Vision Sciences Endoscopes and EndoSheath ® Technology
Contents
1. J Biomed Res2012 26 241 7 CrossRefMedline 28 J Winter SC Thirwell A Jervis P Flexible nasendoscope wth a disposable sheath system versus standard nasendoscopy a prospective randomized trial Clin Otolaryngol Allied Sci2002 27 81 3 CrossRefMedline 29 1 French GL Dirty deluded and dangerous BMJ2012 345 e8330 FREE Full Text 30 a Boyce JM Pittet D Guideline for hand hygiene in health care settings Recommendations of the Healthcare Infection Control Practice Advisory and the HICPAC SHEA APIC IDSA Hand Hygiene Task Force Infect Control Hosp Epidemiol 2002 23 S3 40 314 Carter KC Carter BR Childbed fever a scientific biography of Ignaz Semmelweis Transaction Publishers 2005 32 al Routh CH Loud MD On the causes of the endemic puerperal fever of Vienna Lancet1848 2 642 3 BMJ Group Privacy and Cookie Policy Website T amp Cs Revenue Sources HighWire Press Feedback Help 2014 BMJ Publishing Group Ltd http Awww bmj com content 348 bmj g 2047 ref 9 7 8 Published online before print February 25 2013 Journal of Clinical Urology February 25 2013 Urinary tract infection following flexible cystoscopy a comparison between sterilised cystoscopes and disposable sterile sheaths Steve PMcCombie Jack P Carmichael Srijit Banerjee Sarah J Wood Department of Urology Norfolk and Norwich University Hospital UK Email steve mccombie doctors org uk Abstract Objective The objective of this ar2. deluded and dangerous by Gary L French 29 which exposed the recent trend of doctors who wash their hands much less frequently than expected 30 The issue of scope cross contamination and the growing incidence of negligence in hand washing have a common historical background In the 1800s most European physicians rejected the theories of Ignaz Semmelweis 31 who proposed that hand washing would lower the postpartum mortality rate 32 Since the advent of antibiotics doctors have paid less attention to the value of meticulous sterilization 29 However with the recent appearance of superbugs we need to be more mindful of careful http Awww bmj com content 348 bmj g 204 7 ref 9 4 8 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ Sterilization We must not make the same mistake as Semmelweis s contemporaries who remained passive as their patients suffered the consequences of doctors with dirty hands while a simple lifesaving alternative was sensible affordable and available Like hand washing in Semelweis s day better procedures for cleansing and even sterilizing scopes between uses are mandatory to prevent cross contamination prevent infection and potentially save lives Notes Cite this as BMJ 2014 348 92047 Footnotes e Competing interests have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare e Provenance and peer review Not commissioned externall
3. 0620 E Mail info visionsciences com Innovative Solutions Sterile durable disposable Microbial barrier Unique D Shape endoscopes A reusable endoscope A sterile disposable Patented system allows channel for every for complete isolation of procedure endoscope from patient About Vision Sciences Inc Vision Sciences Inc has brought pioneering concepts to the world of flexible endoscopy for over 20 years With the patented EndoSheath Technology and innovative endoscope designs Vision Sciences Inc has transformed the economics of flexible endoscopy while enhancing patient safety for Otolaryngology Gastroenterology Urology and Pulmonology practitioners Vision Sciences has made a commitment to help physicians transform their practices with the EndoSheath Technology Request a Clinical Research Summary or an Official EndoSheath Technology Infection Control package Call 800 874 9975 or visit www visionsciences com Www visionsciences com Vision Sciences Inc Vision Sciences EndoSheath and Slide On are registered trademarks of Vision Sciences Inc Covered by one or more of the following U S Patents 5 337 734 5 443 781 5 520 607 6 350 231 6 530 881 6 579 582 6 733 440 7 025 923 Other U S and international patents pending PL13203 Rev B 06 2011 Vision Sciences Endoscopes enesis ENDOSCOPY for innovation for reliability for peace of mind and EndoSheath Technology Prepara
4. of a single sheath research confirms that the second sheath prevents contaminants from infecting the next patient 25 The central idea behind the sheath is that a pathogen cannot overcome it Because each sheath is used only once pathogens cannot hide on the outside of sheaths or become resistant to disinfecting liquids One added benefit to using sheaths which no other decontamination protocol offers is protection against prions such as that which causes Creutzfeldt Jakob disease 28 By using sheathed endoscopes healthcare facilities will spend less on labor and equipment7 27 and avoid exposure to noxious chemicals 7 26 Although acquiring new endoscopes that accommodate sheaths may require an initial investment the scopes are less expensive than unsheathed models and better in terms of long term benefits in patient care efficiency and lower operating costs 27 The sheath eliminates unreliable and cumbersome reprocessing condensing the protocol into just a few steps and reduces reprocessing time by up to 31 minutes 7 It also is more cost effective reduces repair costs and decreases investment in multiple scopes that are out of operation while being cleaned 7 26 27 Other sterilization methods exist for endoscopes but each has its drawbacks in terms of safety efficiency and cost Ethylene oxide gas sterilization is a toxic and carcinogenic process requiring additional time for a post sterilization aeration period 8 Hydrogen peroxide gas plasma ste
5. of events thus human error could be an assumption in many of the cases 6 http Aww bmj convcontent 348 bmj g 2047 ref 9 3 8 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ As past experience demonstrates even the most stringent liquid reprocessing guidelines do not prevent outbreaks The complexity of reprocessing protocols and the intricacy of endoscope design are inherent flaws because they foster statistically predictable failures that allow pathogens to persist on the endoscope particularly in the luminal channels4 12 13 and in the cleaning equipment and detergent 6 One of the very few positive outcomes of a contamination incident is the change of disinfection practices that follows After its superbug outbreak the ALGH switched to ethylene oxide gas sterilization 1 Alternatively several other facilities in the US and the UK have begun using sterile disposable sheaths on scopes and have reported improvements in safety 7 25 26 27 The sheath provides a single use sterile barrier between the scope and the patient without hindering functions such as visualization and biopsies The device incorporates a sterile working channel that allows equipment such as biopsy forceps to pass through unhindered 27 Studies show that using the sheath along with a simple alcohol wipe down between uses guarantees sterility offering a vast improvement over current decontamination procedures 26 28 Even if there is a defect in the integrity
