Unfit for Surgery: Doctors Want More Devices Tailored for Children

It took a metal plate improperly lodged in a young boy’s skull to make Dr. David Staffenberg realize just how dangerous adult-sized devices can be in children. The plate was implanted to help stabilize the boy’s skull but ended up resting on his brain. While Staffenberg was able to safely remove the titanium disc, the fact that he was faced with this added risk speaks to a problem pediatricians face everyday: the vast majority of medical devices are made for adults. Doctors work around the problem by jury-rigging adult-sized devices to suit their needs. But they acknowledge that such ingenuity has limits and that the risks to patients are often high. With growing support from lawmakers, doctors are prodding the medical device industry to design a new class of kid-friendly equipment. A law signed by President Bush in September offers financial incentives to companies that design devices for kids. It also gives regulators more power to scrutinize the use of adult-sized devices in children and requires manufacturers to bear the costs of tracking them. While this added oversight has dampened industry’s enthusiasm for the law, there are other more practical reasons device makers remain cautious about jump-starting production. The profit potential is limited because the law allows experimental kid-sized devices to be sold without full federal approval only if they’re used to treat rare diseases. Also, compared to adults, kids are healthier, and therefore a much smaller market to begin with.

Please click on the link below to read the Business Week article:

http://www.businessweek.com/ap/financialnews/D907N7200.htm

For more information on defending medical malpractice, nursing home and general liability matters in Florida contact Howard Citron at The Citron Law Firm, P.A. – www.citronlegal.com.

Heparin Contamination May Have Been Deliberate, F.D.A. Says

Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously. “F.D.A.’s working hypothesis is that this was intentional contamination, but this is not yet proven,” Dr. Janet Woodcock, director of the Food and Drug Administration’s drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday. A third of the material in some batches of the thinner heparin were contaminants, “and it does strain one’s credulity to suggest that might have been done accidentally,” Dr. Woodcock said. Two weeks ago, Food and Drug Commissioner Andrew C. von Eschenbach told a Senate subcommittee that the contamination was done “by virtue of economic fraud,” but he quickly withdrew the remark, saying he had “probably gone too far.” Dr. Woodcock’s statement on Tuesday was part of growing chorus that has labeled the heparin contamination as perhaps the most brazen poisoning episode since 1982, when seven people in the Chicago area died after taking Tylenol that had been laced with cyanide. The Tylenol case led to substantial changes in product packaging, and the heparin contamination has led both Democratic and Republican committee members to call for major changes in the way the F.D.A. functions and is financed. Tuesday’s hearing was also the first in which family members of those who died were asked to testify.

Please click on the link below to read The New York Times article:

http://www.nytimes.com/2008/04/30/health/policy/30heparin.html?_r=1&ref=health&oref=slogin

For more information on defending medical malpractice, nursing home and general liability matters in Florida contact Howard Citron at The Citron Law Firm, P.A. – www.citronlegal.com.