Fw: FDA Finds Unsafe Levels of Phthalates Leaching From Some PVC Medical Devices

[Guest guest]

From: " ilena rose " <ilena@...>

Sent: Wednesday, September 05, 2001 11:34 AM

Subject: FDA Finds Unsafe Levels of Phthalates Leaching From Some PVC

Medical Devices

> Interesting article just posted on the newsgroup.

>

> The breast implant issue, unfortunately, shares the same highly paid

Public

> Relations opponents who have been claiming for years the " safety " of

> phthalates. Here are some of their false " assurances. "

>

> http://www.acsh.org/press/releases/vinyltoys062199.html

> http://www.acsh.org/press/releases/Phthalates111398.html

> http://www.koop.com/news/focus/june/phthalate.html

> http://www.junkscience.com/nov98/coalert.htm

> http://www.junkscience.com/nov98/dinp.htm

>

> Here is what PR Watch wrote on this in 1998.

>

> http://www.prwatch.org/prwissues/1998Q4/dogs.html

>

>

> FDA Finds Unsafe Levels of Phthalates Leaching From Some PVC Medical

Devices

>

>

> Health Care Without Harm Calls on Health Care Providers to Take Action To

>

> Limit Patients' Exposure

>

> MINNEAPOLIS, Sept. 5 /PRNewswire/ -- Today the U.S. Food and Drug

> Administration (FDA) warned that some medical products made from polyvinyl

> chloride (PVC) may expose patients to unsafe amounts of the toxic chemical

> di-2-ethylhexyl-phthalate (DEHP). The agency released the findings in its

> long-awaited safety assessment on DEHP, which is used to soften PVC

medical

> devices such as bags and tubing used to administer fluids, medication,

blood,

> oxygen, and nutritional formulas to patients.

>

> The FDA's scientific assessment found that DEHP may not be safe for

infants,

> children and adults receiving certain medical treatments that involve PVC

> medical devices. The FDA expressed concern for adults and infants

undergoing

> Extracorporeal Membrane Oxygenation (ECMO), infants undergoing exchange

> transfusions, adults undergoing cardiopulmonary bypass, all patients

receiving

> enteral nutrition, nursing infants of mothers on hemodialysis, and infants

> receiving Total Parenteral Nutrition (TPN).

>

> " The FDA today confirmed that some PVC medical devices pose a safety

hazard to

> the most vulnerable medical patients. This should be considered

unacceptable

> because it is avoidable, " said Charlotte Brody, RN, Coordinator of Health

Care

> Without Harm (HCWH). " The FDA has taken a first step toward protecting

sick

> infants and seriously ill adults. Now health care providers need to turn

the

> FDA's assessment into a plan of action that eliminates the unnecessary

threat

> of DEHP leaching from PVC products. "

>

> " The FDA concluded that children undergoing certain medical procedures are

at

> increased risk of harmful effects from DEHP, " explained Ted Schettler, MD,

> Science Director of the Science and Environmental Health Network, a HCWH

member

> organization. " The FDA's finding was based on evaluation of a number of

> studies that show that infants in neonatal intensive care units are likely

to

> be exposed to unsafe amounts of DEHP from multiple PVC medical products.

But

> their concern doesn't end there. The FDA also noted that the levels of

DEHP in

> the breast milk of healthy mothers approach the safety limit for nursing

> newborns. We need to reduce exposures to DEHP, particularly for pregnant

women

> and their developing children, wherever possible " .

>

> The FDA joins other governmental agencies in the United States and abroad

in

> expressing concern about the risks posed by PVC medical devices that leach

> DEHP. In October 2000, the National Toxicology Program Center for the

> Evaluation of Risk to Human Reproduction's expert panel report expressed

> " serious concern " that exposure to DEHP may adversely affect male

reproductive

> tract development in critically ill infants and " concern " over the levels

of

> DEHP exposure to pregnant women, breast-feeding mothers and healthy

infants and

> toddlers.

>

> In July, the Swedish Chemical Inspectorate, acting on behalf of the

European

> Union, reported that people " are exposed to DEHP during their entire

lifetime,

> via the environment, consumer products and medical equipment " and that

there is

> a need to institute additional risk reduction measures now.

>

> Health Care Without Harm is an international coalition of 333

organizations in

> 33 countries working to transform the health care industry so it is no

longer a

> source of environmental harm. For the full FDA report, go to

> http://www.fda.gov , click on " More News " and then " Center for Devices and

> Radiological Health. "

>

> MAKE YOUR OPINION COUNT - Click Here

>

> http://tbutton.prnewswire.com/prn/11690X54421243

>

> SOURCE Health Care Without Harm

>

> CO: Health Care Without Harm; U.S. Food and Drug Administration

>

>

>