Calling all scientists with a good command of English and expertise on medical devices containing nanomaterials

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) needs experts because it has been asked by the European Commission to asses the use of nanomaterials in medical devices. From the Aug. 15, 2012 news item on Nanowerk,

The relevant SCENIHR working group has identified a need in the field of medical devices containing nanomaterials. In line with the Rules of procedure (pdf) of the Scientific Committees, a call for expression of interest for experts in this topic is launched.

To allow for a comprehensive assessment, experts in various scientific fields related to the safety of medical devices containing nanomaterials are encouraged to apply. Experience in risk assessment would be an advantage.

The deadline for submission for this call for experts is 1 October 2012 (kindly note that the registration to the database of experts with regard to the general work of the Scientific Committees is permanently open). Applicants are requested to indicate “SCENIHR: Medical devices Nano – call for experts” in the subject title of the message sent with their application.

The detailed description of the mandate for this request can be found here. It includes details such as this from the  introduction,

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 (see also Wijnhoven et al. 2009).

Furthermore, there are reports on iron-oxide nanoparticles injected into tumour cells to be heated-up by radiation or an external magnetic field1. 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. (p. 1)

The Terms of Reference include,

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.:

o woundcare materials,

o implantable medical devices,

o dental and bone fillings and cements,

o injectable nanomaterials.

In this assessment, where relevant, the SCENIHR is invited to differentiate between free, fixed, and encapsulated nanomaterials. (p. 2)

The deadline listed in the mandate is March 2013. Presumably this is the deadline for the assessment itself while the deadline to apply as an expert is Oct. 10, 2012 according to the SCENIHR webpage for the August 2012 Call for Information on the Safety of Devices Containing Nanomaterials.

ETA Aug.15, 2012 11:20 am PDT: Given that I originally misspelled the word expertise in my headline for this post, maybe I need to check my own expertise … with English.

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