be dried in the cabinet maintenance protocol connection instructions for each type of endoscope user manual 62 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author cleaning protocol loading protocol connection protocol discharge protocol In addition the following environmental factors should be recorded spatial conditions o temperature humidity and ventilation electrical specifications o power and voltage compressed air specifications o Capacity static and dynamic pressures o quality particles moisture absence of oil 10 10 3 Validation points drying storage cabinet s all documentation present in the logbook Has it been determined who releases periodical maintains and repairs the drying storage cabinet after purchase
35. the washer disinfector should be recorded Each washer disinfector has its own logbook The logbook should be stored close to the washer disinfector or it consists of an electronic file that can be seen and complemented by the DSRD and the user near the workspace The following information should be recorded name location and address of the owner contact person serial and model number brand and type version of the washer disinfector year of manufacture of the washer disinfector The following aspects are recorded in the logbook date of replacement of chemical containers and lot numbers overview of measurements tests and inspections with the name of the technician and the results with reference to protocols and possibly other documents overview of daily weekly quarterly and annual inspections with the name of the inspector s overview of the cleaning activities on the machine with the name of the person performing the activities overview of maintenance with the name of the maintenance technician service technician and the details of the release tests overview of failures and repairs with the name of the maintenance technician service technician and the details of the release tests overview of maintenance of water treatment equipment with the name of the maintenance technician service technician and the details of the release tests details of the replacement of water filters pre filter
36. 08 40 327 332 43 Decree sterilised medical accessories in hospitals Article 7 paragraph 3 1983 44 Decree sterilisation companies medical accessories Article 6 paragraph 3 1989 67 Appendix 2 Form for conveyance of a damaged or leaking endoscope Checklist for user The exterior of the endoscope is wiped off with alcohol The channels are dried Note If an endoscope is send in wet this can lead to major damage to the endoscope Label indicating disinfected yes no attached to the endoscope Failure reported to department of Medical Technology Clinical Physics To be completed by the user Inventory code of the endoscope PF Description of the problem The endoscope is by the user wiped off with alcohol manually cleaned mechanically disinfected Inventory code of the washer disinfector Checklist for the technician e Handle the endoscope while wearing gloves possibly use safety goggles and a mouth mask e Wrap the endoscope in foil and take it to the transportation case e Indicate the state of manual of manual pre cleaning and or disinfection on the case and inside the case 68 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 3 Decontamination form Place Date is DECONTAMINATED Note It is not allowed to clinically use instrumentation that is used for animals or for obduction
37. 1 6 2 Version 2 1 2011 103 Appendix 19 Response form for contributions for improvement of the handbook Remarks Standard Quality Handbook Flexible Endoscopes Cleaning and Disinfection version Paragraph Request or suggestion for alteration Line modification Date Contributor Institution E mail You can send your response to the secretary of the SFERD J vbergenhenegouw hagaziekenhuis nl 104 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author www infectiepreventieopleidingen nl gt Stichting Trainingen Infectie Preventie
38. Bacillus species Atypical Mycobacteria Legionella Specific cultivation method Version 2 1 2011 POSSIBLE CAUSES no adequate cleaning and or disinfection procedure especially manual cleaning mechanical or electronic malfunction of the disinfection machine or defective endoscope insufficient final rinse contamination of the rinse water contamination of disinfection machine due to mechanical or electronic malfunction contamination of the filters defective endoscope insufficient drying of the endoscope during storage defective endoscope recontamination of the endoscope due to e inadequate storage and transport e inadequate hand hygiene contamination of material due to incorrect sampling technique or errors in development of the cultures inefficient drying process contamination of disinfection machine contamination of water supply system ACTION check the entire process cycle with special focus on the manual cleaning culture the positive endoscope again perform a complete maintenance of the machine perform a microbiological control of the post disinfection rinse water culture the positive endoscope again Check the water supply and the procedures manual and or machine rinsing perform a complete maintenance of the machine and filters culture positive endoscope again culture the rinse water check the function of the drying cabinet culture the positive endoscope again check the
39. COMPOSED BY ee a Professional Standard miclave eleye 4 FLEXIBLE ENDOSCOPES Cleaning and Disinfection PROFESSIONAL STANDARD HANDBOOK FLEXIBELE ENDOSCOPES Cleaning and Disinfection Published in commission of CSC SEVA VDSMH VHIG NVKF VZI WIBAZ by the Advisory Board Cleaning and Disinfection Flexible Endoscopes SFERD version 2 1 2011 This document has a legitimacy of 3 years The SFERD invites you to send your reactions to this document by means of the response form appendix 19 Please send this to the secretary of SFERD J C van Bergen Henegouw j vbergenhenegouw hagaziekenhuis nl This document may be reproduced and distributed freely provided the SFERD is listed as the author In April 2011 the Professional Standard Handbook 2010 version 2 0 was awarded the VHIG Infection Prevention Price the accompanying sum of money was spent on the translation of the handbook in English This resulted in the Professional Standard Handbook 2 1 English version Vereniging van il Deskundigen Oy ea Steriele Medische f D i Hulpmiddelen A uc vawibaz hb FE GSC Do PREFACE version 2 1 September 2011 In 1993 the Health Care Inspectorate IGZ pointed to the risks of using inadequately cleaned and disinfected flexible endoscopes ref 1 2 Gradually the development from manual to machine disinfection was put into practice From the occupational health and safety regulations
40. CSA employees department inpatient or outpatient examination Requirement Demand T legal requirement ee Medical Directive The endoscope has a CE label according to Medical Device Directive 93 42 EC NEN 10601 The endoscope meets the electricity safety standard NEN 10601 R AR ee S The endoscope can be cleaned and disinfected automatically in all washer disinfectors present in the hopitals compatibility detergents and disinfectants All parts are resistant to the chemicals to be used 3 The endoscope should be designed in such a way that it can be properly cleaned both manually and automatically and disinfected 4 The endoscope can communicate with the at time of purchase present and future data management systems Explanation Technical aspects N N The manuals provides a list of compatible devices and accessories for research and cleaning disinfection The endoscope is resistant to drugs bodily fluids and agents used cabinets Specifications for maximum pressure and pressure differences in the channels is indicated 3 Cleaning disinfection and sterilisation S 3 1 The temperatures for cleaning disinfection and sterilisation are indicated in the product information of the endoscope N Sa lt lt lt N N N The product information shows to which detergent disinfectant and sterilisation agent the endoscope is resistant The endoscope is steam sterilisable 121gr The en
41. EN EN ISO 15883 Disinfecting wasing machines 11 Workgroup Infection Prevention directive Storage and transportation of used instruments for sterilisation Leiden December 2007 www wip nl 12 Construction standards central sterilisation department Board for Healthcare Institutions November 18 2002 13 Construction atandards consultation department outpatient therapy and general examination organfunction Board for Healthcare Institutions 2004 14 NEN 1010 Safety requirements for low voltage installations 15 NEN EN 7396 1 Medical gas pipeline systems Part 1 Pipeline systems for medical gases under pressure and vacuum 16 Safety program prevent damage work safely in Dutch hospitals Health Welfare and Sport VWS June 2007 17 ESGE ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer disinfectors Endoscopy 2007 39 85 94 18 ESGE ESGENA guideline for quality assurance in reprocessing Microbiological surveillance testing in endoscopy Endoscopy 2007 39 175 181 19 Standards for Endoscopic Facilities and Services 3th Edition 2006 Gastroenterological Society of Australia Gastroenterological Nurses Society of Australia 20 ESGE Guideline for Quality Control of Endoscope Service and Repair 2004 Endoscopy 2004 36 10 921 3 21 ESGE ESGENA Technical Note on Cleaning and Disinfection 2003 Endoscopy 2003 35 869 877 22
42. INSANSSDVNVIA 9Sd00dd Risk regarding chemical safety Activity Risk Risk restrictive measure Discharge of chemical Improperly disposing Clear working instructions waste and leaking of chemical special containers and waste disposal procedure Changing detergent and Unintentional spillage Clear working instructions disinfectant in washer and leakage of proper storage of detergent disinfector detergents and and disinfectant special disinfectants containers and disposal improperly disposing procedures Ventilation of the area in Unintentional leakage Proper ventilation use and which the washer of hazardous vapours maintenance of suitable filters disinfectors are set up Risk regarding microbiological safety Activity Risk Risk restrictive measure Transport Contamination Clear working instructions contaminated employees cross closed transportation endoscopes contamination other containers sufficient working materials space good logistical organisation Discharge Contamination vaccinations according to contaminated material employees cross hospital policy clear working contamination other instructions proper use of materials waste containers good logistical organisation including separation of clean and contaminated materials 5 6 Traceability of endoscopes and patients The IGZ prescribes the hospitals to use a system which contains traceability information about which endoscopes is used for which pa
43. Manual pre cleaning of the endoscope Make sure that the channels are filled with detergent before brushing Brush the biopsy suction channel in three directions From the suction valve distally From the biopsy valve distally From suction valve to the connector There are endoscopes in which there are other additional channels that need to be brushed Suck water or detergent through all channels Rinse the jet channel with water or detergent solution Where applicable rinse the CO channel with water or detergent solution Where applicable rinse the elevator channel using a 2ml syringe filled with water or detergent solution O O OO 1 Action depends on the type of leak tester 28 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Wipe the exterior off with a gauze Brush the control knobs of the operating system and the distal end Brush the valves see section 5 2 Remove the endoscope from the sink Place the endoscope on a fibre mat STEP 9 Automated cleaning en disinfection in the washer disinfector OO OO O Open the washer disinfector preferably with a foot or knee switch Position the endoscope into the washer disinfector while wearing gloves Connect the leak tester of the washer disinfector Connect the channel irrigation tubes to the channels of the endoscope according to the instructions of the manufact
44. Note the observation Apply 50ul water on a swab and polish the surface of the object tightly Check the cleanliness of the swab to see if the object came off Note the observation Additionally apply 50ul ninhydrin solution on the swab and incubate the swab during 3 5 minutes Check the swab on a purple coloration to see if the protein from the object stained Note the observation See Tijdschrift voor Hygi ne en Infectiepreventie nr 1 February 2003 p 9 14 82 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 12 Hemoglobin swab test By making use of the pseudo peroxidase activity of hemoglobin traces of blood residues can be detected Even a small amount of 0 1 mg dried and denatured blood gives a colour reaction that is clearly visible The peroxidase activity of hemoglobin works as a Catalyst in the presence of hydrogen peroxide in the oxidation of chromogen which is shown by a clearly visible colour reaction Blood residues become visible within a few seconds as an intense blue colour reaction The peroxidase reaction in blood even gives a positive result after the action of heat alkali and aldehydes Oxidising process chemicals such as hydrogen peroxide can negatively affect the test This method is therefore not suitable to detect blood traces on instruments that have been treated with such chemicals Materials TMB test comprisi
45. P 8 Wipe off the exterior of the endoscope Registration of y patient yes STEP 9 Place in disinfector and enter registration information lt q doctor Ad endoscope ID y STEP 9 Add utrasonically treated spare parts to basket y no B STEP 9 Start automated leak testing cleaning and disinfection Repair by MT Leakage of FN possible SUBP y Emeeecope to WT tyes endoscope Boa no STEP 10 Check tubing and such after process lt lt no yes v STEP 10 Remove endoscope yes 4 hours limit exceeded without drying Solvable by employee STEP 10 Release yes y lt 4 hours reuse mark as disinfected y STEP 11 Dry endoscope in drying cabinet Figure 3 Primary process cleaning and disinfection flexible endoscope Version 2 1 2011 25 INSANSSDVNVIA 9Sd00dd STEP 1 Preparation of the endoscope before use All handling of a disinfected endoscope should be carried out with disinfected hands possibly with gloves Remove the endoscope from the drying cabinet or washer disinfector in case the endoscope is used within 4 hours NOTE Release o Incase of an endoscope from the washer disinfector it should be indicated on the washer disinfector that the endoscope completed the disinfection process without faults o When using an endoscope from the drying cabinet the expiry date should not be passed Place appropriate valves and ca
46. These instruments may no longer be offered for human use again Name supplier Name institution Signed for this supplier Signed for Department of cleaning and disinfection 1 Describe method of decontamination Version 2 1 2011 69 Appendix 4 Routine application of daily maintenance of the washer disinfector ho O sj Q Gam an xe _ K gt ho c O S O G 4 Q gt _ ho ind N z ho O LL Washer disinfector nr ccesceeescneceuss soulyoew Yysijod uleip ues ASS M Buluayos Ap29M ainjeubis xz JUB JDSJUISIP 2ejd y ainjeubis xz u 19 p soejday s jpuey jaued Hunesodo uea S Ajreq s qn yI8Y4D Aed s ul O 429349 Aireq JUB D9JUISIP pue JUSH19 0p yOOUD UO NI9JUISIP 9S 70 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 5 Release form for flexible endoscopy after maintenance Release Washer disinfector specification ccc cece eee eeeeeeeeeee ees Technical validation correct dated 0000e 0 ee eee Microbiological validation correct dated 0000 DY voc eee cece eae Release Flexible Endoscope specification ccsecirecrteseire eoxeaacwwiarann Gnradeane Technical validation correct dated 00005 DV sernass
47. VISION AND ORGANISATION 1 1 Introduction Flexible endoscopes are used for diagnostic and therapeutic applications Because the same endoscopes are used in different patients it is of importance that cleaning disinfection and or sterilisation occur in an adequate manner Inadequate cleaning and disinfection has negative consequences such as Transfer of micro organisms between patients Endoscopy related transfer of gram negative bacteria mycobacteria as well as fungi have frequently been described in literature Transfer of hepatitis B C and HIV cannot be excluded ref 31 35 Wrong diagnosis Next to the risk of infection for patients there is the danger of wrong diagnosis resulting in the unnecessary use of antibiotic therapy In case of inadequately cleaned and disinfected endoscopes tissue of patients can stay behind This material can lead to a wrong diagnosis during diagnostic examination of the subsequent patient Besides a wrong diagnosis regarding for example mycobacteria this could concern malignant cells ref 7 9 36 38 In several Dutch hospitals incidents with flexible endoscopes have occurred during the past years As a result hundreds of patients were recalled to test for HBV HCV and HIV The Health Care Inspectorate IGZ has pointed to the responsibilities of the hospitals repeatedly The goal of the Advisory Board Cleaning and Disinfection Flexible Endoscopes SFERD is the development of this Professio
48. a Microbiological validation correct dated n n D n Release Drying Cabinet specification Technical validation correct dated DY eeeeeeeee Abovementioned instrument is hereby released for responsible use up to one year after date The release is no longer valid if the instrument equipment is repaired subjected to radical maintenance is in this year Date release ccc ccc ccecceeees Signature Expert on Endoscope Cleaning amp Disinfection DSRD This release statement is filed by the DSRD and a copy of this statement will be sent to the head Medical Technology Clinical Physics and the head of the endoscopy department Version 2 1 2011 71 Appendix 6 System specifications of the washer disinfector Parameter Specified Measured Correct values and values AA l Pre rinsing gt a oe E e T E S E S The amount of water thatis taken o ooo o o The quality ofthe water that is taken see Wf The temperature of the incomingwater o The time the machine needs for the water to heat up a to the rinse temperature The temperature of the water during the rinsing phase The time of the actual rinsing phase which is the time ee after the rinse temperature is reached leila A a or The flow generated by the pump s at a given pf pressure Rotation speed wash arms i ae ll Cleaning ooo es ee The amount of water that is taken ee The Fre quay ol the water rats
49. aken after self disinfection and tested for the presence of bacteria For this the procedure used in Appendix 7 can be used Note Often a thermal self disinfection is carried out Perhaps the post disinfection rinse water is of high temperature or was of high temperature shortly before sampling Therefore it is likely that thermally disinfected water will not be contaminated A chemical self disinfection is performed with an higher concentration of chemicals in some systems which may increase the concentration of residues in the rinse water If the sample still contains disinfectant a potential risk of contamination might not be discovered To identify a contaminated washer disinfector or water inlet system it is necessary to run a normal process after performing a self disinfection procedure and then determine whether the post disinfection rinse water of this normal process is free of bacteria 10 7 3 Annual inspection of the washer disinfector All system specifications should be verified at least once a year see 10 6 1 Where necessary adjustments are made e g by adjusting the sensors The DSRD checks whether the verification of the system parameters is performed according to a protocol dedicated for the washer disinfector Before verification starts the washer disinfector logbook is reviewed to determine whether there are details that should be taken into account during the verification Verification of all system specifications can
50. al cans Microbiological quality of post disinfection rinse water Test of channel monitoring using dummy scope Test of channel connection monitoring Verification of system specifications of disinfector Check the channel separators Check the connectors Verification of system specifications of drying cabinet Assessment of logbooks Assessment of traceability registration Audit execution primary process Audit of technology and maintenance Assessment of incident procedure Assessment of omission protocols Revision of protocols Evaluation of management plan To the discretion of the DSRD gt lt ANmeleigeatetye X KK KKK X XX X After process influencing changes or actions After maintenance X X xX X xX X X XALX X Based on the specifications the manufacturer declares that the washer disinfector meets the essential requirements of the Medical Device Directive 93 42 EC standards The specifications are the basis for all measurements tests and inspections Version 2 1 2011 53 LIGNV Ad NOILVAONNI GQNV LNAWSAOddWI LIGNVY Ad NOILVAONNI GNV LNAWSAOddWI The results of the measurements and the procedures followed are tested evaluated according to standards and operating procedures as outlined in this handbook and are recorded together with the underlying information test reports measurement data manufacturer s declarations etc in a report The SFERD is of opinion that for the safety of patients the e
