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Feb 12,2012 - Kohl, Grassley, Blumenthal Urge Release of Delayed Medical Device Rule Senators Push OMB for Strong Post-Market Surveillance WASHINGTON – U.S. Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn., urged the release of a key new rule on post-market surveillance of medical devices. Kohl, Grassley and Blumenthal wrote to the Office of Management and Budget (OMB) Acting Director Jeffry Zients to express their concerns about the delayed release of the Unique Device Identifier rule written by the Food and Drug Administration (FDA). The Unique Device Identifier (UDI) is a tracking system for medical devices approved by Congress in 2007. UDI will enhance post-market surveillance of medical devices, improve data collection on medical devices, and allow companies and the FDA to track faulty devices when problems occur. Kohl, Grassley and Blumenthal wrote that "we take seriously our responsibilities to oversee the safety of medical devices that are used by, and implanted into, millions of Americans on a daily basis" and that "due to our strong desire for a robust post-market environment, we are very concerned with the delayed implementation of the UDI." The letter can be found here. FDA sent the proposed regulation to OMB in July 2011, and under standard procedure, OMB has 90 days to review and release the rule. To date, OMB has yet to release the UDI rule. "As we heard during last year's Aging Committee hearing on medical device safety, patients sometimes don't even know who manufactured their implanted device, and manufacturers can face significant challenges in trying to find and notify patients about recalls," Kohl said. "Unique Device Identifiers provide an important post-market safety tool that will reduce the time it takes to track and locate problematic devices. The longer we wait for a system to be in place, the greater the number of patients placed at risk." "The FDA needs this tool to do a better job of tracking medical device safety," Grassley said. "The sooner the system is in place, the better for patients who have received medical devices. It's frustrating that even when the FDA is trying to beef up patient safety, another part of the government is delaying action. OMB needs to move this forward." "To save lives and stop suffering, we cannot delay implementing this medical device rule any longer," said Blumenthal. "This rule assures that only safe devices already on the market continue in use. There must be tracking of faulty devices when problems occur so that patients are informed and spared risk." Grassley, Kohl and Blumenthal have been working to improve post-market safety of medical devices and have introduced the Medical Device Patient Safety Act (S. 1995), which aims at ensuring problems with faulty devices are discovered more quickly and that recalls are better managed when problems occur.
Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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