There's been much media attention lately to how prescription and over-the-counter drugs are approved and marketed in the United States. But less attention is paid to the medical device market, and still less to devices designed specifically for children.
The Walsh family from Redding, Mass., lost their daughter Casey because of a faulty medical device. Casey was born with hydrocephalus, an excess of fluid around her brain, and doctors implanted a shunt, a kind of drain to ease the pressure in her skull. Things were looking up for Casey by the time she was one year old. But that all changed one day, when her parents noticed she had slept a few hours more than usual. They rushed her to the hospital, but she later died — a malfunction of the shunt had led to the buildup of pressure on her brain.
Casey's neurosurgeon, Joe Madsen of the Children's Hospital in Boston, says the lack of research funds is a major problem in pediatric device research. Only three percent of total U.S. health spending is on children, and 20 percent of children don't have medical insurance. This means device makers have little reason to go after a pediatric market.
One of the challenges in designing medical devices for children is that they grow. Also, because of the high cost of the Food and Drug Administration's approval process, including extra studies that may be required for children, many of the medical devices in use for kids have never been formally approved.
WBUR's Allan Coukell has the story.
This program aired on August 22, 2005. The audio for this program is not available.