EU experts finally confirm phthalates in medical devices are harmful, mainly to little boys

16.10.2007 - Prague / Brussels

The fact that phthalate DEHP (1) is toxic and causes health problems has been known at least for 15 years. However, it was a turning point yesterday when its malignancy in medical devices was recognized by the EU´s Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) in its extensive report (2, 3). In 2002 the committee still insisted on a view that it was not necessary to reduce quantity of DEHP in the medical devices because there was not enough proof of its negative impacts on treated patients. Yesterday the committee changed its opinion for the first time, and recognition of phthalates´ malignancy in the medical devices has brought a historical opportunity to open serious discussion on legal changes as well as a way to eliminate hazardous chemicals from healthcare.

Medical devices made of PVC softened by DEHP phthalate are widely used. Conclusion of the official study says that the DEHP represents the largest health risks mainly for newborn boys undergoing treatment with a help of such devices. „The reason is that the DEHP phthalate negatively influences not only the liver and kidneys but also testicular cells which influence production of sperm. It means that increased exposition of the DEHP phthalate can cause that such boys will face serious fertility problems later in their life,“ said Ing. Miroslava Jopková, head of Arnika´s campaign Don´t Play with PVC“. The scientific committee pointed also on other risky groups – pregnant women and breastfeeding mothers – because exposure to DEHP exists also during the period of pregnancy and breastfeeding.

Jopková added that significant part of the hazardous medical devices can be substituted by safer alternatives. „There is a couple of hospitals in the Czech Republic which started giving out using the devices with the content of toxic phthalates, for instance Neonatological Department in University Hospital Olomouc has substituted 95% off its devices. Other examples are Hospital Na Homolce in Prague and department of children's dialysis in Ostrava hospital.“

Coordinator of international organization Health Care Without Harm (4) Karolína Brabcová taxes the scientific committee with fact it was not more engaged in existence of the safer alternatives. „The report is assessing only chemicals that can be used to soften PVC, but it does not deal with any alternative plastic materials or materials for production of medical devices, though nowadays there are hundreds of them on a market. They could have found many medical devices from which no toxic chemical leak to patients´ bodies if they had focused also on plastic medical devices without softeners (5, 6).

(1) Di(2-ethylhexyl) phtalate (DEHP) is used in PVC as softener (e.g. in medical devices – hoses, blood bags, in soft furnishings (floor-cloth, wallpapers, then in production of plastic raincoats etc.). EU directive 67/548/EEC on classification and labelling of hazardous chemicals classifies DEHP as a substance poisonous to the reproductive system. It can cause congenital malformations, cardiovascular problems and can negatively influence the functioning of thyroid gland. Use of DEHP was limited in toys and other children products.

(2) EU´s Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) Preliminary Report On The Safety Of Medical Devices Containing DEHP-Plasticized PVC or Other Plasticizers On Neonates and Other Groups Possibly at Risk
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/scenihr_cons_05_en.htm

(3) Preliminary Report – page 43: „Available data on exposition to DEHP show that dose of DEHP to which newborn babies are exposed within some treatment procedures, achieves equal or even higher level than doses with reprotoxic effects, according to test on animals. These studies also lead to alarming findings that testicular cells of young males react on toxicity much more sensitively compared to the adults. That is why it can be presumed that newborns can be threatened by negative influence of DEHP on reproduction and development.“

(4) Health Care Without Harm Europe (HCWHE) is international coalition developing effort to protect health by supporting environmentally responsible practices of medical industry. On of areas with which HCWH deals is usage of toxic phtalate DEHP in medical devices.

(5) According to the last survey made by HCWH, European market offers more than 260 medical devices without DEHP and other softeners.
More information: http://www.noharm.org/details.cfm?ID=1555&type=document
Arnika work on similar database of alternatives to risky PVC devises containing toxic softener DEHP:
More information: http://pvc.arnika.org

(6) Medical devices produces from PVC contain 20-40% DEHP. Alternative, safer devices, mentioned in the report, contain similar quantity of alternative softeners. SCENIHR´s conclusion is following: „Information about emissions of alternative softeners are exceptional but it can be presumed that they will be similar.“ (page 39).

 


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