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1. Testing the critical distal end To evaluate the cleaning results obtained for robotic instruments with everyday soils the 8 mm instruments can be used ten times for the robot and reprocessed after the last instance of use these were subject ed to manual and automated reprocessing as specified in the standard operating pro cedure But there was one difference im mediately before thermal disinfection they were withdrawn all excessive water was re moved with compressed air and they were placed in foil packaging and deep frozen un til examination In terms of the risk posed to a patient on reuse the distal metal end the working end including the internal cyl inder of the shaft tip with the Bowden cable have been defined as being especially criti cal To detach this part of the instrument the casing hood can be removed from the test instrument with a screwdriver Using a fine wire cutter the Bowden cables are cut on the control wheels permitting their un impeded rotation Now the metallic distal end can be separated from the shaft pipe and the Bowden cables cut with the wire cutter around 5 mm before the metallic distal end Using a magnifying device the working end of the metallic distal end and in particular the internal cylinder in the Fig 3 and 4 Separation of the distal metallic end and elution by vortexing with SDS solu tion transition region connecting the Bowden cables to the working end is thoroughly
2. eee n ee ee e bm mp em r e El ee e ee ES EE EE Medical Device Processing Manual Skills and Residual Risks Best of FORUM 17 18 Deutsche Gesellschaft fir Sterllgutversorgung e V www wolf corporate de SAFETY FOR EVERYONE 11127 MSS AWARD 14 Top Innovator 2013 NEW independent labelling and documentation system gt Integration of all sterile barrier systems sealable pouches and reels sterilization sheets reusable containers gt Easy import of the desired printing information via a scanner without an additional computer gt Printout of all relevant information incl the designation of instruments or sets gt Documented approval decisions after packaging and after sterilisation gt Easy documentation in the patient file gt Seal check function gt The following labels are available STEAM STEAM EO STEAM FIRM and VH202 Member of ERR C Sterile Barrier Association i nfo h awo D CO m g WWW h awo D CO m FORUM Medical Devices amp Processes 2013 EDITORIAL 1 Manual skills and residual risks ome things we can grasp others we need to understand Even so called validated processes must be performed every day by people with their hands and minds But what good is a valida tion of the technical equipment when the packing station is chaotic Looking at the various rules laws technical regulations standards guidelines and r
3. in 2011 The procedure has changed in so far as a sufficient amount of hand disinfectant must be taken into the dry palm of the hand so that all areas of the hands can be moistened properly and then rubbed care fully into the skin of the hands for 30 sec onds It is important that all skin areas are covered Particular attention should be paid to the fingertips and the nail beds In order to achieve an effect the correct product agent has to be selected taking into account the manufacturer s instruc tions and the activity spectrum which is divided into the groups A to D and is de fined as follows A elimination of vegetative bacteria my cobacteria fungi and fungal spores B inactivation of viruses C elimination of anthrax spores D elimination of clostridial spores Usually the containers are labeled accord ingly by the manufacturers If the letters A D do not apply the spectrum is given in words Bactericide inactivating bacteria Fungicide inactivating fungi Antje Hartwig Dr med Dipl Ing Thomas W Fengler CLEANICAL GmbH Genthiner Str 11 10785 Berlin E mail fengler cleanical de 22 VOLUME 19 Virucidal inactivating viruses envel oped non enveloped vi ruses Enveloped viruses are surrounded by a li pid membrane as for example HBV HCV HIV and influenza viruses The lipid mem brane is fragile and can be damaged by alcohol Enveloped viruses can be inac tivated with disin
4. dis infection and steam or low temperature sterilization In addition cleaning is designed to mini mize transmission of residual soils when the instruments are reused on other pa tients Verification of cleaning efficacy Cleaning efficacy cannot be assessed exclu sively on the basis of a reduction of organic soils to such an extent that the reprocessed items are visibly clean Indeed several in struments with gap regions joints lumens etc do not at all lend themselves to visual inspection Therefore an appropriate meth od must be used to assess cleanliness and presently this is chiefly done through selec tive elution of such instrument regions with a sodium dodecyl sulphate SDS solution and protein detection The acceptance cri terion used hitherto was a residual protein amount of less than 100 ug per instrument However the DGKH DGSV and AKI Guide line states in a footnote that in the case of instruments with everyday soils accept ance criteria that differ from the specified values can be applied to instruments used in special settings e g ophthalmology subject to risk analysis But since it is very unclear just what should be the focus of such risk analysis that suggestion is rarely taken up in practice Guideline compiled by the German Society of Hospital Hygiene DGKH German Soci ety of Sterile Supply DGSV and the Work ing Group Instrument Preparation AKD Assessment needs to be based on th
5. inspected There must not be any evidence of residual soils The distal end is next placed in a plas tic tube and e g 2 ml 1 SDS solution pH 11 is added by pipetting and the tube is screwed closed The tube is eluted for 15 seconds with a vortex the tube is then left to soak for 10 minutes then vortexed and soaked twice again Next the foam is let to somewhat settle the tube is opened and the distal end withdrawn with a forceps One aliquot of solution is sent for analysis e g on site using the Miele Test Kit with reflec tometric measurement In general the residue values obtained for this instrument part which contains a large surface area and must be taken account of in overall evaluation are well below 50 ug BSA equivalent bovine serum albumin This appears adequate with respect to the estimated total surface area The need FORUM Medical Devices amp Processes 2013 for assessment based on the surface area stems from the fact that the standardization committee ISO TC 198 WG13 believes that only by adopting such an approach will it at all be possible to harmonize the results ob tained for a chalazion clamp used in oph thalmology with those of an orthopaedic intramedullary reamer and furthermore this value has already been adopted by the group of authors who compiled the guide line for validation of processes for flexible endoscopes A value of lt 100 ug cannot merely be applied as the standard crite
6. kara EE for system tray heat resistant up to 134 C washable in washer disinfector available with rigid or flexible frame in two sizes also for storage and transport of fragile instruments 49 4363 905900 telefax 49 4363 90590590 8 VOLUME 19 FORUM Medical Devices amp Processes 2013 Package labelling and packaging process documentation C Wolf n general information should be add ed to medical devices that ensures safe handling In this regard the fol lowing information should also be recog nisable to the user at all times LOT number Sterilisation date and type of sterilisa tion Expiry date Designation of the medial device In addition the approval decision for stor age after sterilisation should also be visible on the packaging The new hawo VeriDoc labelling and doc umentation system see Fig 1 enables you to meet labelling requirements document the approval decision on the packaging as well as document the instruments used in the patient file Regardless of whether it s sealable pouches and reels wrappable sterilization sheets or reusable containers the new system enables the labelling and integration of all available preformed ster ile barrier systems Using the included software so called scan lists are first generated on a PC First and foremost these lists contain the names or personnel numbers of the au thorised packagers In additio
7. nated during use and presenting the high est transmission risk on reuse This demand is made because in the major ity of cases hitherto while only sections of instrument surfaces measuring less than 33 3 cm2 have been sampled and accord ingly the acceptance value of lt 3 g cm Fig 1 MIS loading trolley with missing sili cone support at the right front the pressure in each flushing device is more or less lowered but constant is much less than gt 100 ug the value ob tained was then applied as a flat rate val ue to the entire instrument i e its entire surface area That meant that the detect ed protein amount was distributed across the entire instrument despite it perhaps having been confined to a particular criti cal site This will no doubt mean that more and more unacceptable instrument regions will be identified needing recleaning and standardization of the cleaning methods used Standardization achieve ments and efforts Since the first edition of the DGKH DGSV and AKI Guideline was published in 2006 the cleaning processes have been revised and optimized in line with the experiences gained from validation in the field For ex ample today automated cleaning of surgi Dr Winfried Michels c o Miele Professional Carl Miele Str 29 33332 G tersloh E mail winfried michels miele de FORUM Medical Devices amp Processes 2013 cal instruments is carried out mainly with detergents tha
