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Date: July 18, 2005
Contacts: Christine Stencel, Media Relations Officer
Chris Dobbins, Media Relations Assistant
Office of News and Public Information
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FDA Needs System to Monitor Safety of Medical Devices on the Market

WASHINGTON -- The U.S. Food and Drug Administration lacks effective procedures to monitor safety studies that manufacturers are sometimes required to undertake when they put medical devices on the market, says a new report from the Institute of Medicine of the National Academies that specifically examines FDA's surveillance of medical devices used with children. Congress should make sure that the agency establishes a reliable system to track these postmarket studies, said the committee that wrote the report. The information collected by this system should be made available to patients, health care providers, and researchers in a format that allows users to find studies that look at device use in children.

"We are pleased that FDA officials are now taking steps to establish a monitoring system to keep tabs on these postmarket studies of medical devices," said committee chair Hugh Tilson, professor of public health leadership, epidemiology, and health policy, University of North Carolina, Chapel Hill. "But Congress needs to ensure that this system becomes a reality and that key information about these studies is made publicly available."

Postmarket surveillance of medical devices is intended to detect early on any safety problems that may arise as the devices are used with larger and more varied populations – such as children -- and in different circumstances than those examined during premarket evaluations. FDA's surveillance includes collecting and analyzing reports from health care providers, manufacturers, patients, and others about serious health problems or other adverse events that may have been caused by a device. For certain categories of medical devices, the agency can also require manufacturers to conduct postmarket studies.

According to FDA, some 80,000 medical devices are marketed in the United States, ranging from those as simple as plastic tubing and baby bottle nipples to others as complex as pacemakers or cerebrospinal fluid shunts. Although low-risk devices like plastic tubing need not be evaluated by FDA before going to market, between 55 percent and 60 percent of all devices are considered to be higher risk and require agency review. The highest risk devices must undergo a rigorous approval process, but most devices that require review go through a less-rigorous clearance procedure.

When FDA officials have questions about the safety of a high-risk device, they may order the manufacturer to undertake a postmarket study as a condition of granting approval, but the agency cannot require studies as a condition of granting clearance. FDA has the authority to order surveillance studies for certain categories of devices after they have been cleared or approved; these studies are known as Section 522 studies for the part of federal law that gives FDA this authority.

Device makers that sponsor postmarket studies are required to report annually to FDA on their studies' progress, but agency officials lack effective procedures to monitor the studies that have been required as a condition of approval, the committee found. Although dozens of these study commitments have been made, FDA could not identify which involved children, nor say which studies had been initiated or completed or otherwise confirm their progress. FDA officials stated that the agency had ordered two Section 522 studies in recent years. FDA is required to report to Congress in 2007 on the extent to which device makers comply with postmarket study commitments.

Because FDA's current authority to order postmarket studies of devices that go through clearance is limited, Congress should give the agency the authority to require studies for certain devices as a condition of clearance. Congress also should remove the three-year time limit on studies in cases where devices are intended for use in pediatric patients and where issues such as children's growth and development cannot be adequately addressed in shorter studies.

In some respects, substantial progress in detecting and preventing problems associated with device use will depend less on FDA regulation than on the collective efforts of hospitals, clinicians, device makers, and others to improve their own programs for identifying, analyzing, and preventing these problems, the report says. About 151,900 reports on device-related adverse events were submitted to FDA in 2004, and at least 2,684 involved patients under age 21, although the latter number is undoubtedly too low due to lack of age information on many reports, the committee noted.

FDA should improve the links between its own databases and other organizations' reporting systems, and look at ways to encourage individuals filing reports to indicate if a child is involved, the report says. Given the shift of much medical care from traditional health care settings to homes, schools, and the community, it is important to help parents and other non-health care professionals report adverse events and to provide these individuals with information on how to use devices safely, the report adds. 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.

The committee expressed concern about the adequacy of the agency's resources for conducting postmarket surveillance and making relevant data public. Although Congress authorized an additional $3 million in 2003 and $6 million in 2004 for postmarket surveillance of devices, lawmakers did not actually appropriate the funds to the agency, the committee noted.

Charged with evaluating FDA's postmarket surveillance of medical devices used with children specifically, the committee found that it was extremely difficult to identify postmarket studies that considered pediatric issues or focused on children. Children's rapid growth and development, as well as their smaller size and typically active lifestyles, can affect the longevity, effectiveness, and safety of devices, particularly implants, braces, and other products that are used long-term. Because children represent a small market for devices, imposing requirements on manufacturers to conduct studies examining their use in pediatric patients could inhibit the development of new equipment for children, the committee acknowledged. FDA, the National Institutes of Health, and others should set priorities for research on unanswered questions about the safe use of devices with children.

The committee's study was sponsored by FDA. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.

Pre-publication copies of Safe Medical Devices for Children are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at ]

Board on Health Sciences Policy

Committee on Postmarket Surveillance of Pediatric Medical Devices

Hugh Tilson, M.D., Dr. P.H. (chair)
Senior Advisor to the Dean and Clinical Professor of Epidemiology and Public Policy
School of Public Health
University of North Carolina
Chapel Hill

James M. Anderson, Ph.D., M.D.
Professor of Pathology, Macromolecular Science, and Biomedical Engineering
Institute of Pathology
Case Western Reserve University

Erle H. Austin III, M.D.
Professor of Surgery
Division of Thoracic and Cardiovascular Surgery
Department of Surgery
School of Medicine
University of Louisville, and
Chief of Cardiovascular Surgery
Kosair Children's Hospital
Louisville, Ky.

Mark E. Bruley
Vice President for Accident and Forensic Investigation
Emergency Care Research Institute
Plymouth Meeting, Pa.

Paul Citron, M.S.E.E.
Vice President
Technology Policy and Academic Relations
Medtronic Inc. (retired), and
Visiting Professor
University of California
San Diego

William H. DuMouchel, Ph.D.
Vice President of Research and Chief Statistical Scientist
Lincoln Technologies Inc., and
Technology Consultant
AT&T Labs
Florham Park, N.J.

Ellen J. Flannery, J.D.
Covington & Burling
Washington, D.C.

Linda Golodner
National Consumers League
Washington, D.C.

Stephen J. Haines, M.D.
Lyle A. French Chair and Head of the Department of Neurosurgery
University of Minnesota Medical School

Patricia Hicks, M.D.
Assistant Professor
Division of General Academic Pediatrics
Department of Pediatrics, and
Residents Continuity of Care Clinic
University of Texas Southwestern Medical School

Stephen Lagakos, Ph.D.
Department of Biostatistics
Harvard School of Public Health

George Lister, M.D.
Professor and Robert L. Moore Chair
Department of Pediatrics
University of Texas Southwestern Medical School

Jonathan J. Rosen, Ph.D.
Faculty Member
Harvard Medical School;
Senior Research Scientist
Massachusetts General Hospital; and
Office of Technology Implementation
Center for the Integration of Medicine and Innovative Technology Consortium


Marilyn J. Field, M.D.
Study Director