Creating Adequate Reprocessing Instructions

Posted on: September 7, 2017

Help Reduce Healthcare Acquired Infections

Reusable Medical Device manufacturers are required by the US Food and Drug Administration to validate their reprocessing instructions. Statistics say, about one in 25 hospital patients has at least one healthcare-associated infection. With adequate reprocessing instructions, we can help reduce these statistics!

Due to the nature and design of many reusable medical devices, there does not exist a one-size-fits-all approach to reprocessing. This white paper provides an overview of the development and validation for the reprocessing portion of reusable medical device Instructions for Use (IFU). Having well thought out instructions can prepare for smooth validation tests and a faster time to market.