8. for a systematic transfer by faulty processing That would be documented and stand out in the benchmarking of the clinics A hygiene rating therefore should be less about the modern dangers recently described by science like prions and the cause of TSE transmissible spongiform en cephalopathy or vCJD variant Creutzfeldt Jacob disease but primarily about the prevention of transmission of ubiquitous spore formers that might sit under your shoe sole right now such as clostridium tuberculosis bacteria staphylococci and streptococci as well as various parasites I assert that the lethal risk from a reprocessed single use cardiac catheter is higher than the risk of dying from a prion related dis ease This remains an assertion since comparative figures are not available to me For both cases it remains to be proven but who is counting the incidences Courts of law tend to use the less elusive concept of organizational culpability as the causative fault in liability cases Here in Germany less than 1 000 deaths have been documented in the last 20 years that could be linked to prions more than 200 of which were related to one special method of dura mater grafts At this point we need more epidemiologically reliable statements about the actual risks of these so called slow virus infections 2 EDITORIAL FORUM Medical Devices amp Processes 2013 As it is we do not see such a specific risk of infection and rather a confusion
9. identical half cycles in accordance with ISO 14937 Section 9 4 5 it can be concluded that during sterilization all medical devices of which this PCD is representative will al ways reliably meet the requisite SAL lt 10 regardless of the concrete load size in the sterilization chamber when the H O con centration is above the lower limit value defined for routine operation Fig 5 Intubation fiberscope from Karl Storz Fig 6 Mobile bronchoscope MAF GM TM from Olympus 12 VOLUME 19 Fig 7 Da Vinci OR robot from Intuitive Surgi cal with 3D optics The limits calculated and validated for lu men sterilisation are given for the oper ator in the respective user manual and these are binding For example stainless steel lumens with a minimum diameter of 0 7 mm and a length of up to 500 mm can be sterilized in the STERRAD 100NX The Teflon working channels of flexible endoscopes with a maximum length of 875 mm must have an internal diameter of at least 1 0 mm The flexible endoscopes and bronchoscopes used in the urology setting are generally covered by these ef ficacy limits Thanks to interaction over several years with the world s leading instrument man ufacturers an internet database has been set up where operators can get up to date information on whether a particu lar medical device can be sterilized with the STERRAD system on site and which cycle should be selected This STERRAD Sterility Guide provi
10. illustrated in the Figure 1 the pressure drops significantly at the adjacent nozzles but the requisite con stant cleaning pressure is assured for the various process steps This raises the ques tion of what minimum pressure is needed at nozzles and adapters in the loading trolley This can be answered only by the washer disinfector WD manufacturer who must collect the relevant data for each loading trolley and its intended purpose during the type test he must define a specific mini mum pressure and publicise this accord ingly This constitutes a very important re quirement which must be incorporated into the validation guideline Likewise we have absolutely uncontrolled conditions and deviations for manual pre cleaning of instruments which often do not comply with the manufacturer s instruc tions For certain minimally invasive sur gical instruments it is recommended that their lumens be precleaned for a certain time at a particular minimum pressure and only then should they be exposed to an au tomated process But this can only be done in a reproducible manner under unchang ing conditions if the spray pistol is fitted with a manometer something I have to date never seen in a Central Sterile Supply De partment CSSD These are examples of is sues that must be addressed in standards and guidelines by defining appropriate re quirements for them But unfortunately the relevant standards in particular are l
11. in KRINKO 2012 do we find a definition of the term or even a template Generally understood SOP aim at sim plification of the exchange of information e g handling of special equipment per forming complex activities and at patient protection by defining minimum quality standards So this is important and we do want to get it right So we maintain what KRINKO does tell us about the requirements These are the places in the document in which we learn what SOP have to achieve p 1251 The standard operating pro cedures must specifically identify the critical process steps These should be considered in the context of periodic tests to demonstrate the effectiveness of each measure S 1251 The contents of the standard operating procedures must take into ac count the following requirements e The method is specified with suffi cient accuracy In particular the specification in cludes a detailed description of all the successive steps and the tools used in each case The description of the steps contains with reference to the tools to be used E Standard Operating Procedures according to clearly defined minimum stand ards including allowable tolerances to the applicable intensities rinsing and process times flushing volumes number of rinses etc For validation worst case aspects are used in relation to the conditions specified in the description S 1257 The standard operatin
12. in the number of cases treated from 14 576 613 in 1991 to 18 620 595 in 2012 Overlap of these opposing trends means that based on the number of hospitals the number of cases treated by each hospital has risen by 53 This trend is unfolding against a back ground of optimization of all relevant proc esses in hospitals where the latest treat ment concepts are applied and innovative surgical techniques introduced etc With average case numbers of 9 232 per hospi tal 2012 timely quality assured provi sion of the surgical instruments needed is also a challenge In addition to having to assure an adequate stock of instruments increasingly more importance 15 being as cribed to efficient reprocessing methods These are crucial for fast and efficient in strument turnaround times making a sig nificant contribution to reducing the budg et earmarked for instrumentation Ultra delicate optics systems electronic components or certain types of synthet ic materials lend themselves only to low Steam and STERRAD acceptable cycle times no hazardous substances used Relative humidity Fig 2 Sterilization processes in healthcare establishments temperature sterilization processes By means of a three dimensional coordinate system Fig 2 ranks the four sterilization processes normally used in healthcare es tablishments based on the criteria steri lization temperature cycle time and rela tive moisture Both steam
13. of cause and effect a misfolded protein prion does not know whether it is a medical device that it rests on If there really were a specific prions danger any and all reprocess ing of medical devices would be threatened by such aimless settlement professional and proper hygienic processes are either able to defuse potential risks for the following patient or they are not It will be recalled that Florence Nightingale was able to protect her patients quite effectively with her sterilization procedure de rived from cooking jam against lockjaw or gas gangrene after amputations The names of these infections impressively de scribe what they are disease names that were obtained from clinical observation in the sense of looking as described during wars by soldiers and paramedics later adopted by medical science The point being that intuition and experience have led us to the method of steam sterilization Why do we no longer trust our expe riences amongst other factors when it comes to risk assessment There is an overemphasis of the knowledge obtained in labo ratories under artificial conditions that superimposes our obvious and documented experience Wanting to be on the safe side may also prompt us not to use a bridge that leads forward and enter uncharted territory Many new surgical techniques necessitate a trade off between preventive hygiene requirements and functional surgical require ments e g miniaturi
14. role in sterile supply residual moisture a a 2 gt e CO SS dd l bi b k k b b bo b b Here EL Stainless steel wire mesh tray suitable forthe Storage in fine mesh tray for small items in Storage in fabric tray a wire mesh partition entire sterile supply circuit struments have additional protection when provides for a 2 shelf layout with unhindered secured in silicone racks cleaning disinfection and drying SS Reed yaaa 7 ku Permeable to hydromechanical cleaning and Optimal drying thanks to open design while Silicone mats hamper heat and condensate disinfection measures securing the instruments exchange during the thermodynamic steam sterilization process Improve sterilization Prevent residual moisture Grint Suitable tray systems reduce the weight and Special inserts in the tray secure small items increase permeability for detergent sterilant Permeability of the tray shaped design allows Suitable storage of solid instruments reduces for circulation of the detergent sterilant any residual moisture 16 VOLUME 19 FORUM Medical Devices amp Processes 2013 New ebro Thermologger sets Validation and routine control of automated cleaning and disinfection processes for the processing of thermolabile endoscopes WD E I Kruse the Guideline for Routine Inspection and Validation of Automated Clean ing and Disinfection P
15. sterilization and H O plasma sterilization with STERRAD score particu larly well when it comes to meeting the de mand for efficient reprocessing processes With cycle times of between some 30 min utes and one hour both these two proc esses can make an important contribution to a quicker instrument turnaround time saturated steam at 134 C for heat resist ant medical devices and gaseous H O at about 50 C and a dry state relative hu midity of around 5 for heat and mois ture sensitive medical devices Christian Witte Johnson amp Johnson MEDICAL GmbH Robert Koch Str 1 22851 Norderstedt Germany E mail cwitte its jnj com FORUM Medical Devices amp Processes 2013 Process control and efficacy limits of the STERRAD process The relevant parameters of the STERRAD processes have no defined set point val ues since these are determined by the respective load in the sterilization cham ber Hence they differ from one batch to another Of particular importance here are adsorption processes which depending on the size and material composition of the load have a major impact on the HO concentration in the sterilization chamber Following evacuation a constant amount of hydrogen peroxide H O the steriliz ing agent is injected into the sterilization chamber The concentration of the now gaseous H O that has vaporized in the vacuum is a key parameter for a success ful process Immediately after injection
