Information for Health Care Facilities: Reprocessing of Reusable Medical Devices
This page provides links to resources such as guidelines, self-audit tools, education & training materials, and safety communications, including those provided by other government agencies for staff working in endoscopy reprocessing units or Central Sterile Supply, infection control practitioners, as well as providers, notably gastroenterologists, gastrointestinal surgeons and endoscopy nurses.
These resources may help health care facilities establish, implement and/or improve their quality assurance programs related to reusable device reprocessing. Please check back often, as this page will be updated with additional resources once they become available.
Resources from Federal Partners:
From the Food and Drug Administration:
- UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
- Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers
- FDA is Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes
- FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
- FDA clears first duodenoscope with disposable distal cap
- UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication (1/17/2017)
- FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication (1/13/2017)
- FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Communication (8/17/16)
- Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication (3/15/2016)
- PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication (2/19/2016)
- FUJIFILM Medical Systems, U.S.A., Inc. Validates Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication. December 2015.
- Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication. September 2015.
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication. August 2015.
- Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication. March 2015.
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. February 2015.
From the Centers for Disease Control and Prevention (CDC):
- CDC: Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing (3/12/15)
- CDC: Interim Sampling Method for the Duodenoscope – Distal End and Instrument Channel (3/12/15)
- CDC: Interim Culture Method for the Duodenoscope – Distal End and Instrument Channel (3/12/15)
- CDC: Outbreaks and Patient Notifications
- Guideline for Disinfection and Sterilization in Healthcare Facilities - 2008
- CDC Guideline for Infection Control in Dental Health Care Settings - 2003
From the CDC jointly with FDA:
From the Centers for Medicare & Medicaid Services (CMS):
- The ASC infection control surveyor worksheet, Exhibit 351 of the Medicare State Operations Manual (SOM), Publication 100-07, may be used to perform self-audits at your facility
(More detailed information on the Medicare ASC Conditions for Coverage and what is expected for compliance may be found in Appendix L of the SOM)
From FDA jointly with CDC and Department of Veterans Affairs (VA):
Resources from Professional Organizations:
From the International Association of Healthcare Central Service Material Management (IACHMM):
From Multiple Professional Organizations: