steriliza on of endoscopes

Steriliza)on of Endoscopes And Why We Chose a Low Temperature - PowerPoint PPT Presentation

Steriliza)on of Endoscopes And Why We Chose a Low Temperature Reprocessing Method Presenter: Albert Csapo, BA Sponsored by October 6, 2017. About. Vancouver Coastal Health for 24 years Manager of MDRD at

  1. Steriliza)on of Endoscopes And Why We Chose a Low Temperature Reprocessing Method Presenter: Albert Csapo, BA Sponsored by October 6, 2017.

  2. About…. § Vancouver Coastal Health for 24 years § Manager of MDRD at Vancouver General Hospital (VGH) and UBC Hospital since 2009/2013 § Economics, Urban Planning and Healthcare AdministraLon § President Elect & Vendor Director for CAMDR § VCC MDRT Program, Regional Reprocessing standards, Regional MDR CommiOee, MoH Provincial Working Group

  3. The Reason Why…. § SterilizaLon of Endoscopes and Why We Chose a Low-Temperature Reprocessing Method § Duodenoscopes and the challenge of reprocessing § Current standards § Recent CRE outbreaks § FDA recommendaLons § VGH incident & acLons taken § Need for Provincial soluLon § Trial and evaluaLon of new technology § Conclusions/Future ExpectaLons

  4. What are Duodenoscopes? § MulL-channeled flexible scopes that enter through the mouth and travel down into the top of the small intesLne or duodenum. § Endoscopic Retrograde Cholangiopancreatography – ERCP § 650,000 in the US – 2016

  5. The Challenge of Reprocessing Why are duodenoscopes so difficult to reprocess? § Complex design – forceps elevator channel § Lengthy vendor IFU on reprocessing § Delicate and expensive medical device § MulL-channeled endoscope § Material compaLbility issues §

  6. Current Standards Spaulding’s ClassificaLon “ You can clean without disinfec2ng, but you cannot disinfect without cleaning” Dr. Earle Spaulding

  7. Outbreaks of Deadly Bacteria § Despite following the IFU cases of infecLon occurred § Carbapenem-Resistant Enterobacteriaceae (CRE) § Over 350 cases reported worldwide 2010-2015 § Superbug with 40 - 50% mortality rate § Outbreaks in Los Angeles, SeaOle, Chicago, Philadelphia and PiOsburgh

  8. FDA Response & RecommendaLons § Ensure strict adherence to IFU § Competency tesLng of staff § Device design § RouLne/periodic microbiological culturing § Repeat high-level disinfecLon § Use of a liquid chemical sterilant processing system § ETO sterilizaLon

  9. The VGH Experience A small cluster of 3 paLents was idenLfied in 2016 § Carbapenemase Producing Organism (CPO) § ERCP’s completed in 2016 § Source of the infecLon unclear § Duodenoscopes, Valves, buOons?

  10. Ac)ons Taken VGH immediately put in place a number of measures to miLgate the transmission of CPO infecLons in the Endoscopy Clinic § Complete environmental clean of the Endo Clinic § External audit performed – 100% compliance § Complete ETO sterilizaLon of all endoscopes § Steam sterilized of all reusable adapters § New protocol for adapters HLD to SterilizaLon § Vendor in-servicing of all staff § Developed audit tool for ongoing staff competencies § New informed consent procedures as per PICNet § Duodenoscopes HLD – ETO SterilizaLon

  11. The Provincial Solu)on Challenge: § ETO sterilizaLon requires increase of scope inventories at VGH – capital investment § Scope compaLbility issues with ETO § Infrastructure costs of ETO sterilizers § LogisLcs of sending to VGH Required: § Sterilizer(s) for each site performing ERCP’s § Materials compaLbility with LTS § Maintain scope inventory levels – quick cycle Lmes § Cost effecLve

  12. New Technology Trial § New low-temperature sterilizer which uses vaporized hydrogen peroxide and ozone in a mulLphase process § Validated in Canada – TJFQ180V Duodenoscope § Requires and Oxygen source i.e. O2 tanks, concentrator, direct line. § No special HVAC requirements/renovaLons

