Agawam, Massachusetts – With automatic washing gaining popularity, a new management brief warns that manufacturers of reusable medical devices must account for cleaning validation and instructions for automatic – as well as manual – washing procedures.
The brief, Automatic Washer Validation for Medical Device: Are you in compliance? is available to download.
The U.S. Food and Drug Administration (FDA) requires reusable medical device manufacturers to ensure all sets of cleaning instructions – both automatic and manual – are validated and meet the parameters indicated on a medical device’s labeling.
Manufacturers of reusable medical devices that only create a set of instructions on manual washing may therefore raise compliance issues for users.
“More and more health care facilities, especially those that perform a high volume of procedures, are installing autowashers to reduce labor/training costs and achieve greater consistency of their cleaning processes,” according to the brief’s author, Philip Nosel, M.S., supervisor – reusable medical devices, Microtest Laboratories, Agawam, Mass.
“With a validated set of autowasher cleaning instructions, a reusable medical device has a better chance of being used safely both today and in the future,” he said.
The new brief provides an overview of the FDA’s requirements for automatic washing cleaning validation. It also discusses the benefits of automatic washing.
Download a copy of Automatic Washer Validation for Medical Device: Are you in compliance?
Source: Microtest Laboratories