Medical Devices
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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
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