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!
In Part 2 of this series, Philip Nosel, Reusable Medical Device Testing Supervisor at Accuratus Lab Services, shares what you need to know about current regulatory expectations for performing disinfection and sterilization validations for reusable medical devices.
Tags: Reusable Device
AAMI ST77 Reusable Device Studies Microtest offers exceptional testing of medical devices manufactured for reuse in clinical settings. Tests include: High/low-level disinfection Cleaning studies Steam/EO/chemical sterilization Our AAMI ST77 reusable device studies are ideal to support initial U.S. FDA Section 510(k) submissions on new products or for use after a relevant change to an existing… Read More
Categories: Medical Device