Yes, there was will
Did Todd Sloane write his Oct. 28 editorial lamenting the "do-nothing" Congress "Where there's no will, there's no way" (p. 32) on Oct. 25?
On Oct. 26, President Bush signed into law the most far-reaching Food and Drug Administration medical technology reforms in more than a quarter century. The Medical Device User Fee and Modernization Act of 2002, a bipartisan bill that Congress passed unanimously, gives the FDA significant new resources and regulatory tools to improve patient access to 21st century medical technology.
Enacting this legislation was particularly challenging because the issue of medical device-user fees has been contentious for the past 10 years. The last effort failed in 1994. Yet in this election year, Democrats, Republicans, FDA officials and industry leaders successfully came together on this measure.
Sen. Judd Gregg (R-N.H.), ranking Republican on the Senate Health, Education, Labor and Pensions Committee, said the bill "includes the most significant improvements in the way medical devices are reviewed and regulated, arguably since 1976." Even casual observers of Congress know that "the list of what wasn't accomplished" is always far longer than the list of what was, especially in election years. That is what makes enactment of major legislation such as the medical technology bill particularly praiseworthy. This bill directly benefits American patients through more timely access to advanced medical technologies, and Congress deserves to be recognized for it.
Advanced Medical Technology Association
More on health hazard
A Nov. 11 Outliers item (p. 48) raises the important issue of the Food and Drug Administration's concern about Di(2-ethylhexyl)phthalate, or DEHP, a chemical used to soften medical devices made of PVC plastic. However, by focusing entirely on speculation regarding the FDA's proposed position on labeling, your item fails to give readers the most vital information about the FDA's recent actions.
In July the agency issued a public health notice recommending that healthcare providers limit the DEHP exposure of certain patients, particularly developing males, whom the agency believes are at greatest risk of harm. The FDA said healthcare providers should use alternatives to DEHP-containing devices when possible for certain medical procedures. To find these procedures, see www.fda.gov/cdrh/safety/dehp.pdf.
In September the FDA, in draft recommendations, urged medical device manufacturers to voluntarily label medical devices made with DEHP and replace DEHP-containing PVC with alternative materials, with a primary focus on devices used in neonatal intensive-care units. Major healthcare systems and facilities are now working to replace certain DEHP-containing medical devices, particularly in NICUs.
It is also important to note that the U.S. government is not alone in its concern about DEHP. Japan's Ministry of Health, Labour and Welfare recently recommended that healthcare professionals not use DEHP-containing PVC medical devices; a Health Canada panel has said the devices should not be used on pregnant women, male infants or other patients; and the Swedish chemicals agency is proposing to ban DEHP in children's toys, certain medical devices and some food packaging in the European Union. The EU recently banned DEHP from cosmetics because the chemical is considered to be a reproductive toxin.
All of these governmental agencies agree that DEHP exposure should be limited within the healthcare setting. Cost-effective alternatives exist for most DEHP-containing medical devices. We urge healthcare providers to read the FDA's public safety notice and to use safer alternatives. It is in that context that requiring manufacturers to label, rather than just recommending it, is a necessary step to enable healthcare providers to identify products at the point of delivery of services so they can apply the FDA's own recommendations to avoid DEHP.
Health Care Without Harm
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