51. and put on a fibre mat always with a still functional and connected leak tester pump Turn off the leak tester and pull the connection a little back from the device in order to vent the endoscope Wait for at least 1 minute until the pressure is decreased completely Disconnect the leak tester from the endoscope STEP 7 Handling of a damaged endoscope lf an endoscope does not function properly but there is no leak then this endoscope can be disinfected and dried normally Subsequently the malfunction is reported to the Medical Technology Clinical Physics An endoscope with leak cannot be disinfected and may contaminated with pathogenic microorganisms The endoscope should be treated as follows before presenting it for repair Clean the not yet disinfected endoscope on the exterior and wipe it off with 70 alcohol Dry the channels mechanically or manually If the endoscope is shipped wet this can cause major damage to the endoscope Provide the endoscope with a label marked contaminated The user fills in the conveyance form see example appendix 2 The technician handles the endoscope with gloves possibly with safety goggles and mouth nose mask The technician wraps the endoscope in film and carries it in a transport case On and in the case it should be clearly stated that the endoscope is contaminated After repair and before usage the endoscope should always be reprocessed STEP 8
52. annel separators are in order The SFERD suggests that the scopes connectors and channel separators are inspected annually Microbiological testing of flexible endoscopes as described in this section is not intended to verify proper operation of the washer disinfector It is therefore of no use to sample endoscopes periodically The SFERD decided to include the monitoring 2 Where applicable such as temperature relative humidity flow through channels flow through cabinet HEPA filter condition Version 2 1 2011 63 LIGNV Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOdd WI techniques in the handbook because situations can occur in which it is useful to check whether the source of infection can be the endoscopes Endoscopes are only microbiologically controlled following a specific defect of the scope washer disinfector water treatment or drying cabinet and a suspected incident of endoscopy related infections The procedures described are general i e for each type of endoscope it should be determined which channels and other risks items should be checked 10 11 1 Annual inspections of the endoscopes and accessories The endoscope should be inspected annually This can be performed by the instrumentation technician of the institute supplier of the endoscopes or by a specialized maintenance company The inspections should be performed on the following hygiene related issues faults and defects that a
53. area as the area where pre cleaning of endoscopes takes place the maximum storage time is reduced to a month Remarks e Incase the drying process of the endoscope is not completed it needs to be presented for disinfection again if not applied within 4 hours e Incase of a not properly functioning drying cabinet or in case it reports errors the Medical Technology Clinical Physics should be called for help and the not adequately dried endoscope should be handled with a maximum expiration time of 4 hours e The drying cabinet should be validated as is stated in chapter validation e tis recommended to include the drying process in the process time registration STEP 12 Reprocessing after office hours Directly after use the first pre cleaning takes place at the endoscopy room as is described in STEP 3 This is followed by the pre cleaning as described in STEP 8 As soon as possible the pre cleaning is followed by machine cleaning and disinfection Suggestion If qualified personnel are present the endoscope can be disinfected automatically The endoscope remains in the washer disinfector until the next workday The endoscope must be disinfected again before being taken out of the de washer disinfector the next day ATTENTION this is not possible in case of a pre setting of thermal disinfection with the use of a time switch Further studies on time s between use and disinfection has not been conducted and i
54. arried out in accordance with the IGZ advice by the DSRD in collaboration with the Infection Control Department to assess rooms facilities equipment logs and test procedures at all endoscopy departments and the Medical Technology Clinical Physics This audit can be of general or thematic nature An example of a general audit is provided in appendix 17 and 18 The results and possible recommendation proposals are reported to the management concerned 10 2 Risk inventory and evaluation Next to the requirement of regular audits on the quality of performing general procedures that concern disinfection of endoscope the IGZ encourage periodic evaluation of the effectiveness of handling emergencies in combination with tracking and tracing This requires the DSRD to devise a possible incident and to investigate whether patients involved in the look back process can be traced The efficacy of the agreements on this within the institution should be evaluated for the available expertise of infection prevention instrumentation and management level The improvement points defined in this process must be documented as well as the performed STEPs and findings in the handling of the practice incident by means of a report This means devising an incident analysing the risk at instrumentational level procedural microbiological risk handling the deviation so that no further risks are present analysing the patients exposed to the risk bearing age
55. be performed by any qualified party supplier validation agent Medical Technology Clinical Physics but can be 60 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author combined with the maintenance for reasons of efficiency as many parameters should be checked during maintenance anyhow Clear agreements should be made with the party that performs the verification procedures on what verification will be done by what method and with what accuracy The DSRD finds another party for inspections not covered by the maintenance company The DSRD checks whether the party concerned is competent and has adjusted its procedures to the washer disinfector manufacturer WARNING It is strongly discouraged to make temporary modifications to the washer disinfector for the performance of the verification measurements or controls E g disconnecting tubes in the washer disinfector in order to place sensors disconnecting sensors to test warning systems or changing the process parameters There is a risk that the modifications are not properly restored after performing the measurements The machine will no longer function as intended by the manufacturer and the processes may not be performed effectively In this way the verification measurements and controls become a danger to the patient Adjustments in the technique of the washer disinfector are to be done by the supplier if it is
56. by e presence of an operational quality system to manage the process of cleaning and disinfection of endoscopes e presence of a structural process of quality assurance of which the formulated improvement points are executed e consideration of the following principles applicable laws and regulations on quality assurance of cleaning and disinfection of endoscopes such as the Quality Act of Healthcare Institutions ref 40 Health Care Professions Act ref 41 and the act on medical devices The Dutch Healthcare Inspectorate uses the guidelines of the Dutch Workingparty on Infection Preventionto assess the conditions of quality assurance of cleaning and disinfection of endoscopes Following and applying the developments shall take into consideration the state of the technology These should be considered to be directives for the continuous improvement process particularly where new buildings or renovations come up The staff having the necessary expertise should be given the opportunity to meet the previously mentioned requirements in the scope of good healthy working conditions a stimulating work climate with expert attention to the environment 50 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 10 IMPROVEMENT AND INNOVATION BY AUDIT amp CONTROL 10 1 Performing audits Next to the regular organisation audits NIAZ a yearly substantive audit should be c
57. ce in a closed transport system system aE Transport system is sealed in case of clean endoscopes At transportation of endoscopes it is clear whether the endoscope is clean or contaminated Transport system is cleaned and disinfected after transportatio of contaminated endoscopes 94 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column A logbook is kept for each disinfector whether automated or not in which the following items are recorded ee ee i a Fe an Number of the endoscope Pf Name code of loading employee Pf Name code of operating endoscopy specialist Pf ic Name code of unloading employee Pf When replacing detergent and disinfectant the following system information is recorded ia iil ft Pa Batch number detergent disinfectant Pf Machine Number Pf Signature of the employee who s has replaced the container Pf Signature control colleague Pf Version 2 1 2011 95 answ er the questions by entering yes no or partly in the appropriate column a nee ics practice endoscopy There is a separate routing between clean and contaminated ace ic Uc anda hai ia rings watches and or bracelets worn ei labialis every scopy the scopist washes or disinfects his her _ before touching other things 10 4 After every scopy the ass
58. connectors The WD manufacturer shall demonstrate this capability during type testing for all the types of endoscope that the WD is designed to process In addition to the information specified in ISO 15883 1 2006 Clause 8 the WD manufacturer shall provide the following information the devices and or device families for which the WD manufacturer has evidence that they can be processed satisfactorily and any precautions necessary for particular devices or operational conditions The WD manufacturer s instructions shall recommend that any requirements e g for manual cleaning and or disassembly of the endoscope prior to processing in the WD provided by the device manufacturer should be followed Version 2 1 2011 57 LIaNY Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOdd WI investigate whether the endoscope can be effectively cleaned and disinfected in the washer disinfector the right connectors for the new endoscope present the new preparatory activities described are included in the work instructions by the manufacturer 10 6 3 System specifications The values of process parameters should be specified for the endoscope washer disinfector so that it can be determined by measurements whether the machine still functions within the specifications of the manufacturer The values of process parameters should be specified by the manufacturer of the washer disinfector including the use of detergent and
59. d as contaminated transport Place protective cover subsequently after completion of the examination The WIP indicates a shelf life of a year if the endoscope is dried properly The SFERD believes that this ignores risks occuring during storage during the opening and closing of doors to move the endoscope in and out The SFERD recommends a period of one month also regard to the advice to clean and disinfect the drying cabinet every month In 1968 Spaulding developed a cleaning disinfection and steilisation scheme for medical devices base don the infection risk for patients Spaulding assumed three categories critical semi critical and non critical Critical means that a high risk of infection for the patient excists if the medical device is contaminated with microorganisms In this case sterilisation is required In semi critical risk the risk of infection for the patient is lower and disinfection of medical devices is sufficient For non critica risk cleaning is sufficient if cleaning fluid is used instead of water it should be transparent in order to assess the brightness of the output 26 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Make sure that the identification of patient physician and endoscope ID are provided STEP 4 Transport of an used endoscope Put the used endoscope back into the container on the fibre mat or
60. d disinfection of endoscopes WIP www wip nl a Occupational health safety 1 5 The drying cabinet meets the occupational health and safety law www arbo nl a Explanation iv o and environment 2 Validation yes ni The drying process is validated of which a validation report is available provide a copy There is an installation qualification program protocol provide programme protocol There is a qualification program protocol on the release of the process provide programme protocol i Gempalonalfealhiand Slew andenvrenment year 3 1 Supplier indicates the compressed air consumption specify consumption a a E er a ee 3 2 Supplier indicates energy consumption Specify consumption 3 3 The supplier manufacturer accepts the retum ofthe drying cabinet thatneeds O SSSSSSCSCSCSCSSCCOCC C S i ici sioen rove eene morang hegna nn FET safety standard provide specified working heights 3 5 The noise level is during the entire process _ lt 65dB A provide test report ee ae es 3 Requirements regarding Technique A e A J OCOC OC CS 4 1 The drying cabinet should be suitable for all types of flexible endoscopes used Technical aspects in the hospital provide declaration 4 2 Malfunctions or incomplete processes are reported with both a visual and an audible signal 43 The drying cabinet features a continuous channel connection check oo The drying cabinet
61. d kept up to date Maintenance All the activities specified by the manufacturer in the maintenance schedule and preventive replacements of parts to ensure the continuous safe operation of the washer disinfector Manufacturer The natural or legal person 1 with responsibility for the design manufacture package and labelling of a device before it is placed on the market under its own name regardless of whether these operations are carried out by that person himself or on his behalf by a third party or 2 who assembles packages precesses fully refurbishes and or labels one or more ready made products and or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name Owner Board of Directors Management of the health care facility its representative s and successor s who own the washer disinfector Repair All executed activities to resolve a malfunction in the washer disinfector 6 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Release functional A device is functionally released for use if the responsible person in this handbook the DSRD regards the device functionally able to function in a safe and effective manner on top of the technical release Release technical A device is technically released if the responsible department in this handbook called Medical Technology Clinica
62. department PR amp Information is responsible for the communication with the media 48 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author STEP 10 Evaluation and establishment of prevention strategy The course of the procedure is evaluated and reported to all involved parties Based on this evaluation possible improvements are formulated to prevent repeat of this incident in the future The improvements can be included in the endoscope management plan If necessary the procedures are changed STEP 11 Termination process report The DSRD reports on the procedure in a final report This report is send to at least BoD infection prevention committee members of the expert team and the IGZ if relevant 8 5 Image damage on the institution Every organisation delivers not only services to members of society but also takes part of it An organisation can show that it drew lessons from an incident and can therefore distance itself from the unfavourable situation before the incident After all the applicable examinations should be resumed in the interest of the healthcare according to the new quality standard This new standard is established after demonstrable implementation of for example customised or new equipment increased expertise among practitioners improved support in the organisation by the supplier of the involved accessories or changed procedu
63. disinfectant and the concentration and temperature in which these agents should be used All specifications must be provided in measurable quantities so that it can be verified by measurements The parameters of the various process stages are listed in Appendix 6 Depending on the age the brand and model washer disinfector additional process parameters can be relevant or not all of these process parameters are applicable For all process parameters the value and allowed tolerances should be specified If a process parameter is not applicable this should be substantiated 10 6 4 Changes made by the manufacturer supplier In response to a corrective action of the manufacturer changes to the washer disinfector can be made The DSRD should verify these changes in cooperation with the manufacturer in which the arguments of the manufacturer should be assessed by DSRD Recorded in the machine logbooks by the supplier The influence on the cleaning and or disinfection efficacy for each type of endoscope that can be treated in the washer disinfector Influences on the reproducibility of the processes Influences on the quality of the post disinfection rinse water Influences on the effecacy of self disinfection cycle The findings of these evaluations are documented by the DSRD Where the DSRD determines that the modifications are such that the effecacy and or reproducibility of the washer disinfector have been compromised he
64. disinfection rinse water culture See Appendix 10 positive cultures assessment list Check endoscope channel Sample collection supplies gloves sterile Luer syringes 25 ml depends on number of available channels possibly sterile aspirating needle bottle with 100 ml of sterile saline 20 ml per channel flush forceps elevator channel possibly in 2x10ml portions sterile tubes Number depends on available channels sterile containers Number depends on available channels Sterile brush or sponge To brush off bio film Sterile channel separator To make sure that the actually intended channel is sampled Laboratory form for bacteriological analysis 24 NEN EN ISO 15883 1 2006 6 4 2 4 Version 2 1 2011 Uf Sample collection Two people are needed for the aseptic removal of samples of a flexible endoscope Both persons disinfect their hands before culture collection Both persons wear gloves Disconnect the various connections of the endoscope after the disinfection See instructions of manufacturer Leave the endoscope in the washer disinfector tank if possible or place the endoscope on a sterile surface Place the channel separator Ensure that all available channels are sampled suction biopsy channel water air channel forceps elevator channel ERCP scope jet channel etc If necessary use a sterile tube to connect a syringe to a channel Rinse suction channel with 20 ml sterile saline solution while the biopsy i
65. doscope is steam sterilisable 134gr The endoscope is formaldehyde sterilisable a a 6 The endoscope is ethylene oxide sterilisable w we No ES 3 4 5 7 The endoscope is plasma sterilisable 4_Requiremenis regarding suppor education DE 4 1 There is an English instruction manual available 4 2 lThere is an English operational regulation available There is a protocol with respect to corrective preventive and insopective maintenance available for the technicians certificate issued There is a protocol with respect to corrective preventive and inspective maintenance available for the technicians A technical manual is delivered h d A w B The supplier has access to an English soeaking technical helpdesk The supplier provides a manual for the user A cleaning and disinfection directive is provided and education in this 4 4 4 5 6 7 8 M n EE is arranged on request 4 9 The supplier provides training on request a ee 5_Requirements regarding usabillly res fe 5 1 Assessment following trial placement Li 6 Requirements regarding traceability and registration PLY nc The endoscope contains an identifier that can be read by the registration software present in the hospital 7 Installation requirement A a A A present A o 8 1 The supplier proposes maintenance contracts a S 8 2 The supplier proposes a price list of most commonly available
66. e in such a way that only one type of detergent or disinfectant encloses the chemicals in a specifically shaped or coloured container This will prevent exchange of chemicals belonging to suppliers with a wide delivery range of the same containers Replace the container pay attention to the correct colour coding at the connection Explicitly read the labelling in your language A check should be performed by the second person when the containers are entirely connected unless the check runs automatically Register in the logbook date time name of the replaced agent name of the washer disinfector in case this does not run automatically it shall be signed by two individuals Remarks e Mix up of containers results in insufficient cleaning and disinfection of the endoscopes e Use of not compatible chemicals can lead to damage to endoscopes and washer disinfector e The detergent and disinfectant used for manual reprocessing of endoscopes should be standardised at organisational level e Do not transfer residuals into the new containers e The containers with residual disinfectant should be closed and processed according to the hospital regulations STEP 16 Self disinfecting of the washer disinfector Most of the washer disinfectors are equipped with a self disinfection program This program is performed to remove a possible bio film During the self disinfection internal parts of the machine will be reached that are not d
