August 7, 2024- The FDA recently introduced online resources to provide information about reprocessing single-use medical devices for health care facilities and FAQs. The FDA remains dedicated to providing resources to help health care facilities establish, implement, or improve their quality assurance programs related to reprocessing single-use medical devices. The webpage provides information to help health care facilities understand the use of reprocessed medical devices originally labeled for single-use, and to clarify the level of FDA’s regulatory oversight of these reprocessed single-use medical devices to remain as safe and effective as the original manufactured devices.
The practice of reprocessing devices that are intended for single-use (known as single-use devices, SUDs) began in hospitals in the late 1970s. Since that time, this practice has become widespread as a mechanism to save costs for health care facilities and reduce medical waste. For example, use of reprocessed SUDs may reduce environmental impact by limiting the use of non-renewable resources and decreasing the amount of medical waste that requires treatment and disposal.
The FDA ensures the safety and effectiveness of reprocessed SUDs by regulating device manufacturers, third party reprocessors, and hospitals that reprocess SUDs in the same manner as the original equipment manufacturer (OEM).