ANA on Baxter phase-out of PVC i.v. bagtubes

["C" <thclax00@UKCC.uky.edu> (by way of ttweed@wildrockies.org (Tony Tweedale))]

                           IV Bags Pose Patient Risk


 American Nurses Association 600 Maryland Avenue, S.W., Suite 100-West
 Washington, DC 20024-2571

 EMBARGOED FOR RELEASE UNTIL: February 23, 1999, 9 a.m. ET

 CONTACT: Michael Stewart, 202-651-7048, or Sara Foer, 202-651-7023;
 RealNews@ana.org ; website: http://www.nursingworld.org/RNRealNews

 ANA WARNS THAT IV BAGS POSE PATIENT RISK

 WASHINGTON, D.C. ã Today, the American Nurses Association (ANA) joined with
 other members of Health Care Without Harm, a coalition campaign for
 environmentally responsible health care, to alert Americans of the newly
 recognized risks posed to seriously ill patients by certain chemical additives
 used in the manufacture of plastic intravenous IV bags and tubing. Called
 phthalates, the chemicals are added to make stiff PVC plastic more flexible.
 The additives were widely publicized just before the 1998 winter holiday
 shopping rush as being present in flexible plastic children's toys. Registered
 nurses warn that phthalates are being delivered directly into the bloodstreams
 of very ill patients.

 In a statement today, Beverly L. Malone, PhD, RN, FAAN, president of the
 American Nurses Association, said, "As the health care professions' premier
 patient advocates, registered nurses are stepping forward to inform the public
 of this threat. In health care, where the primary dictum is úFirst, do no
 harm,' it is both appropriate and imperative that registered nurses take such
 a stand. This is a quality of care issue for the nation."

 DEHP (di-2-ethylhexyl phthalate), the chemical added to PVC IV bags and
 tubing, has been identified by the United States Environmental Protection
 Agency as a probable human carcinogen. Scientific studies have shown that it
 also may damage the heart, liver, testes, and kidneys, as well as interfere
 with sperm production. The printed materials included with some flexible
 plastic health care equipment caution against the use of these containers to
 administer medications to nursing mothers, alert users that safety in
 pediatric care has not been established, and note that studies with solutions
 from these containers have not been performed to evaluate carcinogenic and
 mutagenic potentials or effects on fertility.

 The health risks associated with DEHP's leaching from PVC add to the
 significant risks posed by PVC's manufacture and disposal. Both the
 manufacturing and disposal of PVC produce highly toxic and
 endocrine-disrupting dioxins. PVC is the only plastic linked both to phthalate
 leaching and to the production of dioxin.

 Alternative IV bags and tubing made of PVC-free and DEHP-free materials exist.
 The safer equipment is already available in Europe, and, in the U.S., PVC-free
 IV bags can be found. However, the ANA and Health Care Without Harm report
 that, due to current health care equipment manufacturing and procurement
 practices in the U.S., the desirable equipment will become generally available
 here only when it is demanded by health care professionals, health care
 institutions, patients, and their families.

 "We must ensure that our patients' already-compromised body systems are not
 further harmed by avoidable contact with DEHP," says Malone. "We also take a
 stand for the public health of our communities -- to end the toxic pollution
 caused by PVC-related dioxin."

 # # # The text of this release, Dr. Malone's statement, and other ANA
 materials related to the provision of nursing care without harm to individual
 patients or to the public health environment are available in electronic
 format at http://www.nursingworld.org/RNnoharm. Health Care Without Harm may
 be contacted at: tel: (703) 237-2249, fax: (703) 237-8389, e-mail:
 noharm@iatp.org, website: http://www.noharm.org.

 # # #

 The American Nurses Association is the only full-service professional
 organization representing the nation's 2.6 million Registered Nurses through
 its 53 constituent associations. ANA advances the nursing profession by
 fostering high standards of nursing practice, promoting the economic and
 general welfare of nurses in the workplace, projecting a positive and
 realistic view of nursing, and by lobbying the Congress and regulatory
 agencies on health care issues affecting nurses and the public.



              IV Products Manufacturer to Phase Out Vinyl IV Bags

 American Nurses Association
 600 Maryland Avenue, S.W., Suite 100-West
 Washington, DC 20024-2571

 FOR IMMEDIATE RELEASE April 6, 1999

 CONTACTS: Michael Stewart, 202-651-7048
 Michelle Slattery, 202-651-7027
 e-mail: RN=RealNews@ana.org
 webpage: www.nursingworld.org/rnrealnews/

 Responding to Public Concern, Nation's Largest IV Products Manufacturer to
 Phase Out Vinyl IV Bags

 WASHINGTON, DC -- The nation's leading producer of intravenous (IV) bags,
 Baxter International Inc., today announced a commitment to develop
 alternatives to polyvinyl chloride or PVC for their products, including IV
 bags.

 More than 500 million IV bags are used in the United States every year to
 deliver blood, medication and other essential fluids to sick and injured
 patients. Eighty percent of these are made of PVC. These vinyl IV bags have
 been shown to leach the toxic chemical di-ethylhexyl phthalates (DEHP) into
 the solutions they contain.

