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Phthalates are chemical esters that are added to many plastics to make them soft and flexible. They are found in cosmetics, toys, tools, packaging, and even toothbrushes. Di(2-ethylhexyl) phthalate (DEHP) is a plasticizer for polyvinyl chloride that is used in many medical devices and materials in health care settings: iv bags, iv tubing, nasal cannula tubing, blood bags, total parenteral nutrition bags, endotracheal tubes, iv catheters, urinary catheters, suction catheters, nasogastric tubing, syringes, and chest tubes.

 

At least one study that examined the association between levels of seven phthalate monoesters found in spot urine samples and pulmonary function measures in participants of the Third National Health and Nutrition Examination Survey has linked certain phthalate exposures to diminished levels of pulmonary function in men. However, in the same study, none of the subjects experienced diminished pulmonary function as a result of exposure to monoethylhexyl phthalate, a metabolite of DEHP.1 Because of concerns about DEHP leaching into the body as a result of exposure to medical devices, a risk assessment was conducted by a government-appointed "blue ribbon panel" of scientific experts in 1999.2 The panel concluded that DEHP is not harmful to even highly exposed persons (such as those undergoing regular hemodialysis) and further suggested that because DEHP is a critical element in many medical devices, more harm might be done by eliminating it.

 

A more recent safety assessment by the U.S. Food and Drug Administration expresses concern that certain medical procedures that lead to particularly high levels of exposure to phthalates may not be safe.3 Animal studies have suggested that exposure to very high levels of certain phthalates may have developmental and reproductive toxicity.4 Those most vulnerable to the effects of phthalates from medical equipment are neonates because of their small body mass and unusually high levels of exposure to products containing DEHP in neonatal ICUs. Newborns receiving intensive medical treatment at birth may be exposed to DEHP at levels that are toxic in rodent studies.4 Current recommendations support the use of DEHP-free products in caring for infants undergoing treatment on neonatal intensive care units whenever possible.5

 

Phthalate-free medical devices are increasingly available for use in hospitals. Visit the Health Care Without Harm Web site (http://www.noharm.org/us/pvcDehp/pvcFree) for more information.

 

REFERENCES

 

1. Hoppin JA, et al. Phthalate exposure and pulmonary function. Environ Health Perspect 2004;112(5):571-4. [Context Link]

 

2. Koop CE, et al. A scientific evaluation of health effects of two plasticizers used in medical devices and toys: a report from the American Council on Science and Health. MedGenMed 1999:E14. [Context Link]

 

3. Center for Devices and Radiological Health. Safety assessment of di(2-ethylhexyl)phthalate (DEHP) released from PVC medical devices. Rockville, MD: U.S. Food and Drug Administration; 2001 Sep 5. http://www.fda.gov/cdrh/ost/dehp-pvc.pdf. [Context Link]

 

4. Center for the Evaluation of Risks to Human Reproduction: National Toxicology Program. NTP-CERHR expert panel update on the reproductive and developmental toxicity of di(2-ethylhexyl)phthalate. Research Triangle Park, NC: U.S. Department of Health and Human Services; 2005 Nov. NTP-CERHR-DEHP-05. http://cerhr.niehs.nih.gov/chemicals/dehp/DEHP__Report_final.pdf. [Context Link]

 

5. Weuve J, et al. Exposure to phthalates in neonatal intensive care unit infants: urinary concentrations of monoesters and oxidative metabolites. Environ Health Perspect 2006;114(9):1424-31. [Context Link]