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Tougher medical device oversight urged

The Food and Drug Administration's approval process for medical devices needs strengthening to better protect patients from safety risks, experts told lawmakers.
/ Source: 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, health care 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.

The device industry defended the FDA, saying it provided rigorous oversight of thousands of medical devices each year.

"FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls," said Stephen Ubl, president of the Advanced Medical Technology Association, known as AdvaMed.

"It is important to remember that millions of Americans benefit from" devices each year, he said in a statement.

No FDA officials were asked to testify at the hearing, an omission that drew criticism from some Republican lawmakers.

FDA spokeswoman Mary Long said the agency "takes its regulatory responsibilities over medical devices seriously" and would answer questions from lawmakers.

New FDA Commissioner Margaret Hamburg told Reuters earlier this week she would look closely at the use of an abbreviated approval process that critics say is used too often for devices that need a more thorough review.

Some lawmakers said problems could be addressed by better management and enforcement and more funding.

The criticisms "have more to do with the FDA's actions and inactions and lack of resources" rather than any need for new authority, said Republican Representative Joe Pitts.