The Food & Drug Administration ‘s medical device approval process should be beefed up to better protect consumers, medical experts ranging from physicians to the health Government Accounting Office told Congress, according to news reports.
That’s because the federal watchdog agency’s mechanism for reviewing the safety of products ranging from tongue depressors to state-of-the-art implanted devices is “broken,” one lawmaker said.
“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,” Rep. Frank Pallone (D-N.J.) said at a hearing before the House Energy and Commerce subcommittee he chairs.
GAO healthcare director Marcia Crosse piled on, saying the agency’s apparent inability to make sure devices are safe before they hit the market and to monitor their safety after that “raise concerns.”
That’s especially true for Class III devices such as pacemakers, which Crosse said aren’t always “approved through the most stringent” review process. Sparse post-use data and tracking of problems with the devices are also worrying, she said — not to mention the FDA fails to meet its statutory requirements to make scheduled inspections of medical device manufacturing operations.
“Taken together, these shortcomings in both premarket and postmarket activities raise serious concerns about FDA’s regulation of medical devices,” Crosse said.
Medical device monolith Medtronic Inc. came under especially intense scrutiny at the hearing, due to the recall of 21,000 of its Kappa and Sigma series implantable pacemakers (Medtronic estimates more than 1.7 million have been implanted in patients worldwide) and the death of at least 18 patients after its now-recalled Sprint Fidelis defibrillator leads fractured.
Beth Israel Deaconess Medical Center cardiologist William Maisel, who also heads up the Medical Devices Safety Institute, said such recalls raise questions about the FDA’s ability to swiftly identify safety problems.
“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 the panel, adding that the agency is too reliant on the device industry’s ability to police itself.
Stephen Ubl, president of the Advanced Medical Technology Assn. (AdvaMed), was quick to defend the agency, describing its oversight as “rigorous.”
“FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls,” Ubl said, adding that millions of Americans benefit from medical devices every year.
For her part, newly appointed FDA chief Margaret Hamburg told the Wall Street Journal that she’s pushing for reforms at the agency’s Center for Devices and Radiological Health.
Saying she plans to take a “hard look” at the division’s 510(k) approval process, Hamburg said she’s pushing for earlier safety warnings.
“We don’t feel we can take weeks or months to negotiate a plan for a recall” or relabeling,” Hamburg told the journal.
