U.S. Senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) introduced legislation to help protect patients from unsafe medical devices and improve the management of recalls. 

The Medical Device Patient Safety Act would give FDA important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices. 

The bipartisan legislation would allow FDA to require postmarket clinical studies for medical devices that pose potential safety risks, if they were approved through the expedited 510(k) review process. The bill also would implement Government Accountability Office (GAO) recommendations for improving recalls and give FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track, 510(k) approval process.  

"This reform legislation should be part of the reauthorization of the medical device user fee law next year," Grassley said. "The reforms incorporate well-founded recommendations from GAO and reflect the value of having a robust postmarket surveillance operation in FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better." 

"Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices – causing significant costs to our economy as well as health," said Blumenthal. "This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we're preserving a faster approval track for safe and effective products to reach patients." 

"Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients," Kohl said. "This legislation will help ensure that FDA can act quickly and decisively when there's a problem, and that the drive toward getting new technologies to market won't come at the risk of patient safety." 

Grassley, Blumenthal and Kohl have also sent investigative letters to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct postmarket surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant, which was the subject of a worldwide recall and an April 13, 2011 hearing of the Senate Special Committee on Aging; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements. 

"As the Special Committee on Aging's recent oversight hearing detailed, effective postmarket surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering," the letters state.

While it is encouraging that U.S. Senators are taking an interest in medical device policy issues, the concern is how this legislation could affect the regulation of medical devices and what further requirements on medical device manufacturers it may introduce. Manufacturers undoubtedly recognize the importance of ensuring patient safety in their devices. But hopefully any new requirements imposed on medical devices by Congress will take into account input from the medical device industry.

-Richard Park