6. results were positive indicating Outpatients scenario was ideal for flexible cystoscopy of this nature e The system was rated highly for image quality ease of use and handling e Patients complimented the service and preferred Outpatient setting to day ward or theatre based procedure Conclusions e The Vision Sciences system makes it possible to perform outpatient flexible cystoscopy economically and efficiently with the aid of a disposable Endosheath system Microbiologic Assessment of Disposable Sterile Endoscopic Sheaths Prospective Clinical Trial Alvarado CJ Anderson AG Maki DG Microbiologic assessment of disposable sterile endoscopic sheaths to replace high level disinfection in reprocessing a prospective clinical trial with nasopharyngoscopes Am J Infect Control 2009 37 408 13 In this article Alvarado et al described a clinical trial that included a microbiologic assessment of the ability of the Slide On EndoSheath Technology Medtronic ENT Jacksonville FL to provide protection against bacterial contamination of flexible nasopharyngoscopes Three 30 mm Olympus nasopharyngoscopes ENF Type P4 Olympus America Melville NY were used while covered with an EndoSheath barrier to examine the nasopharynx and larynx of 100 different randomly selected patients The surface of the head and shaft of each nasopharyngoscope was wiped to obtain two samples for culture at each of the following times before application of the End
7. the difficulties in inspection of flexible endoscope long narrow lumens working channels and that these require connection to the EWD VSI endoscopes circumvent these difficulties by removing the working channel from the endoscope and placing them as a single use sterile working channel within the Endosheath Decontamination of Endoscopes 14186 Page 41 42 discusses the need of the user to follow the manufacturers guidelines for cleaning e VSI provides this in data form presentation visual aids and formal training competency documents a Conventional channelled endoscopes require essential manual cleaning due to the direct contact with the patient e VSI endoscope cleaning is prophylactic when used with the Endosheath in accordance with the manufacturer s guidelines 14187 Page 42 discusses in depth the process stages of an EWD This is 9 specific points which must be performed exactly in order to prevent failing the cycle or alarming the EWD due to incorrect set up VSI endoscopes removes this issue 14190 Page 45 46 highlights issues in the transportation of HLD cleaned flexible endoscopes Additional equipment transportation trays with a two covers is required for moving contaminated decontaminated endoscopes These trays will also require cleaning and decontamination Using VSI endoscopes that do not require the routine use of EWD s removes the issues highlighted here with transportation Dec
8. D endoscope washer disinfectors so these are not discussed except in relation to their use with VSI endoscopes 14091 14188 Page 49 50 looks specifically at non channelled Nasendoscopes e It states that because of the nature of their use these non channelled scopes are manually cleaned with an appropriate medical grade endoscopic disinfectant e Vision Sciences endoscopes are non channelled so these guidelines apply e In addition as these scopes are non channelled they also do not require the use of drying cabinets due to the possibility of bacterial contamination on their Surface not being replicated in the absence of liquid water e It also states that as long as direct or indirect recontamination with patient body fluids does not occur no maximum time of storage before reprocessing can be specified These key statements in relation to ALL VSI endoscopes using Endosheath Technology e VSI scopes are also channel less and as such can be considered in the same way whether it is in Bronchoscopy Cystoscopy Trans Nasal Oesophagoscopy and of course Nasendoscopy e On discussion with some leading UK based experts in decontamination that these principals can apply to all VSI endoscopes regardless of therapeutic area e On review of the validated processes and protocols outlined by VSI the experts agreed the Endosheath Technology maintained the highest levels of patient and user safety e Contact details of the experts are a
9. EndoSheath eno Infection Control Considerations The reasons to consider using EndoSheath Technology rather than conventional flexible scopes requiring high level disinfection between uses are numerous The material in this binder relates to minimising the risk of cross infection The Vision Sciences flexible endoscopes do not incorporate a working channel Instead following a prescribed aseptic protocol they are fitted with a disposable sterile sheath which incorporates the working channel In this way the patient is not exposed to a contaminated surface The following pages comprise 1 Aleaflet explaining EndoSheath Technology 2 Aseptic EndoSheath technique wall charts 3 A 21st century nosocomial issue with endoscopes BMJ 2014 348 doi http dx doi org 10 1136 bmj 92047 published 19 MArch 2014 4 A comparison between sterilised cystoscopes and disposable sterile sheaths Steve McCombie Sarah J Wood et al Norfolk amp Norwich University Hospital Journal of Clinical Urology Feb 2013 5 Outpatient Flexible cystoscopy using a disposable slide on Endosheath system M Kimuli S Lloyd Ann R Coll Surg Eng 2007 89 426 430 6 Microbiologic Assessment of Disposable Sterile Endoscopic Sheaths Alvarado CJ et al Am J Infect Control 2009 37 408 13 7 Endoscope Sheaths as Viral Barriers Laboratory FDA Study Baker KH et al Laryngoscope 1999 109 636 9 8 Relevant points in CfPP 01 06 guidelines Contact Genesis Medica
10. contamination between patients making the case at ALGH far from unique The threat of cross contamination may not be visible to a clinician from personal experience alone but broader and more comprehensive studies show that the cleanliness of endoscopes varies greatly A mid 2013 study reported that about 15 of endoscopes in US hospitals failed to achieve an accepted standard of cleanliness after liquid reprocessing the prevailing disinfection process used between patient procedures 3 In this study duodenoscopes were the dirtiest at a 30 contamination rate and colonoscopes were the cleanest at a 3 contamination rate 3 All in all reprocessing is time consuming labor intensive expensive and most importantly susceptible to failure Among the most problematic features of an endoscope are the luminal channels which often become contaminated by endoscope accessories 4 The lumen are difficult to access and can easily harbor pathogens through multiple reprocessing procedures http www bmj com content 348 bmj g2047 ref 9 1 8 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ even when the protocol is followed correctly 4 Not only must the cleaning protocol be followed strictly but the equipment and reprocessing environment also must be well maintained 5 Disinfectants and cleaning materials for endoscopes are often contaminated themselves in these incidents 6 lronically the commonly used liquid reprocessing procedure is someti