67. e is an appropriate working height according to occupational health and safety standard provide specified working heights There is an extraction system on the washer disinfector Specify size 3 11 The noise level is during the entire process _ lt 65dB A provide test report a 2 Requirements regarding Technique reso Technical t 4 1 The washer disinfector should be suitable for all types of flexible endoscopes used in the eo ee hospital provide declaration Malfunctions or incomplete processes are reported with both a visual and an audible Pf fp signal 4 3 During the entire process the endoscope is tested for leak tightness 4 4 The washer disinfector is equipped with an automatic test that identifies blockages during the process 4 5 The washer disinfector features a continuous channel connection check for each Feats chara lener maximum uma tomas at se momoe o 4 6 The washer disinfector gives a signal when preventive maintenance is required in a timely nama D a 4 7 nterchanging connecting the detergent and disinfectants not possible describe Irani e In case of a broken sensor there is a provision to prevent flooding Em There is leak tray for the detergent and disinfectant Specify the volume that can be Ppp received 86 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Al os Lt Q All parts are easily accessible for ma
68. ection quantity Method Culture medium Culture temperature Duration incubation Standard Quarterly at validation and after processes influencing repair 100cc 0 22 0 45 um filter Filter on RoA 28 32 C 5 days lt 10 cfu 100mlI See review list of possible causes for each pathogen Test on Mycobacteria environmental Mycobacteria Frequency Collection quantity Method Culture medium Culture temperature Duration incubation Standard Test on Legionella Frequency Collection quantity Method Culture medium Culture temperature Duration incubation Standard If indicated e g proven inadequate cleaning phase or report of increased number of patients with atypical mycobacteria Using conventional culture method from own laboratory No Mycobacteria The water supply network regularly cultures according to Legionella management Endoscopy management does not recommend additional cultures lt 100 cfu L Legionella The water treatment system should be maintained and disinfected according to the directives of the manufacturer In order to perform microbiological determinations check whether this has been done Perform a normal cycle particularly if the determination is performed after self disinfection of the disinfector Take a sample of the post disinfection rinse water of the process using aseptic technique Make use of the sampling protocol provided by the manufacturer of the disinfector Collect
69. ector regular maintenance and appropriate occupational attitude Clear working instructions protective clothing mask proper ventilation of the workspace and appropriate occupational attitude Gloves appropriate occupational attitude Noise level below 80 dB hearing protective measures Risk for endoscopes and washer disinfectors Activity Transportation of contaminated endoscopes Manual pre cleaning of contaminated endoscopes Loading and unloading of washer disinfector Storage clean endoscopes Risk Damages Damages leaks corrosion bio film Damages failures leaks of the endoscopes and washer disinfectors Damages Risk for the environment Risk restrictive measure Clear working instructions protective transportation containers Clear working instructions appropriate detergent materials mechanical cleaning thermal self disinfection Compatibility check clear working instructions appropriate detergent materials preventive maintenance Protective transportation containers proper drying cabinets proper storage cabinets INSANSSDVNVIA sSd00dd Environmental Risk Risk restrictive measure Activity Disposal of chemical Improperly disposing Clear working instructions waste and leaking of chemical special containers and waste disposal procedures Discharge to sewer Improperly discharging Clear working instructions chemical waste discharge permit Version 2 1 2011 39
70. ecurity regarding both the employees themselves and the patients This requires a description of the task to be performed within the organisation in a quality handbook of endoscopes When performing a task based on a quality handbook an employee can have the confidence to execute the necessary procedures in a proper and safe manner Procedures are derived from guidelines and established in protocols based on local conditions The protocols were established with support of the team and give direction to the daily operations This allows procedures to be standardised auditable and improvable The protocols should also address the care of a safe working environment In this context the statutory registration of dangerous substances is met and care is taken for working conditions with regard to for example activities that involve noise and climate To maintain the quality of working and labour conditions it is necessary that an organisation has access to the Medical Technology Clinical Physics a division Infection and DSRD Good equipment should be used that meets the state of the art This requires the willingness of a Board of Directors to invest in this Version 2 1 2011 43 Ad NOILVIOSdddV ALAIOOS Ad NOILVIOSdddV 8 APPRECIATION BY SOCIETY The appreciation by society is an important factor in the quality of care within the Dutch hospitals The development of performance indicators add to the improved transparency in healthcare Media a
71. eets regarding the agents According to hospital environmental plan enough space for separated waste Ceiling made of dust free and moisture resistant material and enough space above ceiling for technology 20 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author lt J gt mMm Interior design Requirements Standards gt U aspects gt O All equipment Should be provided with information visible to the user and G C technician e g a printed sticker with regard to the period in which m J the device may be used considering the maintenance status lt T Leak tester In such a vicinity of the sink that no contact between water and D electrical facilities is possible a Endoscope Sufficient space for the required number setup loading unloading disinfector and operation Consider pass trough equipment Utilities compressed air water electricity ventilation data sewer connection Drying and Spatially separated from contaminated work Consider hatches Storage cabinets Utilities medical grade air electricity data processing Sink and work bench Sink stainless steel with rounded edges equipped with water pistol Sizes according to length endoscope Work bench contaminated area sufficient for the activities taking an ultrasonic bath into account Smooth finish without seams with water barrage Rear wall of the work bench should be smooth and ea
72. eof oO SS S S Note The specifications of the manufacturer for of the ee water ee can differ for each process stage VII Self disinfection lt lt S E The amount of water that is taken a ee ee The quality of the water that is taken see VI ee The temperature of the incoming water If applicable the amount of disinfectant that is dosed e disinfectant solution to the disinfection temperature ble a disinfection phase gages ee TTT during the disinfection phase The duration of the actual disinfection phase gome A or The flow generated by the pump s at a given ae oressure Rotation speed wash arms o S o G o o VIII Moisture removal from the channels at the end arme proessa fT ila S A channels Intended air pressure aa Intended temperature of the air a Setting of the pressure relief to prevent damage to the gt endoscope Duration of purging rs rr E S E IX Leak detection test O p y Note The parameters for the leak detection test have no direct influence on the result of the cleaning and disinfection but the leak detection is an important PART of the process that can be simply involved in the validation Oooo T e y Intended pressure Intended pressure CC Setting of the pressure relief to prevent damage to the a ae endoscope a a aaa A S G pressure drop during the test 74 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is lis
73. equirements should be taken out of service in such a way that it actually cannot be used 10 10 Validation drying storage cabinets The validation of drying cabinets is derived from the N784 CEN TC102 NWIP STORAGE CABINETS heat sensitive endoscopes version January 2008 and focuses on the Dutch market This EU standard for drying cabinets is merely a first draft The final version is possibly some years away Hereby the SFERD tries to give direction to the validation procedure drying cabinets Because of the wide variety of drying cabinets existing cabinets will not in part or not at all meet these requirements When buying or replacing drying cabinets it is advisable to include the validation possibilities in the set of requirements 10 10 1 Difference between drying and storage cabinet A drying cabinet is a cabinet in which a disinfected flexible endoscope can be hung wet and where the channels of the endoscope can be connected to pass heated and or dried HEPA filtered air through the channels A drying cabinet dries the entire endoscope the channels and the exterior The drying cabinet can be connected to a tracking recording system by which it can be easily determined for how long each endoscope is placed in the cabinet A storage cabinet is an enclosed cabinet with overpressure at room temperature in which a dried flexible scope is stored The difference between a drying cabinet and a storage cabinet is that the drying cabinet dries
74. ergencies Materials which are ultrasoniccaly cleanden are generally sterilised Preferably the ultrasonic cleaning is carried out at the CSA or central disinfection unit or replacement with single use devices is persued Version 2 1 2011 21 INANSASVNVA 4AO0EdNOSAY 4 2 Acquisition of endoscopes washer disinfectors and accessories The purchase replacement of equipment flowchart figure 2 illustrates the cycle on the acquisition and or replacement of endoscopes water disinfectors and or drying cabinets The flowchart can be used as a guide to involve relevant disciplines within the hospital in the selection of equipment Where a similar type of washer disinfector is used in multiple departments within the institution the use of the same detergents and disinfecting agents for the various phases of manual and or mechanical cleaning and disinfection Standardization is preferred 4 3 Schedule of requirements endoscopes washer disinfectors and drying cabinet The requirements are an assessment tool in market research for purchase and are designed as a checklist divided into the following categories of requirements Statutory User convenience Validation Traceability and registration Health and environment Installation condition Techn olog ical Maintenance Process Support education Cleaning and disinfection These main categories consist of subcategories The supplier needs
75. ering yes no or partly in the appropriate column 2 1 The method for cleaning is established in the protocol EHR Date protocol Sa 2 The protocol is available near the sink and easy to look into for everyone 2 3 During manual cleaning non sterile gloves are worn manual cleaning non sterile gloves are worn K B E E e a solution of enzymatic cleaner in lukewarm water used product is used A ee of solution according to regulation Lae af used concentration ph solution is refreshed daily or in case of visual contamination LL 4 frequency er En immersion a leak test is carried out Li a 8 The scope is placed into the counter immediately after the maximum time examination eo he scoop is Ree a eee off onthe ext I a gauze r ee CO off on the exterior with a gauze or washcloth a S soaked in cleaning solution and then rinsed with water eT Ring caps and any other loose parts are brushed soaked in Pf cleaning solution and then rinsed with water 2 12 P bans ana oner spare pans are utreicay vestea answ er the questions by entering yes no or partly in the appropriate column The ultrasonic bath is filled with water and ultrasonic fluid and set brand ultrasonic at the right temperature of lt 40 degrees C used product pe e solution according to regulation El used concentration The ultrasonic fluid is refreshed at least daily En ee ie load regulation is present Em date regulation 3 5 This regulation is
76. ers Representative BoD Representatitve Communication Epert Endoscope Disinfection Medical microbiologist Manager involved departement Medical specialist involved dept Representative Medical Technology possibly occupational physician in case of risk in staff possibly representative supplier 6 BoD assigns expert team 7 deciding on the policy to be implemented 8a 8b 11 corrective measures determine recall population and strategy no recall patients end of process report 9a interventions 9b recall evaluation and establishment of prevention strategy end of process report Figure 4 Action plan incident procedure 10 11 46 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 8 4 Amplification on phases in the incident procedure STEP 1 Notification The DSRD receives a notification based on signals from staff medical specialist results of periodical controls maintenance validation culturing deviating process parameters of the automated cleaning and disinfection process findings of production registration by means of tracking amp tracing STEP 2 Inventory and analysis The DSRD identifies and analyses the notifications The table in section 8 2 examples incidents can be used as a guide In case the notification turns out to be merely a deviation from daily practice then thi
77. esseenseesceneeseensesees 15 3 1 Responsibility ANd competence cccseeeccececeeeeeeceeeeeeeceeeeeeeeeseeseeeessaaeeeessaeeeeeeesaes 15 3 2 Training and education ccccceccccceseeeeeececeseeecseueeeeeseaseceeseauceeessaeeesssaaeeeeeetenseeeeses 17 4 RESOURCE MANAGEMENT ssssssnnnnnnsnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn ennnen 19 4 1 Building and interior ats cxcceymecetceaneecnteatortaten anaes eve vactesieicetiananwagtedncinsntenenesueaessmaesin 19 4 2 Acquisition of endoscopes washer disinfectors and accessories 0eeeeeeeees 22 4 3 Schedule of requirements endoscopes washer disinfectors and drying cabinet 22 5 PROCESS MANAGEMENT ississssssesssvccsscscussrisnsnsssmesnsscecswcunaeivecussedvcrvetenaniess 24 5 1 Primary process cleaning disinfecting and drying flexible endoscopes 24 5 2 Cleaning disinfection and or sterilisation Of ACCESSOLICS cceecceessseeeeeeeeeeeeees 34 5 3 Disinfection Of TEE transducers ccccccccccesececeeseeceeeceeeeeeeeeaeeeeseeeeeseueeeseaeeeeesnees 36 5 4 Installation of a washer disinfector ccccceccceececeeecceceeeeeceeeeesseeeeeeeeeeessaeeeeseaeeeees 37 5 5 Risk inventory and evaluation cccccccceeeeeeeeceeeeeeeceeeeeeceeeeeeeeseeeeeeeseuseeeessaaaeeeees 38 5 6 Traceability of endoscopes and patients cccceeeccceeececeeeeeseeeeeeeeeeeeeeeesseeeeeees 40 6 APPRECIATION BY CUSTOMERG
78. features a continuous flow monitor for each connected DE channel 4 5 The drying cabinet gives a signal when preventive maintenance is required P Napa is good accessibility to all components relating to the maintenance and ff repair 4 7 A no break facility is present for data storage T 4 8 The drying cabinet is resistant to power failures speciy 0o SSS SOSS 4 9 The drying cabinet should be designed in such a way that the contact surface with the endoscope is minimal The drying cabinet contains a bacteria filter monitor o 4 11 The drying cabinet can communicate with existing data management systems at the time of purchase E E1 Te power camot be continued aterriemupion oie process ST A A i lt lt 6 1 The process parameters are addressed in the product information of the drying cabinet time temperature pressure The drying cabinet features continuous temperature monitoring o Drying time should be established in the programs The equipment operates with appropriate drying cycle in bacteria free compressed air to prevent contamination of the scope 6 5 There is overpressure in the cabinet 6 2 6 3 6 4 Version 2 1 2011 89 7 RequiementeregaramgaipponTeduaton OOOO p O y O 7 1 There is an English instuction mancal availabe i D 7 3 There is a protocol with respect to corrective preventive and inspective maintenance available for the technicians 7 4 The tec
79. fely working with chemical agents During this period the employee is coupled to a supervisor The supervisor will monitor progress by means of partial qualification lists After all aspects of introduction have been approved by the management of the department the employee is allowed to perform activities independently Maintaining employee skills Each employee should maintain their skills expertise in the field of cleaning and disinfection This is accomplished by frequent execution of processes and attending of internal and or external courses in case of developments in areas such as Version 2 1 2011 17 INSANWSSVNVA JodNOSJH NVANH INSANSASVNVA 4A0EdNOSsAY NVANH A relevant legislation cleaning methods and machines cleaning and disinfecting agents occupational health and safety environmental laws copy of the certificate of participation is added to the portfolio of the employee Abbreviated competency description vocational training certificate and or or the level of an independent employee independent professional masters the Dutch language spoken and written can read and interpret instructions knowledge regarding contents of protocols and regulations applied knowledge of insight into the activities and practices of other departments and knowledge of functioning of the flexible endoscopes that are used there affinity with hygiene technology and working with protocols applied knowledge of com
80. ficiently By applying risk management optimal patient safety is achieved This means that the risks arising from human or technical and or organisational imperfections in the process of health care provision are eliminated as much as possible The different steps of the primary process are described in the flowchart figure 3 The risks are presented in a risk table Section 5 5 and 8 2 This provides overview and clarity for all parties involved The administrative measures have been described for the most important risks This chapter describes the following process steps STEP 1 Preparation of the endoscope before use STEP 2 Transport of disinfected dry endoscope STEP 3 Pre cleaning in the endoscopy room by the operator STEP 4 Transport of an used endoscope STEP 5 Preparations before cleaning and disinfecting of the endoscope STEP 6 Leak testing of the endoscope STEP 7 Handling of a damaged endoscope STEP 8 Manual pre cleaning of the endoscope STEP 9 Automated cleaning and disinfection in the washer disinfector STEP 10 Release of the flexible endoscope after disinfection STEP 11 Drying the flexible endoscope STEP 12 Reprocessing after office hours STEP 13 Loan flexible endoscopes and accessories STEP 14 Deviations from the primary process of channel less endoscopes STEP 15 Replacing the detergent and disinfectant containers STEP 16 Self disinfection of the washer disinfector STEP 17 Maintenance of the washer disinfector
81. have to be disinfected according to the prescribed procedure lll Patient categories N A IV Users Employees department CSA employees department inpatient or outpatient examination Requirement Demand aa Explanation T Legal requirement a Medical Directive The washer disinfector has a CE label according to Medical Device Directive 93 42 EC a a O O o NEN standard 1 2 The washer disinfector meets the EN ISO 15883 1en EN ISO 15883 4 a a ed R8152 1 3 The washer disinfector meets the standard commission directive 1994 R8152 on sterilisation and sterility NEN 10601 1 4 The washer disinfector meets the electricity safety standard NEN 10601 E E NEN EN IEC 61010 2 040 2005 1 5 The washer disinfector meets the safety requirements for electronic equipment Part 2 040 Special requirements for sterilisers and washer disinfectors used to treat medical supplies NEN 1006 1 6 The connections of the washer disinfector meet the requirements of the water supply fag eee NEN 1006 Wip guidelines 1 7 The washer disinfector meets the directive Cleaning and disinfection of endoscopes WIP www wip nl Oecup arona Hee ely Le The washer disinfector meets the occupational health and safety law www arbo nl and environment OOO OOo o of The cleaning and disinfection processes are validated a validation report of this should be present bring along copy 2 2 There is an installation qualification program protocol provide prog
82. he development of this Professional Standard Handbook Cleaning and Disinfection Flexible Endoscopes in which existing regulation in the field of cleaning and disinfection of flexible endoscopes is translated into a practical standard The choice of the SFERD to publish a first version this Professional Standard Handbook as a dynamic document in 2009 turned out link up with the developments in the field which are dynamic as well Due to the publication of the first version contacts were tightened and strengthened This has led to a positive contribution of different scientific professional associations the IGZ the WIP the NEN workgroup Cleaning and Disinfection and mainly the technical professional associations in healthcare gt Dutch Society for Medical Physics NVKF gt Dutch Society of Clinical Engineers VZI gt Taskgroup Instrumentation Management University Hospitals WIBAZ They united in the Federation for Medical Technology and contributed as such as member of the SFERD to this second version of the Professional Standard Handbook This collaboration has in our opinion led to the clarification of the structure of the Professional Standard Handbook Furthermore this collaboration has yielded a profitable discussion in the field of validation which has resulted in a more distinct validation policy Next to the representatives of the involved associations a major contribution was given by the workgroup Validation 2 Profe
