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International Health

 

 
Filed with: Abbott Laboratories, Tyco

Phaseout PVC Products

WHEREAS:

Polyvinyl chloride (PVC) plastic, the primary component in 25% of all medical products, including IV, blood, enteral feeding bags and others, creates dioxin in production and disposal;

Dioxin, a known human carcinogen, has been linked to endocrine (hormone system) disruption, reproductive abnormalities, altered glucose tolerance, testicular atrophy, neurological problems, infertility and other effects in both animals and humans;

The Environmental Protection Agency has determined that the U.S. population already has bodily dioxin levels at or near levels which can cause adverse effects in laboratory animals;

Large quantities of chemicals called "phthalates" are used to manufacture flexible PVC medical products. Flexible PVC products may contain significant amounts of di-ethylhexyl-phthalate (DEHP), a plasticizer that is a probable reproductive toxicant and toxicant of the liver and kidney;

DEHP has been found to leach out of medical devices and into fluids they are carrying, putting vulnerable populations (e.g., premature infants, dialysis patients and pregnant women) at risk of adverse health effects related to DEHP exposure;

A National Toxicology Program's "Expert Panel" expressed "serious concern" about DEHP exposures from PVC medical devices used in the treatment of critically ill infants;

The Food and Drug Administration (FDA) issued a public health notification identifying a number of medical procedures that posed the highest patient risk from DEHP exposure, including enteral nutrition, infants receiving parenteral nutrition and exchange transfusions;

In its recent draft guidance document, FDA recommends that medical device manufacturers help minimize patient exposure to DEHP by clearly indicating, "through user labeling," that devices contain DEHP, and by "replacing PVC containing DEHP" with alternative materials;

An expert advisory panel's report to Health Canada recommended that PVC devices containing DEHP should not be used in a number of circumstances including: In all newborns and pre-pubertal males; for high exposure procedures such as ECMO; in some adults such as heart transplant patients; for pregnant and lactating women;

Other manufacturers have announced the development of cost-effective, high-quality alternatives to PVC, responding to the growing market for non-PVC medical supplies, although alternatives are not always available.

THEREFORE, BE IT RESOLVED: That the shareholders request the Board of Directors of ABBOTT LABORATORIES to adopt a policy of phasing out the manufacture of PVC-containing or phthalate-containing medical supplies where safe alternatives are available.

SUPPORTING STATEMENT:
Establishing as a priority the manufacture of blood bags and tubing without phthalate plasticizers would provide safer patient care in applications which currently expose patients to the greatest health risks. To implement this policy, the company might choose to: maintain an inventory of products which contain PVC or DEHP; investigate and track the availability of alternatives; establish policies for environmentally preferable manufacturing; request suppliers and purchasers to aid in the development of alternatives. By adopting these mechanisms, Abbott Laboratories will demonstrate that there is a market for such devices, encourage the development and marketing of additional alternative products, and demonstrate commitment to safe products.

 


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