WP: More Scrutiny Sought For Reused (one-time-use medical) Devices

More Scrutiny Sought For Reused Devices
House Member Questions FDA's Role
By Alec Klein
Washington Post Staff Writer
Tuesday, December 13, 2005; Page D02


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....


http://www.washingtonpost.com/wp-dyn/content/article/2005/12/12/AR2005121201469.html