Vision Sciences Endoscopes and EndoSheath ® Technology
Contents
1. turnover of the existing endoscopy lists in this unit Conclusions We would commend urologists and managers to consider the investment in out patient flexible cystoscopy provision for both diagnostic and surveillance endoscopy and that the Vision Science CST 2000 with slide on endosheath system be part of the planning Acknowledgement The authors have no financial involvement or interest with Dantec Dynamics Ltd Garonor Way Royal Portbury Bristol BS20 7XE UK References 1 Silberman HD Non inflatable sterile sheath for introduction of the flexible nasopharyngolaryngoscope Ann Otol Rhinol Laryngol 2001 110 385 7 2 Spach DH Silverstein FE Stamm WE Transmission of infection by gastroin testinal endoscopy and bronchoscopy Ann Intern Med 1993 118 117 28 3 Bretthauer M J rgensen A Kristiansen BE Hofstad B Hoff G Quality control in colorectal cancer screening systematic microbiological investigation of endo scopes used in the NORCCAP Norwegian Colorectal Cancer Prevention trial BMC Gastroenterol 2003 3 15 8 4 Fraser V O Rourke S Jones M Murray P Clouse RE Klasner J et a Gastro intestinal endoscope disinfection a prospective randomized trial comparing auto mated and manual disinfection Abstract Gastrointest Endosc 1992 38 277 5 Colt HG Beamis JJF Harrell JH Mathur PM Novel flexible bronchoscope and single use disposable sheath endoscope system a preliminary technology evalu ation2. 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 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 commonly 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 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
3. This Provisional PDF corresponds to the article as it appeared upon acceptance Fully formatted PDF and full text HTML versions will be made available soon A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths BMC Urology 2013 13 46 doi 10 1186 1471 2490 13 46 Peter Hjorth J rgensen Peter _Hjorth82 Hotmail com Torsten Slotsbjerg Torsten Dalgaard Slotsbjerg regionh dk Henrik Westh Henrik Torkil Westh regionh dk Vicki Buitenhuis Vicki Buitenhuis regionh dk Gregers Gautier Hermann Gregershermann Hotmail com ISSN 1471 2490 Article type Research article Submission date 26 March 2013 Acceptance date 30 September 2013 Publication date 7 October 2013 Article URL J l Like all articles in BMC journals this peer reviewed article can be downloaded printed and distributed freely for any purposes see copyright notice below Articles in BMC journals are listed in PubMed and archived at PubMed Central For information about publishing your research in BMC journals or any BioMed Central journal go to http Awww biomedcentral com info authors 2013 Jorgensen ef al This is an open access article distributed under the terms of the Creative Commons Attribution License http creativecommons org licenses by 2 0 which permits unrestricted use distribution and reproduction in any medium provided the original work is property cited A microbiological eva
4. and a second one tire surface of the control head Both wer in sterile specimen containers for cultur each procedure the bronchoscopist rated th p Mance of the device using a semi quantitative r score O minimum 5 maximum ResuLTS Fifty three procedures were performed in twelve months The proceddfes consisted of nineteen BAS thirty one BALs three PCT The procedures were steriles two 3 8 turned out positive for CONS ar Sphingomonas paucimobilis Both of these results were contaminated on purpose by an operator touching several afeas and other devices in the ICU A The devi e was judged positively for perfomance in terms of Fi visualization defined by clarity of the image and brightness suitability defined by general comfort and easiness of use and function usefulness defined by potency of aspiration and injecti n tip movements Mean visualization score was 3 9 95 Cl 2 2 5 6 Mean suitability score was 3 0 95 Cl 1 6 4 4 Steriles E Contaminated on purpose by an operator Mean function usefulness score was 3 1 95 Cl 1 7 4 5 The Operator s experience defined using a score 1 fellow 2 attending physician had no influence on the performance of the device The following table shows the relative univariate analysis Student s t test Procedures Mean Mean Mean visualization suitability function i The EndoSheath Technology seems to have the potential to
5. lumen of biopsy channels was evaluated Following observa tions in endoscopy units factors influencing protein adsorption inside luminal endoscope channels and the action of current initial cleaning techniques were evaluated using a proteinaceous test soil and very sensitive fluorescence epimicroscopy Findings Disposable endoscope accessories appear to be likely to contribute to the contamination of lumens and were useful indicators of the amount of proteinaceous soil transiting through the channels of luminal endoscopes Enzymatic cleaning according to the manufacturer s recommendations and brushing of the channels were ineffective at removing all proteinaceous residues from new endoscope channels after a single contamination Rinsing immediately after contamination only led to a slight improvement in decontamination outcome Conclusion Limited action of current decontamination procedures and the lack of applicable quality control methods to assess the cleanliness of channels between patients contribute to increasing the risk of cross infection of potentially harmful micro organisms and molecules during endoscopy procedures O 2012 The Healthcare Infection Society Published by Elsevier Ltd All rights reserved 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 Shea
