Medical device and MedTech insights, news, tips and more

FDA Releases List of Reuseable Medical Devices with Highest Infection Risk

June 12, 2017

Infection Risk

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

 

More insights

October 12, 2023
Brainomix and Nanoflex Robotics to Collaborate on an AI-Assisted Robotic System for Remote Stroke Intervention
Learn More
October 10, 2023
FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System
Learn More
October 9, 2023
FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.