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Device Reprocessing Recommendations Updated

The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) issued an update to amend previous recommendations for provider and health care facility practices in maintaining, cleaning, disinfecting, and sterilizing reusable medical devices. The agencies have removed language advising health care facilities to verify that vendors who service and repair these devices are approved or certified by the manufacturer. This removal comes after the agencies received feedback that no formal standardized programs or processes for manufacturer certification of third-party vendors currently exist.

The updated recommendation further clarifies that health care facilities that hire contractors for reprocessing should verify that the contractor has an appropriate training program consistent with a facility’s own requirements and specific to the devices used by the facility. Providers should ensure reprocessing is done correctly as part of routine infection control policies and procedures.

Contact Erin O’Malley, director of policy, at or 202.585.0127 with questions.


About the Author

Maryellen Guinan is a principal policy analyst at America's Essential Hospitals.

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