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Groups Petition FDA to Require DEHP Labeling on Devices

Maria Fontanazza

September 1, 2007

3 Min Read
Groups Petition FDA to Require DEHP Labeling on Devices


A number of healthcare groups are urging FDA to mandate the labeling of polyvinyl chloride (PVC) devices that contain di-2-ethylhexyl phthalate (DEHP). In a petition and letter sent to FDA in late July, Health Care Without Harm called for the labeling of these devices due to the risk that the toxic chemical poses to young males. The organization is a nonprofit coalition that aims to reduce pollution in the healthcare industry.

The petition recommends that devices containing DEHP include a “prominent, clearly worded warning label” stating exposure risks. The label should also identify the populations that would benefit from the use of alternative devices, including pregnant or breast-feeding women and male infants. These groups could experience adverse health effects if exposed to DEHP, according to the National Toxicology Program (NTP).

Last year, a report issued by the NTP concluded that devices with DEHP can potentially interfere with the development of the male reproductive tract. The chemical, a plasticizer, is added to PVC-containing devices to make them softer and more flexible. Many types of devices, including tubing, catheters, and intravenous bags, contain DEHP. The problem is that it can leach out of a device and into the solution that comes in contact with the plastic.

According to Health Care Without Harm, the “lack of labeling allows confusion and misleading statements when companies defend the safety of their DEHP-containing devices.” The group also says manufacturers confuse healthcare providers by asserting the safety of these devices.

“Irrespective of whether or not manufacturers are receptive [to the proposed labeling requirement], the point is that consumers, practitioners, and purchasing agents need to know whether or not [a] device contains DEHP so that they can make an informed purchasing decision,” says Ted Schettler, MD, science director at the Science and Environmental Health Network (Ann Arbor, MI). “That's what the problem has been all along. When practitioners in hospitals are trying to address this issue, they frequently don't know if the device they're using has DEHP in it.”

In 2002, FDA called attention to the issue by releasing a public health notification. It advised limiting use of DEHP-containing devices in high-risk patients. The agency also suggested alternative materials such as silicone. And it listed a source where hospitals could find alternative devices. However, it didn't impose any labeling requirement on manufacturers.

Schettler says that more data have emerged since that notification. The new information has changed the landscape and should prompt the agency to review and consider the petition's recommendations, he adds.

“Things are sufficiently different now and it's hard to imagine an argument that [DEHP-containing devices should not] require labeling,” says Schettler. “You have devices that demonstrably contain a reproductive toxicant that leaches out and exposes patients at risk to significant-enough doses to exceed FDA's tolerable exposure index.”

The NTP is part of the Department of Health and Human Services. Its full report on the risks that DEHP poses to human reproduction is available online at http://cerhr.niehs.nih.gov/chemicals/dehp/DEHP-Monograph.pdf.

Copyright ©2007 Medical Device & Diagnostic Industry

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