11. cope into the Sheath ensure that the insertion Tube is Clean Dry and Undamaged Ah IMPORTANT NOTE The tip of the scope MUST be straight when placing into Sheath If there is any resistance in loading verify that the Sheath channel is properly aligned If the channel is misaligned twisted straighten the channel before continuing scope insertion i Lock Sheath to Scope by turning knob 90 horizontal eatr TS Ready for use Verify angulation function and water flow suction before use If setting up sterile remove outer gloves Unfold cover over control body of Scope and secure with clips AFTER THE PROCEDURE REMOVAL 4 Y is r Unlock Sheath rom Scope by Turning the Locking Knob to the Vertical Position EndoSheath VISI ON Technology Vision Sciences Inc 40 Ramland Road South Orangeburg NY 10962 SCIENCES Telephones 800 874 9975 845 365 0600 Fax 845 365 0620 E Mail info visionsciences com EE owt IN Remove Scope from Sheath IMPORTANT NOTE If resistance is felt during removal STOP Make sure the sheath and Scope are STRAIGHT and ensure the channel is not wrapped around the insertion tube Use the drape bag as a barrier between the fingers ed and sheath gently grasp the window of the Sheath and remove the Scope WITHOUT rotating the Scope Deposit used Sheath and gloves into drap
12. e bag and dispose as per hospital policy Genesis Medical Ltd 7 Trojan Business Park Cobbold Road London NW10 9ST Tel 44 0 20 8451 4100 Fax 44 0 20 8451 4115 Website www genmedhealth com enesis ENDOSCOPY Endoscope with EndoSheath Technology for innovation for reliability for peace of mind Reprocessing Chart for Recommended Cleaning Procedure The EndoSheath Technology is a sterile disposable durable protective barrier which isolates an endoscope from patient contact and limits the need for elaborate chemical disinfection or EtO sterilization procedures after every endoscopy procedure EndoSheath Technology allows for fast and effective reprocessing of an endoscope and ensures a sterile Insertion Tube for every patient IMPORTANT NOTES O Users should review complete manufacturer s guidelines for equipment disintection sterilization found in the user s manual O Users should review EndoSheath Technology installation removal process found in the user s manual WARNING This chart is only for reprocessing of Vision Sciences endoscopes using EndoSheath Technology A NOTE If the endoscope was dry when the sheath was fitted it will be dry when removed If moisture is observed A this could indicate a breach of the sheath and high level disinfection can be considered If high level disinfection is After EndoSheath Technology Removal Remove endoscope from Sheath and After removing the Sheath In
13. eak tester the hand bulb until the needle water and observe if for 30 seconds endoscope and contact connector clockwise until it is reaches the green section Maintain Angulate the distal bending section Genesis Medical for secured pressure for 10 seconds observing up and down while the Endoscope is repair the needle position Endoscope may immersed The absence of air bubbles require several pumps of the bulb to confirms the scope is air tight completely pressurise Remove from water and open the leak tester s valve Ensure the needle E mM d oSsh eat H on the pressure gauge fails to zero Technology and disconnect the leak tester from the endoscope In the event that high level disinfection sterilization is required please refer to the protocols Genesis Medical Ltd in the user s manual for proper steps to ensure complete and efficacious reprocessing 7 Trojan Business Park Cobbold Road London NW10 9ST Vision Sciences Inc 40 Ramiand Road South Orangeburg NY 10962 Tel 44 0 20 8451 4100 Telephone 800 874 9975 845 365 0600 Fax 845 365 0620 Fax 44 0 20 8451 4115 E Mail info visionsciences com Website www genmedhealth com 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ This site uses cookies By continuing to browse the site you are agreeing to our use of cookies Find out more here x LUPUS SCIENCE amp MEDICINE A BMJ Feature Feature A 21st century nosocomial issue wit
14. ed controlled trial Urology2007 70 883 7 CrossRefMedlineW eb of Science O e Sabnis RB Bhattu A Vijaykumar M Sterilization of endoscopic instruments Curr Opin Urol2014 24 195 202 CrossRefMedline 9 e http Awvw bmj com content 348 bmj g 2047 ref 9 5 8 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ Department of Veterans Affairs Office of Inspector General Healthcare inspection follow up colonoscope reprocessing at VA medical facilities 17 Sept 2009 www va gov oig 54 reports VAOIG 09 02848 218 pdf 10 a Srinivasan A Wolfenden LL Song X Mackie K Hartsell TL Jones HD et al An outbreak of Pseudomonas aeruginosa infections associated wth flexible bronchoscopes N Engl J Med2003 348 221 7 CrossRefMedlineW eb of Science 11 od Tosh PK Disbot M Duffy JM Boom ML Heseltine G Srinivasan A et al Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures Texas 2009 Infect Control Hosp Epidemiol201 1 32 1179 86 CrossRefMedline 12 C tre JC Nicolle MC Salord H P rol M Tigaud S David G et al Outbreaks of contaminated broncho alveolar lavage related to intrinsically defective bronchoscopes J Hosp Infect2005 61 39 45 CrossRefMedline 13 ul Corne P Godreuil S Jean Pierre H Jonquet O Campos J Jumas Bilak E et al Unusual implication of biopsy forceps in outbreaks of Pseudomonas aeruginosa infections and pseudo infections related to bronchoscopy J Hosp I
15. en patients on the day case waiting list for diagnostic flexible cystoscopy were randomly chosen to be part of the pilot for the out patient flexible cystoscopy list Initially small numbers were listed to establish the processes the last list accommodated 10 patients com fortably All patients were given an information sheet in the waiting area prior to the procedure They were interviewed using a simplified assessment sheet and consented by the operator Appendix 1 Patients did not fully change as in the day ward setting but removed their lower half garments in the treatment room behind a screen The Vision Science CST 2000 flexible cystoscopy was used for all procedures At first glance the flexible cystoscope looks similar to existing instruments but closer inspection reveals sev eral key differences Fig 1A D The cross section of the instru ment is crescenteric and measures 15 8 F by 16 8 F It has a lever to lock onto the disposable sheath and a depression valve for irrigation The sheath incorporates a 6 F working channel for biopsy and ureteric stent removal e To demonstrate that Outpatient flexible cystoscopy was a feasible practice e 27 patients awaiting diagnostic or check cystoscopy in the Leeds area were invited to attend an Outpatient Clinic to evaluate the Vision Sciences CST2000 scope that uses the Endosheath system e The performance of the system was evaluated and patient feedback obtained through questionnaire e The