6. reduce the downtime between bronchoscopies by eliminating need of high level disinfection between procedures the nursing team is no longer exposed to noxious disinfectants The performance is satisfying even if some improvement could be suggested and the comparative study will confirm the first data on reduction bacterial contamination Vision Sciences Endoscopes enesis ENDOSCOPY for innovation for reliability for peace of mind and EndoSheath Technology Preparation 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 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 FEO on y Place Sheath into installation stand with accessory port facing out A Attach the end of the irrigation suction tube to an irrigation sucti
7. sheath to be cut off Finally there was no break in the integrity of the sheaths or damage to the instrument Ann R Coll Surg Engl 2007 89 426 430 427 KIMULI LLOYD OUT PATIENT FLEXIBLE CYSTOSCOPY USING A DISPOSABLE SLIDE ON ENDOSHEATH SYSTEM Figure 3 The installation stand attached onto a table A before securing the endosheath B The distal end of the cystoscope is inserted into the opening of the sheath C while the eye piece is covered by the remainder of the sheath D FLEXIBILITY The instrument handled identically to conventional scopes with no restriction of movement Fig 3 or handling The instrument is lighter than most which is a distinct advantage when the camera was attached to the eyepiece The working channel allowed passage of a biopsy forceps which in one patient facilitated retrieval of a foreign body Fig 4 428 Ann R Coll Surg Engl 2007 89 426 430 OPTICS There was no noticeable reduction in quality of vision by looking through the transparent tip at the end of the scope Patient feedback All patients complimented us on the service and preferred to come to out patients rather than attend day ward or day theatre They did have higher expectations of attending for KIMULI LLOYD Figure 4 A foreign body retrieved from a patient an appointment whereas day theatre patients seem to accept a longer wait for their procedure Discussion Out patient flexible cystoscopy is not a new c
8. 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 What is the VSI Endosheath product offering a VSI Endoscopes are channel less flexible endoscopes over which a specific sterile external Endosheath is fitted This provides a sterile insertion tube in contact with the patient rather than a high level disinfected scope provided by the EWD e The Endosheath endoscope combination means the scope never directly makes contact with the patient e The sterile working channel is incorporated in the Endosheath and the instruments never touch the endoscope 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 o 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 produ
9. 01 06 guidelines 11 Partial list of UK Endosheath users Contact Genesis Medical 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 November 2013 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 Techn
10. 5 0620 E Mail info visionsciences com EE owt IN Remove Scope from Sheath Ah 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 drape 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 Reprocessing Chart for Recommended Cleaning Procedure for innovation for reliability for peace of mind 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 proces
11. Chest 2000 118 183 7 6 BBC Tests advised for scope patients In BBC News UK edition 21 June 2004 Ann R Coll Surg Engl 2007 89 426 430 429 KIMULI LLOYD OUT PATIENT FLEXIBLE CYSTOSCOPY USING A DISPOSABLE SLIDE ON ENDOSHEATH SYSTEM APPENDIX 1 The simplified assessment sheet used to assess patients before undergoing cystoscopy Leeds Teaching Hospitals NHS Trust Flexible Cystoscopy Date of admission Name addressograph Next of kin carer COMIENCE aras AA eee GP Transport home Car taxi bus ambulance Accompanied or self PAST MEDICAL HISTORY MEDICATION Heart disease Heart murmur Yes No Warfarin Yes No Diabetes Yes No Antibiotics Yes No Possibility of pregnancy Yes No Allergies to drugs antibiotics latex etc Yes No URINALYSIS Protein Yes No Blood Yes No INFORMATION FOR CONSENT Verbal written Yes No PRE OPERATIVE CHECK Signature Identity band applied 7 Allergies noted 9 Relevant blood results present Urine tested Pulse BP OPERATIVE PROCEDURE STERILISATION TRACKING DISCHARGE CRITERIA Passes urine Clear blood stained Has had something to ea