83. he endoscope can be released Mark the release on the release form flexible endoscope see appendix 13 or in an automated manner When not all conditions are met then the problem must be solved and the disinfection process be repeated When used within 4 hours after disinfection the transport containers should be provided with a label on with the expiration time is noted When the endoscope is not used within the prescribed time it must be presented for disinfection again Prior to transport the endoscope may be dried with compressed air both on the inside and outside Version 2 1 2011 29 INSANSSDVNVIA sSd00dd INSANSSDVNVIA 9Sd00dd STEP 11 Process of drying the flexible endoscope Ifthe endoscope is not directly used place in the drying cabinet Connect all channels of the endoscope according to the manual of the supplier The drying takes 30 120 minutes depending on the type of drying cabinet Place the valves and other removable parts in a wire basket in the drying cabinet Set the drying time according to the instructions from the supplier After completion of the drying process and verification of the process parameters and approval the endoscope can be released After completion of the drying procedure the endoscope and the valve and other Spare parts can be stored indefinitely in a drying cabinet or dust free storage cabinet according to the WIP If the drying and storage cabinets are in the same
84. he incident is caused by a malfunction of the equipment the supplier will be contacted to be involved in the determination of the further investigation and strategy STEP 8 Elaboration of decision making A Corrective measures Establish measures to ensure that no further risk and establish measures to prevent incidents in the future B Recall population and strategy determination based on collected data the period of risk and population at risk is established based on the risk assessment it is determined which investigations will be performed and when they will be performed based on decision making the strategy with respect to the communication to patients staff and media is determined C No recall If the expert team decides a recall not necessary the procedure is terminated here the notification estimation and the decision making should be reported STEP 9 Actions based on the policy A Interventions The established corrective measures are performed The head of the department is responsible for the execution B Recall The recall is performed as established The medical microbiologist is due to the risk estimation of blood borne diseases responsible for the recall process The involved medical specialist is responsible for the contacts with the patient s The occupational physician is responsible for the contacts with the employees if they have been at stake C Communication Board of Directors and or the
85. hnicians are trained for both corrective and preventative maintenance SE 75 A tecirical manoal Severed A 76 The supplier has access to an English speaking technical helpdesk ae ae SES E_ Requirements regarding wsabiliy es SSSSOSSSSSCC S 8 2 in case of an alarm or notification the drying cabinet gives a clear description of jf the problem identified and gives an instruction for the solution at user level 8 3 The un loading doors can be hygienically The un loading doors can be hygienically opened iad 4 ae drying cabinet provides logical support by means of on screen instructions during operation 9 Requirements regarding traceability and yes registration 9 1 The functionality for the registration of endoscope charge process data date and time patient specialist and operator is present 9 2 The data are registered each drying cycle centrally and decentralised and digitally saved among others drying cabinet pati nt scope specialist procedure 9 3 The drying cabinet can communicate with the management system OD T S TO maalaten requirements D S e a 10 1 Draws and measurements of the installation facilities drainage ventilation exhaust water are delivered T1 Requirements regarding maintenance a a 2 E 11 1 The supplier proposes maintenance contracts The supplier proposes maintenance contracts Oo Tan copay accepts the Standard Service ASSEN SSO of the FHI a E A E eae
86. i eased cabinet acordat 6 4 The method for replacing the barrels of detergent and disinfectant BHR E e 6 5 This protocol is in the vicinity of the machine and is easily rae oe a Replacing the barrels with detergent and disinfectant is in Li i Pp koeie A answ er the questions by entering yes no or partly in the appropriate column The method of drying the endoscope is described in a protocol EEM date protocol 7 2 The protocol is located in the vicinity of the drying cabinet and easily accessible for everyone 7 3 Endoscopes which are not used within 4 hours after disinfection are dried in the drying cabinet for at least 30 minutes set drying time 7 4 Endoscopes which are not used for a period gt 4 hours without EE o drying are disinfected before use again 7 5 There is a policy in writing on how long endoscopes may hang Pf ca in the drying cabinet applied storage life 7 6 The drying cabinet is cleaned domestically once a month Pf ethedlectcleanng is aelabeandsgned 7 7 Periodic maintenance and frequency of change of filters is EER date protocol The mode of transportation of contaminated and clean endoscopes is described in a protocol The protocol is available on the ward and easily accessible for The transportation of endoscopes is limited from disinfection area If no yes is entered at 8 3 following questions are addressed date protocol specify transport Transportation of endoscopes takes pla
87. ical logbook is present for the ultrasonic bath Loe frequency 102 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column The purchase of endoscopes occurs in accordance with a predetermined set of requirements established in collaboration with users Expert TD ID procurement etc Is a compatibility statement available for each endoscope including the washer disinfector and the detergent and disinfectant used Have agreements been made at purchase of the endoscope about who performs maintenance during the warranty jor a a _ o o w _ dates of regular preventive maintenance zx activities to be carried out during preventive maintenance E o1 ao NY o1 ao oo the validation protocol or checklist that is checked Sz oO iN 2 are endoscopes technically checked at the following moments 5 4 2 after repair external 5 4 3 after maintenance annually major is there a release procedure before commissioning of an 5 5 endoscope is an up to date technical logbook available for each endoscope a lt ao o D a J gt h answ er the questions by entering yes no or partly in the appropriate column and tracing external technical expert minimally 2 times a year How is a loan endoscope registered 6
88. ied Discard endoscope 79 Appendix 9 Flow chart for microbiology tests on the post disinfection rinse water Microbiological control naw f Filter sample Post disinfection rinse water of washer disinfector Determination laboratory according Culture Me to ISO 15883 gt 10 cfu 100 ml End procedure Assessment list positive cultures yes Protocol sample Perform self disinfection and collection collect new samples after replacing new water filters Determination e laboratory accordin no to o 15883 g gt 10 cfu 100 ml End procedure Assessment list positive cultures yes Take washer disinfector out of service and contact the manufacturer supplier no Discard washer disinfector efect or possible cause identified Perform self disinfection and lt collect new samples after replacing new water filters 80 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 10 Estimation sheet on microbiology in endoscopes and or washer disinfectors MICRO ORGANISMS Escherichia coli other Enterobacteriace ae Enterococcus Pseudomonas and other non fermenting Gram negative rods possible contaminants Staphylococcus aureus Coagulase neg Staphylococcus Micrococcus
89. inage ventilation exhaust water are delivered 10 2 Specific requirements for water quality are delivered rionance a The supplier proposes maintenance contracts including costs 11 2 The supplier proposes a price list of most commonly available parts The company accepts the Standard Service Agreement SSO of the FHI 11 4 All required components can be delivered within 24 hours The supplier provides passwords and codes for repair and maintenance of hardware and 11 5 software or mechanical components A technician of the supplier can be present within 24 hours A loan washer disinfector can be made available within 2 days For software and hardware problems the maximum downtime is 24 hours Software licenses should be valid for the lifetime cycle of the device 11 10 Software and hardware updates and features for software and hardware updates can be performed on behalf of modalities and control for at least 10 years Version 2 1 2011 11 Requirements regarding ma N ee A A ee ee ee eee wo wo wo wo wo 87 Appendix 15 Requirements for flexible endoscopes Aim of the flexible endoscopes For non invasive diagnostic and therapeutic examinations Il Interaction with washer disinfector drying cabinet and medical supplies All types of flexible endoscopes and accessories have to be disinfected according to the prescribed procedure lll Patient categories Diverse IV Users Employees department
90. infection aided by the input from experts CSA employees provide a safe construction for cleaning and disinfection of endoscopes As a result of outsourcing the care for endoscopes disinfection can be designed even completely outside the organisation In all organisational models protocols logging tracking and tracing should adequately be installed and periodically audited Organisational managers as well as professionals of scope disinfecting and or scope utilizing departments have the task to guarantee in the interest of the patient the quality of care at the operational level respectively the application level when using medical devices and to prevent inexpert use The Medical Technology Clinical Physics steers the life cycle of medical equipment In addition the department supports and provides recommendations on the quality and safety of medical devices from a technical point of view The department Hygiene and Infection Prevention contributes with expertise in the areas of cleaning disinfecting advising solicited or unsolicited on qualitatively legitimate patient care The DSRD monitors operational conditions and procedures for the use of endoscopes based on laws and guidelines Furthermore the DSRD detects improvement measures in patient care on behalf of the Executive Board or Board of Directors of the institution or his delegate As part of the purchasing procedure the DSRD verifies the required compatibility declarations
91. infection after bronchoscopy JAMA 1997 Oct 1 278 13 1111 34 Agerton T Valway S et al Transmission of a highly drug resistant strain strain W1 of Mycobacterium tuberculosis Community outbreak and nosocomial transmission via a contaminated Version 2 1 2011 bronchoscope JAMA 1997 Oct 1 278 13 1073 7 35 Chauffour X Deva AK et al Evaluation of disinfection and sterilization of reusable angioscopes with the duck hepatitis B model J Vasc Surg 1999 Aug 30 2 277 82 36 Cox R deBorja K et al A pseudo outbreak of Mycobacterium chelonae infections related to bronchoscopy Inf Control Hosp Epid 1997 Feb 18 2 136 7 37 Kressel AB Kidd F PSeudo outbreak of Mycobacterium chelonae and Methylobacterium mesophilicum caused by contamination of an automated endoscopy washer Inf Control Hosp Epid 2001 Jul 22 7 414 8 38 Silva CV Magalhaes VD et al Pseudo outbreak of Pseudomonas aeruginosa and Serratia marcescens related to bronchoscopes Inf Control Hosp Epid 2003 Mar 24 3 195 7 39 EN ISO 17664 2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices 40 Quality Act Healthcare Institutions 2010 41 Act on professions in individual healthcare 1993 42 A J Buss M H Been et al Endoscope disinfection and its pitfalls requirement for retrograde surveillance cultures Endoscopy 20
92. intenance and repair deliver installation guide pre installation guide 11 All parts are resistant to the chemicals to be used 12 Data storage there is a facility to prevent data loss Pt fo 13 The washer disinfector is resistant to power failures Specify Pf fo 14 There is a facility to prevent backflow of water from the water compartment to the water supply system 4 15 Can the following processes be interrupted independently by authorized personnel cleaning flushing disinfection discharge disinfectant flushing microbiologically safe water production microbiologically safe water AL ALAR ujuja A drying 4 16 What is the distance of the contact area between washer disinfector and the endoscope Pee S The machine features a drain for water control Pf fo 4 18 The machine features a bacteria filter monitor PO 4 19 The manufacturer establishes a filtration plan on behalf of the water supply and provides advice on the installation of the filters 4 20 The washer disinfector can communicate with existing data management systems at the time of purchase Please indicate to which systems it can be linked Requrermana regarding We process A 5 1 The washer disinfector operates according to the pass principle clean contaminated separated 5 2 lal The program cannot be continued after interruption of the process rhea 7S me endoscope is not released if the process
93. ion and temperature according to the recommendations of the manufacturer Put the fibre mat on the counter bench Remover the valves and distal caps The SFERD strongly recommends the use of single use brushes adjusted to the diameter of the chanel The brushes can be used for half a day for several endoscopes of the same type With this advice the SFERD aims an adequate pre cleaning which is better achieved by using good quality brushes instead of the sterility of used brushes Reusable brushes can be used half a day when disinfected but often show a quick reduction in quality due to the disinfection process Version 2 1 2011 27 INIWJ YNYIN SSJ9 Odd INSANSSDVNVIA 9Sd00dd STEP 6 Leak testing of the endoscope The endoscope is placed on a fibre mat with the controls facing up Turn on the leak tester Connect the leak tester to the connection at the light conductor plug on water cap of the endoscope check the pressure The cardan envelope slowly swells Immerse the endoscope entirely in the sink filled with detergent in which the entire length of the endoscope can be submerged Wait for at least 1 minute until the pressure is raised sufficiently Check the endoscope for leakage while wagging the tip Incase of leakage of the endoscope see STEP 7 Incase there is no leak of the endoscope manually perform the pre cleaning see STEP 8 The endoscope should be removed from the fluid
94. ion controls and flow temperature measurements duration of phases of Cleaning process Disinfection process and Drying starting time finishing time duration of the process and possibly the duration of various other phases of the process The data that should be registered per work process workspace is presented below The performance of the endoscopy o patient information o physician o identification number and charge number of the endoscope The loading and connection of the endoscope in the washer disinfector o patient information o identification number endoscope o identification number washer disinfector including position of connection left right top bottom oname of the operator Release of the endoscope o Identification number endoscope o Identification number washer disinfector oname of the operator Retention period registration data There are no legal terms postulated for the retention of technical data on cleaning and disinfection For sterilisations the Decree sterilised medical devices in hospitals ref 43 states that protocols of a lot of sterilisation lot shall be preserved at least 6 months For sterilisations for third parties there is an established retention period for sterilisation protocols of 5 years in force ref 44 Retention periods of 6 months are regarded to be on the short side within the work field since there is a chance that presentation of symptoms of infecti
95. ion tubes daily check for defect O rings daily cleaning of control panel and handles daily cleaning of exterior washer disinfector weekly cleaning of the strainer in the chamber drain softening of the washer disinfector as soon as the washer disinfector indicates this frequency depends on the hardness of the water used These checks are also considered as part of the validation see section 10 6 10 9 5 2 Cleaning disinfection and or sterilisation of accessories Accessories that are used during endoscopy can be divided into four groups 1 Accessory instruments used during endoscopy 2 Rinse systems 3 Endoscopy accessories 4 Accessories used during cleaning process In case the accessories directly contact the sterile tissue during endoscopy these need to be sterile The prescribed method for the four groups is described below Group 1 Accessory instruments used during endo therapy These instruments directly contact the sterile tissue during the endoscopy The application of single use accessories is preferred Reusable accessories should be sterilised In case of usage of an irrigation system sterile water should be used Group 2 Rinse systems Sterile water bottle is filled with sterile water and should be renewed daily Use of single use bottles is preferred Reusable bottles should be sterilised 34 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely
96. ional costs structural alterrations INSANSSVNVA no Project leader Se 1 Ea reer e exploitation costs maintenance Head of dept e consequences training for personnel Endoscopy employee ae Investment Mli Specialist Submission investment demand agreement e e Infection Prevention advisor Perform risk analysis workgrou es e Medical Technician ysis workgroup y e Head CSA O Expert Formulate schedule of requirements SoR occupational health and safety Purchaser Request offer absed on SoR purchase Employee ICT Selection of equipment by workgroup based on completed SoR and accompanying offers no possible Trial placement s Negotiations with supplier yes purchase and project leader Purchase of equipment Installation of equipment Release of equipment technical and functional Training and education users Equipment choice Evaluation puchase and usage of equipment Figure 2 Flowchart purchase replacement endoscope disinfector and or endoscope drying cabinet Version 2 1 2011 23 INSANSSDVNVIA 9Sd00dd 5 PROCESS MANAGEMENT 5 1 Primary process cleaning disinfecting and drying flexible endoscopes Processes are the basis of every organisation A process shows the order and interactions of several activities that should be executed during a process By providing insight into the risks these can be minimised and the processes can be organised and improved ef
97. ipt and check of the endoscope and or accessories within the institution at the department Medical Technology Clinical Physics and subsequently at the department for cleaning and disinfection Loan endoscopes should be returned in the washer disinfector so that the appropriate specifications of the endoscope are saved in the washer disinfector Cleaning disinfection and possibly sterilisation by the department concerned Delivery of the endoscopes and or accessories to the user After use return for decontamination as soon as possible e Explanation Documentation by the supplier When offering the endoscope or accessories it is always assumed that this is the first time it is offered In case of a repeat it should be reported that all documentation already is in possession of the departments concerned Documentation that should be provided by the company according to EN ISO 17664 ref 39 identification of the endoscope Cleaning disinfection and possibly sterilization protocols on behalf of loan packages service regulation and regulation functionality test decontamination declaration Receipt of the endoscopes accessories routing and verification the endoscope and or accessories must be delivered in a closed transport packaging at Department of Medical Engineering Clinical Physics at least 1 day in advance of the scheduled intervention the endoscope is entered in the registratio
98. isinfected during normal use The procedures are based on thermal disinfection Procedure Check whether the washer disinfector does not contain an endoscope and set the self disinfection program The self disinfection program of the washer disinfector should be applied according to the regulations of the supplier At least weekly preferably after the weekend if consultation hours start on Monday Certain types of washer disinfectors are equipped with rinse water filters that need to be removed during the thermal self disinfection The supplier of the rinse water filters prescribes a disinfection and sterilisation procedure in case of prolonged and possibly uninterrupted use of the filters After this procedure the filter should be tested with the use of an integrity test also Known as a bubble point test Note The SFERD assumes that sterilisation can only be effective if this treatment is preceded by adequate cleaning and disinfection The rinse water filters cannot be adequately cleaned disinfected and dried in the opinion of the SFERD Therefore the sterilisation process of these filters cannot be validated Next to the physical problems that are involved with the construction there are other issues The filters turn out to Version 2 1 2011 33 INSANSSDVNVIA sSd00dd INSANSSDVNVIA 9Sd00dd trap metal particles that obstruct the filter bed when in function These particles will lead to damage that can harm the subsequent app
