Automatic Washer Validation for Medical Devices: Are you in compliance?
A management brief by Philip Nosel, Accuratus Lab Services
Reusable medical device manufacturers are required by the U.S. Food and Drug Administration (FDA) to ensure all sets of cleaning instructions are validated and meet the parameters indicated on a device’s labeling. However today, many companies only create a set of instructions on manual washing.
With automatic washing gaining popularity, manufacturers must account for cleaning validation and instructions for both manual and automatic washing procedures. This management brief discusses the benefits of automatic washing and provides an overview of the FDA’s requirements for automatic washing cleaning validation.