Roughly half of all hospitals find that reprocessing single-use medical devices is a great way to reduce costs without harming patient care. But hospitals that reprocess their own single-use medical devices need to be aware of the regulations in this area.
Hospitals that reprocess their own single-use devices must meet the following regulatory requirements:
- Reporting adverse events
- Maintaining a quality system
- Accepting executive responsibility for meeting reprocessing requirements
- Establishing sterilization process controls, as well as validation and monitoring of processes
The FDA and GAO have concluded that reusing single-use devices can be an effective means of saving money with no additional risk to patients, but only if reprocessing is carried out in compliance with FDA guidance and regulation. Don’t put your patients, your reputation or yourself at risk by failing to understand those requirements.
With Reusing Single-Use Devices on your bookshelf, answers to any questions about reprocessing single-use devices will be at your fingertips. FDAnews, a publishing company with more than 30 years experience covering the FDA, compiled this book to provide a single-source reference for anyone interested in this topic.
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