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Fall 2005 Vol. 5 No. 3

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©Dynamic Graphics Medical Device Monitoring Needs a Boost

Pacemakers, wheelchairs, stents, and other medical technologies save countless lives and help people lead fuller lives. Although the complexity of some devices like pacemakers necessitates extensive clinical evaluation before they can be used with patients, premarket testing may not catch all potential problems. And problems with even comparatively simple medical devices can lead to serious injuries, for instance when the stiff wire arms of orthodontic headgear unintentionally spring free as the wearer sleeps.

To ensure the safety of medical devices after they are put on the market -- especially ones used with children -- Congress should see to it that the U.S. Food and Drug Administration establishes a better system for postmarket monitoring, says a new report from the Institute of Medicine.

Approximately 80,000 medical devices are marketed in the United States, ranging from simple plastic tubing to cerebrospinal fluid shunts. Postmarket surveillance is intended to detect early on any safety problems that may arise. Devices used with young people merit particular attention because children's rapid growth and active lifestyles can affect the longevity and functioning of many products, and likewise the devices may affect children's development.

The report calls on Congress to bolster FDA's authority to require manufacturers to conduct postmarket safety studies for certain categories of devices. And given children's growth spurts and developmental changes, which can occur over many years, studies of devices used with children should not be limited to the typical three years. The agency also needs to monitor more carefully the status of these studies. Although FDA has asked for dozens of postmarket studies, it could not say with certainty which had been initiated or completed or otherwise confirm their progress because of inadequate systems for tracking them, the report says. Moreover, FDA needs to share publicly the data collected.

FDA should encourage health care providers and patients and their families to submit reports about problems associated with devices. Patients, families, and others who are taking on greater responsibility for operating complex medical equipment may not know that they can report problems to FDA or that the agency has a safety checklist for using medical devices at home.

It is important to note that device-related problems are relatively rare. While millions of patients use medical equipment every year, 151,900 reports on adverse events were submitted to FDA in 2004. At least 2,684 involved patients under age 21, although this number is undoubtedly low due to lack of age information on many reports.
  -- Christine Stencel

Safe Medical Devices for Children. Committee on Postmarket Surveillance of Pediatric Medical Devices, Board on Health Sciences Policy, Institute of Medicine (2005, approx. 352 pp.; ISBN 0-309-09631-6; available from the National Academies Press, tel. 1-800-624-6242; $44.95 plus $4.50 shipping for single copies).

The committee was chaired by Hugh Tilson, professor of public health leadership, epidemiology, and health policy, University of North Carolina, Chapel Hill. The study was funded by the U.S. Food and Drug Administration.

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Copyright 2005 by the National Academy of Sciences