A new, free white paper outlining the application of disinfection and cleaning validation requirements for reusable medical devices in line with Food and Drug Administration (FDA) regulations is now available from Microtest Laboratories. "Reusable Medical Device Disinfection and Cleaning Validation Requirements " outlines the salient aspects of validating that a medical device can be safely reused; addresses disinfection studies and processes, rather than sterilization; and provides cleaning validation information germane to all reusable medical devices.
The author of the paper is Steven Richter, PhD, president and scientific director of Microtest Laboratories. Richter is a former FDA official. "Reusable medical devices come in all shapes and sizes - from specula to colonoscopes. Generally, these devices have expensive components that require them to be cleaned and disinfected or sterilized," Richter notes. "Recently, the FDA began requiring additional information on 510(k) submissions, demanding clarity in the options afforded to practitioners. Microbiologists generally treat all medical devices equally, even though many devices require special treatment."
Richter adds, "Historically, manufacturers were not required to validate that cleaning and disinfection processes were effective in reducing microbial and protein loads to safe levels. The FDA may have asked manufacturers for data regarding disinfectant use during reprocessing, but manufacturers would often simply perform cursory simulated-use tests that might not pass muster with FDA reviewers today. Currently, the FDA requires validation studies for both disinfection and cleaning. Both disinfection testing validation and cleaning validation studies are important to the manufacturer because they will validate the safety and efficacy of the disinfection process. It is important to qualify both the cleaning and disinfecting processes prior to validation activities. This new white paper is aimed at helping practitioners determine the best practices for performing these critical disinfection testing and cleaning validation studies."
Download a free copy of this white paper from:
