Plasticisers in medical devices
Plasticisers in medical devices - Vinyl Council Australia
| Plasticisers are added to PVC to make it flexible. Blood bags and intravenous tubing are common examples of flexible medical products. Since the 1940s, the most commonly used plasticisers have come from the family of phthalate esther compounds, and of these, by far the most widely used is DEHP (di-2-ethylhexyl phthalate). Sometimes DEHP is known as DOP (di-octyl phthalate). In the 1970s, concerns were raised about human exposure to DEHP, as the plasticiser was believed to cause cancer in rats. Since then, phthalates have been extensively studied. DEHP is not considered a likely carcinogen for humans. However, in rodent studies, DEHP is suspected of interfering with the androgen hormone and affecting male reproductive development. Many of the recent studies have concentrated on this area of research. In the general population, DEHP toxicity has been found to be of low concern. The level of exposure is low and the chemical metabolises rapidly and is excreted readily. Fears for certain patients arose, however, because they are potentially exposed to greater amounts of DEHP, especially during life saving, intensive care procedures. Particularly for neonate (or premature) male babies there is concern about whether DEHP exposure affects their reproductive development. Professor Michael Kamrin’s 2008 report, 'Phthalates: an overview', summarises the research studies conducted since 1999 by many international institutes. His overview assessed new research into areas where previous information had not been conclusive i.e. reproductive and developmental health studies. Professor Kamrin’s report endorses the safety of phthalates in medical devices, |
| Although there have been some minor changes and refinements in the evaluations over time, none of the additional research and deliberations has significantly altered the earlier assessments of a lack of a phthalates risk. |
| View Professor Kamrin’s overview: http://www.acsh.org/factsfears/newsID.1192/news_detail.asp |
| International manufacturer, Baxter reports on the use of DEHP plasticiser on its website: |
| Five to seven billion patient-days of acute exposure and one to two billion days of chronic exposure to DEHP-plasticized medical products over the last 40 years without report of significant adverse effects attest to the safety of this chemical. |
| View Baxter’s policy: PVC in Medical Products. |
| Click here to view more about Plasticisers and the scientific health assessments. |