16. the H O concentration reaches its peak value This concentration then declines considerably in some cases depending on the items being sterilized due to chemi cal reactions and disintegration process es Both the maximum H O concentration immediately after injection as well as the temporal course of the H O concentration in the ensuing diffusion phase are depend ent inter alia on the size of the load in the sterilization chamber and on the material and surface composition of the sterile sup plies see Fig 3 To ensure that this sterilization process is safely operated with a SAL lt 10 precise lower limit values have been defined for the H O concentration and incorporated into the process control If this interrup tion limit is undershot during routine op eration see Fig 3 the cycle is automati cally interrupted by the process control and a corresponding error message gen erated Fig 4 Kidney stone lithotripsy with the fle xible laser ureterorenoscope Cobra from Richard Wolf H202 mg Liter 1 half cycle Possible H O concentration in routine operation Fig 3 example STERRAD 1 OONX Another feature of the process control in volves division of the entire process into two identical half cycles with one ampoule containing a constant amount of H O be ing injected at the start of each half cycle Together with the interruption limit the prerequisites for microbiological perf
17. the market it is up to the operator to assure the good quality of these reconditioning measures that we call reprocessing see volume 16 of the International FORUM Medical Devices amp Processes Dr med Dipl Ing Thomas W Fengler Cleanical Investigation amp Application www cleanical de CONTENT MANUAL SKILLS AND RESIDUAL RISKS 1 Editorial 4 W Michels Standardisation of Cleaning Efforts and Manual Precleaning of Robotic Instruments 8 C Wolf Package labelling and packaging process documentation 10 C Witte STERRAD H O plasma sterilization the efficient alternative for sterilization of high tech medical devices 14 Moisture in medical device units MDUs 16 Kruse New Thermologger Sets 18 R Graeber A Hartwig T W Fengler Standard Operating Procedures according to the German KRINKO 2012 21 A Hartwig T W Fengler Hygiene at the MD Related Workplace 24 Processing is always at least partly a manual task Best OF VoL 17 18 Only clean medical devices function safely Nur saubere Medizinprodukte funktionieren sicher 4 VOLUME 19 FORUM Medical Devices amp Processes 2013 Developments for standardization of cleaning efficacy and manual precleaning of robotic Instruments W Michels leaning is the first and an impor tant step when reprocessing the instruments used for surgical pro cedures Its purpose is to assure the effec tiveness of the subsequent steps i e
18. Fig 4 illustrates a schemat ic diagramme of kidney stone lithotripsy with the two channel laser ureteroreno scope Cobra manufactured by the firm Richard Wolf Fig 11 ProART Robotic Transducer from B K Medical Intubation fiberscopes are specially de signed to meet the requirements of anaes thesia and intensive medicine providing for intubation under visual control The intubation fiberscope from Karl Storz il lustrated in Fig can be equipped with a LED battery light source for mobile use Fiberscopes have a very intricate design and contain several components that do not tolerate steam sterilization Thanks to the ultra short cycle times of less than one hour the STERRAD process assures repeated use of this highly valuable medi cal device throughout the day Fig 6 illus trates another example from the group of flexible endoscopes this is a mobile bron choscope from Olympus with integrated monitor and data storage medium 3D optics 3D optics were first developed for use in robot technology and first used as a sys tem component of the Da Vinci operating FORUM Medical Devices amp Processes 2013 robot from Intuitive Surgical Fig 7 Spa tial vision during minimally invasive pro cedures underpins well targeted and pre cise working practices even for the most delicate tissue structures 3D optics contain two independent pre cisely matched optic systems within mini mum space Thermal tension
19. ackages 3 Review of all packages for integrity moisture and humidity Ge 4 Scan Steri batch release E 5 Parametric verification of the physical values according to the selected processes 6 Verification results are positive documented release by confirming with YES Verification results are negative documented with NO in the protocol Further procedure see SOP 02 Non Release of Medical Devices IMPORTANT Observe cooling time 20 to 30min then order picking for customer or storage Created by Date Signature reviewed Date Signature approved Date Signature e g Head of CSSD e g QM Representative Director of administration 20 VOLUME 19 FORUM Medical Devices amp Processes 2013 Example SOP 002 Department Reprocessing of Medical Devices CSSD Hospital Logo Non Release of Medical Devices Unden ul ll _ ll Sterile Goods Storage RoomNo Siderooms ll ll Quality Assurance reliable sterilization error minimization Who Only Designated Persons When After the end of the process How Read each computer batch record and review each sterilized item Non release whole batch 1 Sterilization temperature and time not reached gt process failed 2 The sterilizer signals failure gt inform CSSD management 3 Any unreleased batch and disorder must be documented by a Designated Person 4 All packages of this charge are to be taken back to the packing stat
20. agging behind the current state of the art in science and technology Instrument cleaning based on the cleaning arms technology holds out prospects for important improvements in the future and in this respect certain developments are long overdue But we must bear in mind that instrument cleaning in particular cleaning of joint instruments is largely determined by the load The configuration used so far for the cleaning arms and spray pattern does not always ensure that the cleaning jets will be able to gain direct access to gap regions This depends on how the gap is po sitioned versus the direction of the cleaning jet Often reflected cleaning solution jets are better at accessing joint gaps than are direct cleaning jets Therefore scissors or clamps are better cleaned when they are not placed separately in the machine but sur rounded by other instruments that gener ate reflected jets This means it is difficult to assemble a proper load and always avoid over or underloading The long duration of cleaning processes al lows for a broad fluctuation range but this is not very efficient These are just a few as pects that require further standardization While in recent years there have been cer tain achievements in process standardiza tion to paraphrase the German author Jule Mann There is still much to be done let s file it away Reprocessing instruments that are difficult to clean or are of in tricate desig
21. asure to interrupt the chain of infection is surface disinfection Microorganisms pathogens can survive for months on surfaces and be transferred to humans via hands or dust Therefore surface disinfection is an important meas ure to prevent the transmission of disease Surface disinfection must be carried out routinely or continuously There is a dis tinction between targeted disinfection and final disinfection Targeted disinfection is event related and takes place for example on areas of visi ble contamination with blood pus secre tions or other body fluids or in outbreak situations or occurrence of specific patho gens Also dust the taxi for microorgan isms and other contamination should be removed by use of surface disinfection Fi nal disinfection occurs after the transfer or death of a resident or patient infected or colonized with pathogens In this case disinfection has to cover all near patient surfaces or all accessible surfaces and ob jects resp that may be contaminated with pathogens The different types of surface disinfection and when to use which should also be ex plained in job related procedural instruc tions Areas with frequent hand or skin contact should be disinfected regularly Here are some examples door knobs handrails keyboards phones monitors surfaces in communal sanitary areas toilets sinks areas for processing food or changing diapers floors in high r
22. at is closed at both ends This procedure must be repeated thrice each time turning the instrument by 90 Fig 2 This is an onerous procedure and besides the techniques used for perform ance qualification are not always availa ble Unfortunately often such really criti cal instruments are not tested Otherwise it would have been noted that the clean ing process was not assuring acceptable results Because of their construction for the instruments mentioned above by way of example the measures described for sampling should in principle be defined as manual pretreatment steps for the ensuing automated process so as to achieve satis factory results Fig 2 Method for sampling intramedullary reamers or potential precleaning method 6 VOLUME 19 In terms of the nature of the residual soils after use dental transmission instruments are not a problem However they are of complex design and the turbines in par ticular the drives may be contaminated Standard EN ISO 15883 2 Section 5 1 1 States that the connectors on WD loading racks must have powered devices to power the instrument or its drive during the proc ess From a theoretical perspective this is plausible as it ensures that during the proc ess the contact points in the drive can be ac cessed by the cleaning solution But to date such flushing devices have not been fitted nor have any investigations been carried out on the need for them These are but
