Most Pediatric Medical Devices Not Tested on Children

By Ashley Thomas, Vanderbilt Law School-

Medical devices can be useful in the treatment of a variety of illnesses, but in the field of pediatrics rarely are these devices first tested on children. According to a recent study on pediatric device approvals, most medical devices have only been tested on individuals 18 years or older. This study was designed to analyze the developments made in pediatric medical devices after the passage of the Pediatric Medical Device Safety and Improvement Act (“PMDSIA”) in 2007. The PMDSIA was intended to ensure that children were not left behind as revolutionary advances are made in medical device technology. Prior to the passage of the PMDSIA, medical device manufacturers had little incentive to focus their attention on children. Since the implementation of the PMDSIA, children have made up only 10 percent of participants in clinical trials.

The study specifically analyzed all medical devices that were intended for therapeutic use in pediatric patients and approved by the Food and Drug Administration (“FDA”) through either the premarket approval process or the Humanitarian Device Exemption (“HDE”) program. Most class III devices, such as heart valves, pacemakers, and stents, have to be tested under the premarket approval process before they can be legally marketed. Approval under this process generally requires that the manufacturer demonstrate reasonable assurance that the device is safe and effective for the target population and typically requires that the manufacturers conduct at least one clinical trial. The HDE is a new program designed to address small markets, i.e., diseases or conditions that affect fewer than 4,000 patients in the United States each year. Unlike the devices processed under premarket approval, devices in the HDE program are statutorily exempt from some of the requirements of the premarket approval process and need to only demonstrate a probable benefit.

The devices that were selected came from a list compiled by the FDA for its annual report to Congress on pediatric medical devices between 2008-2011. Among the 25 devices analyzed, researchers found that 11 of those devices were not tested on any patients 21 or younger. The Food, Drug and Cosmetic Act defines pediatric patients as those at 21 years or younger. Only four devices were tested on patients who were under the age of 18. In the study, three devices were specifically approved for children under the age of 18 while the rest were approved for 18-to-21 year olds.

The results from the study are troubling because the data indicates that pediatric medical device manufacturers have developed devices primarily for adults. The data suggests that most devices manufactured for adults are later approved for children despite the limited evidence of their safety and effectiveness in this group. Children are not mini-adults. They are still growing and developing human beings, which poses a different set of challenges for evaluation of safety and effectiveness of medical devices. The study cited a problem with conducting research on pediatric patients in that pediatric device trials have a smaller potential pool of participants. Other issues to contend with include a more complicated informed consent process, lower pediatric disease burden and poor incentives for industry in terms of return on investment for pediatric drugs. The results demonstrate the challenges that manufacturers and physicians face in evaluating these products for the pediatric population.

Going forward in making treatment decisions, physicians and patients should be aware of the limited data on the safety and efficacy of pediatric devices. Currently, there are no special incentives for device manufacturers to conduct post-approval studies in children. Hopefully, the FDA will create more incentives for manufacturers leading to more research and long-term studies being conducted on medical devices in children.

Ashley Thomas resides in Nashville, Tennessee, and is a student at the Vanderbilt School of Law, expected to graduate in May of 2014. Ashley is a Student Member of the American Health Lawyers Associations and a research assistant at Vanderbilt’s Center for Patient and Professional Advocacy. Ashley graduated from Northwestern University with a B.A. in political science in 2009.