12. EndoSheath Technolog 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 contami nated surface The following pages comprise A leaflet explaining EndoSheath Technology Microbiological evaluation cystoscopes Bronchoscope in a critical care unit Aseptic EndoSheath technique wall charts A comparison between sterilised cystoscopes and disposable sterile sheaths Steve McCombie et al Norfolk amp Norwich University Hospital Journal of Clinical Urology Feb 2013 Outpatient Flexible cystoscopy using a disposable slide on Endosheath system M Kimuli S Lloyd Ann R Coll Surg Eng 2007 89 426 430 Microbiologic Assessment of Disposable Sterile Endoscopic Sheaths Alvarado CJ et al Am J Infect Control 2009 37 408 13 Endoscope Sheaths as Viral Barriers Laboratory FDA Study Baker KH et al Laryngoscope 1999 109 636 9 Current limitations about the cleaning of luminal endoscopes R Herve C W Keevil Jo of Hosp Infect 83 2013 22 29 10 Relevant points in CfPP
13. JF Klm IY Jackson DJ Mcdougall EM Clayman RV Evaluation of practice efficiency with a novel sheathed flexible cystoscope a randomized controlled trial UROLOGY 2007 70 883 887 5 Lawrentschuk N Chamberlain M Sterile disposable sheath system for flexible cystoscopes UROLOOGY 2005 66 1310 1313 6 Kimuli M Lloyd SN Out patient flexible cystoscopy using a disposable slide on endosheath system Ann R CollSurgEngl 2007 89 426 430 7 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 37 408 413 8 Petersen BT Chennat J Cohen J Cotton PB Greenwald DA Kolwalski TE Krinsky TL Park WG Pike IM Romagnuolo J Rutula WA Multisociety guideline on reprocessing flexible GI endoscopes CHE 2011 32 527 537 9 U S Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Guidance for Manufacturers seeking Marketing Clearance of Ear Nose and Throat Endoscope Sheaths Used as Protective Barriers 2000 http www fda gov medicaldevices devicere gulationandguidance guidancedocuments ucm07 3746 htm 10 Baker KH Chaput MP Clavet CR Varney GW To TM Lytle CD Evaluation of endoscope sheaths as viral barriers Laryngoscope 1999 109 4 636 639 11 Turan H Balci U Erdinc FS Tulek N Germiyan
14. and removing the sheath on the FC took approximately one to two minutes The current marked prize in Denmark is about 49 per sheath 2012 but most OPDs would be required to change their FCs to FCs compatible with an endosheath system Nevertheless when looking at the economical aspect of using sheaths for FCs the cost of high level disinfecting and staff performing manual cleaning must be considered in the equation 4 Conclusion The reprocessing of FC using endosheaths as preformed in this study provides a patient ready procedure The results display a reprocessing procedure with low risk of pathogen transmission high patient safety and a valid alternative to the recommended high level disinfection procedure of FC However the general impression was that sheaths slightly reduced vision and resulted in some patient discomfort Competing interests The Foundation Juchum and the Boemske Foundations have provided financial support for this study Authors contributions PHJ is first author on the article and has been instrumental in the connection of the urological and microbiological parts of the study as well as being involved in the clinical execution of the flexible cystoscopies TS is responsible for the conception and design of the study acquisition of data analysis of data as well as drafting the primary manuscript TW has been an important Key person behind intellectual content of the microbiological part and critically revi
15. ath 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 Journal of Hospital Infection journal homepage www elsevierhealth com journals jhin Journal of Hospital Infection 83 2013 22 29 Available online at www sciencedirect com Current limitations about the cleaning of luminal endoscopes R Herve C W Keevil Environmental Healthcare Unit Centre of Biological Sciences University of Southampton Southampton UK ARTICLE INFO Article history Received 1 September 2011 Accepted 22 August 2012 Available online 23 October 2012 Keywords Luminal endoscope Decontamination Prion CJD SUMMAR Y Background The presence and potential build up of patient material such as proteins in endoscope lumens can have significant implications including toxic reactions device damage inadequate disinfection sterilization increased risk of biofilm development and potential transmission of pathogens Aim To evaluate potential protein deposition and removal in the channels of flexible luminal endoscopes during a simple contamination cleaning cycle Methods The level of contamination present on disposable endoscopy forceps which come into contact with the
