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. Although 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, 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).

The report noted that about 80,000 different types of medical devices are sold in the United States. In 2004, FDA received 151,900 reports of device-related adverse events.