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A Closer Look at the Device Reprocessing Guidance
Medical Device and Diagnostic Industry

After digesting last week’s final FDA guidance on medical device reprocessing, stakeholders discussed their impressions of the agency’s recommendations. A lawyer points out a new quirk manufacturers will need to consider, while a patient advocate explains why he believes the guidance does not address the underlying problem.

The Basics
As reported last week, FDA has released its final guidance on medical device reprocessing. This gives manufacturers guidelines for cleaning, disinfecting, and sterilizing reusable devices that are reprocessed in the health care setting.

The subject of medical device reprocessing of reusable devices has been under consideration by FDA for years. Back in 2011, the agency held a public workshop and issued draft guidance on the topic.