Concerns raised over use of chemicals in medical devices


Exposure to ‘phthalates’, a chemical component contained in some PVC-made medical devices, harms patients’ health, an EU scientific committee concluded in a study. The findings come after a ban on phthalates in toys was decided upon in 2005.

Phthalates are chemicals used to soften plastics in products as varied as clothes, PVC materials and food packaging. They are believed to be harmful to human health, causing damage to the reproductive system and increasing the risk of allergies, asthma and cancer. 

Their use in medical devices is a particular cause for concern, because high risk groups, such as newborn babies, can be highly exposed during medical treatment.

The Commission requested the scientific committee on emerging health risks (SCENIHR) to examine the safety of PVC-made medical devices softened with the phthalate ‘DEHP’. The report follows a similar study conducted in 2002, which concluded that there was a lack of exposure data to provide sufficient evidence of a link between DEHP-PVC and detrimental effects on health.

The report, published on 15 October, takes into account new scientific data and concludes that despite a lack of clinical evidence for harmful effects on humans, the high exposure of patients to phthalates during medical treatment is a cause for concern.

Commenting on the report, Lisette van Vliet of Health Care Without Harm Europe (HCWHE), an NGO, said: “The report is good because it recognises that premature babies in particular are getting very high doses of DEHP, and that these levels are so high that we should do something now, not wait for conclusive epidemiology studies that are years away.” 

However, David Cadogan from the European Council for Plasticisers and Intermediates said: “Whilst the scientific committee has expressed concern about its use in some instances, such as in applications involving male neonates and foetuses, we believe their fears to be precautionary when weighed against the evidence.”

“There are some plasticisers now available which are shown to be less hazardous than DEHP but their use, even in high exposure situations, should be carefully balanced against the performance they can offer,” he added.

Stakeholders are invited to comment on the report until 26 November 2007.

  • European Council for Plasticisers and Intermediates:Web site
  • Phthalates Information Centre Europe:Web site

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