99. ist should be able to assume that the correct endoscopes are present at the right time The decontamination cycle should be aimed at having the endoscope available for patient examination in time It is up to the specialist to make sure that the presented endoscope is properly cleaned and disinfected so that patient safety is not at stake as expressed in the guideline of the Order of Medical Specialists on medical equipment ref 30 42 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 7 APPRECIATION BY HEALTH CARE STAFF In this area of the EFQM model it is reflected to what extend the organisation is of additional value to its employees The appreciation by health care staff should be evaluated by means of staff satisfaction surveys Based on the results of such surveys an organisation can learn lessons to bind staff and interest them New developments can lead to the expansion of tasks that can lead to different pay scale being applicable following an official assessment of the new activities Function Appreciation in Health Care Management has to create a balance between work payment development and enough challenge for the employee A positive motivation leads to more dedication and more effective performance of tasks JAVLS SYVO HLIVAH Within the work field flexible endoscopes it is of importance that employees are content and have a feeling of s
100. istant washes or disinfects his her hands before touching other things 10 5 After every scopy hands are washed and disinfected after taking off the gloves hygiene disinfector The top of the lid sealing edges and operation panel are disinfectant domestically washed and subsequently disinfected at the end of checklist present the day The endoscopist wears ci a a E E a a B B a a A A a ic 96 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column The assistant wears Soa a a 10 12 Protective coat ry 10 13 Mask if suspecting pulmonary tuberculosis EEH 10 14 Protective glasses or splash goggles EE 10 15 Sufficient hand washing facilities available TE 10 16 The tap has elbow or foot operation A 10 17 Alcohol dispenser available 10 18 Soap dispenser available 10 19 Towel dispensers with paper towels available Pf 10 20 Foot operated bin available at least not manually rn Version 2 1 2011 97 answ er the questions by entering yes no or partly in the appropriate column ee S a Oe E i a S he a A LA a E De G Endoscopy training location rtf Employees have frequent in service training annual endoscopy conference a annual internal training E annual training at supplier answ er the questions by ente
101. ke a solution of detergent in water in a container Clean the transducer with a single use cloth or gauze which is immersed in the solution Work from clean to contaminated repeat this 1 time Properly wrench the cloth which is immersed in a portion of the solution again and use it to clean first the control panel and thereafter the transducer work from clean to contaminated Rinse the transducer with water so that all chemical residues have disappeared Again check the transducer carefully to see whether all contamination has disappeared visually and whether the chemical residues are resolved 36 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Disinfection Use 70 alcohol or a disinfectant that is approved by the supplier Perform adequate hand hygiene Wear new gloves Method1 Drench a cloth in 70 alcohol Wipe off the transducer with a cloth or gauzes drenched in 70 alcohol The alcohol should have a contact time of 30 seconds on the transducer use timer Ajr dry the transducer The transducer can be used again only after the alcohol is fully evaporated Method 2 Use the method as is described by the supplier of the disinfectant Pay attention to the prescribed concentration contact time and rinsing procedure to remove the disinfectant Storage and transportation of the transducer Store the transducer in a way
102. l Physics has technically released the device for use In many cases an additional functional release also needs to be obtained Storage Cabinet a k a Endoscope Storage Cabinet A storage cabinet is a sealed cabinet with or without overpressure at room temperature in which a dried flexible scope is stored The difference between a drying cabinet and a storage cabinet is that in a storage cabinet the channels of the endoscope cannot be connected Supplier Every natural or legal person who is entitled by the manufacturer to deliver install and maintain washer disinfectors User Trained employee who is authorised to operate a washer disinfector Validation Validation is the evaluation of the results of measurements tests and checks that have been performed in a period in order to obtain assurance that the washer disinfector still meets the specifications that the manufacturer has established Based on the specifications the manufacturer has declared that the washer disinfector meets the essential requirements of the Medical Device Directive 93 42 EC The specifications are the basis for all subsequent measurements tests and checks The results of the measurements and the performed procedures are tested evaluated according to the standards and regulations as outlined in this handbook and are recorded in a report together with the underlying information test reports data from measurements statements etc Washer disinfecto
103. lication during sterilisation The SFERD advises to follow the recommendations of the manufacturer of the disinfector Deviations of the procedure should only occur when substantiated and argued In case of deviations from the prescribed procedures the liability of the manufacturer may expire The washer disinfector remains substantially hot during a considerable time so that a cooling period in necessary In the meanwhile the endoscope disinfection cannot take place This needs to be taken into account when planning the thermal self disinfection STEP 17 Maintenance of the washer disinfector According to the manual the Medical Technology Clinical Physics in consultation with the DSRD declares the type of maintenance that is required Afterward the responsibilities for this maintenance can be divided by at least the DSRD and the Medical Technology Clinical Physics The supplier recommends that the user performs frequent checks and the user maintenance on the washer disinfector The performed checks and maintenance should be logged the form Maintenance of the washer disinfector can be used as an example for this see appendix 4 The form is saved per washer disinfector in the logbook By checks and maintenance is meant among others commencement of the self disinfection cycle of the washer disinfector minimally once a week daily check for proper connection of detergent and disinfectant daily check for defect connect
104. m VMS from January 1 2008 and starts with the reduction of hospital infections The core of a VMS consists of a risk inventory systematics for safely reporting incidents a method for incident analysis and systematics to manage the resulting recommendations and improvement measures Introduction of these systematics within the field of cleaning and disinfection of flexible endoscopes will have a positive effect on patient safety At European level attention is paid to ensuring the quality of washer disinfectors through standard EN ISO 15883 ref 10 To ensure the technical specifications validation tests are specified in this standard Part 1 4 and 5 of EN ISO 15883 give overviews of the test program for endoscope washer disinfectors 1 3 Organisation and Vision of the SFERD The development of an adequate VMS for the cleaning and disinfection of flexible endoscopes causes many points of discussion in practise This has lead to increasingly frequent encounters of infection prevention advisers within the VHIG on the digital discussion forum It soon became apparent that endoscopes disinfection and patient safety extend beyond the field of attention of VHIG and the discussion was expanded to the CSC VDSMH and SEVA This exchange of thoughts supported by the boards of these associations has led to the establishment of the Advisory Board Cleaning and Disinfection Flexible Endoscopes SFERD After the publication of the first edition of this
105. m them in the future Patient satisfaction can be investigated There are investigational methods available for this and there are examples of questionnaires To match the service to the expectation of patients organisation wide creative initiatives can lead to the increase of the patient supply This can result in an increased demand of examinations requiring the use of flexible endoscopes Nice decoration with an eye for colour and function in combination with a friendly and discreet treatment gives the patient confidence to be in good hands Indications that the requirements laid down in guidelines and standards are met can contribute to a justified sense of patient safety Transparency in the form of leaflets about examinations that the patient might undergo will reassure the patient and will help to ensure that the patient can be examined in a relaxed ambience Staff and other resources should be available to allow the patient to communicate complaints or suggestions about the patient experience both verbally and in writing The patient must be convinced that when reporting complaints or suggestions his points are at least considered when assessing possible improvements of future patient care audits or emergency response exercise 6 2 Turn over availability endoscopes Within a team of an endoscopy department the medical specialist can be seen as a customer with demands rights and duties In the treatment of the patient the special
106. manual in 2009 the SFERD is extended with the NVKF VZI and WIBAZ in order to focus on the technological aspects as well The advisory board worked on sub problems within working groups For this second version in particular the working group Validation has worked on a new approach to validation and the addition of drying cabinets to the validation process The SFERD strives for a future durability of 3 years with this version of the SFERD Professional Standard Handbook In the future the SFERD will take care that relevant developments in the field of cleaning and disinfection of flexible endoscopes will be incorporated into new version of this handbook The SFERD has focussed on abovementioned enforced professional and international standards It was the starting point to prevent conflict of the content of this handbook and existing standards Nevertheless there are issues were the vision of the SFERD does not entirely match the mentioned standards In the view of the SFERD automated cleaning and disinfection should be the primary choice for all flexible endoscopes if not the only choice Automated disinfection is the only reproducible method of disinfection that ensures tracking and tracing Manual disinfection should only be seen as an emergency procedure for endoscopes without channels Despite the fact that this handbook focuses on flexible endoscope the SFERD wants to emphasise that the washer disinfector should not be used for other
107. medical devices that lack a compatibility statement as provided by the supplier of the washer disinfector This means that rigid endoscopes that are used in naturally non sterile body cavities can be disinfected in the washer disinfector only if this is indicated by the supplier of the washer disinfector When single use devices become available for endoscopes or probes these devices will be preferred 10 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author In addition the SFERD fully supports the principle of the IGZ to have cleaning and disinfection of endoscopes performed by qualified personnel The feasibility of this goal will be enhanced if the cleaning and disinfection is centralised as much as possible so that the activities will be executed by a specialized group of employees In order to sufficiently train this group the SFERD appeals to participating member organisations to develop a thorough educational program Despite the fact that evidence based guidelines were pursued the SFERD must conclude that its advices in this handbook are based mainly on best practice and common sense Apparently ample challenges exist for research and publications about aspects of the cleaning and disinfection procedures of flexible endoscopes Version 2 1 2011 11 gt in OS Om I QU gt I ZJ S lt m d ae rae AOW1Od 8 ADALVYELS 2 STRATEGY amp POLICY
108. mproperly cleaned and disinfected endoscopes and or accessories Moreover the aim is to take measures to prevent such an incident in the future and to investigate whether patients employees have been at risk of transmission of microorganisms In case of an incident the prevailing procedure is used in the hospital The head of the incident committee recommends the Board of Directors to assign an expert team if necessary consisting of DSRD medical microbiologist and or virologist a representative of the department infection prevention a representative of the Management Board of Directors a representative of Medical Technology Clinical Physics and a representative of the involved endoscopy departmenit s The expert team is responsible for performing a further analysis of the nature and extent of the identified incident and the consideration of risks to patients and staff informing the management based on the findings advising the management about the steps that should be taken and the measures to guarantee the patient and staff safety establishing an evaluation report and establishing a prevention strategy to prevent such a situation if necessary delivering internal and if necessary external reports among others on behalf of the IGZ identifying and analysing all necessary information determining whether there really is an incident based on all available information 44 Professional Standard Handbo
109. n 2 1 2011 99 Appendix 18 Audit form endoscopy Medical Technology Questionnaire on behalf of endoscopy management APPENDIX 18 Department of Medical Technology Department Location s Type of disinfector s Type of endoscopes 100 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column The purchase of washer disinfectors occurs according to ISO NEN EN 15883 The purchase of washer disinfectors occurs in accordance with a predetermined set of requirements established in collaboration with users Expert TD ID procurement etc Does the quality of water supply to the washer disinfector comply with the directive R 4101 1 of the guideline Sterilization and Sterility used water Is a compatibility statement including the endoscopes and the cleaning and disinfecting agents used available for every washer disinfector Have agreements been made wth regard to the washer 1 5 disinfector about Who performs maintenance during warranty EHR O dates of regular preventive maintenance i ae a teii activities to be carried out during preventive maintenance protocol present the validation protocol or checklist that is checked Are washer disinfectors validated before commissioning F a Are washer disinfectors validated at
110. n system of the institution by the Medical Technology Clinical Physics the Medical Technology Clinical Physics is responsible for the transportation the department concerned 13 The same standards apply to both a loan disinfector and e new disinfector 14 Loan lease for use in patients during a given period received by order number in the organisation On approval exclusively serving assessment not in combination with use in patients trial placement etc 15 Compatibility is determined a Endoscopes should be registered with serial number and period of stay in the institution 1 Decontamination proper cleaning and disinfection with a validated process that leads to a medical device that can be further supplied safely If this condition cannot be met consultation with the supplier is necessary Version 2 1 2011 31 INANSSDVNVIA sSd00dd INSANSSDVNVIA 9Sd00dd the supplier should keep a logbook of the endoscope that contains the decontamination declarations and the history of the instrumentation which should be accessible to the user on request the supplier declares that the materials are decontaminated at the delivery of the endoscopes to the institution He cannot make use of the certificate issued by a previous user Return by Medical Technology Clinical Physics if the endoscope is cleaned and disinfected immediately after use it is ready for dispatch to the supplier within 1 working day including the iss
111. nal Standard Handbook Flexible Endoscopes in which the existing regulation in the field of cleaning and disinfection of flexible endoscopes is translated into a practical field standard This includes among others a validation and release procedure a complaints and recall procedure and an audit and control system 1 2 Starting points Primum non nocere above all no damage with this lofty phrase the medical world points out that we do not want to cause any harm to our patients This means that we need to prevent that exogenous transfer of microorganisms could occur during examination or treatment with the use of a flexible endoscope In the IGZ reports Cleaning and disinfection of scopes too flexible dated April 2002 and Follow up study endoscope disinfection dated June 2004 the IGZ already pointed out the omissions in cleaning and disinfection of flexible endoscopes The IGZ emphasises the compliance to the professional standard Cleaning and disinfection of endoscopes of the WIP whose first version dates from 1992 and the prevailing Version 2 1 2011 9 NOILVSINVDYO ANV NOISIA dlIHSdaqva 1 NOILVSINVDYO ANY NOISIA dIHSdadqva 1 version of 2009 ref 5 In 2007 the safety program Avoid harm work safely ref 16 was presented to the Minister of Health Welfare and Sport VWS Ab Klink by Inspector General for Healthcare Gerrit van der Wal This safety program proposes the introduction of a safety management syste
112. nding of parts 10 11 4 Optional control of the endoscopes POSSIBILITY 1 Microbiological Control Endoscope Channels The channels of the endoscope can be microbiologically checked by rinsing the channels with sterile saline the method is described in Appendix 7 Elaboration method laboratory See Appendix 7 64 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Interpretation positive culture See flowchart and assessment list Appendix 8 and 10 POSSIBILITY 2 Checking the cleanliness of the endoscope Check the cleanliness of the exterior of the endoscope including the operation panel and the connection to the light source The inspection is conducted visually Contamination residues can be made clearly visible by wiping the surface with a damp swab By the use of ninhydrin see Appendix 11 protein residues on the swab are stained and by the use of TMB see Appendix 12 hemoglobin is made visible Note The ATP measurement is used in the food industry to obtain an overall impression of the bacterial contamination on surfaces in a quick manner The ATP measurement is not sufficiently developed as a control method for endoscopes Research information and acceptance criteria are missing in order to apply this method effectively Version 2 1 2011 65 LIGNVY Ad NOILVAONNI GQNV LNAWSAOddWI Appendix 1 Bibliography 1 State Supervision Public Health
113. ng 0 1 tetramethyl benzidine TMB in 5 acetic acid 3 hydrogen peroxide solution 1 SDS solution for rinsing the lumen Activate 1 ml of TMB solution by adding 4 drops of 3 hydrogen peroxide solution This solution is then ready for use Note A ready to use TMB solution is available from the suppliers of chemicals used in analytical laboratories Equipment e Test tubes e Cotton swabs free from peroxidase test e 1 ml pipettes e Injection Syringes 10 ml for rinsing the lumen Selection of the endoscope to be examined e Choose an endoscope that contains clearly visible blood e Label the endoscope e Clean the endoscope in the usual manner Sample collection Direct method Activated TMB solution can be applied directly on the surfaces of the endoscope with a dropper or cotton swab to visualise blood residues in situ Swab method Fill a test tube with 1 ml of activated TMB solution The outer surfaces of the endoscope can be sampled with a cotton swab If the surfaces are dry the swab must first be moistened with a drop of water or 1 SDS solution Place the swab into the activated TMB solution Check in advance whether the swab itself gives no colour reaction by performing a blank test Version 2 1 2011 83 Rinse Method for hollow instruments Blood residues in lumen can be determined by spraying the lumen with a few millilitres of 1 SDS solution The presence of hemoglobin can be demonstrated with micro hemat
114. nput is temporarily kept closed and the rinsing liquid rinse fluid on the tip is collected ina sterile container Move the syringe plunger powerfully up and down three times during rinsing Blow air through channels with syringe until all rinsing liquid rinse fluid is collected in a container keep biopsy input closed Rinse biopsy channel through the biopsy input with 20 ml sterile saline while the suction channel is kept closed and the rinsing liquid on the tip is collected in a Sterile container Move the syringe plunger powerfully up and down three times during rinsing Blow air through channels with syringe until all rinsing liquid is collected in a container Brush the suction channel and biopsy channel with a properly fitting sterile brush Beat the brush in a container with rinsing liquid or cut the single use brush off Mark the sample with origin of the sample and date Rinse water air channel with 20 ml sterile saline and collect it on the tip in a sterile container indicate sample origin on container Rinse any other channels with 20 ml sterile saline Rinse the forceps elevator channel with 20 ml of sterile saline optionally in portions of 2x10ml Note the sample origin date and time and reason for culture collection periodic monitoring after repair after purchase repeat culture after positive results on the laboratory form Transport samples as soon as possible to the laboratory for examination In case of longer transp
