Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices

WG on Nano in medical devices
SCENIHR members: Igor Emri, Philippe Hartemann, Ana Proykova, Konrad Rydzynski
External experts: Jim Bridges, Lars Bjursten, Wim De Jong, Robert Geertsma, Arne Hensten, Nils Gjerdet
Acknowledgement: The members of the working group are acknowledged for their valuable contribution to this Opinion.
Contact: SANCO-C2-SCENIHRec [dot] europa [dot] eu (SANCO-C2-SCENIHR[at]ec[dot]europa[dot]eu)
On request from: European Commission
Doi: 10.2772/41391
Adopted on: 06 January 2015

Content of the opinion:

This Guidance addresses the use of nanomaterials in medical devices and provides information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. According to the EU Recommendation for the definition of a nanomaterial (Commission Recommendation 2011/969/EU, EC 2011) any particulate substance with at least one dimension in the size range between 1 and 100 nm is considered a nanomaterial. These particles (nanoparticles) exhibit specific characteristics that differ from the characteristics of larger sized particles with the same chemical composition.

The use of nanomaterials in medical devices poses a challenge for the safety evaluation and risk assessment of these medical devices as the specific character of the nanomaterial used should be taken into consideration. The various aspects of safety evaluation and risk assessment of medical devices containing nanomaterials are addressed in this Guidance. The use of nanomaterials in medical devices can vary considerably. Examples are the use of free nanomaterials being a medical device and administered to the patient as such (e.g. iron oxide or gold nanomaterials for heat therapy against cancer), free nanomaterials in a paste-like formulation (e.g. dental filling composites), free nanomaterials added to a medical device (e.g. nanosilver as antibacterial agent in wound dressings), fixed nanomaterials forming a coating on implants to increase biocompatibility (e.g. nano-hydroxyapatite) or to prevent infection (e.g. nano-silver), or embedded nanomaterials to strengthen biomaterials (e.g. carbon nanotubes in a catheter wall). In all these cases the potential exposure to the nanomaterials should be considered. It is additionally recognised that wear-and-tear of medical devices may result in the generation of nanosized particles even when the medical device itself does not contain nanomaterials.

Keywords:

Medical devices, nanomaterials, risk evaluation, SCENIHR, Scientific Committee on Emerging and Newly Identified Health Risks

Opinion to be cited as:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Final Opinion on the Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices, January 2015.