HEALTH CARE WITHOUT PHTHALATES

Health care without PVC – examples of PVC substitutes in the Czech Republic and in the world.
Why should PVC be avoided in health care? PVC (polyvinyl chloride) is a plastic substance whose production, use, and disposal are accompanied by leakages of toxic substances. That is given particularly by its composition. Besides chlorine, PVC consists of hundreds of ingredients providing the final product with the required characteristics like transparency or flexibility. Many of those ingredients are known to cause harm to human health and to the environment. They include heavy metals like lead, as well as many other substances. Esters of phthalic acid, or phthalates, are most frequently used as softeners. But those substances are not fixed in the PVC and get released to the environment during use. Particularly when medical aids made of such materials are used, their influence on human health is obvious, in connection with exposure to phthalates.

Phthalates and the health Phthalates constitute a relatively large group of chemicals. They are used particularly as softeners in plastics (most frequently in PVC), as ingredients in cosmetic products, but also in insecticides or adhesives. As the history of use of chemicals has experienced many times before, it has been shown that some items from the group of originally harmless substances have negative impacts on human health. Problematic phthalates include primarily di-2-ethyl hexyl phthalate (DEHP), which is also the most frequently used, as well as dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP).
The use of the most risky phthalates was forbidden in cosmetics, toys and other products for children. But no legislation has so far regulated their use in medical aids made of softened PVC. Facts on DEHP
DEHP is a colourless and usually odourless liquid. It is used for softening of inherently hard PVC and for improving its flexibility and processability. According to studies on animals, DEHP is known as a toxic substance endangering the reproductive capability (damage to male and female reproduction system), causing congenital defects (e.g. skeleton defects, eye defects, defects of nervous set constituting the base of the nervous system of the older embryo), cardiovascular problems and infertility. DEHP also damages the kidney and the liver, accumulating in them.1,2,3,4,5,6,7,8
 Inhalation of DEHP increases the risk of respiration diseases asthma and allergies.9
 The EU Directive 67/548/EEC classified DEHP as a reproduction-toxic substance. R60 may impair fertility and R61 may cause harm to the unborn child are used to identify the hazardous character of the substance.
 DEHP is not firmly bound in PVC and is released to the environment e.g. through evaporation from PVC flooring, interior equipment of cars or office supplies or to the human body e.g. from toys, food package materials or medical aids during use.
 DEHP easily dissolves in liquids containing fats. Such liquids include blood, blood derivatives, breast milk and preparations for parenteral and enteral nutrition, through which the toxic substance penetrates more easily the human organism. 10
 Medical aids commonly contain 20 – 40 % DEHP on average. Examples of medical equipment made of PVC
 Blood bags and sets
 Plasmapheresis circuits
 Nosogastric probes
 Dialysis sets, bags
 Catheters
 Containers for intravenous solutions
 Containers for intravenous nutrition
 Components of intravenous nutrition system
 Laboratory utensils
 Inhalation masks
Most endangered patient groups From the perspective of phthalate exposure, the most endangered group consists of dialyse patients and newborns in intensive care units, as they come into close and often repeated contact with a number of medical aids containing such substance. Premature babies are particularly sensitive to phthalate effects, as their reproductive system is still developing and has reproductive systems depending on context, it will be: “as their reproductive is still developing and they have low weight” OR “as their reproductive system is still developing and has little weight” low weight the phthalate intake per kg of weight is higher.
Increased phthalate exposure is imminent particularly in the following procedures:
 blood transfusion
 full parenteral and enteral nutrition
 respiration therapy
 exchange transfusion

