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Regulatory Focus™ > News Articles > EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues

EU Science Agency Calls for Experts, Information on Host of Medical Device Safety Issues

Posted 09 August 2012 | By Alexander Gaffney, RAC, Louise Zornoza,

The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published seven announcements calling for information and experts on a host of emerging and established regulatory issues related to several classes of medical devices.

The 8 August announcements come in response to several requests that it update earlier scientific opinions or issue new ones where no earlier opinion exists.

Nanomaterials and Metal-on-Metal Hip Implants

One of the announcements calls for an assessment of the health effects of nanomaterials used in medical devices, which will cover non-invasive as well as invasive devices, such as implantable devices and injectable nanomaterials. The European Commission is currently preparing a proposal for a revision of the medical devices directives that might include provisions on the risk classification, labeling and instructions for use of devices containing nanomaterials. 

A second pair of announcements calls for a safety assessment of metal-on-metal (MoM) joint replacements with an emphasis on hip implants.  SCENIHR said it is particularly interested in assessing the range of materials used in the implants, the number and severity of adverse events associated with MoM implants versus those with non-MoM implants, postmarketing data and the effectiveness of surveillance systems. A related announcement by the European Commission calls for experts in this area to make their services available to SCENIHR.

PVC Plastics in Medical Devices

A third pair of announcements calls for both experts and information on the safety of medical devices containing Di(2-ethylhexyl) phthalate (DEHP), a plastic compound commonly used in medical devices containing PVC piping. An earlier assessment by the US Food and Drug Administration (FDA) notes the compound is "controversial," and called for further studies and a minimization of the compound when possible.

SCENIHR mirrored those concerns in its 8 August announcement, noting, "Safety concerns have been expressed for high-risk patients groups, such as neonates, infants, pregnant and breast-feeding women exposed to DEHP." Though it noted earlier research had not established a causal relationship between DEHP and adverse effects, it noted lack of causality," Does not mean that there are no risks."

In light of new research showing risks to human health from the product, SCENIHR said it wanted to revisit an earlier 2008 opinion to see if it should be revised.

Dental Amalgam and EMF

A final call for information from SCENIHR calls for a reassessment of dental amalgam, a mercury-based filling used to treat cavities. As with DEHP, SCENIHR has earlier found the use of dental amalgam to be safe for use in dental patients, but later research by the World Health Organization has introduced several concerns the committee said it wanted to explore, including the environmental impact of using amalgam. Among the committee's concerns is whether dental amalgam is in fact safer for use in patients than its emerging alternatives, which SCENIHR said had not been extensively studied.

FDA announced in 2011 it is in the process of reassessing its views on amalgam as well, and Jeffery Shuren, director of the Center for Devices and Radiological Health (CDRH), said an announcement on the rule would be forthcoming, "By the end of the year." It was unclear in his announcement whether he was referring to the end of 2011 or 2012.

A final call for experts in electromagnetic fields (EMF) was also issued by SCENIHR as part of an ongoing review of the health effects of exposure to EMF radiation.

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