Originally Published MX September/October 2005
BUSINESS NEWS
IOM Report Calls for Improved Postmarket Monitoring
In July, the Institute of Medicine (IOM; Washington, DC) issued a report sharply criticizing FDA's ability to track the performance and safety of medical devices following their market introduction. The report, Safe Medical Devices for Children, was the culmination of a two-year study that focused primarily on medical devices for the pediatric population. But the authors state that their findings readily apply to all devices and age groups.
The IOM committee on postmarket surveillance of pediatric devices found the most obvious deficits in FDA's performance to be "a lack of effective procedures for monitoring the status of required postmarket studies and the lack of public information regarding such studies."
Committee chair Hugh Tilson, MD, DPH, said, "The system needs to be public, transparent, and understandable, with less secrecy and more openness in the sharing of information." Tilson is senior advisor to the dean and clinical professor of epidemiology and public policy at the University of North Carolina School of Public Health (Chapel Hill, NC).
Susan Gardner, PhD, head of FDA's Office of Surveillance and Biometrics, said that the report "made some important recommendations . . . which we had recognized and where we had already started to implement changes." For example, Gardner noted that FDA had already established an electronic tracking system for postmarket studies.
"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 Tilson. "But Congress needs to ensure that this system becomes a reality and that key information about these studies is made publicly available."
Yet the IOM committee questioned FDA's ability to conduct adequate postmarket surveillance, given its lack of adequate funding. Congress authorized $3 million in 2003 and $6 million in 2004 for such studies, but the funds were not actually appropriated.
The report includes an extensive list of recommendations for FDA. The complete text of the report can be viewed via the Web site of the National Academies Press at www.nap.edu/books/0309096316/html/index.html.
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