23. blished in 2001 that attempted to answer open questions and to adapt the document to the state of science and technology Amaz ingly it took a particular instrument to the foreground that has very little to do with the rapid technological progress of the last 10 years the Standard Operating Proce dure SOP SOP as a tool to ensure the reproducibility of processes and reprocessing results has been upgraded massively in KRINKO 2012 as compared to the older version Especial ly in connection with manual processes and in the processing of medical devic es with increased reprocessing require ments e g flexible endoscopes cysto scopes bronchoscopes is the writing of and the compliance with SOP a minimum condition And regarding the question of suitable validated methods Annex 1 Writing up an SOP is required in 15 cas es out of 16 individual steps In fact in 11 cases that is the only action required One might say that SOP are just as es sential for the legitimate operation of a processing department as is the use of wa ter and process chemicals Unfortunately the requirements for SOP are not as clear ly set out as they are for water and chemi cals at least by reference to applicable standards nor is the term Standardar beitsanweisung very precise as such it is indeed generally translated into English with SOP however it really only means standard working instructions Nowhere
24. des a comprehensive service and can be accessed at www ster radsterilityguide com worldwide from any computer with internet connection Typical high tech medical de vices for which their manufac turer has recommended the STERRAD process The rapid advances in medical instrument development is lending momentum to in novative surgical techniques involving the use of highly valuable complex and ultra precise medical devices These contain inter alia filigree optic systems electronic components or certain synthetic materials which often are not able to tolerate high FORUM Medical Devices amp Processes 2013 Fig 8 3D optics system Einstein Vision from Aesculap Fig 10 Semi rigid optics device from Poly Diagnost temperature or pressure values As a re sult in recent years low temperature steri lization processes are once again attract ing more attention In the reprocessing instructions they are required to provide in compliance with ISO 17664 leading man ufacturers are increasingly recommend ing the STERRAD process for sterilization of their heat sensitive medical devices A number of such examples are given below Flexible cystoureteroscope bronchoscope and intubation fiberscope There has been a sharp rise in the trend to wards using flexible endoscopes for urol ogy procedures In addition to assuring gentle use for the patient these hold out prospects for completely novel treatment modalities
25. e flushing of the working channels is essential Yara La Aa Ee Sep RI WW d the N A lt L E AR CG Wi 1 amp 1 Wa K F E S S Saa D 78532 2 Tuttling n Germany Phone venue GC CA 902 ae 7461 708 105 E Mail info karlstorz de 90 Fax 1 800 321 1304 E Mail info ksea com 0 Fax 1 305 262 89 86 E Mail info ksela com Quality cycle of instrument reprocessing Intervention OR or endoscopy Disassembly of medical devices Y Storage o A Removal of gross 4 contamination 4 A Commissioning ree Transport Documentation S Cleaning A manual automated N gt D Sterilization Si P Disinfection thermal chemical TED Inspection Maintenance Packaging sterile barrier system miso CEN G61 final rinsing and drying required riences TT TS schitke STOR a P RO F E S S j O N A L KARL STORZ ENDOSKOPE MEASUREMENTS FOR LIFE H CLEANICA gmbh
26. e re spective surface area because this is the only way to harmonize the results obtained e g for a delicate root canal instrument with those for an orthopaedic intramedul lary reamer The working groups responsible for the guidelines compiled by the DGKH DGSV and AKI for validation of automated as well as manual cleaning and disinfection will now set the acceptance criteria in line with the respective surface area at lt 3 ug cm thus taking account of the ancient wisdom of Paracelsus who stated Poison is in eve rything and no thing is without poison The dosage makes it either a poison or a remedy The effectiveness of the post cleaning proc ess steps is in any case determined by the layer thickness of any residual soils per sisting after the cleaning step since this helps to protect embedded microorgan isms against the reprocessing agents dis infectants sterilants Likewise the resid ual protein amount that can be transmitted when reusing an instrument depends on the instrument surface area that comes into contact with the patient and the pro tein amount that can be passed on at that time This means that the chief determinant here must be contamination burden in rela tion to a particular surface area This amendment is accompanied by the de mand that when inspecting after cleaning instruments contaminated during every day use the focus should definitely be on those instrument parts primarily contami
27. ecommendations for hygiene in the reprocessing of medical devices one can easily lose track What is important what is right What is redundant or even superfluous Currently ISO 17664 is under revision and the European Directive is being renewed and will no long er have to be transferred into national law The diversity is irritating concerning the sheer number of rules and the inconsistent use of some terms Example What do I expect when asking for biocompat ibility or how do I actually test if a material is pyrogen free A claim is worthless if the performance is not verifiable And we are not even talking about actual and unannounced inspections which are ap parently planned with the new European Regulation What is remarkable about the development of such rules is that they are always trying to encompass everything while not every thing is testable some items therefore remain floating suggestions or rather requirements and leave the problem of feasibility to the users He feels the burden of responsibility but often feels left alone when he is looking for concrete aid in the regulations What is missing here is the acknowledgment of the limits of controllability a sense of permissiveness Millions of instruments are handled every day in order to produce medical devices for an intended use again they were contami nated and now by means of a procedure become sterile again at least it is the unprovable goal that at the end of thi
28. ective equipment and also in respect to the need for vac cinations The microorganisms that can make you sick can not be seen with the naked eye there is an invisible risk of infection But the risk is manageable if appropriate hygiene measures are implemented Also some employees lack of knowledge about the transmission routes of microorganisms is a reason for occasional carelessness Information on the transmission paths of pathogens should be included in the regu lar training of employees outside of medi cal institutions such as the repair service for medical devices There is for instance airborne droplet infection microorganisms can be trans mitted through tiny droplets of mucus that come from human airways flying through the air and being inhaled by other peo ple Then there is smear infection the in direct transfer through contact of an ob ject that is contaminated with infectious secretions such as saliva urine stool The direct transmission from a sick indi vidual to a healthy person through direct physical contact or by touching contami nated materials or surfaces would be con tact infection Additional protection is afforded to specif ic jobs by the personal protective equip ment PPE which must be provided by the employer PPE includes head hair pro tection eye protection full face protec tion protective gown apron gloves and safety shoes Articles of protective equip ment shou
29. fectants that have a lim ited virucidal effect Non enveloped vi ruses are not surrounded by a membrane envelope typical examples are norovirus or rotavirus Non enveloped viruses have a higher resistance to chemical or physi cal processes and other environmental influences and may require the use of a particularly powerful disinfectant which are declared as virucidal For the day to day practice procedural instructions should be issued so that all employees can perform their job related activities in a similar way These instruc tions must be as brief and intelligible as possible and displayed in a workplace re lated manner and impossible to overlook They also form the basis for the regular training of personnel for proper implemen tation of activities and processes Table 1 shows an example of a procedural instruction for Hygienic hand disinfec tion in 11 points Items 1 to 9 can be ac commodated concisely in the head of the document In points 10 and 11 the activ ity or process is to be described compre hensively Example for Item o Process Description Hygienic hand disinfection All washing facilities are equipped with a wall dispensers for hand disinfectant A hollow handful of hand disinfectant undi luted gets rubbed into dry hands moisten ing all skin areas Pay special attention to fingertips and thumbs The skin should be kept moist with the agent throughout the application time of 30 seconds A
30. fter treat ment the agent must be fully absorbed by the skin Example for Item 11 Execution of Hygienic hand disinfection Always before the washing of hands After entering the place of work before start of activity After using the toilet After taking off the gloves When leaving the place of work after the end of activity After coughing or sneezing FORUM Medical Devices amp Processes 2013 Hand hygiene is more than just hand dis infection even though this is the most im portant part But proper washing and care of hands is important too in order to main tain the natural protective function of the skin Ifthe skin has neither cracks and inju ries nor is it softened up too much patho genic microorganisms have a hard time penetrating Hand washing should be done only before the start of the shift and if they are real ly dirty The water should be lukewarm and the washing lotion should be pH neu tral and non scented To dry the hands disposable towels are recommended For hand care the right lotion is to be select ed on the basis of the manufacturer s in structions The lotions differ in composi tion water in oil w o or oil in water o w and are intended for various uses and cir cumstances before during or after work Gloves should only be worn when it is re ally required or necessary in accordance with procedural instructions Surface disinfection Another hygienic me
