A two-part series on the reprocessing of medical devices that appeared in the Washington Post (Dec. 11 and 12,2005) has focused attention on a particular patient safety issue: the reuse of devices labeled for single use. The Post claimed that a growing number of U.S. hospitals are ignoring the warnings of manufacturers by reusing medical devices designated for one-time use because the cost savings are significant. Consequently, patient safety is being compromised.

According to the Association of Medical Device Reprocessors, the savings axe indeed significant: On average, hospitals can save as much as 50 percent by reprocessing, as opposed to purchasing new devices. Some dramatic examples, cited by the Post, include cardiac catheters ($279 new, $58 reprocessed); blades used in orthopedic surgery ($30 new, $14 reprocessed); and deep-vein thrombosis compression sleeves ($124 new, $11 reprocessed).

Reprocessing has other impacts, as well. The AMDR noted that its members reduced hospital waste by 935 tons in 2004, the first year such numbers were tabulated.
Advertisement

Nevertheless, there are some disturbing facts surrounding the reuse of single-use devices. Hospitals are not required to tell patients that reconditioned devices may be used in surgery. And federal records and interviews show that single-use devices have malfunctioned during reuse, although the AMDR claims that there are many more examples of failure of original devices than of those that have been reprocessed.

The Food and Drug Administration has oversight over the reprocessing industry. Although it has always conducted periodic inspections of reprocessors’ facilities and required them to follow good manufacturing practices, the agency requested a review of the practice of single-use device reprocessing in 1999. According to the resulting report, Single-Use Devices: Little Available Evidence of Harm from Reuse, But Oversight Warranted, issued by the General Accounting Office in June 2000, “FDA’s regulation of SUD reprocessing … has been inconsistent.”

To address this concern, the agency instituted a new regulatory framework in 2002 with the passage of the Medical Device User Fee and Modernization Act, which amends the Federal Food, Drug, and Cosmetic Act. Among the act’s significant provisions were new regulatory requirements for reprocessed single-use devices, including requiring reprocessors to submit data validating that their work produces safe devices.

However, following the Washington Post series on the reprocessing industry, Rep. Rosa DeLauro (D-Conn.), the ranking Democrat on the House Appropriations Committee subcommittee that oversees the FDA, called for more rigorous federal oversight of reused medical devices deemed for one-time use. In a Dec. 12, 2005, press release, DeLauro acknowledged that the FDA has made progress in monitoring the industry, but expressed concerns about the FDA’s role. “As the Post series demonstrated, what medical providers save in costs with reprocessing medical devices, they lose in patient safety,” wrote DeLauro. Rigorous oversight of reprocessing is needed.” DeLauro is especially concerned about the fact that the FDA allows physicians to voluntarily report problems with faulty medical devices, and does not require medical facilities to report device malfunctions.