115. nt involving the required expertise for identifying the patient s risk evaluating the patient group at risk track and trace involving the clinicians and formulating the strategy including a plan for patient information patient treatment and a communication plan After completion of all actions the incident should be evaluated to identify possible future improvements in these kinds of procedures or evaluations Perhaps new ideas are put forward for next practice incidents 10 3 Agreements on management Responsibilities regarding endoscopy are noted in this handbook Maintenance and repair of endoscopes are handled by the Medical Technology Clinical Physics the user does not contact the supplier at this point In this way it is possible to properly register all actions that have taken place concerning endoscopes and washer disinfectors These actions are registered in logbooks digital registration system and reported to the DSRD Version 2 1 2011 51 LIGNVY Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOdd WI User maintenance to the washer disinfector and for example the replacement of filters detergents disinfectants and the self disinfection etc should be performed by the cleaning and disinfection department itself The activities are to be incorporated in a procedure of the department and reported in a logbook see example Appendix 4 10 4 Assessment of management With regard to testing pr
116. nventions about validation is iadaie crus tasinoniaiericsaummnvaieldinoinancatmolsdsialanciattaluGRenectanetes 52 10 6 Validation of the washer diSiNf CtOr c ccccccseeeeeceeeeeeeeseeeeeeeseeeeeeeeseseeeesaaneneeees 56 10 7 Periodical inspections verification specifications and other controls 0 58 4 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 10 8 Other controls washer disinfector ccccceecececececcececcccecececcecececcececueuececeeaceesseaerecs 61 10 9 Release washer disinfector fOr USC cccccccsesceeceeseeeeceaeeeeeceeeseeeecsaaeeeessaaeeeessnses 61 10 10 Validation drying Storage cabinets cccecccceceeeeeeceeeeeeeeeeeeeeeesseeeeeesaseeeesaaaeeeeees 62 10 11 Control Flexible ENdOSCOpeS cccccccceceeseeseeeceeeeeeeeeeeeeeeesaeeeeeeeeeesseaeeeeeeeeeeesaaees 63 Appendix t BID IIO GRAINY arawe ascends ceacie manne ancecicinesusanecanuescadsainataanteegudeauchaidaeamtataetnaudticeascencnaseane 66 Appendix 2 Form for conveyance of a damaged or leaking endoscope c ceeeeeeseeeeees 68 Appendix 3 Decontamination fOFM ccccceceeeeeeceeeeeeceseeseeeesaeeeeeecaeeeeeessuaueeeesesaeeeeessaeeeesaaaees 69 Appendix 4 Routine application of daily maintenance of the washer disinfector 06 70 Appendix 5 Release form for flexible endoscopy after maintenance
117. ocedures legislation and national guidelines are taken into consideration The head of the department where an endoscopic procedure is performed is responsible for the handling and use of cleaned and disinfected endoscopes and accessories The operating procedures are periodically tested under the responsibility of the DSRD For this purpose the following actions are planned see Table 3 for an overview The logbooks are assessed once a year The registration of replacement of chemicals is checked every month A consultation with the involved departments about culture results production numbers and the expected purchase of materials is held once a year An audit is held at the department once a year The procedures are evaluated every 2 years At the annual audit it is also tested whether there are possible omissions in the existing procedures and whether additional procedures are necessary 10 5 Conventions about validation The washer disinfectors should meet the Medical Device Directive 93 42 EC and carry the CE mark Periodical validation is necessary to guarantee reproducible cleaning and disinfection The validation is explicitly not meant to prove that the washer disinfector meets the requirements of the standard and the Medical Device Directive 93 42 EC standards This has already been established by the manufacturer and the CE mark indicates that the requirements are met The cleaning and disinfecting power of the machine is
118. ok Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author advising the management about the measures that should be taken to guarantee patient safety including temporarily stopping the endoscopic examinations 8 2 Aspects on the application of incident management The incident procedure is applied in an identified deficiency in the cleaning and disinfection process of endoscopes The table below contains examples of possible incidents however this table is not complete The DSRD makes a risk estimation of the incident based on the report and in consultation with a doctor a risk estimation of the risk for the patient if necessary Based on this assessment the procedure below can be started Table 2 Examples of incidents inadequate cleaning and disinfection process of endoscopes and or accessories inadequate pre cleaning e g channels are not brushed use of wrong and or expired chemicals working with wrong concentrations exposure times and or temperature contamination of the post disinfection rinse water and or culture fluid of the endoscope detection of fixed organic material in endoscope and or washer disinfector use of non sterile accessories for invasive diagnosis treatment Inadequate transportation and or storage of endoscopes insufficient drying of endoscope improper storage of endoscopes e g in transport cases Contaminated defective washer disinfector contamination
119. ons due to patient examination can manifest itself after 6 months The SFERD recommends a retention period of 5 years for the technical data on cleaning and disinfection This allows an organisation to demonstrate that the manifestations of infections in a patient in all probability cannot will not have been caused by inadequate endoscope disinfection This retention period includes the look back periods which are held in the evaluation of incidents regarding inadequate cleaning and disinfection procedures of endoscopes It is recommended that a back up of all available data is made periodically It is undesirable that the data is only stored locally on a workstation the data must be managed centrally on a network Version 2 1 2011 41 INSANSSDVNVIA sSd00dd SYHAWOLSNO Ad NOILVIOSdddV 6 APPRECIATION BY CUSTOMERS 6 1 Patient safety Within the EFQM model see figure 1 the appreciation by cooperating partners customers and suppliers is of great importance for successful operation of the organisation Partners are external organisations with a close and or long term collaboration These can be suppliers and or buyers sometimes in changing roles It is necessary to know how they appreciate products service and cooperation What is their opinion about the products service or cooperation Does the organisation have insight into the arguments for why one uses its service or not And what can the organisation expect fro
120. opes Distribution area clean endoscopes Storage operational stock of chemicals at the department Waste Ceiling Air conditioning can be arranged according to the Building standards central sterilization department ref 12 In the cleaning area additional suction sections need to be placed due to aerosols reinfection of the disinfected endoscopes by aerosols generated during pre cleaning should not be possible Extraction of the washer disinfector according to the recommendation of the manufacturer Point extraction above a work bench in accordance with occupational health and safety policy According to management plan of hazardous materials environmental permit Also see the safety information sheet regarding disinfectant Smooth impact resistant easy to clean resistant to detergents and disinfectants Wet floors should not become slippery Preferably automatic door or by means of foot operation open close Windows in accordance with occupational health and safety requirements According to standards no shading Sufficient space for the receipt and temporary storage of contaminated endoscopes including the means of transport Sufficient space for the storage and distribution of clean endoscopes including transportation option pass through in the wall Fluids in drip tray detergents and disinfectants according to occupational health and safety environmental requirements also see the safety information sh
121. ort times gt 4 hours measures should be taken according to agreements with the laboratory concerned PA retrograde culture method can also be used for microbiological testing of endoscopes see ref 42 78 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 8 Flow chart for microbiology tests on flexible endoscopes Microbiological control flexible endoscope lt Filter sample D Determination laboratory according to ISO 15883 Protocol sample Culture no gt 20 cfu channel End procedure no Contamination collection Determination laboratory according to ISO 15883 Recollect sample Culture gt 20 cfu channel no End procedure no Contamination Sample after no repair Clean and disinfect endoscope again pi Recollect sample e Protocol sample collection y Corrective maintenance Patient recall procedure Assessment list positive cultures Remove endoscope from circulation and investigate possible causes of contamination and take further steps efect or possibl Recollect sample Protocol sample collection Version 2 1 2011 yes cause identif
122. parts Liye 8 3 The company accepts the Standard Service Agreement SSO of the FHI Li All required components can be delivered within 24 hours i ee Defect endoscopes are repaired within a predetermined period During this period a loan scope is available During at least 10 years the parts are available i re g 7 A technician of the supplier can be present within 24 hours T Maintenance and repair can be carried out by medical technicians 8 8 soecial tools can be delivered 88 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 16 Schedule of requirements for drying cabinet Aim of drying cabinet Drying and storage of flexible endoscopes and their accessories both exterior and channels Il Interaction with endoscopes and their accessories All types of flexible endoscopes and accessories must be able to be dried in accordance with the prescribed procedure Ill Patient categories Various IV Users Employees department CSA employees department inpatient or outpatient examination Requirement Demand flegalrequremens SSS Medical Directive 1 1 The drying cabinet has a CE label according to Medical Device Directive 93 42 EC NEN standard Not available yet NEN 10601 7 3 The drying cabinet meets the electricity safety standard NEN 10601 Wip guidelines 1 4 The drying cabinet meets the directive Cleaning an
123. person Ensures that the washer disinfector is used according to work instruction the endoscopes are prepared according to work instruction daily and weekly inspections are performed and the logbook is kept If in doubt about the functioning of the washer disinfector the contact person consults the DSRD Manufacturer supplier The manufacturer supplier delivers a washer disinfector that meets the requirements as stated in the purchase agreement This means that the washer disinfector should comply with the Medical Device Directive 93 42 EEC and the standard NEN EN ISO 15883 Parts 1 4 and 5 The manufacturer specifies clearly which endoscopes can be processed in washer disinfector connection materials are needed for each scope and which necessary pre treatments should be performed before the endoscope can be placed into the machine e g brushing of the biopsy channel The manufacturer specifies all process parameters and shows how these can be verified If it is necessary to carry out a temporary adjustment to the machine or the software for the verification of a process parameter the manufacturer must provide a protocol for this The manufacturer must also specify the user maintenance Owner The owner provides sufficient resources to enable cleaning and disinfection of flexible endoscopes in a responsible manner The owner also provides the necessary maintenance of the equipment and staff training Technician performing measurements
124. procedure for storage and transport culture the positive endoscope again check the procedure for sample collection and elaboration culture the positive endoscope again check the drying procedure for storage and the ventilation of the storage culture the positive endoscope again check the water supply system and procedures e manual and or machine rinsing e perform a complete maintenance of machines and water filters culture the positive endoscope again culture the rinse water 81 Appendix 11 Ninhydrine swab test Note This is the basic procedure the fluid quantity and the incubation period used for the specific swabs incubator and incubation temperature should be qualified Materials Method Swabs simple cotton swabs plastic Incubator set at 220 C Optional needles 0 9 x 70 to avoid bending of the swabs during the incubation Water for injection Ninhydrin Order No N4876 Sigma The Netherlands 2 in 70 isopropanol Order No 1 09634 1000 Merck Netherlands in water ready for use within 3 weeks Pipette with a capacity of 50 ul of fluid Selection of endoscope to be examined Choose an endoscope that contains clearly visible contamination blood Label the endoscope Clean the endoscope in the usual manner Assessment of the cleaned endoscope Check the cleanliness of the object to be examined by visual observation Pay attention to spots circles colour variations foreign materials etc
125. provided the SFERD is listed as the author Group 3 Endoscopy accessories This group of accessories does not directly contact the sterile tissue but there is a major chance of severe contamination with tissue and bodily fluids Preferably the single use accessories are used Reusable accessories are preferably sterilised Reusable valves should be brushed both in open and closed position n this way as much contamination as possible is removed Afterward they will be placed in an ultrasonic bath the washer disinfector and the drying cabinet Group 4 Accessories used during cleaning process The instruments do not directly contact the patient These accessories are preferably single use Reusable brushes should be rinsed with water directly after use Thereafter they can be cleaned and disinfected with the endoscope Table 1 Accessories and their respective means of disinfection or sterilisation Group Types of accessories Ultrasonic bath Machinated Sterilisation and machine disinfection disinfection only 1 Biopsy forceps loops ERCP materials and irrigation X equipment 2 Water rinse bottle and hose X 3 Valves caps and mouth X piece 4 Cleaning brushes water jet channel tubes X nm NB single use accessories are always preferred over reusable ones Savary probes can be mechanically disinfected after manual pre cleaning in case the supplier provides a compatibility declaration accesso
126. ps STEP 2 Transport of disinfected dry endoscope Place the endoscope on a new fibre mat or otherwise protected against damage due to movement in a clean dust free container that is closed with the use of a cover dust cover plastic cover or comparable The container must be clearly marked or sealed indicating that the endoscope is disinfected The container is marked with the expiry period taking into account whether or not it is properly dried and transported to the examination endoscopy unit When using the endoscope on a patient gloves should be worn During the endoscopy all general precautionary measures as recommended by the WIP should be used Used materials and liquids should be applied according the Spaulding principle STEP 3 Pre cleaning in the endoscopy room by the operator Directly after endoscopy the following operations should be performed while wearing gloves Suck up clean water with the use of the suction and biopsy channel i Continue sucking until a clear fluid is visible as output Rinse and blow through water air channel with use of valve Wipe off the exterior with an unsterile gauze Set the friction controls of the endoscope in a neutral position free Disconnect the endoscope and bring it to the decontamination room In case the decontamination room is not directly adjacent to the endoscopy room the endoscope must be transported in a closed container identifie
127. puterization and automation 18 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 4 RESOURCE MANAGEMENT 4 1 Building and interior A primary prerequisite of adequate cleaning and disinfection of endoscopes is that the routing of the endoscope used is such that potential contamination of the clean and disinfected endoscope with microbiologically contaminated material used endoscopes and accessories is prevented This goal is preferably achieved by a physical INSANSSVNVA separation of activities In case the circumstances do not allow for this a rational sequence of activities in the same area should prevent crossing over of clean and contaminated materials The extend and design of the cleaning disinfecting area should be adjusted to the preservation of this principle To achieve this the following construction and equipment requirements must be met Construction aspects Surface area and spatial arrangement cleaning disinfection Spatial separation Future Water Electricity Requirements Standards Sufficient surface area for placing all necessary facilities namely area for receiving contaminated endoscopes workspace manual pre cleaning washer disinfectors drying cabinets and storage cabinets for endoscopes distribution area disinfected endoscopes hand hygiene facilities area for waste area for storage
128. py cccceseeeecceseeeeeeeseeseeeeseeeeeeeseeeeeeesseeeeeesseaeeeeessaaeeesaenees 91 Appendix 18 Audit form endoscopy Medical Technology ceeeeeeeeeeeeeeeaeeeeeeeeeeeees 100 Appendix 19 Response form for contributions for improvement of the handbook 104 Version 2 1 2011 5 SLNALNOO 40 4 1EeVL SNOILINISSG 40 LSI LIST OF DEFINITIONS Adverse event An adverse event is an unforeseen event in other words a deviation from the protocols and work instructions Contact person Person at the department where the washer disinfector is in use who has the authority to execute repairs maintenance tests and checks as well as the responsibility for daily and weekly inspection e g head of the department Drying Cabinet a k a Endoscope Drying and Storage Cabinet A drying cabinet is a cabinet in which a wet disinfected flexible endoscope can be placed and in which the channels of the endoscope can be connected in order pass compressed filtered air through them A drying cabinet dries the entire endoscope the channels and the exterior Flexible endoscope Medical device for looking into body cavities for diagnostic and or therapeutic purposes Incident An incident is every adverse event that leads to possible damage to a patient and or employee Logbook Digital or written document in which all relevant data about inspections maintenance malfunctions and usage is recorded an
129. r Machine designed to deliver an automatic process for cleaning and disinfection of flexible endoscopes Abbreviations ARBO Working conditions CSA Central Sterilization Department DSMH Expert on Sterile Hospital Supplies DSRD Expert on Endoscope Cleaning and Disinfection EFQM European Foundation for Quality Management IGZ Dutch Health Care Inspectorate MT Medical Technology Department NIAZ Netherlands Institute for Accreditation in Healthcare PDCA Plan Do Check Act SFERD Advisory Board Cleaning and Disinfection Flexible Endoscopes TEE Transesophageal Echocardiography VMS safety management system VWS Ministery of Health Welfare and Sport WIP Dutch Workingparty on Infection Prevention Version 2 1 2011 T SNOILINISSG SAO LSI INSANNOOCd SIHL AO NOILISOdNOO COMPOSITION OF THIS DOCUMENT The EFQM model is a valuable resource for healthcare institutions and professionals and gains increased popularity in healthcare The model provides a structure to combine the interests of patients with the organisational goals in a balanced manner Moreover the model turns out to function as means of communication between Board of Directors healthcare professionals managers department heads and employees due to the unambiguous method and classifications into 9 fields and the improvement cycle as illustrated in the figure below The model contains five coherent fields of organisation ae PLAN Leadership Employees Strategy
130. ral precautionary measures or specific measures that are applicable in a specific situation Possible risks and required measures are described per category below Risks for employees Activity Risk Risk restrictive measure Transportation of Injury contamination and Clear working instructions contaminated physical complaints protective clothing vaccinations endoscopes according to hospital policy and appropriate occupational attitude Manual pre cleaning of Injury contamination Clear working instructions contaminated contact with chemical protective clothing vaccinations endoscopes fluids through skin according to hospital policy mucous membranes or and inhalation and physical appropriate occupational complaints attitude 38 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Loading and unloading of washer disinfector Replacing detergent and disinfectant containers Storage clean endoscopes Ultrasonic activities Injury contamination contact with chemical fluids through skin mucous membranes or inhalation contact with electricity and physical complaints Contact with chemical fluids through skin and inhalation Injuries physical complaints Hearing loss over time Clear working instructions protective clothing vaccinations according to hospital policy proper ventilation of the workspace extraction of the washer disinf
