More Scrutiny Sought For Reused Devices
House Member Questions FDA's Role

By Alec Klein
Washington Post Staff Writer
Tuesday, December 13, 2005

A key member of Congress called yesterday for more rigorous federal oversight of reused medical devices designated as one-time-use instruments.

The Food and Drug Administration has made progress in monitoring the industry -- called reprocessing -- but "significant gaps remain," said Rep. Rosa L. DeLauro (D-Conn.), the ranking Democrat on the House Appropriations subcommittee that oversees the FDA.

Reprocessing is a growing industry that is believed to serve hospitals in all 50 states and the District and 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.

DeLauro, however, expressed concerns about the FDA's role. 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.

"Rigorous oversight of reprocessing is needed," she said, citing Washington Post reports on the industry published Sunday and yesterday.

DeLauro said she wants the FDA to increase the number of inspectors assigned to reprocessors; now, there is no set number. She also said she plans to address the issue in an appropriations bill next year and possibly call for a hearing on the matter.

Naomi Halpern, an attorney for the Association of Medical Device Reprocessors, said the group "looks forward to working with Congresswoman DeLauro as she develops legislation affecting the regulation of the medical device industry."

The FDA said that prior to 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. In a statement, the FDA said it "provides stringent regulatory oversight" and "will act swiftly" if reprocessors do not comply with its requirements.