16. est for validation of these opinions Sections 14095 Page 56 to 14099 14206 Page 65 ook at chemical compatibility with EWD s as well as enzymatic detergents and flexible endoscopes A full list of compatibility is available upon request VSI endoscopes are generally compatible with the common used chemicals in the UK Traceability All VSI Endosheath packaging have tracking LOT number labels in triplicate on the exterior of the sterile package Endosheath Tracking can then be maintained to the highest standards in addition to any tracking traceability brought about by periodic use of the EWD system An example of the Journey of an endoscope through the system Section 14218 Page 76 outlines the manual cleaning phase of scope reprocessing e VSI endoscopes do not require routine use of EWD systems Section 14218 outlines the manual cleaning phase of scope reprocessing which can be maintained with the Vision Sciences scopes e The process would routinely change to the appropriate protocol for the specific endoscope and Endosheath combination being used as outlined in the training competencies and resources provided by VSI e IF gross contamination is suspected or the local protocol dictates periodic use of the EWD system then this can be conducted in accordance with CfPP 01 06 s guidelines Summary e The unique nature of the VSI Endosheath Technology aseptically fitting sterile sheaths incorporating the wor
17. exible cystoscopy Vision Sciences Disposable endoscopy sheaths Slide on endosheath system Stuart N Lloyd Consultant Urologist Pyrah Department of Urology St James s University Hospital Leeds LS7 OTF UK E slloyd140 btinternet com Flexible cystoscopy is the most frequently performed urological procedure both as a diagnostic and surveillance tool Freely available facilities to flexible cystoscopy is fundamental to modern urological practice but this is often limited by access to facilities sterilisation and instrument times for the procedure delaying diagnosis and treatment Most units ation resulting in significant waiting perform flexible cystoscopy in a day ward theatre setting others in purpose built endoscopy units few in the out patient setting Within our unit flexible cystoscopy is performed in day ward theatres waiting times for non urgent flexible cystoscopy has reached 9 months Purchasing and servicing a large number of instruments was considered costly Moving flexible cystoscopy into an out patient setting with the implementation of the new Vision Sciences flexible cystoscope using slide on endosheath system may overcome these difficulties and provide an opportunity to improve efficiency This paper reports our initial experience with this new device comparing it with standard flexible cystoscopy in an out patient setting A26 Ann R Coll Surg Engl 2007 89 426 430 Key Points Twenty sev
18. h endoscopes BMJ 2014 348 doi http dx doi org 10 1136 bmj g2047 Published 19 March 2014 Cite this as BMJ 2014 348 92047 Anne Marie Noronha senior associate Steve Brozak president Author Affiliations 1WBB Securities 67 Walnut Avenue Clark NJ 07066 USA sbrozak wbbsec com Endoscopic procedures provide lifesaving diagnostic information but do they put patients at unnecessary risk of deadly infection from cross contamination On 3 January 2014 the results of a year long investigation by the US Centers for Disease Control CDC into an outbreak of New Delhi metallo B lactamase NDM producing carbapenem resistant Enterobacteriaceae CRE were released Of 69 patients with confirmed CRE infections 29 went to Advocate Lutheran General Hospital ALGH for the same procedure an endoscopy 1 The endoscopy itself is not dangerous but the current cleaning process used between procedures leaves patients susceptible to infection and troubles many healthcare practitioners With more than 18 6 million gastrointestinal endoscopies and at least a half million bronchoscopies every year in the US alone 2 medical practitioners must take the utmost care during the cleaning process between patients especially with the emergence of superbugs such as CRE But the safety profiles of the cleaning protocols are less than acceptable in preventing life threatening outbreaks The endoscopes are frequently the means for facilitating pathogenic cross
19. ical compatibility and functional compatibility with the specific EWD Size and Numbers of EWD s Section 14076 14168 Page 23 discusses the need to assess how many EWD s a facility may require o There is no formal requirement for VSI scopes to undergo EWD reprocessing between every case providing the endoscope is not grossly contaminated e The overall number of EWD machines required may be reduced as the main reason for multiple EWD s is to maintain efficiency within the Endoscopy service on offer and indeed Endoscopes as highlighted in section 14169 and 14170 Page 24 VSI scopes are reprocessed in between cases using a validated protocol consisting of intermediate level disinfection cleaning regime combined with e an aseptic technique for loading a sterile Endosheath for each patient highlighted in sections 14169 and 14170 Page 24 Reprocessing 14078 14173 Page 27 points to the use of disposable or re usable reprocessing accessories such as cleaning brushes cleaning tools endoscope valves and water bottles e The guidelines refer to the need to for single use items which can incur additional cost e Reusable items for these purposes also incur on going costs as functional inventory must be maintained meaning additional cleaning and maintenance costs o VSI scopes have no channels and removes the need for many of these items EWD operation and endoscope storage and transportation 14083 Page 33 points out
20. implicated types of endoscopy varied Bronchoscopy and gastrointestinal endoscopy contributed the highest numbers of incidents see table 1 and upper Gl endoscopy infected the most patients per patients exposed see table 24 6 The infectious agents identified the most were Mycobacterium tuberculosis and Pseudomonas aeruginosa both of which are life threatening and have associated antibiotic resistant strains 6 Table 1 Patients exposed to endoscope related contamination by type of intervention 1974 2004 Intervention Outbreaks reporting patients contaminated Arthroscopy 1 Bronchoscopy 39 Cystoscopy 3 Endoscopic retrograde cholangiopancreatography 7 Lower gastrointestinal endoscopy 12 Upper gastrointestinal endoscopy 10 Gastrointestinal endoscopy 1 Total 69 Outbreaks not included in lower or upper Gl endoscopy Data only include outbreaks that also report patients exposed Adapted from Seoane Vazquez E Rodriguez Monguio R Visaria J Carlson A Exogenous endoscopy related infections pseudo infections and toxic reactions clinical and economic burden Curr Med Res Opin 2006 22 2007 21 Table 2 Ratio of patients exposed to patients contaminated by type of intervention Intervention Number of Number of patients Number of patients outbreaks exposed contaminated contaminated Arthroscopy 1 352 7 2 0 Bronchoscopy 15 4001 270 6 7 Cystoscopy 2 773 25 3 2 http Awww bmj com content 348 bmj g2047 ref 9 2 8 3 19 2014 A 21st cen
