FDA Asked About Oversight Of Reused Medical Devices

The chairman of the House Committee on Government Reform has asked the Food and Drug Administration for information about how it oversees the reuse of single-use medical devices and requested that Congress's watchdog agency investigate the growing practice.

In a letter yesterday, Thomas M. Davis III (R-Va.) asked the FDA to provide a detailed explanation of its regulation of the industry, called reprocessing. That includes what steps the agency is taking to "ensure that reprocessed single-use medical devices are safe and efficacious." The letter was co-signed by Henry A. Waxman (D-Calif.), the ranking minority member on the committee. The FDA declined to comment.

In their letter to the Government Accountability Office, Congress's investigative arm, the two lawmakers yesterday asked the GAO to "examine the safety of single-use device reprocessing and the adequacy of FDA's oversight of reprocessing." GAO spokesman Paul L. Anderson said the agency will respond within a week. When the GAO looked into the matter in 2000, it "found little available evidence of harm from reuse," but also said that "reprocessing is not invariably safe, and relatively little is known about the practice."

The Association of Medical Device Reprocessors said it looks forward to working with the congressmen.

Earlier this week, Rep. Rosa L. DeLauro (D-Conn.), the ranking minority member of the House Appropriations subcommittee that oversees the FDA, called for more rigorous federal oversight of the reprocessing industry.

In articles published Sunday and Monday, The Washington Post examined the reconditioning of single-use medical devices. The devices are used nationwide, including in at least eight medical facilities in the Washington area.

Device manufacturers say they cannot vouch for the safety of their reconditioned single-use devices, but reprocessors say there is no credible evidence that their refurbished devices are riskier than new ones. They also say no surgery is without risk, and many hospitals cite the practice's safety and cost savings.

The FDA said that before 2000 it did little to oversee reprocessors other than inspect their facilities and require them to follow good manufacturing practices. Now, it requires reprocessors to submit data to validate that their work produces safe devices. DeLauro and others, however, are raising questions about the oversight of the FDA, which has no set number of inspectors assigned to reprocessors. The agency relies on doctors to voluntarily report problems with faulty medical devices, and medical facilities are required to report to the FDA deaths but not device malfunctions.