31. g proce dure must include e the form of documentation of the re lease decision and e the procedure for deviations from the correct process flow QM Based on these requirements we have cre ated a standard operating procedure ac tually there are two documented release and non release which we hereby offer as a template for anyone who needs it These SOP are in use in the practice of a Central Sterile Supply Department so they are kept as concise as possible E Ronald Graeber Antje Hartwig Dr med Dipl Ing Thomas W Fengler CLEANICAL GmbH Genthiner Str 11 10785 Berlin E mail fengler cleanical de FORUM Medical Devices amp Processes 2013 VOLUME 19 19 Example SOP 001 Department Reprocessing of Medical Devices CSSD Unclean Area Hospital Logo Release of Sterilized Medical Devices tt cn hen TT sam J Quality Assurance reliable sterilization error minimization Who Only Designated Persons When After the end of the process How Read each computer batch record and review each sterilized item 1 Review of chemical indicators to even and complete changing according to manufacturer s specifications and reference illustration gt BD test indicators on the labels and indicators on the package The indicator of the BD test should be discarded after reading The result is to be documented 2 Review of the full correct identification of the sterilized medical devices on the p
32. ion repacked be provided with a new batch label to be scanned again and to be sterilized Procedure Non release of individual packages of a batch 1 If the indicator is missing on the package 2 If the package is broken 3 If the packaging shows signs of moisture and or humidity 4 Any non approved package must be documented by a Designated Person 5 All non released packages are to be taken back to the packing station repacked be provided with a new batch label to be scanned again and to be sterilized Created by Date Signature reviewed Date Signature approved Date Signature e g Head of CSSD e g QM Representative Director of administration FORUM Medical Devices amp Processes 2013 VOLUME 19 21 Hygiene at the MD Related Workplace Hygiene training for employees who work with medical devices outside of medical facilities A Hartwig Th W Fengler he term hygiene according to the World Health Organisation refers to conditions and practic es that help to maintain health and prevent the spread of diseases Medical hygiene therefore includes a specific set of prac tices associated with this preservation of health for example environmental clean ing sterilization of equipment hand hy giene water and sanitation and safe dis posal of medical waste All hygienic measures have the objective that pathogens such as Bacteria enterococci staphylococci streptococci clo
33. isk areas Floors and work surfaces should be smooth with sealed joints wipeable and resistant to disinfectants Personal protec tive equipment should be worn when car rying out surface disinfection Disinfectants are hazardous substanc es therefore the manufacturer s infor mation operating instructions and safe Table 1 Example of a procedural instruction Hygienic hand disinfection in 11 points Title Scope Purpose Accountability Definition abbreviations Applicable Documents Effective Distribution Amendment Process description Execution Hygienic hand disinfection Acceptance of defective medical devices Interrupt the chain of infection Head of department Disinfection inactivation of microorganisms Infection Protection Act Occupational Safety and Health Act 20 02 2013 Staff department heads management 28 02 2013 Hygienic hand disinfection how to do it When to do it FORUM Medical Devices amp Processes 2013 ty data sheets must always be observed When producing a disinfectant solution the proper concentration or dosage must be adhered to It is important to ensure that the entire surface to be disinfected will be wetted by the disinfectant solu tion and that reaction times are observed Personal protective equipment PPE We can often observe a lack of insight re garding the importance of regular hand disinfection surface disinfection and the wearing of personal prot
34. kaged underwent a sterilisation process visually inspected and approved When using medical in struments a second check should also be made to ensure that the sterile barrier system is intact and or has been sealed correctly The written approval can also be performed in the appendix to the pa tient file The guidance document ISO DTS 16775 requires that quality properties should be checked with an appropriate system and recommends commercially available dye penetration test kits or other seal indica tors e g Seal Check Christian Wolf CEO hawo GmbH Obere Au 2 4 74847 Obrigheim Germany E mail VeriDoc hawo com FORUM Medical Devices amp Processes 2013 VOLUME 1919 Fig 3 Before performing this test the barcode on the seal indicator or dye penetration test can be scanned see Fig 6 The sys tem then automatically prints a label with the relevant test information such as test date time ID of test person as well as in strument identification After comparing the Seal Check with a reference card see Fig 7 the test can be approved directly on the label with a signature and this can either be placed directly in the test system or documented in a separate list E Fig 4 a Fig 4 b Fig 5 Fig 6 10 VOLUME 19 FORUM Medical Devices amp Processes 2013 EE STERRAD H O plasma sterilization the efficient alternative for sterilization of high tech medical devices C Witte Hospita
35. ld be designed for single use and are to be discarded after the single use The protective equipment should be worn only at the workplaces in accordance with a procedural instruction When leaving the workplace the protec tive equipment must be removed Should reusable items be used after all they must not be taken home for cleaning Defective items have to be discarded and replaced with new ones Workplace hygiene Structured yet not overwhelming work place hygiene should be an integral part of occupational health and safety The right level of hygiene is a plus for health protec tion at every workplace The proper equipment of the respective worklace is a prerequisite for the imple mentation and application of hygiene This is regulated by the national workplace reg ulations e g for work rooms changing rooms wash basins and toilet rooms rec reation rooms or first aid rooms Room temperatures noise and lighting and the condition of the floors are also regulated Once the work places are equipped and work has started these should be checked in the course of regular risk assessments Workplaces need the appropriate stand ard of hygiene which means they and their surroundings are clean and maintained Any defects must be reported immediate ly Contaminations deposits that can lead to hazards must be removed immediately Collecting proof for the quality of results is one of the most important tasks Manu fac
36. ls Source Statistisches Bundesamt q 1 13 0 r Ph a gt n Treatment cases million 28 wl Temperature E j E E EK 25 0 Be d e gt gt Faster instrument turnaround times needed Fig 1 Situation in German hospitals from 1991 to 2012 odern and economical routine surgical operations call for optimum time management of all relevant processes Innovative surgi cal techniques require increasingly more complex high precision instruments that often are not autoclavable H O plasma sterilization with STERRAD offers a safe and fast low temperature alternative Background For several years now two opposing trends have been observed in the German health care sector On the one hand the number of hospitals as well as the number of availa ble beds has declined sharply over the past 20 years while during the same period of time the case numbers have continued to rise Based on data from the Federal Of fice of Statistics this trend is illustrated in Fig 1 for the period 1991 to 2012 The number of hospitals declined from 2 411 in 1991 to 2 017 in 2012 by around 16 and the total number of available beds was reduced from 665 565 1991 to 501 489 2012 by as much as 25 Con versely at the same time there has been a sharp rise of around 28
37. n Every CSSD or medical device reprocess ing centre knows from experience which instruments or instrument sets can or cannot be directly loaded on the WD trol ley and satisfactorily reprocessed with the cleaning disinfection processes available Standard operating procedures must state which instruments need to be precleaned with a brush by soaking ultrasonic clean ing etc to achieve an appropriate cleaning result after automated reprocessing This VOLUME 1915 entails initially at least visual inspection to ensure the absence of soil residues For performance qualification of an automated reprocessing process using a semi quan titative or quantitative protein detection method these critical instruments are of ten not included If we take for example the case of the non dismantable bone punches or intramedullary reamers such instru ments cannot be eluted to ensure that an adequate amount of more than 50 of the remaining soils can be recovered for pro tein detection More laborious measures are needed here For example the work ing end of the bone punch must be placed in a test tube containing a few millilitres 1 SDS solution of pH 11 Next the test tube with the instrument is mounted on a stand and immersed into an ultrasonic bath and sonicated while moving it manually To sample an intramedullary reamer this must be placed at an angled position on an agitation bench to open gap regions and eluted into a tube th