21. king channels on the Vision Sciences non channelled scopes are different from traditional channelled flexible endoscopes e Sheaths fitted over non channelled scopes are acceptable in the document This means that Clinicians can be assured of maintaining adherence to the guideline whilst significantly reducing risk of cross bio contamination and improving operating efficiency
22. l for further information a PowerPoint presentation on the Infection Control considerations copies of referenced papers a bibliography of relevant peer reviewed papers Much material is available on the website www genmedhealth com April 2014 VISION sciences VIS ION Infection Control sciences with EndoSheath Endoscopy EndoSheath Technology The sterile disposable solution for flexible endoscopy EndoSheath Technology is not your typical barrier Designed to offer a strong durable proven effective microbial barrier this is not just a simple cover By providing a barrier between the endoscope and patient EndoSheath Technology allows for less complicated cleaning and disinfection routines and improves equipment turnaround time All the difficult to clean endoscope components with EndoSheath Technology are disposable including the barrier the channels the ports and the seals Clinically proven EndoSheath Technology allows for efficient effective endoscope reprocessing in any setting A he With EndoSheath Technology there is strength in numbers er e 20 years on the market 30 FDA clearances e a e E d e 37 systems with CE Mark e 9 systems with HealthCanada license e million procedures performed worldwide 0 cross contamination complaints with sterile disposable EndoSheath Technology ay EndoSheat echnology A brand with strength A name you can trus
23. mes called liquid sterilization even though it does not sterilize the instrument According to guidelines from the Society of Gastroenterology Nurses and Associates Inc SGNA the protocol requires up to 43 steps and according to another study over half an hour of labor 5 7 To begin debris is removed during pre cleaning Next leak testing makes sure that all internal channels are intact and that no holes contribute to instrument contamination The scope then must be taken apart to allow access for manual cleaning which removes any foreign material that may interfere with disinfection The endoscope is then immersed in a high level disinfectant 5 The disinfectant must be potent enough to remove contaminants yet gentle enough to preserve the integrity of the instrument since a disinfectant that is too concentrated may decrease the life span of the instrument 8 The scope is then rinsed dried and stored 5 The SGNA also offers several guidelines for maintaining the cleaning reprocessing environment to help make reprocessing as effective as possible 5 Regrettably endoscope contamination is not a new phenomenon In 2006 Seoane Vazquez and colleagues reported meta data analysis on all available contamination incidents in the US during the 30 year period between 1974 and 2004 6 Research showed that 10 989 patients were exposed to a contaminated instrument and 740 patients were contaminated although not all reports stated how many were exposed 6 The
24. nfect2005 61 20 6 CrossRefMedlineWeb of Science 14 J Gonzalez Candelas F Guiral S Carbo R Valero A Vanaclocha H Gonz lez F et al Patient to patient transmission of hepatitis C virus HCV during colonoscopy diagnosis Virol J2010 7 217 CrossRefMedline 15 ol Larson JL Lambert L Stricof RL Driscoll J McGarry MA Ridzon R Potential nosocomial exposure to Mycobacterium tuberculosis from a bronchoscope Infect Control Hosp Epidemiol2003 24 825 30 CrossRefMedlineW eb of Science 18 Aumeran C Poincloux L Souweine B Robin F Laurichesse H Baud O et al Multidrug resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography Endoscopy2010 42 895 9 CrossRefMedlineWeb of Science WE Ryan K Patients at Chanute hospital possibly exposed to hepatitis HIV Wichita Eagle 16 Jul 2013 ww kansas com 2013 07 16 2890467 patients at chanute hospital possibly html 18 e U S Department of Veterans Affairs VA continues notification process for veterans affected by reprocessing issues Press release 3 April 2009 www 1 va gov opa pressrel pressrelease cfm id 1661 19 4 Smiley D Vet who contracted Hep C wins malpractice suit against VA hospital Miami Herald 21 November 2012 www miamiherald com 2012 11 21 3108483 vet mho contracted hep c wns html 20 0 Hall KM Court rules against Tenn vet in colonoscopy case Associated Press 1 June 2012 http bigstory ap org article court rules against
25. nt such as biopsy forceps can be threaded is difficult to clean and inspect making it an easy place for bacteria to hide 4 In 2001 three consecutive outbreaks in one French hospital were caused by a loose port at the entrance of one luminal channel 12 The resulting infection rates were 117 out of 418 scoped patients 12 In 2003 two implicated bronchoscopes in a different French hospital had damaged lumens which were promptly replaced In this incident 4 of 16 scoped patients were infected 13 Despite the high rate of endoscope contamination and published outbreaks resulting from such contamination the medical community tends to attribute mishaps to negligent cleaning and human error The Emergency Care Research Institute which lists inadequate reprocessing of endoscopes as one of its 2014 Top 10 Technology Health Hazards asserted that guidelines should be continuously reviewed and technicians should be better trained 21 However this advice is over two decades old and the problem still persists The CDC has also been warning about cross contamination since 199122 and other medical organizations have concurrently tightened procedural guidelines 23 24 Meanwhile the proportion of incidents caused by equipment defects and cleaning equipment contamination not human error has since risen according to the 30 year US based study 6 Additionally not all incidents covered in the study were reported to have had an in depth investigation into the Causality
