Reusable Medical Device Challenges

Reprocessing IFU Development and Validation

Reusable medical device manufacturers are required by the U.S. Food and Drug Administration (FDA) to ensure all sets of cleaning instructions are validated and meet the parameters indicated on a device’s labeling. In light of 2015  news items on the use of potentially contaminated endoscopes in Los Angeles, Seattle and Philadelphia, and the FDA’s March 2015 release of new guidance for reprocessing of reusable medical devices,  industry attention has refocused on the cleaning of reusable medical devices.

Due to the nature and design of many reusable medical devices, there does not exist a one-size-fits-all approach to cleaning.  This white paper provides context to the issues facing reusable medical device manufacturers as well as an overview of the development and validation of a reusable medical device’s Instructions for Use (IFUs).