A Washington-based environmental group has petitioned the Food and Drug Administration to issue guidelines or require labeling on PVC tubing and blood, intravenous and other fluid bags that contain the plasticizer di(2-ethylhexyl) phthalate.
Health Care Without Harm filed the petition July 24 with the support of six other health-care organizations, including the American Medical Association.
The document asks the FDA to initiate rule-making or issue guidance requiring medical device manufacturers to consistently label all medical devices that may cause patient exposure to DEHP and may be used in situations that could interfere with the normal development of the male reproductive tract.
An industry spokesman said labeling is unnecessary and not supported by any new research since the last time FDA assessed the issue five years ago.
``Labeling would create the implication that something is wrong when it isn't,'' said Marian Stanley, manager of the Phthalate Esters Panel of the American Chemistry Council in Arlington, Va. ``We strongly believe that labels should mean something and, in this case, it is just not needed.''
HCWH is a nonprofit global group of 443 organizations in 52 countries dedicated to protecting the well being of patients in the health-care industry. It filed similar petitions in 1999 and 2001 that the FDA rejected. At that time, the FDA said there was little or no risk from exposure to PVC IV bags or PVC bags used to store and administer drugs.
The FDA had no comment on the new petition.
In 2002, the FDA said the greatest concern with regard to exposure from DEHP was the effect on the development of the male reproductive system. The agency said, however, that it had not received reports of these adverse events in humans, but there also have been no studies to rule them out. It suggested precautions be taken to limit the exposure of the developing male to DEHP.
The FDA recommended in 2002 that hospitals consider alternatives to PVC bags, if available, when high-risk procedures are performed on male neonates, pregnant women carrying male fetuses and peripubertal males.
HCWH hopes the FDA will be convinced to act now because of a 2006 National Toxicology Program report that reaffirmed FDA's 2002 assessment, as well as the decision of the European Union in March to require labeling of any products containing phthalates that come into contact with the human body.
However, the EU standard is based on a list of substances classified as carcinogenic, mutagenic or reprotoxic and does not look at exposures.
``Requiring regulatory action is totally unnecessary,'' said Allen Blakely, spokesman for the Vinyl Institute in Arlington, Va. ``This is political. If someone wants a bag PVC-free, they can certainly put it in their specifications.''
In April 2006, Hospira Inc. and Baxter Healthcare Inc. brought to market non-PVC IV bags. Baxter's Aviva premium IV bags are for use with newer therapies and lipid-containing nutrition products, and in neonatal, pediatric and oncology applications.
The VisIV bags from Hospira are a non-PVC product made from a multilayer thermoplastic film that includes polypropylene. It eliminates the overwrap, cuts waste by 40-60 percent and reduces the risk of infections and contamination for both caregivers and patients.
About 300 million IV bags are used annually in the United States, according to Hospira, as some 90 percent of all hospital patients receive some form of IV therapy.
In its petition, HCWH suggested there are safer alternatives to products containing DEHP.
``Alleging that something is safer when we already have something that is safe based on millions of hours of use is misleading,'' Stanley said, and ignores potential adverse health effects from whatever alternative material is used.