16. ct correctly and in accordance with the validated protocol The trained users are registered and provided with certificates of competence Types of EWD and cycles Section 14073 14165 Page 17 discusses the use of EWD devices e VSI Endoscopes can be re processed in an EWD o Like all manufacturers of endoscopes VSI would firstly ensure chemical compatibility and functional compatibility with the specific EWD 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 o The guidelines refer to the need for single use items which can incur additional cost o 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 Decontamination of Endoscopes 14186 Page 41 42 discusses the need of the user to follow the manufacturers guidelines for cleaning VSI provides this in data form presentation visual aids and formal training competency documents Conventional channelled endoscopes require essential manual cleaning due to the direct contact with the patient VSI endoscope cleaning is prophylactic when used with the Endosheath in accordance with the manufacturer s guidelines 14190 Page 45 46 highlights issues in the transportation of
17. d measures 13 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 KIMULI LLOYD Figure 1 CST 2000 Flexible cystoscope with the sterile single use slide on disposable endosheath Figure 2 Crescent shaped flexible cystoscope with A or without B an endosheath C The lever that locks the cystoscope into the sheath D The irrigation valve OUT PATIENT FLEXIBLE CYSTOSCOPY USING A DISPOSABLE SLIDE ON ENDOSHEATH SYSTEM The cystoscope is sterilised at the beginning and end of the list with conventional techniques using peracetic acid The single use slide on sheath is employed between each patient For each procedure both the operator and the assistant wear double layer sterile gloves so as not to con taminate the instrument when re sheathing At the begin ning of each procedure the individually pre packaged sheath is secured on a table top fixed device The instru ment is inserted into the sheath and the two are locked together with a catch on the instrument Fig 2A D The sheath is pulled over to cover the rest of the cystoscope before attaching a camera The instrument is introduced into the urethra in a standard fashion after cleaning and insertion of local anaesthetic jelly At the end of the proce dure the assistant slides the sheath off the instrument removes the outer gloves and i
18. 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 involvement 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 in the 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 endosco
19. e 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 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 article 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
20. entiation of the guidelines of reprocessing FEs In comparison with other types of endoscopes the decontamination of FCs is less complicated because they are single channel instruments When using FCs with endosheaths the work channel is placed in the sheath and the endoscope will generally only become contaminated from handling This study did not look into optical quality or patient comfort In a retrospective overview of the post procedure descriptions and when asking the urologist who performed the cystoscopies poor optical quality and handling problems were mentioned Our general impression was that the sheaths slightly reduced vision and resulted in some discomfort for the patients as compared to FC without sheaths A recent published trial by Krebs et al assigned 97 patients in a control group with unsheathed FC and a group undergoing sheathed FC EndoSheath System The Sheathed procedure saved between four to 31 minutes of reprocessing time while avoiding exposure to irritants found in conventional soaking methods The control group scored better than sheath group regarding to insertion of FC general handling and rinse water setup P lt 0 01 No significant difference was found between the two groups comparing procedure time optical quality and patient comfort both before and after the procedure 4 Three non comparative studies reported a minor disadvantage in sheathed FC concerning handling and set up 4 6 The process of applying
21. ewer of the final draft of the manuscript VB has been involved is the practical setup and execution of the study She has been clinical involved in the flexible cystoscopies and collection of data GGH is responsible for the intellectual content of the urological part of the study as well being the connecting and coordinating person throughout the process He has given final approval of this version to be published All authors read and approved the final manuscript Acknowledgements We would like to thank the personnel at the Department of Urology Frederiksberg Hospital Denmark and the Department of Clinical Microbiology Hvidovre Hospital Denmark for helping us collecting data analyzing data and logistics We would like to thank Vision Sciences Inc for lending us a FC with the Slide On Endosheath System References 1 Hermann GG Steven K Thind P Mathiasen H Jensen JB Petersen A Agerb k M Friis S Danish Bladder Cancer Register 2010 Year Report Danish BladderCancer Register amp Research Centre for Prevention and Health https www sundhed dk content cms 54 1854_ endelig 20 10 dbcr rapport _1_pdf 2 Clemens JQ Dowling R Foley F Goldman HB Gonzalez CM Tessier C Wasner MA Young E Joint AUA SUNA white paper on reprocessing of flexible cystoscopes J Urol 2010 184 2241 2245 3 Burke DM Shackley DC O Reilly PH The community based morbidity of flexible cystoscopy BJUI 2002 89 347 349 4 Krebs A Borin
