Still no solid evidence vinyl medical devices harmful
It seems contradictory, but a Health Canada report leaked to newspapers in late January prompted both alarmist head...
It seems contradictory, but a Health Canada report leaked to newspapers in late January prompted both alarmist headlines and sighs of relief from defenders of vinyl.
"We welcomed the Health Canada expert advisory council report," says Marion Axmith, director general of the Vinyl Council of Canada, a council of the Canadian Plastics Industry Association. "It provides additional confirmation of the safety of vinyl products containing DEHP." DEHP is used as a plasticizer in polyvinyl chloride (PVC).
Whether last week’s expert panel report and others that have been undertaken over the past few years damn or defend PVC really depends on which side of the vinyl debate you sit.
What the report actually says can be interpreted in two ways. On the one hand the panel found no direct evidence of toxicity to humans, but on the other hand, recommends alternatives be found because of the theoretical possibility of risk.
The report begins with these words: "There are essentially no data to confirm toxicity of DEHP or its metabolites in humans; indeed DEHP has been used in [vinyl] blood bags for several decades without reports of disease or unexplained "abnormalities" in humans."
The report goes on to explain that there are data relating to tests on animals that show reproductive and developmental toxicity. The panel concluded the animal data "must be taken to indicate at least the theoretical possibility of developmental and testicular toxicity, particularly in the young human with high exposure levels."
The report recommends, as a precaution, that alternate measures should be introduced as quickly as possible for certain instances; namely for infants and young children receiving transfusions and other procedures involving vinyl tubing containing DEHP. “These alternatives, however, must meet the same stringent health and safety standards as medical devices currently in use,” says Axmith.
Health Canada expects to release a risk assessment of vinyl medical devices very soon.
The Vinyl Council of Canada (VCC) and a U.S. chemical manufacturers group called the Phthalate Esters Panel played a pro-active role in providing information to Health Canada for its expert advisory panel.