A key Canadian health advisory panel wants the medical device industry to scale back its use of a controversial phthalate common in PVC medical tubing and bags, saying that it could be dangerous for children and adults receiving high-dose medical treatments during procedures such as heart operations and hemodialysis.
The recommendations, released Jan. 24 by Health Canada, urge much stronger action to reduce use of di(2-ethylhexyl) phthalate than what was advocated in a Food and Drug Administration report in September. The panel, appointed by HC, said the risk to healthy adults is small, but it recommended a precautionary approach.
Health Canada, roughly equivalent to the FDA, is expected to adopt most of the recommendations, said Robin Walker, chairman of the panel and chief of the neonatal unit at the Children's Hospital of Eastern Ontario, in Ottawa.
An HC spokesman said the agency will give the panel's conclusions serious weight, and noted that ``the recommendations from the panel are precautionary and are based on animal studies.'' HC will make a decision by summer.
At deadline, industry officials said they still were digesting the report and declined comment.
The HC report suggests interpretation of the animal studies is key. The panel said there is very little data on human risks, but much relevant animal data suggests people could suffer developmental and reproductive harm from DEHP. The panel said alternatives have to be at least as safe as DEHP.
``Where science is borderline, there is a lot of room for interpretation,'' Walker said. ``There are a lot who would say, `If you don't have proof of human harm, you don't regulate.'
``We take the position, if you don't have proof of human harm - but you have good evidence from animal studies that it is a possibility, and you have highly exposed population - they deserve the precaution of reduced exposure,'' he said.
Specifically, the report said DEHP should not be used in newborns and males before puberty undergoing high-exposure procedures like cardiac surgery, total parenteral nutrition therapy and some transfusions.
The panel also does not want DEHP used for adults undergoing heart operations and hemodialysis, and in procedures involving pregnant and lactating women. And the panel wants labels saying a product contains DEHP.
But the report also said that DEHP should continue to be used in blood-bag storage because it extends the shelf life of blood.
The panel included one person nominated by the plastics industry, Ron Brecher, a toxicologist who also sat on an earlier review chaired by former Surgeon General C. Everett Koop. The Koop report pronounced DEHP completely safe.
Brecher said the two panels ``were doing different things.''
``I don't think anywhere in the Health Canada report does it say these products cause harm,'' he added.
Brecher referred additional questions to Walker, who said all the members of the HC panel agreed with its report.