August 2015

Author:
Megan Fox, MBA, Senior Medical Research Manager, NAMSA

Abstract:

This article focuses on the newly released FDA guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff” and the effects it will have on the industry. The objective of this guidance is to provide more robust recommendations for reprocessing medical devices with the intent of reducing the risk of patient infection. The guidance focuses on the criticality of manufacturers developing reprocessing instructions which can be easily understood and followed by end users to ensure that reusable devices remain safe and effective for reuse after reprocessing.