Reprocessing Single-Use Devices
- Revised Publication:
- November 13, 2024
- Declarations of Conflicts of Interest:
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- Gene T. Ricupito declares no conflicts of interest.
- Rebecca T. Alvino was an APIC Text Associate Section Editor at the time of chapter writing. Her editorial position on the APIC Text had no bearing on her chapter authorship and she did not handle materials as an editor. Rebecca Alvino declares no other conflicts of interest.
Abstract
As environmental, resource, and financial sustainability efforts take a more prominent role in healthcare, reprocessing single-use devices (SUDs) is one strategy considered or implemented by healthcare facilities. It is imperative that healthcare facilities considering SUD reprocessing understand the regulations and requirements that are to be assumed by the entity reprocessing the SUD, whether this is the healthcare facility or a third party. Under U.S. Food and Drug Administration regulations, an entity that reprocesses SUDs must adhere to the same requirements as the original equipment manufacturer; as a result, the entity becomes the device manufacturer for reprocessed SUDs.