medical device guru

FDA Releases List of Reuseable Medical Devices with Highest Infection Risk

Biologics, Wound Care, Infection Prevention June 12, 2017

The Food and Drug Administration on Thursday published a list of reusable medical devices that hold the greatest risk of infection transmission or poor performance if not appropriately reprocessed, reports Regulatory Focus.

Infection Risk

 

The agency will now require device makers to submit validated instructions for use — along with validation data regarding the cleaning, disinfection, and sterilization of the device — as part of the premarket notification submission process, according to the report.

The list — an FDA requirement designated by the 21st Century Cures Act — features numerous types of bronchoscopes and endoscopes, among other devices.

See the full List at Becker’s Hospital Review: FDA publishes list of reusable medical devices with greatest infection risk

 

AUTHOR - Authorship Credit Noted Above
SHARE
YOUR FIRST STEP TO SUCCESS
IS JUST A CLICK AWAY
Search our current open opportunities to take your first step to success in Medical Device and Healthcare IT today. Focusing on you and your career is our Job, now it’s time for you to find yours. Let’s get started.
VIEW JOBS