38. n all avail able instruments sets or containers are also included with their names or desig nations A barcode is automatically as signed to each item or set on the list The lists are then printed on any commercially available printer and made available to the user in the CSSD at the packaging location see Fig 2 Additional information such as the size of the pouch sterilisation sheet or container can also be directly added so that a suitable sterile barrier system is always used This process only has to be performed once for the initial installation 1 If this is not immediately apparent 2 When using other seal indicators a corresponding barcode can be added to the scan lists Fig 1 For daily use an additional computer is no longer required When the work process is started the user first scans his name Then the designation of the item or set to be packaged is scanned The system now knows what should be packaged and by whom In addition you also have the option of assigning an indi vidual expiry date to the packaging This is especially important when event related expiry dates have been defined by the op erator After successful packaging sealing wrapping or closing of reusable contain ers the sterile barrier system undergoes a visual inspection This includes checking the quality properties listed in ISO 11607 2 such as making sure there are no punctures or tears no open seals or that there is a con
39. nus vaccination Utilise correct hand disinfection and hand hygiene Avoid trauma to the skin Wear personal protective equipment No eating and drinking at the workplace Correct surface disinfection Keep workplace and surroundings clean Follow procedural instructions Perform risk assessments Review of the results by sampling and documentation E 24 VOLUME 19 FORUM Medical Devices amp Processes 2013 Processing Is always at least partly a manual task Fig 1 Instrument inspection and mainte nance is distinct in each case and requires care and knowledge Fig 4 Sealing a soft package creating the sterile barrier to be finalized during the steri lization process Fig 7 Preparation of pre cleaning with the help of water and compressed air using per sonal protective equipment PPE Fig 2 Assembling trays and reducing the contents in collaboration with the surgery team Fig 8 Then and now manual dexterity ex pertise and personal protective equipment PPE are required Fig 9 Organising the unclean side with over view and an orderly mind Fig 3 Single package from a roll targeted for specific medical products Fig 6 Assembling some tubing into a special tray basket Fig 10 Loading of a washer disinfector is manual labour and requires experience Fig 11 Even flexible endoscopes require ma nual process steps th
40. ny A vaccine has been licensed in the People s Republic of China since April 2012 but an approval for Europe is not yet in sight Vaccination against tetanus is also recommended Hand hygiene Hygienic hand disinfection is another measure of hygiene and one of particu larly high priority at that In more than 80 of cases infections are transmitted via the hands The breaking of the chain of infection is of great importance Failure to perform hygienic hand disinfection is not a trivial offense it can be judicially pun ishable as gross malpractice To achieve effective disinfection of the hands the staff should be regularly trained in the proper implementation of hygien ic hand disinfection and sources of error should be pointed out specifically Com mon errors are the hands are washed too frequently but not often enough disinfected jewelry watches and rings are not taken off at work nail polish or artificial nails are used worn skin friendly products are not being used hands are not completely dried before disinfection dirt is not removed beforehand not all surfaces of the hands wrists are being treated exposure time is not observed hands are not kept moist for the entire exposure time The correct sequence disinfect first then wash is not observed The rub in method in 6 steps was re placed in Germany by the personal re sponsibility method for rub in
41. on the load and packaging systems there can be residual moisture providing portals of entry for microorgan isms and jeopardizing sterility see EN 285 Part 8 4 0 2 Weight increase in metal load in DIN 58953 Part 9 max 10 kg weight Containers are reusable and dimensionally stable but have comparatively small portals of entry for the sterilant steam For trays in soft packaging the entire surface serves for Residual moisture reduces the tensile strength of the packaging system and creates portals of exchange of gaseous media it is easier to entry It is a common reason for repackaging and resterilization since shelf life is not assured detect residual moisture and damage The number and arrangement of the medical devices have an impact on the amount of residual moisture The bottom of the bowl should face Too much is not smart tube lengths should The amount of residual moisture is camou be less than 2 m etc flaged by textiles Use of non perforated metal a WW Cleaning and drying problems because of too few perforations in the Various materials have very differ screws are not properly cleaned perforated plate tray and layer system ent thermal capacity and accord screws are bathed poor drying ingly cooling behaviour leading to condensate formation and drying problems FORUM Medical Devices amp Processes 2013 VOLUME 19 15 Container material and design play a major
42. orm ance qualification as set out by ISO 14937 Section 9 4 5 are thus met Moreover STERRAD processes are run completely independently of the quality of the local media such as e g the water or steam quality Apart from the active in gredient cassette with the H O ampoules all that is needed is a power supply con nection This provides for validation and documentation of the efficacy limits in particular for long and narrow lumens These are well known for the demands they make on the sterilization processes already during their development stage and independently of the subsequent site of operation VOLUME 19111 Per half cycle reduction of the microbial count by at least 6 log levels 2 half cycle Small load 50 Time minutes Relationship between H O concentration and load size in sterilization chamber Pursuant to ISO 14937 Section 9 4 5 to validate the efficacy limits special proc ess challenge devices PCDs are inocu lated with more than 10 cfu of the test organism G stearothermophilus which is highly resistant to the process These PCDs are then placed at the site deemed most appropriate in the load and exposed to a greatly reduced H O concentration beneath the interruption limit in routine operation and only the first half cycle is run see Fig 3 If no viable organisms can be detected in or on the PCDs during the ensuing evaluation by extrapolating this finding to the entire process two
43. owden cables and as such the working end would be continually moved during the process and the contact surfaces always accessible This would present a technical challenge and would be very expensive Since robotic in FORUM Medical Devices amp Processes 2013 struments that have a coagulation function must not for material compatibility rea sons be precleaned with a hydrogen perox ide solution as is normally the case for oth er MIS devices the adherent residues must be removed by brushing while moving the Bowden cables Only when visual cleanli ness of the working end is assured through manual pretreatment thorough cleaning i e reduction of the residual protein to an appropriate degree can be assured The internal distal shaft region with the seal to the working end represents another critical zone in these instruments In unfa vourable cases as much as a few hundred microliters of blood can be recovered from this region To assure cleanliness of this cavity it must be filled immediately after use via the cleaning channel with an en zymatic detergent For manual precleaning replenishing the cleaning solution at regu lar intervals until the recovered solution is relatively colourless has proved beneficial This paves the way for thorough cleaning in the WD Experiences based on perform ance qualification of instruments with eve ryday soils have shown that satisfactory cleaning results can be thus achieved
44. remendous amount of medical devices that the respective manufacturers have to process in some way or have to throw away An appropriate risk assessment of workshop medical devices must of course be based on as much sound information as possible regarding their use e g did tissue contact with animals and or body tissues including corpses presumably or actually take place Such documentation would help in the selection of appropriate processing steps What is not helping are the worst case scenarios which have unsettled reprocessors for two decades now when it comes to the perceived prion risk Even 20 years after the peak of the mad cow disease in Great Britain most people are still reading their newspaper the right way around to name a possible symptom Neither in daily life nor through surgical contacts did a significant number of transmissions happen although it is possible to provoke it in animal experiments by direct inoculation of infectious ma terial into brain tissue Regarded by epidemiological criteria the risk of a BSE epidemic has been irrelevant these twenty years What is highly relevant on the other hand are infections with staphylococci streptococci tuberculosis and spore forming chlostridiae and of course MRSA Therefore we sterilize instruments after proper processing and hope that an infection has been rendered impossible by the chosen process Experience seems to prove us right because there is still no evidence
