FDA halts expansion of network to monitor medical device safety
Agency backs off goal of linking 500 hospitals to system aimed at early detection of problems
By Ross Kerber, Globe Staff
The Boston Globe
July 14, 2005
Read the full article at boston.com.
Despite its plans to closely monitor deadly malfunctions and misuses of medical devices through a new computer reporting system, the Food and Drug Administration has frozen the project in place well short of its goal of connecting 500 hospitals.
The system, known as MedSun, allows doctors nationwide to directly report to the FDA problems with pacemakers, stents, and defibrillators. The FDA had aimed to connect 500 of the nation's 5,000 eligible hospitals, but is stuck at 350 and won't fund further expansion for the next several years.
That means more doctors are using an older system, through which they report problems to manufacturers, who then notify regulators. Some fear the process allows device makers to downplay bad news to the FDA.
The FDA estimates that problems with medical devices cause 300,000 deaths and injuries annually. The FDA, doctors, and hospital administrators hoped MedSun would alert them more quickly to problems and uncover patterns that might otherwise take years to discover.
Critics say the FDA's handling of MedSun contradicts its pledges to step up safety monitoring. The lack of additional funding is ''consistent with the pattern of the FDA under this administration, to act in a way that is complicit with the entities they're supposed to regulate," said US Representative Maurice Hinchey, Democrat of New York, who sits on a subcommittee that sets the FDA's budget.