22. he 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 leak 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 Telephon
23. hen divided in three categories Clean FC lt 5 cfu sample Critical FC 5 50 cfu sample and High risk FC gt 50 cfu sample The result was compared with data of 10 years continuous control sampling recorded in the Copenhagen Clean Endoscope Quality Control Database CCQCD and analyzed with a Chi square test for homogeneity Results All 100 endosheaths passed the leak test All samples showed a Clean FC and low means of cfu A query to the CCQCD showed that 99 8 1264 1267 of all FC with a built in work channel reprocessed in a WD were clean before use Conclusion The reprocessing of FC using endosheaths as preformed in this study provides a patient ready procedure The results display a reprocessing procedure with low risk of pathogen transmission high patient safety and a valid alternative to the recommended high level disinfection procedure of FC Keywords Flexible cystoscopy Endosheaths Microbiological assessment Disinfection Bladder cancer Background Flexible cystoscopy is a common procedure in Danish urological outpatient departments OPD Based on the Danish Bladder Cancer Registry up to 20 000 cystoscopies are performed each year for either diagnostic purposes or as part of post surgery follow up of bladder tumors BT 1 FC can be classified as semi critical or critical devices and therefore a high level disinfection between each patient has been suggested 2 No general guidelines for reprocessing f
24. le 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 disposable 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 EndoShe
25. lexible endoscopes FE include FCs The recommended standard disinfection of FCs consist of manual cleaning followed by rinsing and drying in a washer disinfector WD and finally flushing of the FC work channel with alcohol This practice is time consuming as well as relatively expensive and requires specific equipment facilities and trained staff It is therefore of importance to develop and evaluate new approaches concerning this everyday urological procedure Studies on FCs with or without the use of disposable polymer endosheaths have been made All have focused on optical quality procedure time patient comfort and financial aspects 3 6 The present study is to our knowledge the first to evaluate bacterial contamination of cystoscopes protected by endosheaths and the efficacy of reprocessing Data on bacterial contamination in relation to level of disinfection are necessary where implementing new FC procedures in clinical use Methods We included 100 patients who underwent flexible cystoscopy in the OPD Frederiksberg Hospital Denmark in the follow up of BT from August to December 2010 Only one cystoscope was used Model CST_4000 Vision Sciences Inc Orangeburg NY USA covered by the sterile single use Slide On Endosheath System with the built in work channel in the endosheath EndoSheath Vision Sciences Inc Orangeburg NY USA After cystoscopy cultures were obtained immediately after removal of the sheath using
26. luation of level of disinfection for flexible cystoscopes protected by disposable endosheaths Peter Hjorth Jorgensen Corresponding author Email Peter_Hjorth82 Hotmail com Torsten Slotsbjerg Email Torsten Dalgaard Slotsbjerg regionh dk Henrik Westh Email Henrik Torkil Westh regionh dk Vicki Buitenhuis Email Vicki Buitenhuis regionh dk Gregers Gautier Hermann Email Gregershermann Hotmail com Department of Urology Frederiksberg University Hospital Frederiksberg Denmark s Department of Clinical Microbiology Hvidovre University Hospital Hvidovre Denmark Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark Abstract Background Flexible cystoscopy is used in urological outpatient departments for diagnostic cystoscopy of bladder cancer and requires a high level disinfection between each patient The purpose of this study was to make a microbiological post disinfection efficacy assessment of flexible cystoscopes FC using disposable sterile endosheaths Methods One hundred endosheaths underwent a leak test for barrier integrity after cystoscopy Microbiological samples from these cystoscopies were obtained after removal of the endosheath and after cleaning the scope with a detergent cloth rinsing with tap water followed by 70 ethanol disinfection and subsequent drying The number of colony forming units cfu from the samples was counted after 72 hours and t
27. nning 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 or 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 Lyt
