Reprocessing of Reusable Medical Devices
- Posted by Mark Goins
- On January 10, 2017
- microbiology
The FDA requires manufacturers of reusable medical devices to provide reprocessing instructions that ensure that the device can be used safely and for the purpose for which it is intended. Developing and validating these instructions can be a complex and highly specialized activity. Guidance on this process can be found in a document created by the FDA Center for Devices and Radiological Health entitled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” The guidance indicates, the labeling of a reusable medical device should clearly specify the appropriate material and equipment parameters to adequately reprocess the devices. Reprocessing is defined as validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection. The validation of the cleaning and disinfection process may also be a necessary part of Premarket Notification - also called PMN or 510(k). (more…)