PEDIATRICIANS APPLAUD MEDICAL DEVICES LEGISLATION
Access to pediatric medical devices will save lives, improve outcomes for children

Washington, DC - The Pediatric Medical Device Safety and Improvement Act, introduced yesterday by Senator Chris Dodd (D-CT), represents an important step towards developing needed pediatric medical devices. The American Academy of Pediatrics (AAP) has endorsed the bill and is grateful to the senator for his leadership and vision in helping children.

“There is a critical need for pediatric medical devices that help diagnose and treat diseases and conditions affecting children,” said AAP President Jay E. Berkelhamer, MD, FAAP. “This legislation is exactly what we need to develop medical devices manufactured with children’s needs in mind.”

Although children and adults often suffer from similar diseases and conditions, their medical needs and physiology differ considerably. Many of the most advanced chemotherapy catheters are still too large for infants, requiring them to use less advanced tubing that leaves them more vulnerable to infection. Stapling devices used in certain pediatric surgeries often weigh more than the patients. Devices that keep a failing heart beating while a patient waits for a transplant, known as left ventricular assist devices, are not available for children ages 5 and younger.

“Because children have unique biochemistry, physiology, growth rates, activity and environmental influences, it complicates the development and production of new devices. Developing medical devices for children is also less profitable for companies because fewer children need medical devices than adults,” said Dr. Berkelhamer. “This legislation will help break down these barriers, and encourage the development of life-saving pediatric devices.”

The legislation will offer incentives to manufacturers to create medical devices designed specifically for children. It will also give the Food and Drug Administration (FDA) the authority to require post-market studies of approved pediatric devices to ensure their continued efficacy and safety.

The AAP, with support from the National Organization for Rare Disorders, the Elizabeth Glaser Pediatric AIDS Foundation, the American Thoracic Society, the American Pediatric Society, the Association of Medical School Pediatric Department Chairs and the Society for Pediatric Research, is committed to moving the Pediatric Medical Device Safety and Improvement Act through Congress in order to bring infants, children and adolescents a comprehensive solution to the lack of pediatric medical devices in this country. A number of device manufacturers have also endorsed the legislation.

The AAP will work with lawmakers to pass this legislation as soon as possible.

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The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well being of infants, children, adolescents and young adults.