26. oSheath Technology and the endoscopic examination immediately after the examination and removal of the EndoSheath disposable and after a disinfection procedure consisting of the following steps vigorous wiping of the endoscope with an enzymatic detergent rinsing with running tap water drying with gauze wiping with gauze soaked in 70 ethanol and air drying in a vertical position All samples were plated on 5 sheep blood agar and incubated for 72 hours at 37 Bacterial colony types were enumerated and identified by using standard methods The study also included leak testing of the 100 used disposable sheaths removed from the nasopharyngoscopes and of 20 unused sheaths taken from the clinic inventory The barrier integrity of the EndoSheath Technology was assessed by using a pressure decay system 138 2 inches of water 5 Ib per square inch Bacteria grew in cultures of 16 head and 6 shaft samples obtained before the endoscopic procedure 13 head samples and 1 shaft sample taken immediately afterward and no samples obtained after the disinfection procedure The contamination found was low level 2 to 100 colony forming units and due primarily to skin commensals mainly coagulase negative Staphylococcus and Bacillus species One sample was positive for Staphylococcus aureus none showed gram negative bacilli or fungi None of the 120 used or new sheaths lost barrier integrity on leak testing Alvarado et al noted that not a single leak o
27. only 42 5 of its endoscope reprocessing units were adequately cleaning endoscopes 18 Because US government agencies are generally required to publicly divulge their findings the VA s information may provide better representation of all endoscope facilities including those that are not subject to the same mandated reporting Infections resulting from scope contamination break the trust between patients and doctors and place a financial burden on healthcare institutions Two VA patients one with hepatitis C and the other with HIV successfully sued the federal government 19 20 The statute of limitations meant an unfortunate veteran who was infected with hepatitis B could not seek compensation because the time limit had expired before he learned that he had been infected 20 Following an outbreak last year at the Neosho Memorial Regional Medical Center substandard scope cleaning was detected and 244 patients were notified of possible exposure to HIV hepatitis B and hepatitis C 17 In 2002 an outbreak of P aeruginosa infected at least 32 of 414 exposed patients at Johns Hopkins Hospital and may have played a role in three deaths 10 At an unnamed Texas hospital in 2009 an arthroscope transmitted the same bacteria to seven patients 1 1 Among those healthcare organizations that were able to determine the exact cause of their disease outbreaks the lumen of the endoscope was most often found to be the chief culprit 4 The lumen through which auxiliary equipme
28. ontamination of Nasendoscopes 14091 14188 Page 49 50 looks specifically at non channelled Nasendoscopes It states that because of the nature of their use these non channelled scopes are manually cleaned with an appropriate medical grade endoscopic disinfectant Cleaning should also be undertaken irrespective of the use of covering sheaths but crucially does not exclude the use of such sheaths In addition as these scopes are non channelled they also do not require the use of drying cabinets due to the possibility of bacterial contamination on their Surface not being replicated in the absence of liquid water It also states that as long as direct or indirect recontamination with patient body fluids does not occur no maximum time of storage before reprocessing can be specified These are significant and key statements in relation to ALL VSI endoscopes using Endosheath Technology VSI scopes are also channel less and as such can be considered in the same way whether it is in Bronchoscopy Cystoscopy Trans Nasal Oesophagoscopy and of course Nasendoscopy On discussion with some leading UK based experts in decontamination that these principals can apply to all VSI endoscopes regardless of therapeutic area On review of the validated processes and protocols outlined by VSI the experts agreed the Endosheath Technology maintained the highest levels of patient and user safety Contact details of the experts are available on requ
29. r tear had been detected in the total of 755 sheaths in their study and all previously reported clinical trials in which the EndoSheath Technology was used Endoscope Sheaths as Viral Barriers Laboratory FDA Study Baker KH Chaput MP Clavet CR Varney GW To TM Lytle CD Evaluation of endoscope sheaths as viral barriers Laryngoscope 1999 109 636 9 The aim of this bench study conducted by scientists at the Center for Devices and Radiological Health of the US Food and Drug Administration FDA was to characterize virus transmission through otolaryngologic endoscope sheaths in which a hole or tear had been made with an excimer laser or acupuncture needle EndoSheath Technology n 22 with a hole or tear ranging from 2 to 84 um were applied to an endoscope which was then submerged in a high titer virus suspension 108 viruses mL The inside of each EndoSheath barrier and the endoscope on which it had been placed were then rinsed separately to determine the amount of any virus that had penetrated through the hole A sequential test was also conducted In this experiment a virus challenge was first performed outside an EndoSheath disposable in which a 30 um hole was created before it was applied to an endoscope The EndoSheath Technology was then removed from the possibly contaminated endoscope and a second EndoSheath barrier in which a 20 um hole had been made in the same location as the 30 um hole in the first EndoSheath dispo
30. rilization also has a long processing time is expensive and can be corrosive to certain materials Neither of these methods protects against prions 8 The advent of antibiotic resistant bacteria such as CRE and deadly viruses requires that cleaning standards be continuously improved Just about every invasive instrument we use is sterilized better than the endoscope Syringes and needles are almost universally disposable and many surgical instruments are subjected to intense heat and pressure between uses Endoscopy demands the same standards because the instruments come into contact with or break the delicate mucosal membranes In 2013 the UK Department of Health DH recommended a tracking traceability and audit trail designed to systematically expose instances of cross contamination before becoming widespread 21 US outbreaks between 2000 and 2004 lasted an average of 84 days 6 and the recent CRE outbreak at ALGH lasted the full year 1 highlighting the importance of a vigilant surveillance system The system proposed by the DH will provide the medical community with a more accurate and active survey of epidemiology and hopefully push its constituents to replace liquid decontamination with a more effective alternative The BMJ is an appropriate venue for this discussion because of its undeterred criticism of conformist practices with the intent of improving healthcare In 2012 the BMJ addressed nosocomial infection in an article titled Dirty