28. nserts a new sterile sheath into the table top holding device The operator inserts the cystoscope into the new sheath removes the outer gloves before pulling the sheath onto the rest of the instrument The cystoscope is now ready for the next patient The de sheathing and re sheathing process takes about 2 min A standard catheterisation pack was used to provide the swabs and paper towel The assessment of the procedures was evaluated accord ing to ease of use flexibility and vision Staffing ratios and patient flows were developed as the clinic progressed until the ideal levels were identified The patients were asked to give feedback of the out patient cystoscopy service Results Out patient setting The out patient setting proved to be ideal for flexible cystoscopy utilising a treatment room used for catheterisation and the main waiting area as pre waiting and recovery area The optimum staffing ratios were a receptionist one trained assistant and one untrained nurse and the operator Instrumentation EASE OF USE Once the operator and assistant became familiar with the sheathing the whole process of sheathing and re sheathing became smooth and efficient The whole process was more intricate than normal but the benefits outweighed the disadvantages Care was taken not to put the instrument down after use until it was re sheathed ready for use again On four occasions the sheath clung to the scope due to friction requiring the
29. oglu C Bacteriuria pyuria and bacteremia frequency following outpatient cystoscopy JU 2006 13 25 28 12 Wendelboe AM Baumbach J Blossom DB Frank P Srinivasan A Sewll CM Outbreak of cystoscopy related infections with pseudomonas aeruginosa New Mexico 2007 Urol 2008 180 588 592 ENDOSHEATH TECHNOLOGY A NEW ALWAYS READY ALWAYS STERILE FLEXIBLE BRONCHOSCOPE A PRELIMINARY EVALUATION IN CRITICAL CARE UNITS VASTO D De Nuzzo D De Luca S D Andreagiovanni G Giuliani S Spadano D Alba e F Petrini 42 Anaesthesiology Pain Therapy and Intensive Care School Perioperative Medicine Pain Therapy RRS and Critical Care Dep Chieti University Hospital ASL 2 ITALY Bronchoscope associated pneumonia can be caused by the improper use of the disinfection disinfection is time consuming The single use EndoSheath Technology is designed to isolate the contact with the patient and provides a instrument always ready always sterile OBJECTIVE To examine the impact of the EndoSheath METHODS The bronchoscope was Technology on reducing the bacterial contamination of in critical care units In our ICU MESA from June the bronchoscopes and obviating the need of routine 2012 to June 2013 The device before the high level disinfection in reprocessing to measure application of the protective s the procedure overall performance of the device matic cleaning drying and disinfection wi hanol A sterile pledget was wiped on the tube
30. ology ay EndoSheat echnology A brand with strength A name you can trust 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 So
31. on 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 Endoscope 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 36
32. oncept but this requires either support with sterilisation units or several pre packed scopes which may limit the number of procedures that could be performed The use of the re sheathable flexible cystoscopy overcomes most of these obstacles potentially freeing up valuable day theatre or endoscopy theatre time Vision Science also manufacture disposable sheaths for ENT instrumentation which have found favour in many centres including our own The disposable nasopharyngo laryngoscopy sheath has proven cost effective and has resulted in large numbers of procedures being performed in the community setting rather than in secondary care The US FDA approved sheath is a proven effective barrier to micro organisms as small as 27 nm equivalent to a polio virus particle size and is designed to isolate the patient from the cystoscope Current high level disinfection of flexible cys toscopes uses either glutaraldehyde or peracetic acid The effi cacy of glutaraldehyde relies on meticulous manual pre cleaning although symptomatic iatrogenic infection rates are low this is likely to be due to under reporting as previous studies have shown a 15 17 positive culture rate in patient ready scopes Though more effective peracetic acid disin fection is equally time consuming labour intensive and potentially a costly process There have been scares about cross contamination between patients undergoing endo scopies Three tho
33. out of material with high integrity unlikely to tear or leak in contrary to other commonly clinically used barriers 9 An evaluation of sheaths as a viral barrier has shown a low risk of viruses from contaminated scopes penetrating micro holes and tears in the sheath 10 The risk of a urinary tract infection UTD after FC is estimated to be lt 2 to 7 5 3 Diagnosing UTI in relation with FC can be difficult due to hematuria urge dysuria and leucocyturia all symptoms that can occur with or without the presence of bacteriuria In the reported cases of UTIs found in relations with FCs it has primarily been endogenous bacteria presumably the patient s own microorganisms 11 Exogenous FC related infections appear to be very rare in cystoscopy Only two major outbreaks have been reported with UTIs caused by Pseudomonas aeruginosa as a consequence of insufficient reprocessing of the FC Other studies have showed a correlation between outbreaks and previously damaged or poorly decontaminated instruments 12 Current USA Multisociety Guideline on Reprocessing Flexible GI Endoscopes 2011 does not address reprocessing of FCs and FBs 8 In Denmark only automatic decontamination in a WD is recommended when reprocessing FE Compiled data from the CCQCD has shown a constant low risk of contaminated FC after manual cleaning including brushing of the work channel followed by a high level disinfection in an automatic WD This suggests a differ
