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You Better Watch Out

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI August 1999 Column


The presence of a former U.S. Surgeon General adds some weight to a group discounting claims that plasticized PVCs are dangerous to your health.

In this column published around Christmas time last year, I quoted a member of a chemical manufacturers' group who was commenting on the decision of prominent toy stores to pull plasticized vinyl toys from the shelves. Although of the firm belief that the plasticizers were "completely harmless," the gentleman nevertheless predicted that the medical industry would inevitably succumb to public and legal pressures and "go the way toys go."

Well, Christmas may have come early in 1999 for the vinyl industry, for the manufacturers that depend on the availability of plasticized PVC to make a wide range of devices, and for the patients who use those products. And the ubiquitous, bewhiskered public figure bearing good cheer and a NOEL (no-observed-effect level) blessing is not Santa Claus but the former U.S. Surgeon General, C. Everett Koop.

Koop is the chairman of a panel of leading physicians and scientists that conducted a comprehensive review of the scientific literature concerning di(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), two chemicals used as plasticizers in flexible vinyl products. The 17-member panel was convened by the American Council on Science and Health (ACSH; New York City) last February in response to ongoing questions about the safety of DEHP and DINP. The group examined a variety of data—including primary and secondary scientific literature; risk assessments prepared by regulators in the U.S., Canada, and Europe; and scientific manuscripts still in preparation—and issued a final report on its findings. (The full report, "A Scientific Evaluation of Health Effects of Two Plasticizers Used in Medical Devices and Toys," and a complete list of panel members can be found at, with an executive summary available at

The conclusions in the report, according to Koop, are unambiguous: "Consumers can be confident that vinyl toys and medical devices are safe. The panel's findings confirm what the U.S. Food and Drug Administration and the Consumer Product Safety Commission have been saying about these products all along. There is no scientific evidence that they are harmful to children or adults."

The certainty expressed in Koop's pronouncement should come as no surprise. Serious scientists have long recognized, as the report states, that for DEHP—the phthalate used in medical devices—"results in rats and mice, in whom many of the [harmful] effects have been observed, are not appropriate for human risk assessment." In fact, the panel concludes, DEHP "is not harmful to even highly exposed people, those who undergo certain medical procedures such as regular hemodialysis or extracorporeal membrane oxygenation."

What is unusual, however, is the extent to which the panel emphasizes the beneficial characteristics of DEHP, and the forcefulness with which these sentiments are expressed in the report. For example, attributes imparted by DEHP to flexible tubing include "minimum interference to patient movement," the "strength to resist permanent deformation," the "ability to resist kinks that may impede or block fluid flow," and the "ability to withstand pressure infusion," among several others. These properties "are often critical in life-saving and medical intervention measures," and eliminating DEHP "could cause harm to some individuals." Any materials proposed as alternatives to DEHP or flexible PVC would have to be evaluated in terms of equivalent "patient safety, functional effectiveness, cost-efficiency, and regulatory compliance."

Such language represents an aggressive counterattack to the claims of "environmental groups" and others that their attempts to ban DEHP are in the interest of public safety. It appears as if Dr. Koop is making a list, checking it twice, and shouldering a sack of coal destined for the proponents of junk science.

Jon Katz

Copyright ©1999 Medical Device & Diagnostic Industry
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