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EC SCENIHR publishes preliminary Guidance on determining Health Effect of Nano in Medical Devices

The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published a draft opinion, Guidance on the Determination of Potential Health Effects of Nanomaterials used in Medical Devices. The Committee concludes that ‘the potential risk is mainly associated with the possibility for release of free nanoparticles from the device and the duration of exposure’, and is ‘dependent on the method of use’. As such SCENIHR recommends a ‘case-by-case approach… for risk evaluation’, and proposes ‘a phased approach…to avoid unnecessary testing’.

The guidance document ‘highlights the need for special considerations in relation to the safety evaluation of nanomaterials, in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials’. The information provided for safety evaluation and risk assessment in the document ‘is discussed in the context of the general framework for biological evaluation of medical devices as described in the ISO 10993-1:2009 standard’.

SCENIHR proposes a 4-phase approach. These phases are:

  1. ‘An evaluation…of the potential for the device to release nanoparticles either directly or due to wear of the device during use’. If particle release is expected to be low ‘even under realistic worst-case conditions of use’, no further consideration of risk is required
  2. If further consideration is required, phase 2 aims ‘to determine the distribution of the particles released and also their persistence potential’. If particle release is expected to be low ‘even under realistic worst-case conditions of use’, no further consideration of risk is required
  3. If further consideration is required, phase 3 assesses hazard ‘by selecting toxicity tests that are relevant based on the nature of the observed exposure and potential persistence in specific organs’
  4. Following on from phase 3, phase 4 gathers all input for final risk characterisation; ‘estimated risk needs to be compared to the risk from the use of comparable devices not incorporating nanomaterials in judging the acceptability of the risk’

 

NIA intends to comment on the preliminary opinion on behalf of its membership; NIA Members can learn more here. Members and non-Members can follow this link to read the entire draft opinion.

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