Tough medical device oversight needed, US panel told

* Lawmaker says FDA device approval system "broken"

* FDA struggles to review all complaints about devices

* AdvaMed industry group says FDA oversight is rigorous

By Lisa Richwine

WASHINGTON, June 18 (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.

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.

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(Reporting by Lisa Richwine; Editing by Brian Moss)