17 December 2015, PDF |
86 pages |
Geertsma RE, Park MVDZ, Puts CF, Roszek B, van der Stijl R, de Jong WH
RIVM Report 2015-0149
The application of nanotechnologies in medical devices is a growing area and numerous medical disciplines benefit from innovative features enabled by nanotechnologies. Knowledge about the safety evaluation of nanotechnology is also evolving. Recently, scientific guidance has become available, specifying considerations to be taken into account when nanotechnology is used for the manufacture of a medical device. The combination of knowledge and guidance forms a suitable basis for the risk assessment of nanomedical devices. These are the main conclusions of an overview performed by RIVM on applications of nanotechnology in medical devices.
One of the most important types of nanotechnological applications is nanocoatings, which increase biocompatibility and thus improve integration with the surrounding tissues of a variety of medical implants used, for example, in cardiology (stent coating), orthopaedics (coating on joint replacement implants) and dentistry (dental implants). In addition, antimicrobial properties of nanomaterials are used in coatings, and also in wound care and medical textiles.
Another clear trend is the use of nanomaterials to mimic naturally occurring structures. This leads to optimal biological, physical, and mechanical characteristics of implants.
A third trend of applications is related to the electrical and magnetic properties of materials on the nanoscale. This is especially relevant to medical devices used in neurology and cardiology, for instance to improve the treatment of cardiac arrhythmia. Furthermore, nanotechnologies enable the development of batteries with greatly increased lifetime for use in active implantable medical devices.
A number of nanotechnology applications are specific to oncology. Examples include diagnostic tests used in the early detection of cancer, and devices for the identification of the boundaries of a tumour or metastases during surgical interventions. Nanomaterials can also enhance the effect of therapies like chemotherapy or radiation therapy through locally increased temperature, or they can kill tumour cells directly at high temperature.
Like all medical products, the risk assessment of nanomedical devices needs to be performed on a case-by-case basis. The potential for release, leading to a higher or lower exposure to nanomaterials, is considered the most important feature driving the extent of the "nano" risk assessment.