Reusable Medical Device Disinfection and Cleaning Validation Requirements
A white paper by Stephen G. Richter, Ph.D.
Reusable medical devices generally have expensive components that require cleaning and disinfection. Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. This paper describes the salient points for validating that a medical device can be safely reused. It covers disinfection processes, not sterilization.
The FDA now requires validation studies for both cleaning and disinfection. These studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. This white paper will help the practitioner determine the best practices for performing these pivotal studies.