131. ramme protocol PP fo There is a qualification program protocol on the release of the process provide programme protocol The supplier has a list of critical process parameters including criteria that can should be validated enclose list The supplier provides an education training for external validator certificate is issued O Indicate how the education training is structured and which validators have attended this enclose list validators 2 7 The supplier provides a release report and a validation report directly after installation E SSC SCS Ves Supplier indicates the water consumption Specify consumption Supplier indicates energy consumption specify consumption The supplier manufacturer accepts the return of the washer disinfector that needs to be replaced The agents that are applied in the detergent and disinfectant are permitted according to the discharge permit The detergent and disinfectant are deliverer in an appropriate UN approved package A safety sheet PDF regarding the detergent and disinfectant is available deliver 3 7 Indicate the average amount of residual liquid in the storage tank i 3 Occupational health and saf D lt The washer disinfector is equipped with facilities that prevent that substances is released into the envronment that substances remain in the user accessible areas of the units that substances remain on the treated endoscopes Ther
132. re visible at first sight corrosion or other deposit cleanliness of the exterior of the endoscope including the operation panel and the connection to the light source wear and tear of the coatings readability of the length markings on the endoscope state of the connection to the light source compressed air and water bottle readability of the type designation and serial number or other unique identification number functioning of the RFID chip correlation RFID chip data and the data of the endoscope leaks manual leak test control that involves movement of the cardan 10 11 2 Checking connectors The connection between machine and endoscope should not influence the operation of the machine as a result of leaks flow restrictions or other limitations The check of connectors includes inspection of state of the O rings and interface with the endoscope damage to the connector and tubes attached to the connector 10 11 3 Checking channel separators The channel separators should not influence the operation of the machine as a result of leaks flow restrictions or other limitations The check of channel seperators includes inspection of the mechanical action of movable parts do the parts slide smoothly attachment of solid pars are the parts that need to jammed actually jammed completeness of the channel separator are parts missing state of O rings and interface with the endoscope damages scratches be
133. res Unreasonable expectations of society should be prevented state what you do and how you do it For cleaning and disinfection there is high quality of disinfection which should be in line with the type of instruments in relation to the field of application The easily called term sterility should be avoided Communicate in internal and external media that you justify the necessary changes Mention the remaining marginal chance of a risk compared to the time prior to the incident and that this is reduced to a standard accepted by the authorities IGZ WIP Point out the effect of your quality management system and the role of audits in the near and longer term When managing responses from patients the involvement of a confidential counsellor or contact person of a patient can be useful Patients can file a claim to the organisation because of suffering in the form of uncertainty or certainty about an infection caused by the incident Handling these claims should be done in accordance with arrangements with any insurance companies of the institution Dealing with the media can be partially delegated to the department of Public Relations or Communication by the Management Board of Directors Version 2 1 2011 49 ALAIOOS Ad NOILVIOSdddV SLINSAY 9 RESULTS Secured safety on behalf of the patient and staff The patient should be able to count on a justified confidence in responsible care IGZ adage This care is achieved
134. ries that are not resistant to disinfection or sterilisation may once be used and should be discarded after use valves mouth piece and such are treated as the accompanying endoscope if material is resistant to sterilisation Ultrasonic Cleaning Ultrasonic cleaning is recommended for all reusable accessories with the exception of plastic materials Requirements Ultrasonic bath Detergent compatible with ultrasonic treatment and the accessories to be cleaned Gloves Water 18 Sterilisation is always preceded by mechanical cleaning and disinfection Version 2 1 2011 35 podJ0da lt gt z gt Q m lt m a Single INSANSSDVNVIA 9Sd00dd Procedure Fill the bath with water to the lowest indication for the minimal quantity of water top line is the designation for maximum quantity of water Fill up the required amount of detergent to reach the prescribed concentration and mix the liquid well Wait 5 minutes before placing the materials placed in the bath after turning on the ultrasonic bath because the water is degassed during those first five minutes Dissolved gases normally present in fresh water reduce the ultrasonic cleaning effect Accessories should first be brushed valves both in open and closed position and rinsed immediately after use to prevent biological remainders to cake or dry out Materials should be placed in an ultrasonic bath with closed by a cover
135. ring yes no or partly in the appropriate column external internal a The endoscopes are validated on a predetermined frequency Protocols are updated with a predetermined frequency It is clear who has responsibility over authorisations ine i ji external internal who technically frequency chemically frequency microbiologically frequency 12 6 use audit frequency who 12 9 microbiologically frequency frequency 12 10 use audit The machine is validated on a predetermined frequency 12 11 the scope management plan is evaluated annually maa a a a 98 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author answ er the questions by entering yes no or partly in the appropriate column There is a separate area for cleaning and disinfection of endoscopes Is there sufficient surface area for spatial separation of clean and contaminated endoscopes Are there enough technical occupational health and safety air suction Is there a separate administrative workplace available Is there a separate area available for drying and storage of endoscopes The finishing of floors walls borders and ceiling is in accordance with Construction College smooth shock resistant resistant to Is there enough working space Bening the pre Seain of enlarged sink contaminated and assembly of clean endoscopes separated worktops Versio
136. s and bacterial filters Note The replacement of chemical containers can be registered in the logbook but in practice this is often recorded on a separate list 56 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 10 6 2 List of endoscopes with compatibility declaration The washer disinfector manufacturer should specify for which the endoscopes the washer disinfector is suitable NEN EN ISO 15883 4 4 1 3 and 8 a By including an endoscope to the list the manufacturer states that the endoscope will be properly cleaned and disinfected in the process compatibility statement provided that the proper connectors are used to connect the endoscope in the washer disinfector the prescribed chemicals are used and that the pre treatment of the endoscope which is prescribed by the manufacturer of the washer disinfector is performed see BS EN ISO 15883 4 4 1 4 This also means that the institution does not have to test whether the endoscopes can be cleaned and disinfected in the washer disinfector and disinfected unless the institution uses endoscopes of which the manufacturer of the washer disinfector has not established that the washer disinfector is suitable In that case the manufacturer of the endoscope can possibly declare that the endoscope can be effectively cleaned in the corresponding washer disinfector and disinfected In all other cases
137. s completed the process is interrupted and the surrogate endoscope is removed from the disinfector unless the manufacturer of the indicator states that the process can be performed completely including the disinfection phase The result of the test is recorded and compared with the results of previous tests Attention should be paid to a negative trend This may be an indication of wear and tear on parts of the disinfector which could eventually lead to failure of the machine or to an unacceptable decrease in the effectiveness of the cleaning and disinfection process The control test is also performed as a release test after installation maintenance and repair PART 4 Microbiological quality control post disinfection rinse water The microbiological quality of rinse water must be determined after installation of the washer disinfector and or water treatment installation It is recommended that this is repeated twice with an interval of one week Then once more one month after the final determination If consistently acceptable results see acceptance criteria Willes Version 2 1 2011 59 LIGNVY Ad NOILVAONNI GQNV LNAWSAOddWI LIGNV Ad NOILVAONNI GQNV LNAWSAOddWI are found it is sufficient to test the microbiological quality of water once every quarter The protocol for the tests is described in Appendix 7 There is not only an acceptable result if there are no microorganisms found in the post disinfection rinse water The table
138. s procedure will not be continued An exception can be a structural abnormality in the daily actions STEP3 Risk inventory Based on the inventory and analysis the DSRD estimates whether there is has been SCENARIO 1 Risk in the process Omissions in the work process can lead to a risk for the patient and or staff in the long term These omissions should be included and controlled in protocols and or work instructions Patients and or staff were not at stake due to these omissions a recall of patient staff is not indicated SCENARIO 2 Risk to patient and or staff In case of suspected or demonstrated risk for patient and or staff the DSRD directly contacts the medical microbiologist to further assess the risk See step 4 Note that the risk does not always have to be of microbiological origin there may be for example chemical hazards involved In that case a pharmacist toxicologist and safety expert can be involved SCENARIO 3 No risk to patient and or staff The notification turns out to lack a risk for the process the patient and staff after analysis The procedure is terminated the notification is reported STEP 4 Risk estimation The medical microbiologist pharmacist toxicologist and safety expert can assess the risk together with the DSRD The result of this estimation can have three outcomes namely a There is an incidental risk for one patient employee The deviation may already be present but based on the
139. s recommended In connection with the increased risk of recontamination of endoscopes by frequently opening of the drying or storage cabinet a shelf time of one month is recommended In addition is is advised to clean the cabinet every month 12 The SFERD has identified how much time one sets for this in Dutch hospitals The average time was 4 hours With regard to this time on the one hand is referred to the WIP advice for the maximum shelf time of disinfected endoscopes whithout drying and on the other hand to experiences with drying of organic material microorganisms on instruments 30 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author STEP 13 Loan flexible endoscopes and accessories Principal endoscopy department and or Medical Engineering Clinical Physics places loan order for users at the competent department of the institution When applying for the order the conditions of the supplier and documentation regarding technical information and cleaning and disinfection are required Principal informs the involved departments e g CSA DSRD and Medical Engineering Clinical Physics about the endoscope and accessories that are requested and the date and time of delivery appliance and return User within the institution can schedule the examination only if the conditions for adequate cleaning and disinfection have been met Rece
140. scopes Purchaser e coordinates the commercial activities related to the purchase of flexible endoscopes washer disinfectors drying cabinets and peripheral equipment of flexible endoscopes 3 2 Training and education Because endoscopes are used for different patients it is of importance to clean and disinfect in a responsible fashion The quality of this cleaning and disinfection is largely determined by humans Therefore the personnel should be able to adequately perform all duties The aim of the training of these employees is to educate them sufficiently regarding the knowledge required for adequate performance of their duties The manager should have insight into which employees are sufficiently trained In the absence of relevant training offered by third parties the organisation itself should provide the education of employees Starting point The required training s of the employees involved in carrying out cleaning and disinfection should be at least at the level of independent employee independent professional or vocational training Recurrent training For breaking in and maintaining the employees knowledge and skills on cleaning and disinfection the following education is minimally required Introduction program new employee Each new employee follows an introduction program which includes among others the reading of all procedures cleaning and disinfecting endoscopes handling equipment reporting defects and sa
141. sh instruction manual available There are English operational and load regulations available There is a protocol with respect to corrective preventive and inspective maintenance available for the technicians certificate issued N N N Q N 7 7 N gt 4 7 7 5 7 8 The supplier provides connection diagrams for all types of flexible endoscopes used in the hospital 5 Requirements regarding usabil ee The washer disinfector has an ergonomic operation which is simple with minimal contact moments oa lt In case of an alarm or notification the machine gives a clear description of the problem identified and gives an instruction for the solution at user level The un loading doors can be hygienically opened N 8 4 The machine provides logical support by means of on screen instructions during operation M andregatraon PS SC S The functionality for the registration of endoscope charge process data date and time patient specialist and operator is present Each disinfection cycle the data recorded and stored digitally eg concerning machine patient scope a specialist and process flow N The washer disinfector can communicate with internal control systems and networks specify 9 4 The washer disinfector provides the ability to generate management information specify 10 Installation requirements ee Draws and measurements of the installation facilities dra
142. sion and or other deposits that may indicate a leak check whether the notifications on the machine on time of use maintenance interval have not yet expired The manufacturer of the washer disinfector may recommend additional checks 10 7 2 Quarterly inspection of the washer disinfector PART 1 Control channel monitoring system The functioning of the channel monitoring system is checked using a dummy endoscope every three months The dummy endoscope allows for reduction of flow in each channel The washer disinfector should generate an alarm for each blocked channel PART 2 Control channel connection monitoring system The functioning of the channel monitoring system is checked using a dummy endoscope every three months The channels of the endoscope are connected One channel is disconnected and the process is started The disinfector should report an error The test is repeated for each channel The disinfector should generate an alarm for each channel that is not connected PART 3 Process control The verification test is performed using a dummy endoscope according to NEN EN ISO 15883 and commercially available chemical or biological indicator Such a test gives a quick insight into the functioning of the washer disinfector By comparing the test results over time an indication on the reproducibility of the washer disinfector of can be obtained After the intermediate rinse between the cleaning phase and disinfection phase i
143. specialties about the facilities SCENARIO 2 Central cleaning disinfection Endoscopic treatment units at a distance from the cleansing and disinfection room ONEWE Disadvantages Spatial facilities and the expertise are Additional logistics call for means of better used as the activities carried out by transportation and personnel a smaller group Personnel and equipment are more Possible need for more flexible efficiently utilised Stock material can be endoscopes reduced More uniformity The quality assurance is more manageable so less risks for the patient Version 2 1 2011 13 AOI1Od 8 ADALVYELS AON1Od 8 ADALVYELS SCENARIO 3 Decentralised Per one or more endoscopic treatment units a cleaning and disinfection room PANo WETal tle 4 gt Disadvantages Limited expertise of employees Very concise logistics high turn Inefficient use of washer disinfector over and little transportation and employees Efficient use of endoscopes Insufficient coordination between the different departments The quality assurance and documentation management is more difficult Recommendation For reasons of patient safety quality assurance the more efficient use of space facilities and the expertise of the employees responsible for cleaning and disinfection central cleaning and disinfection is preferred This results in better allocation of responsibilities clear logistics and processes that can be planned In the report da
144. ssional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author This workgroup consisted of the SFERD members complemented by Klaartje Weijdema infection prevention adviser DSRD Diakonessenhuis Utrecht Gerband Boelens DSMH DSRD Meander MC Amersfoort Adrie de Bruijn researcher RIVM Bilthoven In April 2011 the Professional Standard Handbook was awarded the VHIG Infection Prevention Price the accompanying sum of money was spent on the translation of the handbook in English For this reason the document has been critically edited once again by the members of the SFERD Furthermore with this the discrepancies with the WIP in agreement with IGZ WIP and ENT association are removed The SFERD hopes that this handbook proves to be a valuable document for your daily practice and invites you to remain critical and keep submitting comments recommendations and new developments The SFERD pursues that this version is valid for a period of three years On behalf of all SFERD members Federation for Medical Technology KMT Job Gutteling medical physicist head of Medical Technology OLVG Amsterdam The Dutch Nurse Association division Gastroenterology and Hepatology V amp VN SEVA Nel Blom endoscopy nurse St Lucas Andreas Hospital Amsterdam Sterilization Association of the Netherlands CSC SVN Peter van Alphen head CSA FlevoHospital Almere Dutch Society of Experts on S
145. sy to clean and seamlessly connected to work bench Cabinet space above work bench to store the materials used in manual pre cleaning Work bench clean clearly separated spatially from contaminated work bench including compressed air pistol Cabinet space above work bench for storage of the accessoires for clean endoscopes Ultrasonic bath Possibly integrated into the pre cleaning work bench Utilities water sewer connection and electricity Clean contaminated Necessity depending on central decentralised work system transport Clean and contaminated transport spatially separated Cleaning and Necessity depending on central decentralised work system disinfection transport Using an automated washer disinfector taking into account space containers and and facilities Utilities for a washer disinfector compressed air utilities water electricity ventilation data and sewer connections Hand hygiene At contaminated side of work bench sink whwith a foot or elbow operated tap alcohol and soap dispenser with elbow operation towel dispenser At the clean side of work bench Alcohol dispenser with elbow operation Occupational health According to the hospitals occupational health and safety plan an and safety eye shower is minimally required Administrative If a PC is used the keyboard should be cleanable workspaces Network connection and proper lighting General Possibility to early warning in case of em
146. taker isee Vip _ of the water that is taken see VI m Dosage of detergent SSS of detergent bart solution to the washing temperature pe TT wash phase ee es a S during the wash phase The time of the actual rinsing phase which is the time pf after the rinse temperature is reached 1a OF The flow generated by the pump s at a given pf E pressure Rotationspeedwasharms S a E E Ill Rinsing between cleaning and disinfection The number of rinsing steps S S The amount of water that is taken ooo o o The qualiy ofthe water that is taken see Wf The temperature of the incomingwater The time the machine needs for the water to heat up S to the rinse temperature The temperature of the water during the rinsing phase Do The time of the actual rinsing phase which is the time 72 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Parameter Specitied Measured Correct values and values e after the rinse temperature is reached The pressure of the pump s at a given flow value and ee Or The flow generated by the pump s at a given S ae pressure Rotationspeedwasharms S S S a S T IV Disinfection O Z o SS d S S The number of rinsing steps S o The amount of water thatis taken o oo o o The quality of the water that is taken see V l To o oo The temperature of the incomingwater o T o T Tanan e