34. pe 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 Flexible 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 9TF UK E slloyd1400btinternet 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 ation resulting in significant waiting times for the procedure delaying diagnosis and treatment Most units 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 fo
35. r 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 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 Vision out patient setting 426 Ann R Coll Surg Engl 2007 89 426 430 Twenty seven 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 wailing 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 an
36. reprocessing and FC with sterile endosheaths with a built in work channel were compared The results of samples obtained before and after reprocessing the FC were analyzed for homogeneity with a Chi square test based on means of cfu The study was performed in accord to the Helsinki Declaration and regulations of the local ethical committee and was regarded as a quality performance project and all patients participating in the procedures were adults and had given their oral and written accept Results All samples obtained after removal of the sheath and after cleaning and alcohol disinfection both from the maneuver part and insertion part of the FC showed a Clean FC with a mean of 0 2 cfus Table 1 Table 1 shows that samples from the FC before and after reprocessing demonstrated no significant reduction of cfus by reprocessing The bacteria identified were coagulase negative staphylococci Bacillus species and Corynebacterium species Table 1 Microbiological samples from 100 cystoscopies preformed with a Vision Sciences FC Model CST 4000 Vision Sciences Inc after removal of the endosheath and after cleaning the FC with a detergent cloth rinsing with tap water followed by 70 ethanol disinfection and subsequent drying Maneuver part Insertion tube ARS AD ARS AD No of samples 100 100 100 100 No of cfu sample Clean FC O 82 87 88 87 1 12 11 9 9 2 4 3 3 3 2 l 0 0 4 0 0 0 l High risk Critical FC gt 5 0 0 0 0 Mean cfu
37. s 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 Remove endoscope from Sheath and After removing the Sheath Inspect decided upon the place in a clean Sterile area Do not the endoscope insertion tube and endoscope must be handle the endoscope with distal bending section and confirm prepared according to contaminated gloves these areas are dry and instructions in the user undamaged manual After EndoSheath Technology Removal CLEANING AND INTERMEDIATE LEVEL DISINFECTION 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 chemical immersion is necessary 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 t
38. sample NS 026 0 6 0 5 0 19 ARS After removal of the sheath AD After disinfection NS Non significant All 100 endosheaths passed the leak test after the cystoscopy and no endoscopes were visibly contaminated with body fluids A query to the CCQCD showed that 99 8 1264 1267 of all FC with a built in work channel reprocessed in a WD were clean before use Discussion After using FCs with disposable sterile endosheaths the ensuing cleaning and disinfection of the FCs serves two purposes The first is to clean the endoscope in case of failure of antiseptic technique by the user The second is to mechanically remove material that may have been deposited by the insertion tube or onto the scope while applying or removing the sheath The use of endosheaths in this study ensured that no body fluids came in contact with the scope making it possible to do the manual cleaning with a pre packed single use cloth moistened with a non enzymatic detergent in the examination room Prevention of contamination with bacteria from the patient and environment is reliably prevented with 70 ethanol Furthermore 70 ethanol protects against most viruses except for instance HPV and evaporates water leaving the FC dry Being dry before reuse it is now possible to do a leak test by inspecting the scope surface for moisture after removal of the next sheath If the surface of the FC was wet after removal of the endosheath it could indicate a leak and
