News|Videos|September 30, 2025

Current Classes and Manufacturer Guidelines for Medical Devices

Understand who the key organizations are when it comes to the cleaning and disinfection of non-critical medical devices.

Medical devices fall under three classes depending on the risk they pose to patients. The classes include potential risk: high, potential risk: medium, and potential risk: low. This segment explains the differences between each class and what requirements are expected of each by the FDA.

Related to this article

A brightly lit Hospital operating room, a surgical team wearing gowns and masks.  (Adobe Stock 1790696595 by Damian)
Turnover pressure can leave critical OR cleaning steps unfinished. Karen deKay, MSN, RN, EBP-C, CNOR, CIC, FAPIC, examines common gaps in environmental hygiene and how shared responsibilities, attention to disinfectant contact time, and ongoing education can help teams strengthen practices between cases.