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March 29, 2012

EC Requests Scientific Opinion on Health Effects of Nanomaterials Used in Medical Devices

Lynn L. Bergeson

On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC’s request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

  • Carbon nanotubes in bone cements;
  • Nanopaste hydroyapatite powder for bone void filling;
  • Polymer setting material with nanoparticles in dental cements;
  • Polycrystalline nanoceramics in dental restorative materials;
  • Nanosilver or other nanomaterials used as coatings on implants and catheters; and
  • Nanosilver used as an antibacterial agent, for example in wound dressings.

Furthermore, according to the request, there are reports on iron-oxide nanoparticles injected into tumor cells to be heated-up by radiation or an external magnetic field. The EC states that, when assessing nanomaterials for medical applications, the risk assessor should be aware of the specific characteristics of nanomaterials to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology. According to the request, the EC is currently preparing a proposal for a revision of the medical devices directives. The proposal might include provisions on the risk classification, the labeling, and the instructions for use of medical devices containing nanomaterials. The deadline for SCENIHR’s opinion is March 2013.