MONDAY, July 18, 2005 (HealthDay News) -- Surveillance of medical devices used for children is lacking, a new U.S. report concludes.
"A major finding was the recognition that there has not been sufficient oversight to monitor or know about problems that may have arisen with the use of medical devices, particularly in children," said Dr. George Lister, a member of the committee that authored the report. He is also chairman of the department of pediatrics at the University of Texas Southwestern Medical School in Dallas.
Titled Safe Medical Devices for Children, the report was released Monday by the National Academies of Science's Institute of Medicine.
The study also found there was really no system in place to ensure that information about potential problems with medical devices make its way back to a central repository so it could be acted upon by regulators in a way that would help patients.
That's not to detract from the "tremendous advances in health care by virtue of devices," Lister said. "This shouldn't diminish that at all, but there have been instances where there were problems."
Advances in pediatric devices have been real, starting with life-sustaining systems such as mechanical ventilators, implanted pacemakers and mechanical heart valves. Even relatively low-tech innovations such as hospital bed rails have improved quality of life for countless children, according to the report.
But the problems are also real, with one U.S. Food and Drug Administration study finding that at least 450,000 Americans of all ages are injured each year by medical devices ranging from wheelchairs to toothbrushes.
Currently, the FDA is responsible for monitoring the safety of medical devices after they reach the market. The new report, requested by Congress, evaluates the FDA's track record and offers recommendations.
The report also illuminates the ways in which medical devices -- particularly devices for children -- are different from drugs, which makes them all the more complicated to regulate.
"Problems with medications are more unidimensional than they are with devices," Lister said. "Devices come in different forms. They don't have a single shape or function. They have far more functions than a medication and far more forms. Unlike medications, devices are there for a long period of time, maybe forever. The device may even be forgotten if it's embedded."
The problems are also far-reaching. "Device problems cover the entire gamut," Lister said. "There are those that we see as relatively non-threatening to someone's health but needed, such as a dental implant. Then there are things that nobody would question are life-sustaining, like cardiac pacemakers or breathing machines. There's no way to say simply, 'It's a device.' "
Certainly, attention needs to be paid to life-threatening situations involving devices, the report said, but also to less serious issues that are more prevalent.
"They may have as broad an implication -- for example a device that is implanted which gets an infection related to it," Lister said. "It may not ever be a splash but if it occurs in a lot of patients, it may have a big burden."
Among other things, the committee recommended that children's hospitals and health-care facilities establish a "focal point of responsibility" to track problems with medical devices. The FDA, too, should have such a central source for pediatric issues within its Center for Devices and Radiological Health.
Other recommendations include strengthening post-market studies of medical devices, and establishing a system for publicly reporting potential problems.
The committee rejected the idea of a "one-size-fits-all" system for monitoring medical devices for children.
"We think that devices are too complicated for that. But a mechanism for having communication between the FDA and other agencies that are involved in health care was distinctively missing," Lister said.
At the same time, committee members don't want the recommendations to be too restrictive, thereby discouraging researchers and manufacturers from making new devices available to patients.
"There is a difference between children and adults," Lister said. "There's much less of a market for children and we recognize that if the barriers are too high for creativity or inventiveness, then we'll have a result we didn't intend."
The FDA's Center for Devices and Radiological Health can tell you more about problems with medical devices.