Europe

In July, the European Commission’s Committee on Scientific Emerging Newly Identified Health Risks (SCENIHR) proposed guidance on medical devices making use of nanomaterials. Many of the risks of nanoparticles to the environment and human health are not known, and SCENIHR’s recommendations aim to learn about these risks while minimizing them. Five phases are proposed for assessing the devices. Phase One would determine either the potential for a device to release nanoparticles or the wear potential of a device with embedded particles. Phase Two would study the effects of released nanoparticles in the body, including the duration of their presence and the toxicity testing necessary if in circulation. Phase Three would assess the toxicity tests needed for the riskiest devices, while Phase Four would compare risks of devices with nanomaterials to corresponding devices without them. Phase Five would factor in potential benefits of a medical device with nanomaterials to a patient to determine its overall risk. SCENIHR has set a comment period for the proposal through October 3.

Source: The Economist Intelligence Unit

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