ACOG Urges Vigilance for Reprocessed Devices


With more hospitals seeking to cut costs through the use of reprocessed single-use medical devices, the American College of Obstetricians and Gynecologists is urging ob.gyns. to be alert about whether reprocessed instruments will be used in their surgeries and if they are safe.

ACOG’s Committee on Gynecologic Practice issued an opinion stating that physicians should be informed whether surgical instruments are original or have been reprocessed for additional use. Ultimately, though, it’s the physician’s responsibility to make a "good faith" effort to find out, according to the opinion. Physicians who have concerns about the quality or safety of an instrument have an ethical obligation not to use the instrument, the committee wrote.

The committee opinion was published in the October issue of Obstetrics & Gynecology (Obstet. Gynecol. 2012;120:974-6).

The ACOG committee didn’t take a position on whether reprocessed single-use medical devices should be used in obstetrics and gynecology, citing a lack of information on the safety, quality, and cost-effectiveness of these instruments.

For instance, in 2008 the Government Accountability Office issued a report saying that there appeared to be no increased health risk as a result of the greater use of reprocessed single-use devices. The ACOG committee pointed out, however, that the GAO assessment may have missed some safety issues because it relied only on voluntarily reported adverse events.

"Reprocessed devices result in cost savings for the hospital, but it is not apparent that there is any financial benefit to the patient or third-party payers," the committee wrote.

Other studies in orthopedics and laparoscopic surgery have found a significant rate of physical defects, performance issues, and improper decontamination of reprocessed single-use devices, according to the ACOG opinion, but those studies have been funded mainly by original device manufacturers.

The committee called for more independent studies on the safety, quality, and cost-effectiveness of reprocessed single-use medical devices in gynecologic surgery.

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