Reprocessing of Single-Use Devices

Reprocessing and reusing single-use devices (SUDs) can save costs and reduce medical waste. But before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, including

• Submitting documents for premarket notification or approval
• Registering reprocessing firms and listing all products
• Submitting adverse event reports
• Tracking devices whose failure could have serious outcomes
• Correcting or removing from the market unsafe devices
• Meeting manufacturing and labeling requirements