EU Report On Phthalates In Medical Devices Gives Too Much To Industry - Comment On Inadequacies Of EU SCENIHR Opinion On DEHP

Main Category: Medical Devices / Diagnostics
Also Included In: Public Health
Article Date: 20 Mar 2008 - 2:00 PDT

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The conclusions of an EU report on the safety of a common additive to medical devices are fundamentally out-of-step with many hospitals' rationale for materials selection when purchasing medical devices.

The final report, published today by the EU Scientific Committee for Emerging and Newly Identified Health Risks (SCENIHR) is correct to identify vulnerable groups, especially male infants, as "at risk" of suffering adverse health effects when treated with medical devices treated with DEHP.

Overall, however, the SCENIHR report was badly weakened by an excessively narrow interpretation of its remit, with the committee completely failing to examine plasticizer-free plastics used in alternative medical devices. Only alternative plasticizers to DEHP were investigated.

Responsibility for the remit of the SCENIHR report lies with DG Enterprise in the European Commission, an entity not well-known for its support of the alternatives industry.

Lisette van Vliet, EU Policy Advisor for Health Care Without Harm Europe, says: "The most disappointing aspect of the report is SCENIHR's failure to investigate the safety of alternative plastics for medical devices.

"These are widely available on the European market, have passed the required tests, and are already in use by a number of hospitals wanting to altogether avoid the health issues and uncertainties around plasticizers.

"Since over 60 European hospitals are engaged in PVC phase-out projects, there is a reasonable likelihood that EU reports on DEHP and alternative plasticizers will be made redundant by a market shift towards alternative materials, driven by hospitals concerned with patient care issues rather than industry protecting its sales of PVC medical devices.".

For more information on European hospitals phasing out PVC, see our factsheet: "PVC/DEHP phase-out is possible anywhere in Europe: Model hospitals show how to succeed": www.noharm.org/details.cfm?type=document&id=1862

The following is a list of some of the European hospitals phasing out PVC-free medical devices:

-- Vienna Hospital Association, Austria (18 Hospitals, nursing homes, geriatric care centres)
-- Styrian Hospital Association, Austria (20 Hospitals)
-- Sønderborg Hospital, Denmark
-- Copenhagen University Hospital, Denmark
-- Kosice-Saca Hospital, Slovakia
-- Karolinska University Hospital, Sweden
-- Skåne Region (10 Hospitals)
-- Na Homolce Hospital, Czech Republic
-- Faculty Hospital Olomouc, Czech Republic
-- Ceske Budejovice Hospital, Czech Republic

About HCWH Europe

Health Care Without Harm Europe is the European branch of an international network of organisations working to reduce the harm healthcare does to human health and the environment. The coalition also has offices in Latin America, the US and South East Asia, with over 450 members representing 55 countries.

Members of the HCWH international coalition include Kaiser Permanente (the largest US non-profit healthcare provider), Karolinska University Hospital (Sweden's leading hospital in environmental issues in healthcare), the Viennese Hospital Association (Austria's largest healthcare provider), and the Royal College of Nursing (UK).

http://www.noharm.org/europe

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