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Thursday, February 14, 2002

Academy Statement on Reprocessed Single-Use Devices

In an effort to control health care costs, single-use device reprocessing has become more prevalent. In 2001, the U.S. Food and Drug Administration (FDA) issued a regulatory guidance¹ governing the use of these devices labeled for single-use. This guidance, which excludes implantable devices, will subject third party reprocessors and hospitals to the same federal requirements as original equipment manufacturers.

The American Academy of Orthopaedic Surgeons (AAOS) recognizes that all devices should be safe and efficacious. Manufacturers currently have the discretion to label devices for single-use without established criteria or oversight, even when the instrument may be safely utilized on a repetitive basis. Some orthopaedic devices may be efficiently cleaned and sterilized and provide the same assurances as a newly manufactured device. The AAOS supports the application of stringent criteria to assess the safety and effectiveness of reprocessed single-use devices.

The AAOS believes that the labeling of a device as "single-use" should be substantiated. If a reprocessed device meets established safety and efficacy criteria, then it may be functional for more than one use. In those instances, single-use labeling would be inappropriate. Single-use labeling should be used only in those instances when it is demonstrated that a device cannot be reprocessed with its safety and efficacy assured. The AAOS strongly urges appropriate labeling for orthopaedic devices.

Commonly reprocessed orthopaedic devices labeled for single use include the monoblock metallics, which are simple, uniform, solid metal devices without moving parts, joints, or attachments. Examples of monoblock metallic devices are saw blades, reamers, knives, burrs and drill bits. Additionally, other commonly reprocessed orthopaedic instruments include surgical drills, arthroscopes, scissors, rongeurs, external fixation devices, trephines, countersinks, bone taps, staple drivers, needle holders, manual surgical instruments and carpal tunnel blades. ²

Hospitals anticipate that their costs for device expenditures will increase considerably as a direct result of the FDA's 2001 regulatory guidance. Consequently, surgeons may be required to limit the use of certain devices due to prohibitive costs. The AAOS is concerned that high costs will impede orthopaedic surgeons' ability to utilize the devices they deem best for their patients.

The AAOS believes that over burdensome regulations may have a negative effect on patient care. The FDA's 2001 regulatory guidance may create unintended adverse consequences in the delivery of care by reallocating precious resources away from patients while simultaneously increasing administrative and equipment costs without demonstrable patient benefit.

December 2001

References

1. "Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff." U. S. Food and Drug Administration, June 1, 2001.

2. Appendix A: List of SUDs Known to be Reprocessed. US Food and Drug Administration, November 13, 2000. www.fda.gov/cdrh/reuse/1168a.pdf

© 2001 American Academy of Orthopaedic Surgeons This material may not be modified without the express written permission of the American Academy of Orthopaedic Surgeons.