Toxic Agent Found in Treated Newborns Is Linked to Plastic

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Toxic Agent Found in Treated Newborns Is Linked to Plastic

By Jane Kay

The San Francisco Chronicle

 

Bay Area hospitals pressuring suppliers for safer products.

 

Researchers have found a plastic-softening chemical used in some

medical devices in the systems of newborn babies getting treatment in

intensive-care units at high enough levels to drive hospitals to seek

safe alternatives.

 

The new study, which appeared Wednesday in the online edition of

the journal Environmental Health Perspectives, is the first to

directly link the greater use of intravenous tubes and other devices

containing the chemical, phthalates, to higher levels of the chemical

in babies' urine.

 

There are no data that show adverse health effects from phthalates

exposure to newborns, but California health officials consider the

chemical both a carcinogen and a toxicant that causes reproductive

harm. Dozens of studies have shown that phthalates, or DEHP, produce

developmental and reproductive system damage in laboratory animals.

 

The study was conducted by scientists in the Harvard School of

Public Health who worked with two Harvard-affiliated hospitals and the

U.S. Centers for Disease Control.

 

The researchers analyzed the urine of 54 babies over three days in

two Boston hospitals. In the urine of infants who had been exposed to

devices containing the highest amounts of phthalates, researchers

found traces of the chemical at average levels more than 17 times

greater than average levels in the general population of 6- to

11-year-olds.

 

The babies exposed to the products containing the lowest amount of

phthalates had levels comparable to the national average in children,

the study found.

 

The authors stress that the life-saving medical devices must be

used where there are no DEHP-free alternatives.

 

However, " our study shows that the shedding of the phthalates is

clearly resulting in a dose to the infants, " said Dr. Howard Hu,

professor of occupational and environmental medicine at the Harvard's

School of Public Health and Medical School and a physician in the

neonatology unit at Massachusetts General Hospital.

 

" When you put our study together with animal studies and recent

studies in humans, there is justification for considering causation

and looking for potential substitutes to the DEHP products, " Hu said.

 

DEHP is widely used to soften the rigid polymer PVC, or polyvinyl

chloride, in dozens of medical devices, including intravenous bags,

blood bags, catheters and other tubing. But devices containing the

chemical are beginning to disappear from newborns' intensive care units.

 

Kaiser Permanente, Alta Bates Summit Medical Center, Catholic

Healthcare West and the John Muir Medical Center in Walnut Creek,

among others, already are buying mostly DEHP-free plastic devices, and

pressuring manufacturers and suppliers to produce safe alternatives,

according to representatives.

 

In addition, the American Academy of Pediatrics and the California

Medical Association have recommended against using medical devices

containing DEHP. In 2002, the U.S. Food and Drug Administration issued

a formal public- health notification, informing doctors, nurses and

hospitals about a possible hazard to certain patients from devices

containing DEHP. The FDA, however, hasn't prohibited use of the chemical.

 

California's Office of Environmental Health Hazard Assessment is

beginning a second public-comment period on a proposed regulation

setting a numerical maximum level for DEHP. When the regulation is

approved, any plastic tubing or other medical device that exceeds that

limit would trigger enforcement action under the anti-toxics

Proposition 65.

 

Stacy Malkan, a spokeswoman for Health Care Without Harm, a

coalition of health and environmental groups, said most of the

progress in ridding products of phthalates has been driven by the FDA

notification and pressure from hospitals.

 

Kaiser Permanente, with 412 intensive-care beds for newborns in 28

California hospitals, has been a leader in trying to eliminate the

chemical.

 

" It's out of IV bags and tubing and out of catheters and feeding

tubes, " said Lynn Garske, Kaiser environmental stewardship manager.

Sometimes, though, DEHP is still in blood bags from its vendors, she said.

 

At Catholic Healthcare West in San Francisco, which is sponsored

by seven religious orders, Dominican Sister Mary Ellen Leciejewski

hopes to have all 40 hospitals - 38 in California - free of DEHP in IV

bags by 2006.

 

" If there are alternatives for other products, we'll use them, "

she said. Finding the alternatives is " no small task, " she said, " but

the detrimental impacts warrant whatever effort is necessary. "

 

Alison Brooks, a clinical nurse specialist at Alta Bates Summit

Medical Center in Berkeley, said she serves on a pediatric council

that guides the hospital's group-purchasing organization. Through that

and the hospital's internal committee, the products used to treat

1,200 newborns a year in the 55- bed newborn unit don't contain DEPH,

Brooks said.

 

" The vendors are on the bandwagon, saying, 'You don't have to

worry. We're DEHP-free,' " she said.