45. rion for all instrument types After all we do not define pollutant concentrations on www interlockmed de KSM Sn SS 77 5 eer eye ees Interlock Medizintechnik GmbH e phone Bit Hee EER S TH the basis of their quantity in the ocean or in a sea because it is the concentration that determines the toxicity Conclusions Reprocessing as used for robotic instru ments entails a combination of a manual and automated process The outcome of the automated process is absolutely dependent on the thoroughness of manual precleaning and pretreatment Hence any variations in the quality of the results obtained are much more likely to be imputable to the manu al steps which can be standardized and VOLUME 1917 reproduced only to an extent The results achieved for the instruments with everyday soils demonstrate that this combination is very successful In the meantime this has been better verified for robotic instruments than for many other instruments that are critical in terms of amenability to cleaning The dictates of validation to find the truth are also being served by activities of the da Vinci working group which is currently drafting recommendations for investigation of cleaning for these instruments backed up by round robin tests 5 Silicone mesh cover a A LSW WT en NED KI
46. rocesses for the Processing of Thermolabile Endoscopes in 2011 it is the operator s responsibility to validate the processes and to ensure that the periodical routine checks which are defined as part of the validation or re qualification be carried out The statutory basis for the reprocessing of medical devices in Germany are the German Medical Devices Act MPG the Medical Devices Operator Ordinance 4 paragraph 2 MPBetreibV within the Infection Protection Act IfSG and the recommendations of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute To help along the implementation of the guideline ebro has developed new thermologger sets for validation and routine control of automat ed cleaning and disinfection processes for thermolabile endoscopes n Germany since the publication of Validation of WD E processes The validation of the processes ina WD E consists of 3 parts installation qualifica tion operational qualification and per formance qualification Parts of the installation qualification and operational qualification will be carried out at the installation of a machine during acceptance testing and need not be repeat ed if this took place no more than 6 weeks in the past The installation qualification ensures that the WD E and included ac cessories has been delivered and installed correctly The operational qualification ensures that the WD E complies with the man
47. s urement range from 1 mbar to 4000 mbar The storage capacity is 100 000 measured values i e up to 10 hours of recorded processes at a measurement rate of 250 milliseconds The temperature and pres sure accuracy is very high 0 05 C or 10 mbar and standard compliant as is documented in the corresponding ISO cer tificate The data loggers are used with the specific EBI 10 interface with an integrat ed antenna EBI 10 transmits on the world wide approved frequency of 2 4 GHz and conforms to the IEEE wireless standard 802 15 4 so that the logger can be used without any problems The WD E valida tion system was complemented with new features in the validation software Winlog validation In collaboration with a major manufacturer of WD E the new routine Custom Programs has been integrated This routine enables the validator to have the evaluation of the individual process steps such as pre cleaning cleaning dis infection rinsing and drying phase per formed automatically Routine inspection of WD E processes The operator shall determine the scope and frequency of routine inspections to gether with the validator According to the guideline the routine monitoring of WD E processes is essential to comprehensive quality assurance Although the number of necessary routine inspections can be reduced to a minimum through process validation for standard compliant WD E we cannot altogether do without them Rou
48. s as encoun tered in steam sterilization would disrupt this precise finely tuned system giving rise to distortion of three dimensional vis ualization In the meantime this 3D technology is be ing supplied as separate optics systems independently of OR robots holding out future prospects for their widespread use in surgery urology and gynaecology Fig 8 illustrates the Einstein Vision 3D Sys tem from Aesculap This 3D optics sys tem is held by an arm mounted to an OR table and its position can be remotely con trolled The new 3D system EndoEye Flex 3D from Olympus Fig 9 has a dual lens sys tem with two high resolution CCD Chips allowing for movement of the endoscope tip by 100 in four directions Like the two previously mentioned 3D systems this 3D Video Optic does not tolerate steam ster ilization In addition to the low process temperature thanks to cycle times of less than one hour STERRAD offers a tremen dous advantage permitting repeated use of these valuable medical devices through out the day Semi rigid miniature optics Semi rigid miniature optics make it pos sible to carry out surgical procedures un der vision control and in settings where Space is at a premium They are used in the lacrimal and lactiferous ducts as well as for knee joint and ophthalmology pro cedures The ultra fine fibre optics with a diameter of only 0 45 to 1 3 mm have a nitinol sheath and are endowed with reso l
49. s process we do have sterile medical devices packaged in a sterile barrier system A proof is possible only through a destructive test where the medical devices are removed and examined for growth of microorganisms This measure of quality assurance is recommended for control sampling which has to follow an independently created test plan Using the example of so called workshop instruments it becomes clear however how the term medical device determines certain procedures intended use These instruments were used in workshops in the context of doctors and nurses continuing education surgical exercises where they might have come into contact with animal tissues to some extent In some cases such tis sue contact is simply not denied afterwards and therefore for safety reasons presumed to have happened by the staff responsible for returning the instruments to the manufacturer And so they get labelled accordingly Do such instruments need to be discard ed then for ethical reasons or can they be led back to their intended purpose on a human patient after proper reprocessing What would be necessary for that to happen and which differences exist Do we believe in the effectiveness of our processing measures The problem is not as marginal as it appears at first sight with 2 000 hospitals and their surgery departments in Germany and with the high number of new instruments and the corresponding need for training there is a t
50. stridia mycobacteria bacterial spores Fungi Candida Viruses HIV polio rotavirus noro her pes 0 parasite cysts not be transmitted from person to person In order to prevent disease and maintain and strengthen health certain measures must be taken The employees who work outside of medical institutions with medi cal devices must be adequately protect ed according to their respective work place and the activities to be performed such as accepting deliveries of defective instruments for repair performing the re pairs etc Vaccinations Avery important measure is to carry out to document and monitor vaccinations in Germany this is regulated in the Social Security Code V 20d para 1 SGB V For vaccination against hepatitis A eg trans mission through drinking water food and hepatitis B e g transmission through blood saliva there is a professional indi cation Vaccination against hepatitis C is not yet possible Researchers at the German Liver Founda tion have conducted the world s largest in ternational prospective multicenter study on the treatment of hepatitis D With their combination of active substances they could for the first time achieve a cure of infections in a quarter of patients Anyone who suffers from hepatitis D is always in fected with hepatitis B Since the introduction of the Infection Pro tection Act in January 2001 hepatitis E is a notifiable disease in Germa
51. t have pH value gt 10 whereas mainly neutral detergents were used dur ing the 1990s Demineralized water is used for the cleaning step in more than 85 of all processes Again in over 85 of all processes evalu ated the cleaning time is 10 minutes None theless there is still a need to develop more effective detergents As regards the me chanical cleaning action the requirements for validation of a constant cleaning pres sure in washer disinfector process steps as well as verification of the rotational speed of the cleaning arms have resulted in im provements which to an extent have now been standardized The reason to test that a constant cleaning pressure is used or vert fy that this is kept within a defined cleaning pressure range is to show whether there are any negative interactions between the chemical substances and or soils with the mechanical cleaning action because of foam formation Hitherto the pressure level here was not relevant i e this was in dependent of a minimum pressure needed to ensure that successful cleaning could at all be expected A review of validation reports revealed that there were significant differences in the pressure values measured at positions in the loading trolley used to flush similar in strument lumens and these differences were more pronounced if loading trolley fittings were missing or defective For example ifa silicone support is missing in the loading trolley as
52. three examples of the clean ing problems encountered when cleaning complex instruments but which in practice are often overlooked The role of precleaning in ro botic instruments Conversely the shaft instruments used in robotic technology have recently attract ed the attention of the official authorities One reason for that is that to objectively verify satisfactory cleaning of such instru ments they were sent in a questionable way to laboratories for examination asep tica 18 2012 Issue 3 20 21 From an ex pert viewpoint there were not sufficient grounds to have confidence in the results Since robotic instruments are synonymous with high tech thus making claims to cer tain standards they also attract the atten tion of academics In these instruments we encounter work ing ends of immense complexity They have a plurality of contact regions where sever al materials are closely packed together side by side or on top of each other as well as many surface areas which can scarcely be accessed by the cleaning solution This working end is at least as complex as the drive of the actuator systems described above but with the difference that the contamination burden and its nature can be more problematic Such instruments may even include coagulation instruments with heat fixed proteins To clean the dis tal working end in a WD the loading trolley would need to be equipped with powered devices to ensure that the B
