How safe is that IV bag?
How safe is that IV bag?
Campaign seeks to ban plastic IV bags
A new campaign is afoot, and it doesn’t involve politics. Plastic IV bags are the subject, and environmental and patient advocacy groups are at the forefront to have them eliminated.
Health Care Without Harm, the Falls Church, VA-based group that is spearheading the move, says the polyvinyl chloride (PVC) bags and tubing leach potentially harmful contaminants into the substances they hold. The contaminant at the center of this controversy is di-2-ethylhexyl-phthalate (DEHP) and is combined with hard plastics to form a substance that is clear, pliable, and ideal for use in plastic tubing and collapsible bags.
The problem, says Health Care Without Harm, is that trace amounts of DEHP can seep into the bag’s or tube’s contents, especially when the contents are similar to oil, as opposed to water-like qualities.
Studies show varying results
Various studies conducted on rodents (mice and rats) and primates, namely marmosets and rhesus monkeys, have shown different effects: Mice were more likely than rats to develop liver cancer. Rats, in turn, were more likely to suffer from testicular atrophy, while marmosets showed no ill effects at all when tested in the same fashion. Rhesus monkeys, on the other hand, were shown to develop slight, microscopic liver abnormalities that lasted up to several years. Although the effects on laboratory animals showed some damage, the finding is not straightforward. Rodents’ livers undergo different processes than those of humans, and therefore, results aren’t directly transferable.
To date, no study has been done to determine whether DEHP leaching from medical devices causes patients harm. The findings of a 1996 study showed that dialysis patients picked up one-eighth the amount of DEHP that proved safe in rodents. It is generally agreed that patients requiring kidney dialysis are at greatest risk as their blood is in repeated contact with the vinyl during the blood-cleansing process several times a week.
Women receiving the drugs Taxol and Taxotere for advanced breast or ovarian cancers are also at risk. Both drugs are oil-soluble, and therefore, more likely to draw out DEHP, and both medications come with a recommendation against administering them in PVC bags.
While the jury is still out as to the potential dangers of plastic IV bags, plastic alternatives aren’t perfect either. Some may cost up to twice as much as PVC bags (which sell for about 90 cents each) because they tend to melt at 250 F, the temperature at which IV fluids are sterilized, and therefore must be dosed with gamma radiation. Manufacturer B. Braun/McGraw of Sheffield, England claims to make a bag with the versatility of plastic but without the additional cost. Even so, some substances — blood in particular — benefit from the plastic IV bags. Blood, for example, absorbs small amounts of DEHP, which serves to keep cells pliable and less likely to break. This allows blood to be stored for up to 40 days — twice as long as with any other container.
For now, plastic IV bags are making the grade, but ultimately it’s up to the Food and Drug Administration to decide if they will continue to pass muster.
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