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.
Resources
AAMI
- 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 ST81:2004/(R)2010 — Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable 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
- TIR34:2007, 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
Government
- FDA Workshop: Reprocessing of Reusable Medical Devices, June 8-9, 2011
- FDA website on Reprocessing of Reusable Medical Devices
- Federal Register Notice of Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability (May 2, 2011)
- Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2, 2011)
- FDA Press Release: FDA looks to improve design and cleaning instructions for reusable medical devices (April 29, 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)