Medical Devices Need Closer Scrutiny, Report Says
Government regulators lack an effective system to monitor the safety of medical devices, which include items as diverse as incubators for premature babies, surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued Monday.
The U.S. Food and Drug Administration, which is responsible for the safety of medical devices as well as drugs, needs additional authority from Congress and better internal procedures, according to an Institute of Medicine panel. The institute is affiliated with the National Academy of Sciences, which provides the government with independent advice on scientific issues.
An FDA official said the report was constructive.
The safety of prescription drugs has been a major healthcare concern since the blockbuster painkiller Vioxx was recalled last year after a study confirmed a suspected heart attack risk. But the panel also found what the report termed “some shortfalls” and “deficits” with the FDA’s oversight of medical devices.
“This report exposes a fissure in the FDA’s safety mission,” Sen. Charles E. Grassley (R-Iowa), who has written legislation to reform the FDA’s drug safety office, said in a statement. “These are the same kinds of problems we see with the ... review of medicines.”
Congress originally instructed the panel to evaluate how well the FDA tracks safety problems in medical devices made for children. But after nearly two years of study, panelists concluded that similar shortcomings compromised the oversight of medical devices for adults.
“To make sure that pediatric devices are safe, there are changes that need to be considered across the board for all devices, as an underlying base,” said panelist Mark E. Bruley, a biomedical engineer who investigates medical device failures for ECRI, a nonprofit health services research agency in Plymouth Meeting, Pa.
About 80,000 types of medical devices are sold in the United States. Last year, the government received about 152,000 reports of safety problems. Children were involved in 2,700 of those cases.
Medical devices gained attention recently when Guidant Corp. recalled about 100,000 defibrillators meant to be implanted in patients. The compact devices are designed to monitor a patient’s heart and administer electrical shocks when needed to correct potentially lethal heartbeat irregularities. But it was discovered that a short-circuit could cause some units to fail without warning, depriving patients of a potentially life-saving jolt.
The panel found that such critical devices do receive close scrutiny from the FDA; the major loophole in oversight, it said, has to do with a broad group of intermediate-risk devices that go through what the agency calls “clearance.”
This group includes such devices as surgical clamps, incubators, sleep apnea monitors and electrical nerve stimulators. Although such devices can play an important role in patient care, the FDA has only limited authority to order manufacturers to conduct follow-up safety studies as a condition of allowing their sale.
In one example cited in the report, children were being injured by orthodontic headgear that came loose while they slept, but parents and doctors did not know that the incidents could be reported to the FDA.
The report called for Congress to considerably broaden the agency’s authority to order safety studies for intermediate-risk medical devices.
But the panel also faulted the FDA for failing to keep track of studies already in progress and to promptly release findings to the public.
“The most obvious deficits in FDA’s performance are the lack of effective procedures for monitoring the status of required post-market studies and the lack of public information regarding such studies,” the report said.
Dr. Thomas P. Gross, who heads an FDA office that monitors medical devices approved for patient use, said the agency has already taken some remedial steps; for example, it has set up a database to track new studies.
“Certainly, there is room for improvement,” Gross said.
The committee also recommended that the FDA tap into the computerized claims databases of large health insurers to look for patterns of possible problems.
And the panel faulted Congress as well, saying lawmakers have failed to deliver on promises of increased funding for monitoring the safety of medical devices.
“Better, more accurate, more thorough reporting is likely to pick up problems faster,” said Dr. Hugh H. Tilson, panel chairman and professor of epidemiology and health policy at the University of North Carolina at Chapel Hill.
