Plasticizer an unacceptable risk for some patients, Health Canada told
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* Barbara Sibbald

A Health Canada expert advisory panel recommends banning the use of medical devices containing DEHP (di-2-ethylhexyl-phthalate) in newborns, prepubertal males and patients receiving intensive intravenous therapies.

DEHP, a plasticizer used to soften the polyvinyl chloride used in IV bags, tubing and other devices, has been linked in animal studies to reproductive problems, particularly a decline in sperm production (see *CMAJ* 1998;159 [3]: 261-2). DEHP and other products such as pesticides and heavy metals have been linked with modulation of the endocrine system. It is not yet known whether small amounts of the chemicals 

The expert panel also expressed concern about the possible toxic effects of DEHP exposure during cardiopulmonary bypass, hemodialysis and similar procedures.

The panel's final report states that infants receiving neonatal intensive care may receive 20 times the exposure to DEHP considered tolerable by the US Food and Drug Administration (FDA). The report recommends using alternative products for patients at “greatest risk” and calls for the labelling of all devices containing DEHP. 

Rich Whate, spokesperson for Health Care Without Harm (HCWH), describes the panel's recommendations as “the strongest call for action on DEHP yet.” HCWH, an international coalition of 350 organizations, disagrees with Health Canada's stance to date on the strength of the evidence against DEHP. Still, Health Canada plans to develop a position statement by this summer that may provide a basis for legislation or guidelines. 

A recent FDA report on DEHP-containing medical devices doesn't go as far as the Canadian panel in its recommendations. It states that critically ill male babies and some other patients should not be exposed to DEHP. — *Barbara Sibbald*, CMAJ