31. sable was placed on the endoscope Another virus challenge was conducted to determine whether any virus would pass outward through the second sheath The first experiment found that small volumes of virus containing fluid penetrated through the holes or tears in the EndoSheath Technology and that up to 45 of passed virus particles could be recovered from the endoscope after removal of the EndoSheath Technology In the sequential test virus was found on the second disposable barrier in only one case Most important according to the researchers no virus was found outside the second sheath Genesis Medical Ltd t 020 8451 4100 7 Trojan Business Park f 020 8451 4115 Cobbold Road e mail genmedhealth com London NW10 9ST www genmedhealth com for innovation for reliability for peace of mind Infection Control of Sheathed Scopes as raised in the CfPP 01 06 quidelines Issues relating to Vision Sciences VSI Flexible Endoscopes Decontamination of flexible endoscopes Operational management manual e This document is not produced in any way in conjunction with the DoH What is the CfPP document e The CfPP published guideline offers best practice guidance on the management and decontamination of flexible endoscopes 14304 Page 6 Tt supersedes the relevant parts of HTM 2030 document Page 7 e The structure of the document is to divide in to five key areas Vision Sciences are not a producer of EW
32. spect decided upon the place in a clean Sterile area Do not the endoscope insertion tube and endoscope must be handie the endoscope with distal bending section and confirm prepared according to contaminated gloves these areas are dry and instructions in the user undamaged manual CLEANING AN INTERMEDIATE LEVEL DISINFECTION after each procedure Gently wash all external surfaces of After washing thoroughly rinse the Wipe down the entire Endoscope with Ensure all external surfaces of the the endoscope with an appropriate outside of the Endoscope with clean Gauze soaked in 70 ethyl isopropyl Endoscope are dry prior to installing instrument grade detergent or lukewarm water alcohol or an EndoWipe Towelette another Sheath EndoWipe Enzymatic sponge Ensure full coverage of alcohol LEAK TESTING If a leak is suspected amp if hiah level disinfection is needed A NOTE If the pressure decreases the leak tester connection may be loose or the pressure valve on the leak tester may be open Re attach the leak tester If the symptoms persists contact Genesis Medical A small stream of bubbles indicates a leak in the endoscope that was not detected by Connect the leak tester to the Pressurise the Endoscope Ensure If the needle position remains pressure gauge Do not endoscope s EtO vent valve Push leak tester s valve is closed Pump steady Immerse the entire scope in continue to use a leaking down and rotate the l
33. t Pioneering Infection Control with EndoSheath Endoscopy EndoSheath Advantages EndoSheath Technology is a proven effective barrier to organisms as small as 27 nanometers per FDA requirements and testing e Over 5 Million EndoSheath products sold over 20 years without a single reported complaint of patient to patient cross contamination EndoSheath Technology is designed to stretch and maintain its integrity and not to tear or break during procedures e All EndoSheath disposables are 100 leak tested during manufacturing with a 0 acceptable failure rate for production e All barriers channels ports seals and tubing are sterile and disposable e Concerns over biofilm bioburden and issues of improperly rinsed devices are eliminated for patient contact areas as they are always new sterile and disposable Easy to use and prepare limiting the complexity of endoscopy preparation routines e Compatible with standard accessories such biopsy forceps needles and other endoscopic devices e Over 30 research studies performed on EndoSheath Technology since 1992 e Disposables feature a 3 year shelf life e EndoSheath Technology is FDA cleared and CE marked Currently available for Bronchoscopy Cystoscopy Esophagoscopy and Laryngoscopy Vision Sciences Inc 40 Ramland Road South 0 burg NY 10962 amland Road South Orangeburg C 0843 Telephones 800 874 9975 845 365 0600 Fax 845 365
34. t or funding being provided by KeyMed Vision Sciences E Tristel Sani Cloth or any other external sources Funding This research received no specific grant from any funding agency inthe public commercial or not for profit sectors Conflict of interest The authors declare that there are no conflicts of interest Ann R Coll Surg Engl 2007 89 426 430 doi 10 1308 003588407X183346 MICHAEL KIMULI STUART N LLOYD Pyrah Department of Urology St James s University Hospital Leeds UK The aim of this study was to investigate the feasibility of out patient flexible cystoscopy Twenty seven patients awaiting diagnostic or check cystoscopy in Leeds UK were invited to undergo out patient flexible cystoscopy using a CST 2000 Flexible Cystoscope Vision Sciences Natick MA USA using the sterile sin gle use slide on disposable endosheath endoscope system EndoSheath Vision Sciences The performance of the cysto scope was evaluated and the patients experiences were documented using a questionnaire The out patient setting proved to be ideal for flexible cystoscopy The cystoscope was rated highly for image quality ease of use and handling All patients complimented us on the service and preferred out patients to a day ward or theatre attendance This study demonstrates that it is possible to perform out patient flexible cystoscopy safely economically and efficiently with the aid of a disposable endoscope system Fl
35. tenn vet colonoscopy case 21 Emergency Care Research Institute ECRI 2014 top 10 health technology hazards Health Devices 2013 www ecri org LL e From the Centers For Disease Control CDC Nosocomial infection and pseudoinfection from contaminated endoscopes and bronchoscopes Wisconsin and Missouri JAMA1991 266 2197 8 CrossRefMedlineWeb of Science http Awww bmj com content 348 bmj g2047 ref 9 6 8 3 19 2014 A 21st century nosocomial issue with endoscopes BMJ 23 43 ASGE Standards of Practice Committee Banerjee S Shen B Nelson DB Lichtenstein DR Baron TH et al Infection control during Gl endoscopy Gastrointest Endosc2008 67 781 90 CrossRefMedlineWeb of Science 24 4 U K Department of Health Choice framework for local policy and procedures 01 06 decontamination of flexible endoscopes operational management 2013 www gov uk government uploads system uploads attachment_data file 192522 Decontamination_of_flexible_endoscopes pdf 25 Baker KH Chaput MP Clavet CR Varney GW To TM Lytle CD Evaluation of endoscope sheaths as viral barriers Laryngoscope1999 109 636 9 CrossRefMedlineWeb of Science 26 Lawrentschuk N Chamberlain M Sterile disposable sheath system for flexible cystoscopes Urology2005 66 1310 3 CrossRefMedlineWeb of Science 27 Gupta D Srirajakalidindi A Wang H Reduced turnover times make flexible optical reusable scope wth EndoSheath Technology significantly cost effective
