By: Louis Pilla
Drawing "dubious conclusions"
The debate over the use of polyvinyl chloride (PVC) I.V. bags ratched up a notch recently when an advocacy group petitioned the Food and Drug Administration (FDA) to warn patients and healthcare providers about potential health risks from this widely used chemical.
At the same time, a major medical technology association expressed concerns over "relentless efforts" to misrepresent the safety of devices that use PVC.
On June 15, Health Care Without Harm (HCWH), a Falls Church, VA-based coalition of some 180 health, religious, labor, and environmental organizations, said it asked the FDA to require warning labels on PVC medical devices that leach plasticizers, as well as requesting other actions. The plasticizer DEHP, or di-ethylhexyl phthalates, is the softener used in PVC products, and is the chemical at the center of the PVC controversy.
The request followed the release of a report commissioned by HCWH that is said to confirm leaching by DEHP. The leaching, according to HCWM, can potentially cause damage to the heart, liver, ovaries, testes, lungs, and kidneys, and interfere with sperm production. The report, said to evaluate more than 100 studies on DEHP, was released by the University of Massachusetts' Lowell Center for Sustainable Production.
DEHP can be released when a PVC medical device is heated or when then the device comes in contact with such things as blood, drugs, saline, or water, according to a summary of the Lowell report.
"Current FDA regulations make no sense," said Charlotte Brody, RN and Co-Coordinator of HCWH, quoted in a statement from the group. According to the statement, the FDA has not set any limits on plasticizer leaching from medical devices, but the agency does restrict the amount of plasticizer to 30% of the weight of food containers. PVC I.V. bags, blood bags, and tubing all contain more than 30% DEHP by weight, according to HCHW.
"Why should plastic food containers be regulated more strictly than plastic medical products?" Brody is quoted as saying. "And why should the FDA warn cancer patients of DEHP leaching with certain medications, but not infants or hemophiliacs, who may be even more exposed?" Those medications include the chemotherapy drugs Taxol and Taxotere, according to the HCWH statement.
"Humans are exposed to substantial levels of DEHP through medical devices" said Joel Tickner, the primary author of the Lowell DEHP report, quoted by HCHW. "Given this exposure, along with other health and environmental concerns of PVC, it's important to investigate alternative materials for medical purposes."
The purpose of the petition is to "ask the FDA to be our ally in making the provision of heathcare safer," said Brody in an interview with Hospitalnetwork.com. The current situation, she said, "puts nurses into a position where they might question their current practice but they don't have a resource on the floor to change it."
Brody indicated that the problem does have limits. She said that there is no reason to believe that a small amount of DEHP from a single I.V. bag is causing a problem. But, she said, a lot of people in society "are getting extraordinary exposure to DEHP." This includes, she said, dialysis patients and children on tube feedings. HCWH, she said, was not suggesting a ban but an "orderly phaseout" where there is likely to be the kind of exposure to DEHP that is higher than what a chemotherapy patient getting Taxol and Taxotere receives.
Specifically, HCWH called on the FDA to take the following actions:
- Require all PVC medical devices that may leach plasticizers to include a warning label and additional information on the potential health risks caused by DEHP leaching and FDA-approved alternatives.
- Warn pregnant women, infants, hemophiliacs, dialysis patients, and others receiving long-term intravenous or tube-feeding treatment that they're more likely to receive high doses of DEHP.
- Expedite the development of safer, PVC-free alternatives to all PVC medical devices that leach plasticizers.
The FDA has 90 days to respond to the petition, in the form of a letter to the petitioner.
Drawing "dubious conclusions"
Not all parties, however, are convinced of the harm from DEHP. On the same day as the release of the FDA petition, the Health Industry Manufacturers Association (HIMA) issued a strong statement expressing concern that patients and physicians are being misinformed about PVC and DEHP in medical devices.
"The best science to date demonstrates that any safety allegations concerning patient exposure to PVC- and DEHP-containing medical products are unfounded," the statement says. Noting that all materials, including glass and metal, leach from containers, the statement notes that experts agree that the evidence to date reveals that DEHP is safe for use in vinyl-based medical devices. In more than four decades of use, the trade group holds, there have been no reports of significant adverse health effects in patients, even those with acute and chronic exposure to DEHP.
"Healthcare Without Harm," the statement says, "has drawn dubious conclusions and ignored the most relevant science in its campaign to eliminate PVC." Washington, DC-based HIMA says that it represents more than 800 manufacturers of medical devices, products, and systems.
The Environmental Protection Agency (EPA) has classified DEHP as a probable human carcinogen. But, Baxter International (Deerfield, IL), one of the nation's leading manufacturers of I.V. bags, contends that the 1982 study that led to that classification is opposed to more recent studies that indicated that DEHP is unlikely to produce liver cancer in humans.
Saying she was troubled by the HIMA statement, Brody noted that HCWH isn't saying that DEHP is certainly dangerous in every application, but that it's dangerous to say it's certainly safe.
The FDA petition follows decisions by various organizations to review or reduce their use of PVC bags. Earlier this year, for example, Baxter reached an agreement with a shareholder group that could lead to the eventual phaseout of PVC from its bags. In May, Universal Health Services, a large hospital management company, annonced that it will seek to replace PVC medical supplies with other alternatives, according to HCWH.
In February, the American Nurses Association (ANA), a member of HCWH, issued an alert about the risks posed by DEHP to seriously ill patients. "We must," said ANA President Beverly Malone, PhD, RN, FAAN, "ensure that our patients' already compromised body systems aren't further harmed by avoidable contact with DEHP."
HCWH's Brody encouraged nurses to approach nursing administration about non-PVC alternatives and encourage the administration to phase out their use.
As for alternatives to PVC, several U.S. and European manufacturers are said to offer PVC-free alternatives for I.V. bags, the Lowell report says. B. Braun McGaw has been quoted as saying it is the only U.S. marketer of I.V. bags made of non-PVC material.