duodenoscope
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Pathology
- difficult to eradicate drug-resistant bacteria that contaminates endoscopes used for duododenoscopy (ERCP)*
* the design of the scopes may impede effective cleaning[2]
Complications
Management
- 48 hour quarantine post decontamination to allow for bacterial cultures before reusing endoscopes
- FDA recommends:
- microbiological cultures
- ethylene oxide sterilization
- liquid chemical sterilant processing
- repeat high-level disinfection
Notes
- potential defect in the PENTAX ED-3490TK duodenoscope
- FDA approves 1st duodenoscope with a disposable distal cap, a new feature to improve access for cleaning & reprocessing (Pentax ED34-i10T duodenoscope)[5]
- FDA recommends transitioning to duodenoscopes with disposable components to reduce risk of infection[7]
- FDA approves 1st fully disposable duodenoscope[8]
More general terms
References
- ↑ Terhune C Superbug linked to 2 deaths at UCLA hospital; 179 potentially exposed. The Los Angeles Times. Feb 19, 2015
- ↑ Jump up to: 2.0 2.1 FDA MedWatch. Feb 19, 2015 Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm434922.htm
- ↑ FDA Safety Alert. 08/04/2015 Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457132.htm
- ↑ Jump up to: 4.0 4.1 FDA Safety Alert. Jan 17, 2017 ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication
UPDATE - Follow Pentax Validated Reprocessing Instructions. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537146.htm - ↑ Jump up to: 5.0 5.1 FDA News Release. September 20, 2017 FDA clears first duodenoscope with disposable distal cap. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576753.htm
- ↑ FDA. Medical Devices. Infections Associated with Reprocessed Duodenoscopes. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454630.htm
- ↑ Jump up to: 7.0 7.1 FDA News Release. Aug 29, 2019 FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection. https://www.fda.gov/news-events/press-announcements/fda-recommends-health-care-facilities-and-manufacturers-begin-transitioning-duodenoscopes-disposable
- ↑ Jump up to: 8.0 8.1 FDA News Release. Dec 13, 2019 FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing. https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective