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.

In many respects the IOM report affirmed the findings of FDA’s internal study of device maker compliance with required postmarket studies, Center for Devices and Radiological Health Condition of Approval Studies as a Postmarket Tool for PMA Approved Cohort 1998–2000, which was issued in March of this year. At that time, the agency characterized manufacturers’ compliance with so-called condition of approval (COA) studies as “suboptimal.” However, the agency report was also critical of FDA’s lack of a tracking system, which makes it “very difficult for anyone to obtain information on the studies or their status, unless that person has extensive knowledge of the individual products under study.”

Upon issuing the COA report, FDA’s Center for Devices and Radiological Health (CDRH) said it had taken a number of steps to “improve the tracking of COA studies and for improving manufacturer compliance with the terms of performance agreed upon at the time of premarket approval.” One of the most-noted changes was transferring the responsibility for designing, tracking, and evaluating COA studies from the Office of Device Evaluation (ODE) to the Office of Surveillance and Biometrics, which has primary responsibility for monitoring the safety and effectiveness of products after they reach the market.

OSB’s Gardner: Implementing changes.

Commenting on the IOM study, Susan Gardner, PhD, head of the 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.

IOM’s Tilson: In search of openness.

“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 IOM committee chair 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 IOM report included an extensive list of specific recommendations for FDA, including the following.

• Establish a system for monitoring and publicly reporting the status of all postmarket medical device studies.
• Include detailed information about the disposition of each study’s findings.
• Expand its authority in requiring postmarket studies to all medical devices, not limited to certain device categories, as is the case now.
• Extend the current three-year time limit, particularly in the case of pediatric devices, to allow for the study of childhood growth and development.
• Work with Congress in demonstrating and securing adequate funds to conduct postmarket studies.
• Collaborate with both public and private research organizations to better define postmarket research agenda and establish priorities for long- and short-term device safety and efficacy.
• Promote the development and adoption of common standards for device coding to capture and link outcomes.
• Focus more on adverse device events.
• Work with all stakeholders on postmarket device reporting systems, including doctors, medical facilities, patient groups, and manufacturers.
• Provide information about linkage between reporting systems.
• Issue yearly reports on postmarket studies.

AdvaMed’s Ubl: Support for change.

Industry association AdvaMed (Washington, DC), which had earlier challenged the methodology and procedures used to compile data for FDA’s COA report, expressed support for the IOM study. Stephen J. Ubl, AdvaMed president and CEO, said the trade group“values the views and recommendations of the IOM and the well-regarded panelists who comprised the committee. AdvaMed members are committed to advancing the safest and most effective medical technologies . . . support robust postmarket surveillance . . . and have been working with FDA to make sure these processes are effective.”

IOM is a division of the National Academy of Sciences (Washington, DC) and conducted the FDA-sponsored study at the request of Congress as part of its charter to provide advice on health policy issues. 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.