Watchdog report says FDA gambles with medical device safety

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Since 2006, the FDA has not ensured that medical devices such as cardiac defibrillators, pacemakers, replacement heart valves and coronary artery stents are being tested according to good laboratory practices (GLPs), according to a report released Feb. 18 by the independent nonprofit group the Project on Government Oversight (POGO).

The report, The FDA's Deadly Gamble with the Safety of Medical Devices, outlined out a case against the officials in charge of the Center for Devices and Radiological Health (CDRH).

The GLP regulations sets specific requirements for the testing of medical devices, and testing requirements are supposed to be met before CDRH deems the devices safe enough to be implanted in humans. "But with CDRH ignoring the enforcement of the regulation, manufacturers and testing facilities are now trusted to monitor their own GLP compliance," according to the POGO report.

"There are many insiders who are deeply concerned that real harm is being done. Such a decision affecting public health should not have been made behind closed doors," said Danielle Brian, executive director of POGO.

The watchdog group has recommended that the Government Accountability Office (GAO) or the Department of Health and Human Services (HHS) audit records that contain evidence of device manufacturers' compliance or noncompliance with the GLP regulation.

Additional recommendations suggest that:
  • Congress or HHS inspector general should conduct an investigation of the decision made by senior CDRH officials to ignore or de-emphasize enforcement of the GLP regulation;
  • After auditing has established the facts, CDRH should implement a program of GLP enforcement;
  • The possible role of GLP non-compliance should be considered whenever a marketed device malfunctions, and these findings should be publicized by the FDA;
  • Senior FDA officials should require full transparency in all agency actions other than those prohibited by regulation or law;
  • Congress should pass legislation and the President should issue an Executive Order to strengthen federal employee whistleblower protections;
  • Congress should pass legislation that would make lawsuits by injured patients possible; and
  • The FDA's policy for reviewing 510(k) devices should be reformed, with the goal of eliminating the 510(k) mechanism for all Class III devices.

The Advanced Medical Technology Association (AdvaMed), an industry group representing device manufacturers, said that the report was flawed and called the FDA's device oversight "rigorous," according to Reuters.

"Manufacturers comply with regulatory requirements not because of the threat of inspections. They do so because it is in the best interests of patients to consistently manufacture safe and effective devices," AdvaMed Executive Vice President Janet Trunzo said in a statement, reported Reuters.