39. sterile saline pledgets Sterile Wipes PDI Inc Orangeburg NY US from the maneuver part and the insertion part of the cystoscope as described by Alvarado et al 7 Then the cystoscope was wiped with a detergent cloth Wet Wipe A S Vallensbek Denmark rinsed with running tap water manually dried off with gauze wiped with 70 ethanol soaked gauze and finally hung vertically for the ethanol to evaporate Post disinfection cultures were also obtained after 10 minutes drying The sample pledgets were placed in 1 ml sterile saline and shaken for 30 seconds Ten drops of 0 02 ml aliquots from the sample were spotted on two 5 blood agar plates Statens Serum Institut Denmark and incubated at 35 C in CO The total number of colony forming units cfu was counted after 72 hours Bacteria were speciated using standard methods The endoscope was visually inspected after use for contamination with body fluids All 100 sheaths underwent a test for barrier integrity post cystoscopy using a Leak Testing Pressure Decay Equipment Vision Sciences Inc Orangeburg NY USA After sampling the cystoscope was reprocessed according to standard operating procedures in a WD As in the Copenhagen Clean Endoscope Quality Control Database CCQCD we defined three grading levels of reprocessing FC Clean FE lt 5 cfu sample Critical FE 5 50 cfu sample and High risk FE gt 50 cfu sample The disinfection quality level of FC after traditional
40. t drink Yes No GP discharge letter and information given Yes No Time of discharge Print name of nurse Signature of nurse 430 Ann R Coll Surg Engl 2007 89 426 430 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 EndoSheath 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 ru
41. that direct contact between mucosa and cystoscope had taken place The few bacteria 1 to 4 cfus we identified originated from skin commensals and were found in a few samples taken both before and after reprocessing the FC As no leak was detected the contamination is presumed to come from the handling of the FC or from sampling procedures A study by Alvarado et al 7 showed clean flexible nasopharyngoscopes FN after they were desheathed and cleaned with enzymatic detergent followed by 70 ethanol disinfection and evaporation They developed the method used in our study and even though a FC is longer than a FN we only found a few cases of contamination with the same environmental microorganisms This indicates that our method of reprocessing the FC without the use of enzymatic detergent was reliable Should a leak occur it will be revealed by the presence moisture on the FC after removal of the sheath This contaminated FC which had contact with body must be processed by manual cleaning with an enzymatic detergent followed by a high level disinfection in a washer desinfector 2 8 This setting requires a separate cleaning room with a basin with a detergent solution to soak and manual clean the FC The quality of the disposable sheaths used was high In a prior study with 875 endoscopic procedures no leak has been reported 7 We used sheaths approved by the USA FDA that are resistant to microorganisms as small as 27 nm and are made
42. thed Scopes as raised in the CfPP 01 06 guidelines Issues relating to Vision Sciences VSI Flexible Endoscopes Decontamination of flexible endoscopes Operational management manual CONCLUSION The unique nature of the VSI Endosheath Technology aseptically fitting sterile sheaths incorporating the working 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 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 It 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 EWD 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
43. usand patients had to be contacted recently due to problems with decontamination Out patient flexible cystoscopy is not a new concept Each urology unit provides flexible cystoscopy in differing OUT PATIENT FLEXIBLE CYSTOSCOPY USING A DISPOSABLE SLIDE ON ENDOSHEATH SYSTEM facilities with varying numbers of instruments and staffing levels In Leeds all flexible cystoscopies are performed within the day theatre setting in four different hospitals with a total of eight lists per week Transportation is need ed before and after each list to move instruments around the city as well as the staff This initiative has proven that all such lists could be moved into an out patient setting The cost of the Vision Science flexible cystoscopy is less than standard instrumentation the cost of the disposable sheaths is 18 VAT each from Dantec Dynamics Ltd All patients in our study preferred out patient rather than day case attendance The next step would be to offer flexible cystoscopy at the time of out patient attendance eliminating waiting times which can only improve the out come of care The flexible cystoscope could be pre ster ilised and ready for use once used it could be available for subsequent patients This process could avoid costly instilla tions of sterilising equipment These lists were carried out in a treatment room in the out patient department adjacent to the day theatre There was no significant impact on the sterilising
44. uth Orangeburg C 0843 Telephones 800 874 9975 845 365 0600 Fax 845 365 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 BioMed Central BMC Urology The Open Access Publisher
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