More Kid-Sized Medical Devices NeededApr 24, 2008 | Parker Waichman LLP
More and more, physicians are realizing that children should not be fitted for adult-sized medical devices. According to Dr. David Staffenberg, a metal plate improperly lodged in a young boy's skull showed him how very dangerous traditional devices—generally made to fit adults—can be when implanted in children. In the case of Staffenberg’s patient, the plate was implanted to help stabilize the boy's skull but ended up resting on his brain. Staffenberg safely removed the titanium plate; however, that did not resolve the overarching issue that the vast majority of medical devices are made for adults. Apparently, doctors work around the problem by “jury-rigging” devices to suit their patients’ needs; however, this practice has limits and patient risk can be high. Also, problems exist not because children are smaller, but because they are also growing and their metabolism is quicker.
Now, lawmakers and doctors are pushing the medical device industry to design a new class of “kid-friendly” equipment and President Bush signed a law in September offering financial incentives to those companies that design child-sized devices. The law also provides regulators with additional power to both analyze the use of adult-sized devices in children and requires device makers to swallow the cost of such tracking.
Industry is not happy about this nor is it happy that there is a decidedly smaller market for child-sized devices—children tend to be healthier than adults—which presents limited profit potential and experimental kid-sized devices can legally be sold without full federal approval only if used to treat rare diseases. "The pediatric market is a mere fraction of the market for adults," said Paul Citron, who recently retired as vice president of technology at Medtronic Inc., a medical device maker. The U.S. market for medical devices is estimated at nearly $90 billion; however, health care experts agree pediatrics is a mere fraction of that. Also, with device makers like Medtronic and Boston Scientific Corp. already under fire for problems with pacemakers, stents, and other adult devices, it is not expected that they will look to expand their market to children.
Some issues fitting children with devices made for adults include heart valves that quickly deteriorate in growing bodies; pacemakers that cause infection, stroke, and death in smaller patients; surgical cameras that are too big for children and cause tissue damage; pacemaker batteries that cannot keep up with children’s faster heartbeats; and oversized oxygen masks. And the Food and Drug Administration (FDA), which regulates devices, has limited information on the frequency with which adult devices are used in children; the one large-scale study, conducted in 2005 by the Institute of Medicine, gave no estimate on related deaths or injuries.
After thousands of doctors complained, the American Academy of Pediatrics increased its lobbying budget over 100 percent to $362,500 in 2007 to help pass legislation on pediatric-device development, but manufacturers say they lack the technology to meet this need. The device bill proposed $30 million in research grants over five years; however, nothing has yet been set aside in the federal budget.