An adequate alternative exists The danger to health related illness to the use of PVC can be reduced. The manufacturers and suppliers offer a number of alternative products that are gradually breaking through in the market. The alternative materials include polyethylene, polypropylene, polyurethane, silicon, ethylene vinyl acetate and multilayer plastics. The European manufacturers of PVC-free medical aids include Braun Medical, Baxter, Clinico, Fresenius Medical Care and Gambro AB.
The following examples of good practice show that health care is able to avoid hazardous substances like DEHP.
Health care praxis without PVC Medical aids made of PVC are still frequently used in hospitals across the world, although they contain great amount of phthalates with known negative impact on health. In the Czech Republic, more and more experts become aware of the risks related to the use of medical aids made of phthalate-softened PVC. In spite of that fact, the process of reduction of PVC in health care is very slow, which is caused by the usually higher price of the alternatives, but also by the still insufficient awareness of the issue.
Success factors of PVC substitutes in hospitals
 The PVC aids in a hospital should be substituted in more than one ward. When purchasing higher amounts of goods, better price conditions can be agreed with the suppliers, which constitutes an essential factor particularly for the purchase department of the hospital.
 If the hospital decides to substitute the PVC products, it should start with those with the lowest price difference between the PVC product and their alternatives e.g. IV bags.
 The media explains the issue of phthalates and PVC to the general public, including the Ministry of Health. In that relation, it is very useful to cooperate with non-profit organizations that have rich experience in communicating with the media.
 The question whether the PVC-free or phthalate-free medical aids have proved successful in practice must be assessed by the individual wards in which they are used.
 To reduce PVC successfully, intensive cooperation between the commercial section of the hospital, the individual wards and the suppliers of medical aids is needed. PVC-free perinatological ward in University Hospital of Olomouc After considering the phthalate-related risks, the decision was made to substitute the PVC aids in the perinatological centre of the University Hospital of Olomouc. During 2003 to 2005, most of the medical aids made of PVC (95%) coming into contact with the newborns were successfully substituted. Only endtotracheal tubes are an exception, as no adequate alternative has been found in the market so far.
Schedule
Autumn 2002: The University Hospital of Olomouc received a letter from the Arnika Association, drawing attention to the issue of PVC medical aids.
2003: Coperation on the issue of PVC in neonatology was initiated between the University Hospital of Olomouc and the Arnika Association. During the Neonatology Days, Arnika led a workshop on the PVC issue for health care workers.
Autumn 2003 – spring 2004: A PVC audit took place in the perinatological ward, with the following findings:
 The ward uses 106 products in total
 81 products including the most frequently used aids or aids coming into long lasting contact with the newborns were selected
 The information on material composition was ascertained for 56 most frequently used aids. 19 of them were made of PVC.
2004 Market research was undertaken and medical aid manufacturers and suppliers were contacted in order to find adequate PVC-free alternatives.
By the end of 2005 95% aids made of PVC, coming into contact with the newborns, were substituted. Safe phthalate-free dialysis in the Na Homolce Hospital
The Na Homolce Hospital of Prague substituted the infusion IV bags made of PVC in 2003. The initiative came from local dialysis centre. Thanks to the long-term character of the therapy, the dialysis patients are exposed to up to 1000x higher DEHP doses than the "healthy" population. Therefore the medical staff of the Na Homolce Hospital started negotiations about safer alternatives with the main suppliers of IV bags. After three years, the hospital shifted fully to bags made of polyethylene (PE), polyamide (PA) and polypropylene (PP). After some time, the dialysis ward replaced also the IV sets softened by DEPH phthalate. That step reduced to a minimum the exposure of the dialyzed patients in the course of the therapy.
First children's phthalate-free dialysis in the University Hospital with Clinic in Ostrava The phthalte-free dialysis material has been used in the ward of the children's resuscitation and intensive care in the University Hospital with Clinic in Ostrava since 2006. That children's dialysis centre was the first in the Czech Republic to order it.
"Three chronically ill child patients come to our centre for dialysis three times a week; we treat about fifteen patients with acute intoxication or acute kidney failure. Therefore we were pleased to see that in recent year, consumable dialysis material without phthalates has been launched to the Czech market," says MUDr. Michal Hladík, senior doctor of the Ward of children's resuscitation and intensive care of the University Hospital with Clinic. "Even if the price of the phthalate-free material is about 1/3 higher than the commonly used materials, we believe that in case of children, it is an investment in their future, reducing the health risks related to their disease."
The replacement of phthalates constitutes the first step towards safer dialysis. The second step consists in some Czech and foreign hospital's asking the manufacturers to launch new PVC-free dialysis sets. The merit of other materials consists in the absence of softeners that might be released into the patients' blood.
Circumspection at selecting manufacturers The commercial department responsible for purchase of aids can ask the suppliers to offer DEHP-free products. For example the Motol University Hospital considers that criterion when entering into contracts. Some examples from abroad

Denmark
The Central Hospital of Grenaa eliminated and replaced 95% of their aids made of PVC. A database of PVC-free alternatives for medical aids, office and household supplies was created and is available both to the hospital staff and to general public; it contains the product names and addresses of their distributors and manufacturers.
Austria
The Vienna Hospital Association operating 18 hospitals, sanatoriums and centres for senior care, is heading towards gradual elimination of PVC. They have adopted a policy aimed at eliminating PVC from packages, construction materials, and medical aids. The endeavour is related to the decision of the Vienna municipality to eliminate gradually the PVC from all municipality-founded projects. The Glanzing and Preyer children's hospitals governed by the Association constitute a good example how to eliminate PVC. They have achieved a situation in which they do not use almost any PVC more. Additionally to PVC medical aids, the strategy of the Vienna Hospital Association applies also to construction materials; since 1990, PVC has not been used for flooring and window frames.
Sweden
In 1997, the Stockholm County Council issued the decision to avoid the use of PVC in all areas where it is possible. The PVC elimination was identified as priority in purchase of new products and it is a part of enforcement of sustainable development policy. The program forbids the use of PVC, unless the tender includes sufficient explanation for its purchase and use. PVC stopped being used in many disposable medical aids.
USA
Kaiser Permanente is the biggest non-profit provider of medical care in the United States. Since July 2001, after the information of potential danger to patients - newborns by DEHP exposure, the staff of Kaiser Permanente proceeded to identify the DEPH-containing medical aids used in newborn intensive care units. The main nurse of one of the newborn wards in Kaiser Permanente gathered the products in the ward and asked experts to help her to identify the products with potential contents of PVC/DEHP, as well as products posing great risk and products for which PVC/DEHP alternatives meeting the quality and function criteria are available. Based on the test results and evaluation, the staff suggested switching to PVC/DEHP-free products in all cases where adequate alternatives were available.
In 2005, another health care provider of the USA – Catholic Healthcare West - contracted the German manufacturer B Braun to supply PVC-free infusion sets for 40 American hospitals, in a value of 70 million USD. A year later, Hospira and Barter, competing manufacturers, launched other alternative PVC-free and phthalate-free sets primarily for newborns.

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