The Food and Drug Administration (FDA) has issued final guidance on reprocessing reusable medical devices.
The FDA’s new recommendations, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” aim to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The complex design of some devices make it difficult to remove contaminants. The guidance includes recommendations that device manufacturers should follow pre- and post-market for the safe and effective use of reprocessed devices.
Specifically, the FDA lists six criteria to address in the instructions for use with every reusable device to ensure user understanding and compliance. Manufacturers are recommended to consider reprocessing challenges early in device design and will need to perform validation testing to demonstrate that their cleaning instructions will consistently reduce contamination. More information on testing protocols and data requirements for pre-market submission are also included in the final guidance.
The FDA is planning a public meeting in May to discuss recent investigations of infection transmission associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals.
For more information visit FDA.gov.