  13. Trial Parameters § 6 month trial period § 8 TJFQ180V duodenoscopes - approx. 5 years old § 2 sterilizing units § O2 Bank used as Oxygen source § IdenLfy super users and train specific core group § One scope per cycle, placed in compaLble bin and wrapped § Sterivent caps used on all scopes § ConLnue with current process of manual clean, HLD in AER and then sterilize § 4 scopes not in trial sterilized in ETO sterilizer

  14. Trial Parameters § Scopes randomly placed into 1 of 2 sterilizers § InspecLon of scope pre and post sterilizaLon (both methods) § Monitor cycle Lmes and aborted cycles § Monitor Hydrogen Peroxide InjecLon Times § Record oxygen tank consumpLon § Sterilant consumpLon § Droplets inside container post sterilizaLon § User feedback

  15. Ini)al Clinical Trial Results (Sep 1- Oct 2/17) § 71 cycles logged § Zero aborted cycles § Average cycle Lmes of 58:56 § 9 scopes per oxygen tank § 9 scopes per sterilant boOle § No droplets found in container aoer 49 cycles § PosiLve user feedback

  16. Pre & Post Scope Inspec)ons § Scope D301 -10 cycles § No issues reported § Scope D302 § Not used in trial § Scope D303 – 15 cycles § Sep 12/17 Slight discolora)on noted aXer HLD, prior to Steriliza)on. Removed when rinsed with sterile water. § Sep 28/17 Image brightness isssue. Sent for repair

  17. Pre & Post Scope Inspec)ons § Scope D304 – 3 cycles § Issue with previous repair and sent back to vendor to correct. § Scope D305 – 13 cycles § Sep 12/17 discolora)on noted aXer HLD, prior to steriliza)on. Discolora)on rinsed off with sterile water

  18. Pre & Post Scope Inspec)ons § Scope D306 – 2 cycles § Not used in trial § Scope D316 – 14 cycles § Sep 12/17 discolora)on noted aXer HLD, prior to steriliza)on. Discolora)on rinsed off with sterile water. Sep 20/17 discolora)on reappeared aXer HLD and removed with sterile water. § Oct 2/17 Elevator movement problem. Sent for repair

  19. Pre & Post Scope Inspec)ons § Scope D317 – 9 cycles § Black build up no)ced post steriliza)on. Removed with swab and sample sent to lab. Scope remained in use.

  20. Conclusion § Average cycle Lmes of < 1 hour on target with Provincial requirements § Staff found the process to be user friendly § DiscoloraLon found on scopes post HLD also noted on scopes not in trial (ETO sterilized). Therefore, seems to be residue from HLD and not the sterilizaLon process. § Lab results from black deposit found on one scope returned as non-organic. SpeculaLon this is excess adhesive from a previous repair. Scope returned to circulaLon. § No noLceable degradaLon of scopes compared to those being ETO sterilized

  21. Future Considera)ons § Aoer reviewing IFU’s and in consultaLon with vendor, the discoloraLon seems to be a result of both processes (HLD 7 SterilizaLon). The recommendaLon is to use just one process. Going forward duodenoscopes will be manually cleaned and sterilized, not HLD. § Will review consumable costs to get an accurate comparison of per cycle costs associated with both sterilizaLon methods. Some costs may be offset by reduced HLD costs. § ConLnue to monitor condiLon of scopes and to log specific repairs associated with reprocessing. § Compare scope degradaLon from both ETO and VHP & Ozone

  22. Ques)ons?

  23. References § Centers for Disease Control and PrevenLon hOps:// seqngs/lab/lab-duodenoscope-sampling.html § CRE Superbug Org hOp:// infecLon/ § Fibertech Medical hOp:// how-it-works-the-ercp-elevator-channel/ § Olympus Europe hOps:// medical_systems/products_services/product_details/ product_details_112768.jsp

Download Presentation
Download Policy: The content available on the website is offered to you 'AS IS' for your personal information and use only. It cannot be commercialized, licensed, or distributed on other websites without prior consent from the author. To download a presentation, simply click this link. If you encounter any difficulties during the download process, it's possible that the publisher has removed the file from their server.


More recommend