Medical Devices

Reusable Device Reprocessing Resources for Health Care Facilities

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.

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:

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):
Guideline for Disinfection and Sterilization in Healthcare Facilities - 2008
CDC Guideline for Infection Control in Dental Health Care Settings - 2003

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):
Preventing Cross-Contamination in Endoscope Processing Safety Communication from FDA, CDC, and the VA. November, 2009.

Resources from professional organizations:

From the International Association of Healthcare Central Service Material Management (IACHMM):
Continuing Education Lesson Plans

From multiple professional organizations:

Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. 2011.

Page Last Updated: 03/12/2015
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