FDA releases final guidance on reprocessing of reusable medical devices

Patient Safety Monitor Insider

March 18, 2015

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.

The new recommendations are aimed at helping device manufactures develop safer reusable devices, especially those devices that pose a greater risk of infection.

Medical devices intended for repeated use are commonplace in healthcare settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in healthcare settings, the complex design of some devices makes it harder to remove contaminants.

FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.

For further information visit www.fda.gov.