Reprocessing of Reusable Medical Devices
Reusable medical devices are devices that healthcare providers can reuse to diagnose and treat multiple patients.
Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among the FDA; healthcare facilities responsible for cleaning, sterilizing or disinfecting the devices; manufacturers, responsible for providing adequate instructions that are user-friendly and proven to work; and other organizations.
The following resources share insights on this topic.
- 2011 AAMI/FDA Medical Device Reprocessing Summit
- The Top Ten Medical Device Challenges BI&T, Mary/April 2011
- Containment Devices for Reusable Medical Device Sterilization BI&T, March/April 2007
- ST79: And Then There Was One BI&T, July/August 2006
AAMI Standards and Guidance
- ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ANSI/AAMI ST91 2015, Flexible and semi-rigid endoscope processing in health care facilities.
- ANSI/AAMI ST81 2004/(R)2010 — Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities
- AAMI TIR55:2014, Human factors engineering for processing medical devices
- AAMI TIR12:2010 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
- AAMI TIR34:2014, Water for the reprocessing of medical devices
- ANSI/AAMI RD47:2008, Reprocessing of hemodialyzers
- ANSI/AAMI HE75, 2009 Edition Human factors engineering — Design of medical devices
- The Quality System Compendium: GMP Requirements & Industry Practice, 2ed
- Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication 9.17.15
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication 8.4.15
- FDA Final Guidance:Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 3.17.15
- FDA: Infections Associated with Reprocessed Duodenoscopes 03.04.15
- FDA: Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication 2.19.15
- FDA Workshop: Reprocessing of Reusable Medical Devices, June 8-9, 2011
- FDA Website on Reprocessing of Reusable Medical Devices
- Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 5.2.11
- FDA: Working Together to Improve Reusable Medical Device Reprocessing March 2011
- 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, Centers for Medicare & Medicaid Services (CMS) November 2010
- Preventing Cross-Contamination in Endoscope Processing, Safety Communication from FDA, CDC, and the VA 2009
- Guideline for Disinfection and Sterilization in Healthcare Facilities, CDC November 2008
- AMDR (Association of Medical Device Reprocessors)