WASHINGTON, DC -- Representatives Edward J Markey (D-MA), a senior member of the House Energy and Commerce Committee, and Mike Rogers (R-MI), today introduced “The Pediatric Medical Device Safety and Improvement Act of 2007” to encourage innovators to design medical devices specifically for children while improving the system to ensure the safety of new pediatric devices on the market. Senator Chris Dodd (D-CT) introduced companion legislation in the Senate.

Rep. Markey said, “Just as kids need car seats in the car while adults are fine with seat belts, kids need medical devices that are designed to work for them and keep them safe. This bill will help children get medical devices that are made just for them rather than being forced to use modified adult devices that may not be appropriate for their growing bodies.”

Rep. Rogers said, “Adult medical devices rarely adapt to the physical or medical needs of small babies or young children. Conquering this challenge would make it possible for the most vulnerable members of our families to experience improvements in the quality of their daily lives, and in many cases make a life-saving difference.”

Although children suffer from many of the same diseases and conditions as adults, children are not just small adults. In addition to size, children also have different rates of growth, anatomy, physiological differences, and physical activity levels—all of these factors affect their medical device needs.

Unfortunately, according to pediatricians, the development of new medical devices suitable for children can lag 5 or 10 years behind those for adults, leaving doctors no choice but to use adult devices essential to medical diagnosis and treatment which are not designed or sized for children. This forces pediatricians to “jury-rig” adult medical devices that are often too large in order to make them fit smaller bodies. This practice, however, is not always effective and leaves children without optimal treatment.

“The Pediatric Medical Device Safety and Improvement Act of 2007” offers incentives to device manufactures to create needed medical devices specifically designed to meet the needs of pediatric patients and it gives the FDA the authority to review these devices and require post-market studies to ensure the continued safety  and effectiveness of these devices.

Specifically, the bill would:

    - Modify the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need.  Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year.  No profit will be allowed for a device used in more than 4,000 individuals.  The HDE modification sunsets in 2013 and a GAO report assessing the HDE modification and its impact on patients and manufacturers is required.
    - Establish a mechanism to allow the FDA to track the number and types of devices approved specifically for children or for conditions that occur in children, as well as the approval times for premarket applications and HDEs.  
    - Require the NIH to designate a contact point or office to help innovators and physicians access existing funding for pediatric medical device development and directs the NIH, the FDA, and the AHRQ to submit a plan for pediatric medical device research that identifies gaps and proposes a research agenda for addressing them.
    - Establish demonstration grants for non-profit consortia to promote pediatric device development, including “matchmaking” between inventors and manufacturers and connecting innovators and physicians to existing Federal resources, including FDA, NIH, the Small Business Administration, VA and others.
    - Grant explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety.
    - Incorporate several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.
    - The Markey-Rogers bill has been endorsed by the American Academy of Pediatrics, The Elizabeth Glaser Pediatric AIDS Foundation, AdvaMed, Stryker Corporation, American Pediatric Society, Association of Medical School Pediatric Department Chairs, and the Society for Pediatric Research.
    - The Markey- Rogers bill will provide assistance to innovators, streamline regulatory processes, and elevate pediatric device issues at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).