Danes want chemicals out of medical devices

Medical devices stethoscope_Smaller.jpg

Danish Health Minister Astrid Krag wants phthalate chemicals, which are used to soften plastic, phased out as part of the EU's new medical devices regulation.

Krag said she would raise the issue during ongoing negotiations to revise the EU regulation, claiming backing from the Danish medical technology industry.

The Danish minister said she was discussing ways to establish private-public partnerships to help Danish companies develop products in areas where there are currently no alternatives to phthalates.

Phthalates are a group of industrial chemicals used to make plastics like polyvinyl chloride (PVC) more flexible or resilient.

These chemicals are nearly ubiquitous in modern society. They are found in, among other things, toys, food packaging, hoses, raincoats, wall coverings, lubricants and detergents. They are also found in cosmetics such as nail polish, hair spray and shampoo, although some have been banned in Europe for such use.

Some phthalates have been found to disrupt the endocrine system, leading to bans across Europe for use in children's toys for instance.

Several phthalate compounds – DEHP, DBP, DIBP and BBP – have been linked to reduced sperm count, testicular atrophy and structural abnormalities in the reproductive systems of male test animals, and some studies also link phthalates to liver cancer in rats.

Phthalates, like other chemicals, fall under the EU's REACH regulation, which was adopted in 2006.

Business opportunity

Krag said patients should be able to feel safe regarding the medical devices, whether they are plastic tubes, catheters, blood bags or other things in the healthcare systems, which unnecessarily put the patient at risk.

"Denmark could spearhead the development of better and healthier products if we create the possibilities for partnerships between the industry, authorities and experts and if we jointly push for stricter EU product requirements in the current EU negotiations," the minister added.

The director of the Danish medical technology industry, Peter Huntley, said the industry supports the health minister's wish to phase out the classified phthalates from medical devices together with the other EU countries.

"We in the Danish medical technology industry have come far regarding the phase-out of phthalates in our products, and we will among the European medical industry advocate for a European phase-out with a reasonable time frame. We have encouraged the health minister to put forward the wish for a phase out in the coming negotiations on new rules for medical devices," Huntley said.

In France, the government has decided that all phthalates in medical devices for children must be removed from 1 July 2015.

Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices. The Parliament is currently debating the shape of new regulation.

The new regulations are scheduled for adoption later in 2013.

>> Read our LinksDossier: Medical Devices: A new regulatory landscape

  • 22 Oct.: The Parliament’s Environment, Public Health and Food Safety (ENVI) Committee is scheduled to vote on its final report on the two proposed medical devices regulations (Roth-Behrendt report).
  • Nov. 2013: Parliament is to vote to accept or reject the report in a plenary session.


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