Tough medical device oversight needed, U.S. panel told

By Lisa Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug Administration's approval process for medical devices needs strengthening to better protect patients from safety risks, experts told lawmakers on Thursday.

At a hearing on medical devices, which range from tongue depressors to artificial hips, Representative Frank Pallone said he was trying to determine if there were problems that should be fixed through new legislation or increased FDA oversight.

"There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety," said Pallone, the Democrat who chairs a House Energy and Commerce subcommittee.

Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings "raise concerns" about the FDA's pre-approval reviews and post-approval monitoring "that are necessary for ensuring the safety and effectiveness of medical devices."

Probes in recent years found the FDA did not require the most stringent review process for all of the most risky devices and that the agency struggled to analyze the tens of thousands of reports received annually alleging harm from devices, Crosse told lawmakers.

RECALLS RAISE QUESTIONS

Cardiologist William Maisel, who heads the nonprofit Medical Devices Safety Institute, said recent recalls of defibrillator wires and other devices raised questions about the FDA's ability to identify safety problems promptly.

"Additional consumer safeguards are needed. Only by demanding more thorough, scientific device evaluations can the FDA hope to reestablish consumer confidence in its ability to protect the public's health," Maisel told a House of Representatives Energy and Commerce subcommittee.