CHILDREN'S GROUPS OFFER WAYS TO IMPROVE CHILD MEDICAL DEVICES

Washington, D.C.---The American Academy of Pediatrics (AAP) and the Elizabeth Glaser Pediatric AIDS Foundation released a document outlining several ways to improve the medical devices that help treat or diagnose diseases and conditions affecting children. The ideas were generated during four meetings held last summer and fall with representatives from health care organizations, government agencies and the device industry. The document was given Thursday afternoon, Jan. 27, to key congressional members who are considering legislative solutions.

Currently, many medical devices are not developed with the needs of children in mind, and can lead to health problems. For example, there are high rates of infection and device malfunction when using shunts, lines and catheters in children. Infections can lead to delayed recovery, permanent disability and in some cases, death.

"There are pediatricians who have taken a device designed for adults and modified it to work for a patient," said AAP President Carol Berkowitz, MD. "We're desperate for equipment that is designed and sized to work in children."

"Children are not just small adults and their special medical needs are too often overlooked," said Kate Carr, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. "It is unacceptable that children lag 10 to 15 years behind adults when it comes to availability of appropriate medical devices."

Some of the ideas that were agreed upon* and included in the meeting summary document are:

• Designating a "point person" or office at the National Institutes of Health to help innovators and physicians access existing funding for pediatric device development.

• Developing a condensed easy approval process with a 30-day fast track review for modifications to existing devices that need only minimal changes to be made appropriate for pediatric use.
  
  
• Improving online adverse event reporting documents, such as using MedWatch, to encourage better collection of pediatric information.

On Jan. 14, the U.S. Department of Health and Human Services (HHS) delivered a report to Congress on the barriers to the development of pediatric medical devices. While it concluded that it is premature to recommend any policy changes, the report was finished before the AAP, EGPAF and the others completed their discussions and agreed on some potential solutions. The recommendations presented to Congress last week represented the most current and comprehensive look at the questions surrounding pediatric devices.

"As we learned in our fight for pediatric drug testing, legislation can make a difference," Carr said. "Our goal is to work with Congress, the FDA and the industry to ensure we meet the special medical device needs of all kids."

"We should move forward on some of these ideas while continuing to assess the needs of patients and the challenges faced by the device industry," Dr. Berkowitz said.

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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.

The Elizabeth Glaser Pediatric AIDS Foundation is the worldwide leader in the fight against pediatric AIDS and other serious and life-threatening diseases affecting children. Our innovative research programs, collaborative training initiatives, advocacy efforts, and rapidly expanding international programs are bringing dramatic changes to the lives of children worldwide.