A study released this week by scientists at Harvard University (Cambridge, Massachusetts) reports that babies in hospital neonatal intensive care units (NICUs) receiving intensive therapy with polyvinyl chloride- (PVC) softened medical devices were exposed to a toxic phthalate at very high levels – an average of 25 times higher than the general population and up to 50 times higher for the most exposed.

As their medical treatments intensified, the sick infants were exposed to progressively higher exposures of di(2-ethylhexyl) phthalate (DEHP), according to the study.

DEHP is described by the researchers as “a toxicant that alters development of the male reproductive system in laboratory animal studies.” The phthalate is used to soften PVC (vinyl) plastic medical devices such as IV bags and tubing, with various studies already having demonstrated that it leaches out of the plastic and into the human body.

The study looked at neonates in two Level III hospital NICUs in Boston – those institutions not named, except for being described as “A” and “B” – for a period of three days in March and April of 2003. It specifically examined urinary levels of mono(2-ethylhexy) phthalate (MEHP), a metabolite of DEHP.

The study concludes that “the use of DEHP-containing medical devices is associated with a monotonic increase in urinary levels of MEHP . . . In particular, urinary MEHP levels among infants in the ‘high’ DEHP exposure group were five times as high as those in the low DEHP exposure group, after adjustment for infants’ sex and institution of care. Urinary MEHP levels among infants in the ‘medium’ DEHP exposure group were twice as high as levels among infants in the ‘low’ DEHP exposure group.”

It concluded that the study data are “generalizable to infants of other Level III NICUs.”

Importantly, however, the researchers wrote that they had no knowledge of data “on whether such exposures are associated with adverse health effects in these neonates” and that only “limited data describe the effects of neonatal exposures on health later in life.”

While the health risks of using DEHP-containing medical equipment is still under debate, the FDA warned healthcare providers concerning the potential effects of these devices, especially noting the risk to certain vulnerable patients – including male infants.

An organization that is convinced of the potential harm is Health Care Without Harm (HCWH; Washington), a healthcare watchdog group that has targeted, among other issues, the potential harm of DEHP, mercury in medical devices and poor medical waste disposal practices.

Stacy Malkam, communications director for HCWH, told Medical Device Daily that while the study did not look at the risks of disease, these risks have been demonstrated in a variety of other studies, primarily in animals. And she said an easy extrapolation suggests ongoing health risks “the higher the exposure.”

She pointed to the FDA’s public notification about possible risks and said that HCWH will continue to address the hospital/manufacturing communities on the issue.

“We hope that the manufacturers will pay attention to what their customers want and switching out [to non-DEHP products] wherever they can. We hope the manufacturers will be responsive and make alternatives where they can and make them more cost effective.”

Anna Gilmore Hall, RN, executive director of HCWH, said there is “no reason to dose sick babies with toxic phthalates when safer medical devices are available. We urge hospitals to switch to PVC-free, DEHP-free medical devices immediately.”

The peer-reviewed study, published in Environmental Health Perspectives, also contained some good news, she noted, in its findings of significantly lower phthalate levels in the babies who received care at the hospital that had switched to DEHP-free medical devices for some applications.

“When healthcare providers switch to safer non-vinyl medical devices, they are protecting their littlest patients from unnecessary toxic exposures,” Gilmore Hall said. Bill Ravenesi, campaign director of HCWH and member of Alliance for a Healthy Tomorrow (Boston), called the study results “alarming” and said that it supports “urgency to the need to pass the Safer Alternatives bill that is currently before the [Massachusetts] state legislature.” Healthy Tomorrow is a coalition that is sponsoring the bill moving to public hearing this month before the Massachusetts Joint Environment and Natural Resources Committee.

The Safer Alternative Bill – H.1286 - S.553 – would mandate a process to evaluate alternatives to DEHP and nine other toxic chemicals in common household products and replace them with safer alternatives.

One of the companies that has made a point of avoiding the DEHP materials, where possible, in its IV bags is B. Braun Medical (Bethlehem, Pennsylvania). It has reported that it adopted this policy in the 1980s, largely due to the possible harm, based on animal study data. (MDD, Feb. 13, 2003).

Late last year, hospital products manufacturer Hospira (Lake Forest, Illinois), said that it would add more than 40 new infusion therapy medication delivery sets to its offering of non-DEHP flexible medical devices by early 2005. It said the move would increase its non-DEHP portfolio by 50% from the previous two years (MDD, Sept. 27, 2004).

It also reported launch of new non-DEHP sets in its medication delivery line, bringing that offering to about 80 non-DEHP products.