The Food and Drug Administration is recommending that hospitals reduce some patient exposure to a common plasticizer used in PVC medical devices, and agency officials said they are considering asking manufacturers to label some medical devices that contain the chemical.
The FDA recommendation, made July 12, does not really break any new ground and mirrors a much-talked about report the agency issued 10 months ago assessing the health risks of di(2-ethylhexyl) phthalate. But it is the agency's first formal recommendation to hospitals on what steps they should take.
Essentially, the agency said it has no evidence that DEHP harms people, but it said relevant animal studies point to problems with reproductive development, particularly for baby boys undergoing extensive treatments and for some adults.
The agency said that caution is needed, in view of available animal data, but it also stressed that the risk from DEHP is relative and patients should not forgo health care.
``The risk of not doing a needed [medical] procedure is far greater than the risk associated with exposure to DEHP,'' the FDA said.
DEHP is used as a softening agent in PVC medical devices such as IV bags and tubing but can leach out and get into blood or medical solutions.
The environmental group Health Care Without Harm, in Washington, criticized FDA's action for not requiring labeling of medical devices that contain DEHP.
Phil Phillips, deputy director for science and regulatory policy in the FDA's Office of Device Evaluation in Rockville, Md., said the agency is preparing to release a nonbinding guidance document that would ask medical device manufacturers to label some devices that contain DEHP.
``Different devices present different degrees of risk,'' he said. ``We tried to identify the types of devices that include PVC where there might be increased risk of DEHP exposure.''
The Phthalate Esters Panel, a unit of the American Chemistry Council in Arlington, Va., said the FDA expressed little or no concern about the vast majority of uses of DEHP, and it questioned whether alternative materials have been studied as much as DEHP.
``Research is continuing which will help clarify whether the theoretical risks outlined by the FDA are indeed real,'' the panel said.