DeLauro Urges Rigorous Oversight of Reused Medical Devices

Monday, December 12, 2005

DeLauro Urges Rigorous Oversight of Reused Medical Devices

WASHINGTON, D.C. - Reacting to a series in The Washington Post on the dangers of reusing medical devices, Congresswoman Rosa L. DeLauro (Conn.-3) today called for more rigorous oversight of devices deemed for one time use. Last month, DeLauro raised concerns over the new medical device program in a letter to FDA Acting Commissioner Dr. Andrew von Eschenbach, (click here for the full text of the letter: http://www.house.gov/delauro/press/2005/November/FDA_reform_letter_11_02_05.html.) DeLauro is ranking member of the House Appropriations Agriculture subcommittee, with jurisdiction and oversight responsibility of the FDA budget.

"News of potential health risks with medical devices has increased significantly in recent months and should prompt concern by the doctors who administer these devices, the patients that use them, and the FDA - the agency charged with oversight of public health matters like the safety of medical devices. The FDA has made strides to increase regulation of medical devices, yet significant gaps remain. It is clear from the Post's investigation that the agency must improve its pre-market approval process and its post-market surveillance of medical devices.

"Relying on a voluntary system for doctors and hospitals to report faulty devices, without a set number of inspectors assigned to investigate reprocessing facilities has led to a number of small facilities operating outside of FDA's oversight system.

"Reusing medical devices deemed for one-time use has serious implications for doctors and patients. As the Post series demonstrated, what medical providers save in costs with reprocessing medical devices, they lose in patient safety. Rigorous oversight of reprocessing is needed."

http://www.house.gov/delauro/press/2005/December/medical_devices_12_12_05.html