53. tine monitoring consists of daily as well as periodic testing For trouble free Iven Kruse ebro Electronic GmbH Peringer str 10 85055 Ingolstadt E mail Iven Kruse Xyleminc com FORUM Medical Devices amp Processes 2013 operation daily tests according to the in structions of the WD E manufacturer must be observed In addition to testing accord ing to risk analysis one should monitor dosage temperature time profile flushing pressure quality of demineralized water and the manual batch control The period ic inspections shall be determined based on the technical features of the WD E and the validation results The successful tech nical execution is dependent on temper www interlockmed de ature time pressure and the dosage of water and chemicals The mandatory pa rameters were determined during the vali dation and must be permanently available The process relevant parameters are to be checked at different intervals and docu mented Where there is no automatic proc ess documentation of each batch docu mentation must be carried out manually Monitoring of temperature time and flush ing pressure can be performed efficiently VOLUME 19 17 by a thermologger system The firm ebro offers a complete routine control set for this purpose The set SL 1110 consists of a thermologger with temperature and pressure sensor and a readout system with software The pressure sensor is equipped with a luer lock connector
54. tinuous closure for containers After a successful visual inspection an approval barcode is scanned The system then automatically prints a label with the corresponding identification information as well as the ID of the packager If dur ing the visual inspection it is determined that something is not right then the ster ile barrier system not approved barcode must be scanned The packaging can now be labelled with a do not use label and separated accordingly Unapproved sterile barrier systems may not be put into circu lation The label also has a class 1 proc ess indicator as well as a separate field for the approval decision after sterilisation see Fig 3 The labels are now put onto the packaging see Fig 4 a b Fig 2 After sterilisation is complete the process indicator integrated on the label changes colour to indicate that the packaged instru ment set or container has undergone steri lisation The corresponding LOT number of the sterilisation process carried out can be supplemented and the sterilised sterile barrier system can be approved for stor age in the field assigned for this purpose see Fig 3 After treatment or operation the so called duplex labels can be easily removed from the sterile barrier systems sealed pouch wrapped set or container and placed in the patient file as a corre sponding appendix see Fig 5 Thus it is clear for each instrument set or contain er used that it was pac
55. turers and reprocessors of medical de vices must be able to prove to their custom ers and the users that their work provides results in accordance with the standards and regulations and the required hygiene standard Documentation is not in itself quality as surance Information is only obtained VOLUME 19 23 Fig 3 Soaking in broth through careful analysis of the collect ed data Here is an example for the provi sion of documented quality of results by means of microbiological checks of med ical devices after automated cleaning and disinfection The washed and disinfected medical devices are packaged so that no recontamination can occur and then sent to a hygiene institution or a recognized laboratory Here samples are taken from the medical device The sampling can oc cur in several ways for example by using Rodac contact plates swabs or by soak ing in broth Fig 1 2 After obtaining the samples they are in cubated in the institute or laboratory and then analyzed The evaluation of the re sults is usually defined through the germ proof It answers the question of how many colony forming units CFU were found Chance is 1 to 3 CFU which is harmless Default is 10 to 24 CFU and means ques tionable results Abundant is more than 25 CFU and means that the quality is objec tionable The verification report must be kept for documentation Summary Get Hepatitis A B vaccination Get Teta
56. ufacturer s specifications and with EN ISO 15883 The performance qualifica tion is supposed to ensure that reproduc ible results will be achieved at any time given compliance with the specified pa rameters and that the process meets the required specifications An important test of the process qualification is a review of the cleaning performance This consists of testing the parameters dosage amount of water temperature flushing pressure and time as well as testing of defined contami nations using specimens or test methods for soiling or of defined surfaces In order to perform the physical tests such as the temperature and pressure measure ment the guideline requires a measur ing system according to EN ISO 15883 1 point 6 2 The temperature sensors may not exceed a maximum diameter of 2 mm and the measurement system must be equipped with a recording clock min imum of 2 5 seconds With the fast and flexible EBI 10 cable loggers from ebro it is possible to perform the validation of WD E processes wirelessly in real time due to the EBI 10 wireless technology The EBI 10 transmits its data from the closed WD E enabling the examiner to observe the process live on the monitor and to stop a potentially faulty process immediately This saves a lot of work and time The absolutely waterproof and vapor tight EBI 10 IP 68 logger with Pt 1000 sensosr has 2 temperature measurement range of 30 C to 150 C and a pressure mea
57. ution up to 30 000 pixels Steam steriliza tion could damage these precision optics instruments Fig 10 illustrates application of a semi rig id optics system from PolyDiagnost Used within a puncture needle it forms togeth VOLUME 19113 er with other components the All Seeing Needle and when used with an additional laser fibre even permits kidney puncture with lithotripsy under vision control Here there is only one puncture site measuring a maximum of 1 6 mm Ultrasound scanners and Doppler probes Ultrasound scanners and Doppler probes are being used increasingly during oper ations Even for minimally invasive pro cedures they are used for imaging of tis sue and vascular structures directly in the internal organs The complex electronic systems used in these probes call for gen tle sterilization using as far as possible a low temperature and dry environment exactly that is assured by the STERRAD systems Fig 11 illustrates such an intra operative ultrasound scanner designed for use by means of a surgical robot E 14 VOLUME 19 FORUM Medical Devices amp Processes 2013 Moisture in medical device units MDUs Y he sterilization unit is a volumetric measure which is why performance units permitting a surgical measure operation are assembled for tray organiza tion These are called medical device units The reference load is decisive for process validation of a sterilization process Depending
58. whereby pres sure connection in the WD E is possible Data analysis is carried out automatically by the software Winlog med printing example interlock HUT www interlockmed de a sar shans Mesh basket labels made of synthetic material heat resistant up to 134 C with tear off perforation We create mesh basket labels according to your requirements even with barcodes and graphics Interlock Medizintechnik GmbH phone 49 4363 905900 telefax 49 4363 90590590 18 VOLUME 19 FORUM Medical Devices amp Processes 2013 the German KRINKO 2012 R Graeber A Hartwig T W Fengler 4 Y he Hygiene Requirements for the Reprocessing of Medical Devices Anforderungen an die Hygiene bei der Aufbereitung von Medizinproduk ten created and published by the Com mission for Hospital Hygiene and Infection Prevention KRINKO at the Robert Koch Institute RKI and the Federal Institute for Drugs and Medical Devices BfArM is a key document for the reprocessing of medical devices in Germany Although it only has recommendatory character in it self it achieves virtually the force of law thanks to a reference in 4 Medical De vices Operator Ordinance Proper reproc essing will be presumed in court if this document we call it KRINKO 2012 for brevity has been observed KRINKO 2012 is an updated version of the original recommendation pu
59. zation the protection of human tissue that is not being cut on the one hand on the other hand the risk of a pos sibly lower degree of hygiene and of potential contact with residual pathogenic microorganisms as may be the case with needle scopic surgery What is fact what is merely an assumption We will only find out when we try under defined conditions of course so the success can be evaluated The benefit must therefore be studied and analysed which may be but does not necessarily have to be done via clinical trials Manual skills determine the quality of reprocessing supported by technical equipment which however needs to be loaded and operated correctly Residual risks remain in a double sense we may have residuals of unknown infectious potential And we have after a trade off a residual risk with the reusable instruments In fact we even have risks with new single use instruments which may malfunction or carry residues from production processes or be burdened with bio incompatibilities Finally we have recently seen reusable mechatronic manipulators whose placing on the market in the European Union was possible interestingly although no validated cleaning method according to CEN ISO 17664 was presented the author was able to witness this in 2008 It remains to be seen if this situation has improved now that specially designed load carriers are available Ultimately once a manufacturer has placed their product on

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