What You Need to Know About Reprocessed Single-Use Devices

As health care expenditures have risen and hospitals struggle to contain costs, there has been greater acceptance of reusing instruments that originally were designed and sold for single-use only. In a new Committee Opinion, The American College of Obstetricians and Gynecologists (ACOG) discuss regulatory, safety, cost, and ethical issues surrounding reprocessed single-use devices.¹

Current law states that hospitals or reprocessing companies are fully liable for reprocessed devices and that single-use devices that are reprocessed for repeat use must adhere to the specifications of the original manufacturer of the single-use instrument.^2,3 One report has stated that use of reprocessed devices is not associated with increased health risk,⁴ but ACOG believes that it “does not reflect the full spectrum of important safety issues” and current evidence is insufficient to support a comprehensive conclusion about the safety of reprocessed single-use devices.¹ In addition, it is extremely unlikely that a reprocessed single-use device will ever be reported as the cause of a postoperative infection, according to ACOG.

The available studies of the quality of reprocessed single-use devices have involved orthopedic and laparoscopic surgical devices and have universally found physical defects, performance issues, or improper decontamination of the devices, said ACOG. These studies have been largely funded by the original device manufacturers, however, and the results have potential for bias.

For hospitals, reprocessed single-use devices are associated with up-front cost savings, but whether these savings trickle down to the patient or third-party payers is unknown. There is no available data on the cost-effectiveness of using single-use devices in gynecological surgery, according to ACOG, but there are recommendations that reprocessed single-use devices must have documentation for the sterility, integrity, functionality, and safety of the device for use in patient care and conform to the original device specifications.⁵

For the ethical use of reprocessed single-use devices, ACOG recommends that hospitals inform all physicians which instruments are reprocessed. Physicians should also give consideration to whether patients have the right to know if a reprocessed single-use device is going to be used on their bodies during an invasive procedure. Surgeons have an ethical obligation to make an effort to know whether reprocessed instruments are going to be used and to not use them if they have any concerns about the quality or safety of a device, states ACOG. Adverse events should be reported to help improve the safety information about reprocessed devices.

Pertinent Points:
- Reprocessed single-use instruments are commonly used and generally considered safe, although there is little to no independent studies supporting this consensus.
- It is the physicians’ responsibility to make a good-faith effort to know which instruments they use are reprocessed.
- Physicians should give consideration to whether it is the patient’s right to be informed that a reprocessed single-use instrument is being used.

References:

1. Committee opinion no. 537: reprocessed single-use devices. Obstet Gynecol. 2012;120:974-976.
2. Feigal DW. Reuse of medical devices labeled for single-use. Available at: http://www.fda.gov/NewsEvents/Testimony/ucm114926.htm. Accessed November 4, 2012.
3. Medical device user fee and modernization act of 2002. Pub L No. 107-250, 116 Stat 216. 2002.4. Government Accountability Office. Reprocessed single-use medical devices. Available at: http://www.gao.gov/new.items/d08147.pdf. Accessed November 4, 2012.
5. Association of periOperative Registered Nurses. AORN guidance statement: reuse of single-use devices. In: Perioperative Standards and Recommended Practices. Denver: AORN; 2012:717-724.