Your Sept. 10 story “FDA report won't end PVC product debate” (Page 1) misses the main point of the Food and Drug Administration assessment — that the majority of medical devices containing DEHP pose little or no health concerns.
The debate may not end, due to the determined stance of some groups on this issue, but the American Chemistry Council's Phthalate Esters Panel believes the FDA assessment strongly supports the continued use of DEHP in most medical devices. The panel wishes to underscore the following points:
First, the agency expressed little to no concern about the safety of medical devices containing DEHP in the majority of applications. Additionally, though not mentioned in your article, the agency rejected Health Care Without Harm's petition to require labeling of all medical devices containing DEHP and to expedite the development of alternatives to DEHP. This decision is consistent with the practical everyday experience by doctors who have saved millions of lives using medical devices containing DEHP.
Your article focused on the possible health effects of some of these medical devices used in very specialized applications. FDA noted that these theoretically derived instances involve a relatively small population. Your article failed to mention that these few areas of potential concern are based on effects observed in rodents. FDA clearly pointed out that, while these effects could theoretically occur in humans, there are no human data that show such effects. FDA also pointed out that additional factors, such as the benefits of the medical treatments, were not considered as part of its safety assessment.
FDA states that its safety assessment is a first step and that it will evaluate other factors, such as the availability and safety of alternatives to DEHP. As FDA notes in its letter to Health Care Without Harm, “Any device manufactured from an alternative material would be required to go through the same review process as a device containing PVC to establish its safety and effectiveness.”
That is how it should be. Alternative materials should be held to the same high standards of safety and performance as DEHP. The Phthalate Esters Panel will continue to research the safety of DEHP and supports all credible scientific research that helps clarify any areas of uncertainty.
DEHP has been used in consumer and medical products for more than 50 years with no validated instance of adverse health effects in children or adults.
Courtney M. Price
American Chemistry Council