147. ted as the author Parameter Specitied Measured Correct values and values a Maximum temperature change of the endoscope the test X E Monitoring jecaiding and Gono er recording and control intended threshold values including the permitted tolerances Threshold limits of flow reduction or pressure increase or change of another variable during congestion control before an alarm is given Threshold limits of the flow increase or pressure decrease or change of another variable during control of unconnected channels Threshold limits of the maximum pressure that may be delivered by a connector may occur in the channels of the endoscope before an alarm is given Pcl G an alarm is given poo ee TT disinfectant before an alarm is given Maximum operational life and maximum number of o cycles for reuse of disinfectant before an alarm is given Threshold limits of the measured parameters or systems that check the nature of the detergent and or disinfectant viscosity refractive index colour to fy recognise exchange of chemicals before an alarm is en The parameters recorded during the process ba A S registers a parameter a securities Version 2 1 2011 15 Appendix 7 Determination of microbiological quality Post disinfection rinse water MICROBIOLOGICAL CONTROL LATS RINSE WATER WASHER DISINFECTOR Test on aerobic mesofilic microorganismen aerobic mesophilic bacteria Frequency Coll
148. terile Medical Devices VDSMH Carol te Beest DSMH DSRD Maasstad Hospital Rotterdam John van Bergen Henegouw secretary DSMH DSRD HagaHospital Den Haag Dutch Society for Infection Prevention and Control in the Health Care setting VHIG Paul Steegh adviser infection prevention Jeroen Bosch Hospital s Hertogenbosch Kees Ballemans president DSRD University Medical Center Utrecht Version 2 1 2011 3 SLNALNOO J40 4 1EdVL TABLE OF CONTENTS TABLE OF CONTENTS surni a RT 4 LIST OF DEFINITIONS nossidsinietn aE e a EE A 6 COMPOSITION OF THIS DOCUMENT ccccesececesseeenseecenseencnseeeceneesenseeseases 8 1 LEADERSHIP VISION AND ORGANISATION 0 ccccssecsseeeeeeseeeeeneesees 9 1 1 TAGOCUICT Oliicarcnsuatehescacoasnetalninbenceaccatetaiuiauitadacsmsnatadunetanacimadsondladadesaddmciticsmmane mince 9 1 2 SIUC OAS reion E A R E sass tecuuieataucemnenmeanenars 9 1 3 Organisation and Vision of the SFERD cccececcecsseeeeeeeeeeeeeesseeeeeeseaaeeeeeeaeeees 10 2 SIRATEGY amp POLICY cocisccecsaecesatwes daca casieossteneceasamsnasuneeansensansdessenessseiadandeweee 12 2 1 Organisation cleaning amp CISINFECTION c ccccccceeeeeeeeceeeeeeeeseseeeeeeeeeeeeessaueeeeeseaeaees 12 2 2 Centrally located versus local disinfections UNItS ccccecseeeeeeeeeeeeeeeeeaeeeeeeaeeeees 13 2 3 IN SVS LUI T E NNT E EE A A E A A IT E E 14 3 HUMAN RESOURCE MANAGEMENT cccccccessesc
149. that contact with contaminated surfaces is impossible e g hanging in a holster cabinet freely The transducer is very vulnerable so it should be protected against dust and falling the location of the holster must be chosen in such a way that this is prevented The transducer must be protected for transportation Transportation can best take place in a container padded with a fibre mat or cloth large enough to accommodate the transducer without excessive bending Hanging it in a narrow pipe properly protects the transducer if the pipe is only used for clean probes In case the transducer is stored in a case the transducer needs to be disinfected before the examination The transportation of a contaminated transducer should occur in a recognizable closed container labelled as contaminated In addition the container should be cleaned and disinfected after cleaning and disinfection of the transducer 5 4 Installation of a washer disinfector An installation check is performed by the supplier in consultation with the Medical Technology Clinical Physics before putting the washer disinfector into use regarding the following items General facilities There must be at least a water supply including filters a sewer connection electricity vaentilation connection and a network connection in the room Instrumentation Testing and if necessary calibration of osensors for temperature pressure and flow o disinfectant dosing system
150. the following moments o pamwe OOOO i72 serena cera fa after maintenance annually major HH 7 lf the washer disinfector is used for a new type of endoscope EHR is there a release procedure before commissioning of a washer 1 8 disinfector registration is an up to date technical logbook available for each washer 1 9 disinfector system answ er the questions by entering yes no or partly in the appropriate column The process parameters and process programs can only be pi _fameddyacpevateyautosorporons o The endoscope compartment is locked during the process If the process is interrupted continuation of the same process is impossible thereafter P The washer disinfector features pressure monitoring of the Pf channels through which obstructions are detected The washer disinfector has a provision that precludes EEM recontamination during the final rinse bacteria free water means The washer disinfector has a process counter serving periodic Pf maintenance The washer disinfector is equipped with a possibility to enter data serving patient tracking The washer disinfector is preventively maintained by an external frequency or internal technical expert at least once a year EEH control and release after regular major maintenance and major Date protocol repairs are established in a validation and release protocol for EER Validation by 2 9 washer disinfectors Release by The washer disinfector has a
151. tient by who and in which washer disinfector the endoscope is cleaned and disinfected Tracking amp Tracing Tracking and tracing is the registration of the successive data that guard the efficacy of the disinfection process Preferably registration of the endoscopy and disinfections processes takes place automatically Required measurement data and registrations Entry of the process number associated with date and time of the disinfection process Entry of serial number of the washer disinfector and the section container left or right place 1 2 3 or 4 etc Entry of endoscope serial number per section or place 40 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Entry of patient identification patient number of the used and to be disinfected endoscope per section or place Executive doctor handling the scope per section of place Executor of cleaning amp disinfection per section or place person who places the endoscope in the washer disinfector and person who takes the endoscope out of the washer disinfector after the cleaning and disinfection process person who releases the endoscope to for safe reuse Entry of an effective interrupted cleaning amp disinfection process per section or place with the entry of measurement data such as pressure measurements including leak test and continuous pressure monitoring for connect
152. ting how to act in case of date procedure malfunctions within reach and accessible for everyone 5 4 The process parameters and process programs can only be Pf authorised persons P anges by aprptatey auforsedpecomel 5 5 The endoscope compartment is locked during the process If the process is interrupted continuation of the same process is EEN impossible thereafter Be re wasting machine ues a arora a M nn by which obstructions are identified C asresionpoganme nn TT disinfection programme ki 5 10 The washing machine has a provision that precludes Pf means Po recontamination during the final rinse bacteria free water 5 11 The washing machine features a process counter serving periodic Pf ane 5 12 The washing machine features a possibility to enter data serving Pf Pe a 5 13 The washing machine is preventively maintained by an external Pf Executor pe E 5 14 The control and release after regular major maintenance and Date protocol major repairs is recorded in a protocol on validation and release Validation by of endoscope washers Release by Version 2 1 2011 93 answ er the questions by entering yes no or partly in the appropriate column PT resegoneadsnetat neem of detergent and disinfectant 6 2 The washing machine is equipped with connections which EE A E and demesne 6 3 Detergent and disinfectant are in a closed cabinet according to Pn storage quantity Pp oro papie a are
153. ting from 2004 the IGZ indicated that the visited hospitals where disinfection occurs centrally see apparent advantages of centralisation such as e better spatial facilities e activities executed by a smaller group so that the expertise is better utilized 2 3 Quality system The cleaning and disinfection process of flexible endoscopes should to be incorporated in the hospital departmental quality assurance system Assurance of the quality of this process should be based on quality thinking and quality cycles Plan Do Check Act cycles The conducting of audits both during purchase and installation of equipment and the implementation of the cleaning and disinfection process should be tested by frequent validations and audits Documents should be provided with usual management aspects such as production date validity author authorisation etc It is essential that there is a right assignment of tasks between the parties involved Documents for procedures with similar equipment used in different departments are required to show identical instructions standardisation 14 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author 3 3 1 HUMAN RESOURCE MANAGEMENT Responsibility and competence In an organisation where employees work with flexible endoscopes responsibilities and competences regarding cleaning and disinfection should be established Each instit
154. to indicate with yes no whether the mentioned criterion is present It is also possible to add comments and refer to enclosed documents The schedule of requirements contain legal requirements and points for attention set by the SFERD It is up to the hospital to value the points of attention or to request certain explanation or information A predetermined risk analysis as is among others recommended by the NVKF ref 29 is necessary to indicate what will be points of attention in the continuation of the acquisition process and what specific contributions by officials are required for this The appendices contain examples of requirements The requirements cannot be copied from one hospital to the next and should modified to fit the situation and needs of the particular hospital The documents in the appendices can be used as a starting point See appendix 14 Schedule of requirements for washer disinfector See appendix 15 Schedule of requirements for flexible endoscope See appendix 16 Schedule of requirements for drying cabinet gt If the compatibility of all endoscopes with the same chemistry is allowed 22 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Purchase Replacement Endoscope Disinfector Drying cabinet Assign Project leader Composition of Workgroup 4AQEdNOSAY articipants workgroup optional Orientation other addit
155. tor after every endoscopy program The transportation of the scopes should take place in closed transport containers that can be cleaned and disinfected properly Since the chance of a look back procedure is so low or it only holds one program in case of leakage of the scope a track and trace registrations is deemed unnecessary The scope is stored dry in a storage cabinet or otherwise dust free storage after disinfection The drying of the scope occurs by air drying it after manual disinfection with 70 alcohol In case the scope is not retrieved dry from the machine after automated disinfection it is advised to wipe off the scope with a gauze with 70 alcohol when removing it from the disinfector so that air drying is advanced STEP 15 Replacing the detergent and disinfectant containers Required materials detergent and or disinfectant compatible with the endoscope and washer disinfector gloves mouth nose mask apron safety goggles 32 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Procedure Observe the prescribed safety precautions see instructions washer disinfector and safety information sheath on chemicals The container with detergent and disinfectant is replaced according to the identification given by the washer disinfector Take a new container from the stock cupboard The types of containers to be used are recognisabl
156. ttention for the quality of healthcare is an important motive to consider the quality of healthcare of paramount importance Incidents regarding cleaning and disinfection of endoscopes received considerable attention in the media This led to image damage of the involved hospitals Healthcare transparency leads to increased social pressure This manifests itself among others in government mandated targets as stated in the Safety Management System VMS The patient safety is an important issue in the contemporary management of the hospitals Society demands the hospitals to safely perform endoscopic examinations and to provide openness of affairs even if safety is only slightly at stake This means that a hospital should have adequate resources for incident management This should be aimed at on the one hand prevention of recurrence of incidents and on the other hand provide clear information about incidents and possible risks for the patient 8 1 Incident management Despite all the attention for proper cleaning and disinfection of flexible endoscopes the possibility remains that an incident occurs The steps that should be taken in incident management are established based on a risk assessment in other words based on the estimation whether the incident possibly causes an emergency The aim of incident management regarding incidents with flexible endoscopes is to take immediate actions to prevent possible transfer of microorganisms through i
157. ue of decontamination form see example appendix 3 the loan endoscope should be registered at the Medical Technology Clinical Physics when returning it to the supplier STEP 14 Deviations from the primary process of channel less endoscopes The risk of transmission of microorganisms is considerably greater when using endoscopes with channels compared to channel less endoscopes This does not mean that these endoscopes can be reused without adequate cleaning and disinfection The WIP prefers an automated cleaning and disinfection process regarding endoscopes without channels When using an endosheath there is no indication for cleaning and the endoscope can be disinfected with 70 alcohol or other disinfectant approved for this purpose after removal of the sheath as described in the WIP guideline Thus without use of the endosheath there is always an indication for automated cleaning A very exceptional reason for manual cleaning can be failure of equipment by a power cut In short this means that the channel less endoscopes that are used with an undamaged endosheath can be disinfected after use with 70 alcohol with a contact time of minimally 30 seconds The channel less endoscopes are transported to the decontamination room in main building where disinfection takes place at the end of the program This helps to ensure that the scopes are automatically tested for potential leaks with use of the leak tester in the washer disinfec
158. urer of the washer disinfector use the appropriate set of tubes suitable for the endoscope Pay attention to the additional channels and connect these Check for any kinks in the tubes Where necessary remove any unused tubes for this see the manual of the supplier Place the valves distal caps and such in the washer disinfector after ultrasonic treatment see section 5 2 Remove gloves and disinfect hands Close the door of the washer disinfector Choose the appropriate cycle according to the instructions of the supplier Register the required information automatically or manually date time identification number of the washer disinfector patient information identification number of the endoscope physician endoscopy nurse assistant or CSA employee Start the cycle If the washer disinfector interrupts the cycle due to an error such as endoscope leak or disconnection the manufacturer s instructions should be followed Call in the help of the Medical Technology Clinical Physics in case of repeated error messages STEP 10 Release of the flexible endoscope after disinfection Check the display of the washer disinfector to see whether the disinfection process has been completed without errors Open the washer disinfector with disinfected hands possibly with gloves or by means of a foot switch Check whether all tubes caps and channel separators are still connected When all conditions are met then t
159. uria dipsticks Acceptance criteria The result of the cleaning process is acceptable if there are no blood residues visible in any of the samples If the micro hematuria dipsticks are used a result of more than 10 hemoglobin molecules per micro litre of eluate indicates that there were traces of blood present in the lumen Safety Handling of chemicals The information provided by the manufacturer of the chemicals e g safety data sheets must be adhered to Where necessary protective clothing examination gloves and safety goggles must be worn Waste disposal All chemicals should be disposed of in accordance with the regulations of the organisation concerned Instruments that have been into direct contact with the activated TMB solution or are flushed or wiped with a SDS solution should be re cleaned and disinfected again 84 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author Appendix 13 Release form flexible endoscopes Release form Flexible Endoscopes Washer disinfector Time Endoscope Tubes Channel Entire programme Control by number connected separator completed present Appendix 14 Schedule of requirements for washer disinfector Aim of the washer disinfector Cleaning and disinfection of flexible endoscopes and their accessories Il Interaction with endoscopes en their accessories All types of flexible endoscopes and accessories
160. ution will realise the execution according to the management model Responsible for the policy on flexible endoscopes is the Executive Board or Board of Directors they should according to IGZ advice ensure a clear allocation of responsibility concerning the process of cleaning and disinfection The IGZ is of opinion that a flexible endoscopes decontamination expert should be appointed For the proper performance of tasks this officer needs to have appropriate authorities such as to stop processes Below is described how the responsibilities can be further realized Expert on Endoscope Cleaning and Disinfection DSRD is responsible for the quality of the processes related to cleaning disinfecting and storage of flexible endoscopes is responsible for monitoring assuring and evaluating the process quality through internal audits is responsible for the quality of the provided improvement recommendations resulting from audits ensures that a policy change is translated into the procedures and work instructions is responsible for reporting and convening a policy team in case of possible emergency regarding endoscopes where patient safety is at stake advises on the purchase of flexible endoscopes and equipment determines the validation plan in consultation with the Medical Technology Clinical Physics the department Infection Prevention and the supplier is responsible for the functional release of the washer disinfector the drying
161. xecution of the prevailing procedures for maintenance and repair of flexible endoscopes and related equipment including execution of validation plan is responsible for recording malfunctions repairs maintenance of flexible endoscopes lend materials and related equipment advises on the purchase of new equipment concerning cleaning and disinfection of flexible endoscopes is responsible for the applicable procedures for the protection of employees reports accidents abnormalities to the DSRD 2 Endoscopy assistant meaning all assistants at endocopy departments both GE Urology Lungs and ENT Regarding the expertise it is recommended that a specifically qualified employee for disinfection is appointed 16 Professional Standard Handbook Flexible Endoscopes Cleaning and Disinfection freely provided the SFERD is listed as the author e is responsible for releasing the washer disinfector or drying cabinet after maintenance technical release Thereafter the DSRD needs to carry out a functional release validation e is responsible for installation transfer and acceptance of the equipment Adviser Infection Prevention e advises on purchase of washer disinfectors e participates in hygiene audits e supports and advises on the development of procedures regarding hygienic aspects e advises in case of an incident e advises on the purchase of detergents and disinfectants for cleaning and disinfection process for flexible endo
162. xtent of inspection and maintenance of the washer disinfectors should be carefully recorded Besides the technical measurements and microbiological checks the machine safety devices should be checked periodically Reliable storage of disinfected flexible endoscopes in drying cabinets is very important to guarantee the usability of the endoscope for a retention period longer than 4 hours Therefore drying cabinets should also be validated according to SFERD Flexible endoscopes have a complicated construction Which may cause defects abnormalities during use If these defects disorders are beyond the detection limits of the washer disinfector they are not identified and an endoscope can remain contaminated even though it flawlessly completed a disinfection process This handbook provides assistances for the checking of a number of hygiene related aspects of the endoscopes With regard to the question of who executes measurements that are necessary to verify the functioning of the washer disinfector the SFERD is of the opinion that the DSRD in consultation with Medical Technology Clinical Physics carries out periodical measurements tests and checks and evaluates the results based on the specifications of the manufacturer The DSRD decides who carries out the measurements tests and checks It is obvious to let the measurements tests and inspections coincide with performing preventive maintenance where possible This saves time increasing

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