Pediatric Medical Device Development Improving Though Barriers Remain

The General Accounting Office (GAO) recently released a report on progress in the development of pediatric medical devices following enactment of the Pediatric Medical Device Equity Act (PMDEA), which was a part of the 2008 Food and Drug Administration reauthorization. The ATS, which strongly supported that legislation, is listed as one of the stakeholder organizations with which the GAO consulted in drafting the report, which examined barriers to pediatric device development and the impact of the pediatric medical device incentive law passed in 2008. ATS Secretary-Treasurer Thomas Ferkol, MD, and Assembly on Pediatrics member Ann Halbower, M.D., represented the Society during the conversations that preceded the report’s release in December 2011.

"The report shows that the PMDEA is spurring the development of new devices for kids," said Dr. Halbower, former chair of the ATS Health Policy Committee. "The ATS will be working with the American Academy of Pediatrics to support funding for this important initiative in 2012 and with industry and other partners on ways to support the development of more devices designed for kids. There are still critical needs in this area to advance respiratory health for children. Critical gaps exist where healthcare reforms are creating even steeper demands: the ability to care for technology-dependent children at home. These gaps include low-cost simplified and dependable home ventilators, safe and effective non-invasive ventilation equipment and interfaces, flexible and re-usable ventilation circuits, and low-cost monitoring equipments, such as pulse oximeters."

Some of the report’s main findings and conclusions are listed below.

• Significant barriers to pediatric device development exist, including physiological differences in pediatric patients and challenges with recruiting pediatric participants for clinical trials.
• The PMDEA helps to support the creation of more pediatric devices, with 107 device projects developed during the program’s first two years.
• Since the PMDEA was enacted, 15 devices have been explicitly indicated for use in pediatric patients.
• The FDA lacks reliable and timely information on pediatric devices approved for the U.S. market.
• The PMDEA demonstration grants for pediatric device consortia and allowing manufacturers to earn a profit on pediatric HDE devices have helped support more approved pediatric devices and the provisions show potential for more devices in the future.
• The FDA needs better data systems in place to produce timely, reliable information to readily identify and track devices the agency has approved for use in pediatric patients.
• The GAO recommends that the FDA develop better data reporting systems related to pediatric medical devices.

The ATS will work with sister organizations to ensure the FDA adopts the GAO report’s findings and recommendations. To read the report in full, please visit www.gao.gov/products/GAO-12-225.