A bipartisan foursome has crafted a Senate bill that would arm the FDA for stronger oversight of medical devices while also pushing it into action.
Jeff Merkley (D-Ore.) and Chuck Grassley (R-Iowa), together with Michael Bennet (D-Colo.) Herb Kohl (D.-Wis.), introduced the Ensuring Safe Medical Devices for Patients Act on March 15.
The legislation would require the agency to issue a final Unique Device Identifier (UDI) rule by the end of 2012 and add medical devices to the FDA’s Sentinel postmarket surveillance initiative. The latter launched in 2008 to monitor prescription drugs for signs of danger once they’re on the market.
The call for a UDI rule, which would mandate tracking capabilities for all implantable devices, was formally issued nearly five years ago but has since stalled. In February, Kohl, Grassley and Sen. Richard Blumenthal (D-Conn.) wrote the White House’s Office of Management and Budget to demand action.
The letter amounted to a turning up of the heat from familiar voices. A week prior, Grassley had written FDA commissioner Margaret Hamburg, MD, to ask why the agency accessed employees’ private email accounts after six whistleblowers complained to Congress about hasty device approvals. (The whistleblowers filed suit in January.) And in June 2011, Grassley and Kohl released a report advising more stringent oversight of medical device recalls.
Safety problems and recalls of certain medical devices—an average of 700 recalls each year since 2005, and close to 5,000 device-implicated deaths in 2009 alone—have called into question whether the FDA and its Center for Devices and Radiologic Health (CDRH) have the tools needed to protect patients and keep harmful devices off the market, Merkley’s office noted.
“When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldn’t have to worry that the device that is supposed to improve their health could actually make them sicker,” Merkley said in a prepared statement. “Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market.”
The bill has been endorsed by numerous groups, among them Consumers Union, the Health Care Supply Chain Association and the Union of Concerned Scientists.