A report by the National Academy of Sciences' Institute of Medicine directed by the US Congress concluded that medical devices sold for children need better monitoring to uncover side effects and ensure safety besides outlining the need to empower the FDA to monitor and requisition safety studies from manufacturers when approving devices.
The report also believes that improved tracking of devices on younger patients will also pave the way for safety in the case of adult recipients of medical devices besides establishing procedures to make such information available to the public.
Dr. George Lister, a pediatrician and co-author of the report said that "special focus needs to be on children", especially because very often doctors resort to jury-rigging devices designed for adults to fit into children's small bodies. He also felt that too few medical devices are actually manufactured specially for children, since the pediatric market is much smaller.
The report also goes to say that irrespective of pre-sale testing, there is scope for unanticipated side effects or device flaws to rise once with the wider use of devices, which as per the FDA would qualify for study of long-term risks even as products are sold.
The Institute of Medicine, an independent group that advises the government on health matters, concluded that the biggest problem is a lack of data on how devices affect children's growth and development, especially given their hormonal changes with the onset of puberty. Citing the case of a preschooler whose rapid growth resulted in damage of a defibrillator implanted to treat her irregular heartbeat, resulting in her collapse with chest pain, the panel said that monitoring was especially needed because the device used mostly in adults had not been adequately studied in young children. Mark Isaac spokesperson for the Elizabeth Glaser Pediatric AIDS Foundation confirmed that children are always the “last in line” when it comes to drug and device safety especially when trying to help them. The foundation has been pushing Congress for improvements and a raised level of vigilance for devices used in children.
When simple devices such as a medication syringe for babies have caused problems like choking, the panel felt it all the more reason for measures to be put in place for better compliance of testing and reportage of medical devices’ potential dangers. The panel said that with the failure of parents and health workers reports of problems, neither safety warnings could be issued nor the devices be improved. They felt that often parents and health workers assume that devices wear out or break but do not know to whom to direct their complaints to.
The panel recommended that the Congress grant FDA the authority to requisition postmarket studies of any device against the current scenario where such authority is limited to certain products. Besides this, it also suggested that Congress fund improved postmarket surveillance for device-related problems in adults and children and direct FDA to establish a public database of all postmarket studies and their findings. It suggested that FDA collaborate with National Institutes of Health to prioritize research on devices used on children besides working with parents, patient advocates, health organizations and the industry to increase reportage of side effects or device flaws.
While FDA believes that the IOM report made valid recommendations and is all set to enact the recommendation of creating a public database of certain postmarket studies, the device industry trade group, AdvaMed declined any comment while still reiterating to the IOM panel on the adequacy of FDA authority. Earlier this year lawmakers authorized an extra $6 million for FDA to establish a database of postmarket studies but never provided the money. Industry watchers feel that this report may result in far-reaching reforms in the already beleaguerd US Health Industry.
