The Institute of Medicine published a report critical of the safety of medical devices for children and the regulatory oversight provided by the FDA. According to this story (registration required) in the New York Times,
major new report concludes, citing missed opportunities to uncover side
effects and make crucial treatments safer for the tiniest patients.
tracking of device safety and other steps will also benefit adult
recipients of medical devices, notes Monday's report from the Institute
Among the panel's recommendations:
- Congress should give FDA
the authority to require postmarket studies of any device; today, it
can force them to perform such studies only for certain products.
- Congress should require FDA to establish a public database showing those studies' status and findings.
should fund improved postmarket surveillance for device-related
problems in both adults and children. Lawmakers authorized an extra $6
million this year for FDA to do that but ultimately never provided the
money, the report said.
AdvaMed, the medical device industry trade group, declined immediate comment but had told the IOM panel that FDA has adequate authority to ensure device safety.