WASHINGTON - A chemical used to soften such plastic items as medical tubing and blood bags could harm young children, according to a Food and Drug Administration (news - web sites) safety assessment released Wednesday.
``We are being specific here, suggesting to clinicians and the users of these devices that they consider devices that are made of alternate materials,'' in treating some patients, particularly male infants, said Donald Marlowe, director of FDA's office of science and technology.
The chemical, called DEHP, can leach from the plastic into liquids and has been shown to harm experimental animals, including affecting the development of the testicles and the production of normal sperm in young animals.
As a result, the FDA launched a safety assessment to see whether the chemical would have the same effect on humans and to establish what it called a ``tolerable intake'' for DEHP.
In its report, the agency concluded that for most adult patients the amount of chemical absorbed is too small to be of concern.
But it said that newborns in intensive care could face exposure from multiple sources, such as intravenous administration of medicine, blood transfusions and even feeding tubes.
That could result in exposure to between 5 and 20 times the tolerable dose, the agency said.
Alternate products that do not contain DEHP are available, though they cost more, Marlowe explained.
He said physicians treating patients ``have to decide about the risk to the patient that they have, and consider alternate materials.''
In theory, the report said, infants of nursing mothers undergoing dialysis treatments could receive large doses of DEHP, but their exact dose is unknown.
Some adults, particularly those receiving large amounts of blood such as trauma cases, could also receive relatively high DEHP doses over a short period, the assessment said.
And it said adults undergoing cardiopulmonary bypass could equal or exceed the tolerable dose. However, in many of those cases heparin-coated tubing is used, which leaches little DEHP, the agency noted.
The report was released as the agency responded to a petition seeking warning labels on all plastic devices containing DEHP.
The agency rejected that proposal, contending that such labels are not needed because of the low hazard level for most patients.
However, the FDA added that because certain materials may pose a higher risk it will consider requiring labels in those cases.
Marlowe said the first items to considered for possible labeling are those most likely to be used on infants.
What is DEHP and how is it used?
DEHP, also known as di-(2-ethylhexyl)phthalate, is a compound used as a plasticizer (softener) in many products made of polyvinyl chloride (PVC) plastic, including some medical devices. Among these are:
IV bags and tubing Dialysis tubing Blood bags and tubing Heart bypass machine tubing Nasogastric feeding tubes Respiratory tubing
Why are there health concerns regarding DEHP?
Exposure to DEHP has produced a range of adverse effects in experimental animals, but those of greatest concern involve effects on the development of the testicles and the production of normal sperm in young animals.
Is there evidence that these effects occur in humans?
It is possible that the effects observed in animal studies could occur in humans. However, there are no human studies to date that show such effects. DEHP-containing devices have been used on newborn babies for many years without apparent ill effects, although studies have not been conducted which would rule out effects on humans.
If these effects occur in humans, which patients would be at most risk?
The FDA believes the greatest concern would be for very young male infants who are critically ill and have prolonged exposure to multiple devices containing DEHP. The National Toxicology Program, a component of the National Institutes of Health, has recently reached a similar conclusion. In contrast, there is little concern for adults receiving intravenous solutions or undergoing peritoneal dialysis.
What has been done to date to assess the potential risk?
FDA has examined the potential risks posed by patient exposure to DEHP by comparing the doses of this compound that patients may receive to a Tolerable Intake (TI) value for DEHP. A TI value is the dose of a compound that is not expected to produce adverse effects in exposed patients. For more information on how the safety assessment for DEHP was performed, as well as the potential risks of exposure to DEHP from various procedures, see the document at http://www.fda.gov/cdrh/ost/dehp-pvc.pdf or http://www.fda.gov/cdrh/ost/dehp-pvc.doc
What is the next step?
FDA will communicate the availability of its safety assessment to health care providers across the country. FDA is also evaluating ways to address the potential risks that may be associated with use of DEHP-containing devices in certain procedures. For example, FDA is investigating the availability of medical devices made from alternatives to DEHP-containing PVC plastics, particularly for procedures performed on newborn boys. The agency will continue to make new information available on this website.
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