 The announcement comes in the wake of mounting public pressure to eliminate
 patients' needless exposure to dangerous chemicals such as DEHP when safe,
 cost-competitive alternatives exist. The company negotiated with public health
 advocates from the Interfaith Center on Corporate Responsibility, a faith
 based North American coalition, and Health Care Without Harm (HCWH), an
 international campaign of 41 hospitals and more than 130 other health and
 environmental organizations, including the American Nurses Association.

 The health risks associated with vinyl IV bags recently garnered international
 attention when HCWH launched a highly visible public education campaign around
 this issue.

 Plastic PVC products require a softener to make them flexible, which is why
 they are manufactured with DEHP. DEHP, shown to leach out of the vinyl IV
 bags, has been classified by the EPA as a probable human carcinogen. Studies
 have shown that DEHP can damage the heart, liver, testes and kidneys and
 interfere with sperm production.

 "The medical ethic is 'first, do no harm,'" said Charlotte Brody, R.N.,
 Co-Coordinator of HCWH, and a member of the South Carolina Nurses Association.
 "We applaud Baxter's decision to reduce the risk of harm by removing PVC from
 IV bags."

 In addition to disclosing the susceptibility of patients to DEHP exposure, the
 coalition noted that vinyl IV bags also have a high chlorine content.
 Consequently, vinyl manufacturing and disposal by incineration create dioxin
 -- one of the world's most toxic chemicals.

 "I welcome Baxter's initiative. I think it is appropriate that a medical
 device manufacturer should use the precautionary approach to avoid the
 problems of PVC given the availability of alternatives. I plan on watching
 closely how it develops in practice over the next several years," said Dr.
 Peter Orris, Professor of Preventive and Internal Medicine at the University
 of Illinois School of Public Health. Dr. Orris is the American Public Health
 Association's representative to HCWH.

 Baxter did not specify when the phasing out process would be completed.

 The potential dangers of PVC products may be news to the general public, but
 it's not to some in the medical community.

 In fact, certain medications, including the chemotherapy drugs Taxol and
 Taxotere, come with warnings against using PVC equipment for their
 administration. In addition, Abbott Laboratories, another large manufacturer
 of PVC IV bags, warn that these products have not been tested for
 carcinogenicity, mutagenicity or fertility effects, and that children and
 nursing mothers should be particularly cautious when using the product.

 Alternatives to vinyl plastics are increasingly being used in Europe,
 particularly in Austria and Germany. (Baxter recently purchased Bieffe, a
 Swiss maker of non-PVC IV products.)

 Baxter's decision to phase out PVC IV bags came despite attempts by chemical
 trade associations to refute claims that these devices needlessly expose
 patients to toxic chemicals.

 Their claims, however, are largely unsubstantiated. For example:

 CLAIM: Substitutes for vinyl are untested. FACT: Twenty percent of the IV
 market in the U.S. already uses cost-competitive, FDA-approved non-vinyl bags.

 CLAIM: The Consumer Product Safety Commission exonerated DEHP. FACT: The
 agency asked the toy industry to remove DEHP from teething toys in 1986, due
 to concerns about its toxicity and its ability to leach into children's
 mouths.

 CLAIM: There is no scientific evidence of risk to humans from DEHP exposure.
 FACT: Damaging effects of DEHP have been demonstrated in peer-reviewed studies
 of dialysis patients, as well as in animal studies that are designed to gauge
 safety or risk to humans. DEHP has also been found in the blood, brain and
 liver of premature infants who received respiratory therapy through PVC
 tubing.

 Chlorine and vinyl industry associations also claim that the quality of health
 care will decline if vinyl medical products are replaced. To the contrary,
 HCWH contends that eliminating needless exposures to DEHP and dioxin actually
 improves public health, without increasing costs.

 Health Care Without Harm has more than 170 member organizations, including the
 American Nurses Association, 41 hospitals, such as Beth Israel Medical Center,
 New York; New England Medical Center; and the hospitals of Catholic Health
 Care West. Other members include the Oncology Nursing Society, American Public
 Health Association, Breast Cancer Fund, Endometriosis Association, Greenpeace,
 the Sierra Club and many other environmental and social action organizations.

 ###

 ATTENTION JOURNALISTS: For more information about Health Care Without Harm or
 the dangers posed by polyvinyl chloride (PVC) IV bags, please contact Laura
 Burstein at 202-822-5200, extension 222. To review previous ANA action on PVC
 and DEHP, visit our "RNnoharm" webpage: http://www.nursingworld.org/rnnoharm/

 ###

 The American Nurses Association is the only full-service professional
 organization representing the nation's 2.6 million Registered Nurses through
 its 53 constituent associations. ANA advances the nursing profession by
 fostering high standards of nursing practice, promoting the economic and
 general welfare of nurses in the workplace, projecting a positive and
 realistic view of nursing, and by lobbying the Congress and regulatory
 agencies on health care issues affecting nurses and the public.