DODD, DEWINE: ONE SIZE FITS ALL' MEDICAL DEVICES DETRIMENTAL TO CHILDREN; INTRODUCE LEGISLATION INCENTIVIZING INNOVATION, SAFETY
Senators Chris Dodd (D-CT) and Mike DeWine (R-Ohio) yesterday introduced legislation which would ensure that the safety of young children is not compromised by medical devices which are developed with an adult patient in mind. For example, physicians have had to resort to invasive procedures when a baby needs assistance breathing because even the smallest nasal masks on the market in the U.S. today are not designed to fit infants. Children needing heart transplants die at a disproportionate rate, but a device called a Berlin Heart which has shown great promise helping young children and newborns while they recover or wait for heart transplants can only be obtained today in the U.S. on a case by case basis and must be shipped from Germany.
The Pediatric Medical Device Safety and Improvement Act of 2006 improves incentives for the development of devices for children - while still preserving the ability to ensure the safety of new products once on the market. According to pediatricians, the development of new medical devices suitable for children's smaller and growing bodies can lag 5 or 10 years behind those for adults, leaving doctors no choice but to use equipment essential to medical diagnosis and treatment which are not designed or sized for children.
"Like drugs, where for too long children were treated like small adults and could just be given reduced doses of adult products, many essential medical devices used extensively by pediatricians are not designed or sized for children," Dodd explained. "To date, because the pediatric market is so small and pediatric diseases relatively rare, there has been little incentive for device manufacturers to focus their attention on children. This legislation ensures that our nation's children are receiving the best possible medical treatment and care at a critical time in their development." "Children are not just miniature adults, they have their own unique needs, one size does not fit all in this case," said Senator DeWine. "With evaluation at the Food and Drug Administration and the National Institutes of Health, we will be better able to understand how these likely life-saving devices can uniquely affect the youngest of patients. This will enable doctors to provide the best care for our nation's children."
Senators Dodd and DeWines' bill will provide assistance to innovators, streamline regulatory processes, and elevate pediatric device issues at the Food and Drug Administration and the National Institute of Health.
The following groups have worked have worked with Senators Dodd and DeWine on this bill and are supportive of their efforts:
The Elizabeth Glaser Pediatric AIDS Foundation
The American Thoracic Society
The American Academy of Pediatrics
The National Organization for Rare Disorders
The American Pediatric Society
The Association of Medical School Pediatric Department Chairs
The Society for Pediatric Research