36. ticle is to compare the incidence of post cystoscopy urinary tract infections UTIs between cystoscopes sterilised between patients and cystoscopes that use removable sterile sheath technology Patients and methods A total of 200 patients undergoing flexible cystoscopy at the Norfolk and Norwich Hospital Norwich UK between November 2011 and March 2012 were identified prospectively as part of an ongoing audit of the department s services One hundred patients were recruited from day procedure lists using KeyMed cystoscopes sterilised between patients sterilised scope SS 100 patients were recruited from a one stop urology clinic using a Vision Sciences CST 5000 cystoscope with disposable sterile Endosheath technology removable sheath RS Mid stream urine MSUs samples and patient symptoms were recorded prior to the cystoscopy and at least three days following the cystoscopy Results No significant difference was found in the incidence of new MSU confirmed UTI 2 7 SS vs 2 0 RS In those undergoing their first cystoscopy no significant differences were found in either new symptoms 34 1 SS vs 36 7 RS or requirement for antibiotics 13 6 SS vs 13 0 RS Conclusion The introduction of cystoscopes using this technology can therefore safely transform flexible cystoscopy into an outpatient clinic procedure Acknowledgements This was an independent audit carried out by the authors with no involvemen
37. tion Wall Chart PRECAUTIONS gt gt gt gt BEFORE THE PROCEDURE SET UP Review the User s Manual for Recommended Cleaning procedures for the Endoscope If setting up for sterile field double glove with sterile gloves E Carefully place Sheath contents in sterile field Double glove Sterile Apply drape bag to installation stand TR N Deflect Scope tip to ensure Sheath window is seated properly j Double glove before starting removal process Re insert Scope into stand detach clips and move control Body Cover without contaminating handle Remove outer gloves When applicable insert irrigation suction tube through the flow control valve Detach irrigation suction Tube from the Flow Control Vale and Water Source pam fl y Place Sheath into installation stand with accessory port facing out A Attach the end of the irrigation suction tube to an irrigation suction source i Gently insert Scope into Sheath with the endoscope label facing forward and the flat edge of the insertion tube against the flat edge of the Sheath connector opening Ah IMPORTANT NOTE When using a CV 1 5 Sheath attach the irrigation source tubing directly to the sheath connector accessory port Endoscopes and EndoSheath Technology should not be used without a thorough review and understanding of the User s Manual Before inserting the Endos
38. tury nosocomial issue with endoscopes BMJ Endoscopic retrograde 4 554 38 6 9 cholangiopancreatography Lower gastrointestinal endoscopy 4 4179 42 1 0 Upper gastrointestinal endoscopy 3 1130 107 9 5 Total 29 10 lt thin gt 989 489 4 4 Note Data only include outbreaks that report patients exposed and patients contaminated Adapted from Seoane Vazquez E Rodriguez Monguio R Visaria J Carlson A Exogenous endoscopy related infections pseudo infections and toxic reactions clinical and economic burden Curr Med Res Opin 2006 22 2007 21 Owing to limited surveillance limited reporting and lack of immediate clinical symptoms of patients experts agree that the endoscopic cross contamination is significantly under reported and its incidence cannot be accurately determined 6 Outbreaks that are recognized usually involve severe or unusual pathogens which then prompt thorough investigations 6 If an older patient contracts tuberculosis a doctor is not likely to suspect that the patient s latest endoscopy is implicated even though M tuberculosis transmission represents a significant proportion of recent outbreaks 6 Even so since 2000 several outbreaks of life threatening pathogens have been traced to contaminated endoscopes in facilities throughout the US and Europe 9 10 11 12 13 14 15 16 17 In 2009 11 000 patients were notified of possible infection after the US Department of Veterans Affairs VA learned through an internal investigation that
39. vailable on request for validation of these opinions What is the VSI Endosheath product offering o VSI Endoscopes are channel less flexible endoscopes over which a specific external Endosheath is fitted This provides a sterile insertion tube in contact with the patient rather than usually a high level disinfected scope provided by the EWD The Endosheath endoscope combination means the scope never directly makes contact with the patient The sterile working channel is incorporated in the Endosheath and never touches the endoscope o Each Endosheath provides a single use sterile product The working channel is new and sterile for each patient o The risk of cross contamination is vastly reduced because the working channel is disposed of after each case CfPP guidelines specific points of relevance Personnel Section 14069 Page 9 states Training should be provided for all staff involved in the decontamination of flexible endoscopes e Genesis Medical provides comprehensive training packages in the form of presentations supporting materials and training competencies for the users of its products to ensure they are fully equipped to use the product correctly and in accordance with the validated protocol Types of EWD and cycles Section 14073 14165 Page 17 discusses the use of EWD devices o VSI Endoscopes can be re processed in an EWD Like all manufacturers of endoscopes VSI would firstly ensure chem
40. y peer reviewed References 1 ad Centers for Disease Control and Prevention CDC Notes from the field New Delhi metallo B lactamase producing Escherichia coli associated wth endoscopic retrograde cholangiopancreatography 3 Jan 2014 www cdce gov immwY previewmmwrhtml mm6251a4 htm Le qn Peery AF Dellon ES Lund J Crockett SD McGowan CE Bulsiewicz WJ et al Burden of gastrointestinal disease in the United States 2012 update Gastroenterology2012 143 1179 87 CrossRefMedlineWeb of Science de ol Bommarito M A multi site field study evaluating the effectiveness of manual cleaning of flexible endoscopes with an ATP detection system Abstract 040 APIC 2013 annual conference 9 June 2013 4 al Herv R Keevil CW Current limitations about the cleaning of luminal endoscopes J Hosp Infect2013 83 22 9 CrossRefMedline 5 sul Society of Gastroenterology Nurses and Associates Inc Standards of infection control in reprocessing of flexible gastrointestinal endoscopes 2012 www sgna org Portals 0 sgna_stand_of infection_control_0712 FINAL pdf 6 J Seoane Vazquez E Rodriguez Monguio R Visaria J Carlson A Exogenous endoscopy related infections pseudo infections and toxic reactions clinical and economic burden Curr Med Res Opin2006 22 2007 21 CrossRefMedline Pu wal Krebs A Borin JF Kim IY Jackson DJ McDougall EM Clayman RV Evaluation of practice efficiency with a novel sheathed flexible cystoscope a randomiz
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