The Food and Drug Administration (FDA) has published a list of reusable medical devices with the greatest risk of transmitting an infection or performing poorly if not properly reprocessed.
The report — published in accordance with requirements under the 21st Century Cures Act — also includes a list of device features that could cause reprocessing challenges.
As part of the premarket notification submission process, FDA requires that the devices on the list — including bronchoscopes and endoscopes — include approved instructions for use and validation data about cleaning, disinfection, and sterilization.
Contact Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.
