The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon’s ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician–gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database.
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Number 769 (Replaces Committee Opinion No. 537, October 2012)
Committee on Gynecologic Practice
This Committee Opinion was developed by the American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice.
INTERIM UPDATE: The content on reporting adverse events has been updated as highlighted (or removed as necessary) to clarify language on reporting. Information has been added to direct the reader to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.
Published online on February 21, 2019.
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Reprocessed single-use devices. ACOG Committee Opinion No. 769. American College of Obstetricians and Gynecologists. Obstet Gynecol 2019;133:e235–7.