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Posted: Mar 27, 2012
SCENIHR request for a scientific opinion: Health effects of nanomaterials used in Medical Devices
(Nanowerk News) In light of the expected increase in the application of nanotechnologies to medical devices, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is requested to provide a risk assessment of medical devices containing nanomaterials. This evaluation shall take into account different categories of medical devices such as:
a. Non-invasive medical devices, e.g. devices coming into contact with the intact skin,
b. Invasive devices (surgical or not), e.g.:
implantable medical devices,
dental and bone fillings and cements,
In this assessment, where relevant, the SCENIHR is invited to differentiate between free, fixed, and encapsulated nanomaterials.
Today, a more widespread application of nanotechnologies and nanomaterials is imminent or already occurring in many areas, including health care. For nanomedicine, the three largest areas of application are diagnostics, drug delivery and regenerative medicine (ETP Nanomedicine 2009). In addition there are applications in surgery and thermotherapy (Vauthier et al. 2011).
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;
Nanosilver used as an antibacterial agent, for example in wound dressings.
Furthermore, there are reports on iron-oxide nanoparticles injected into tumour cells to be heated-up by radiation or an external magnetic field. This type of use has not yet been clearly attributed to the legislation on medicines or to the legislation on medical devices.
On one hand, the immediate effect is mechanical as the tumour cells burst. On the other hand, one might regard the legislation on medicines applicable as the burst cells are metabolised at a later point in time.
Although the general risk assessment requirements applicable for materials used in medical devices and previous scientific opinions on risk assessment of nanomaterials (see e.g. SCENIHR 2006, 2007 and 2009) are useful when assessing nanomaterials for medical applications, there is a need for further clarification in the risk assessment of such products. Especially for medical devices there is such a need in view of the decentralised regulatory system ("New Approach"). The risk assessor, be it the manufacturer, the Notified Body or the authority, should be aware of the specific characteristics of nanomaterials in order to obtain appropriate information to be able to do the risk assessment of the application of nanomaterials in a medical technology.
The European Commission is currently preparing a proposal for a revision of the medical devices directives. This proposal might include provisions on the risk classification, the labeling and the instructions for use of medical devices containing nanomaterials. The risk classification influences the stringency of the applicable conformity assessment procedure.