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FDA says it will review the issue
All that noise about PVC IV bags was bound to catch someone’s attention. Lo and behold, it caught the attention of none other than the Food and Drug Administration (FDA).
An FDA spokeswoman recently told Home Infusion Therapy Management the FDA will examine the issue in the near future due to the recent commotion surrounding PVC IV bags and tubing and the potential danger of long-term exposure to DEHP. "We’ve been monitoring this issue for years," the spokeswoman said. "However, because of the recent questions that are again being raised, we are taking another look at it and doing a risk assessment."
Specific details about the FDA’s plans are not available at this time. The National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction plans to assemble a dozen or more scientists to evaluate such substances and their effects on human reproduction and child development. However, it is unclear whether this is part of the FDA’s "risk assessment" or if an entirely separate study will be conducted.
The main combatants in the latest battle over di (2ethylhexyl) phthalate (DEHP) were Chicago-based Baxter Healthcare Corp. and Health Care Without Harm (HCWH), a Falls Church, VA, coalition of 41 hospitals as well as other health, environmental, and social organizations.
According to Jackie Hunt Christensen, co-coordinator of HCWH, the issue at hand is to provide patients with the safest health care whenever possible. "This is not an all-or-nothing situation," says Christensen. "Our stance is that providers should avoid [products containing PVC] at all costs whenever possible."
HCWH has not addressed blood bags, for example, because no non-PVC bag is currently available in the United States. However, non-PVC bags and tubing are available for IVs, and these are the bags HCWH hopes health care providers will use in place of the PVC-containing counterparts.
While HCWH says the damaging effects of DEHP — the chemical that leaches from PVC bags and tubing into medication — have been demonstrated in peer-reviewed studies of premature infants, dialysis patients, and primates; other organizations say there is no such danger to humans. And the group that matters most — the FDA — says there has been no evidence in the past of a danger posed to humans, but that it is willing to reassess its current stance.
"Basically, we’re not aware of any problems for patients from the particular vinyl — the PVC — in these bags. We’re aware that there is some leaching that takes place; we’re pretty convinced that it does not present a problem to patients," the FDA spokeswoman told HITM.
For details on DEHP, go to Baxter’s Web site at www.baxter.com and HCWH’s site at www .noharm.com for studies and press releases detailing both sides of this complicated matter.