Commissioned by the Netherlands Ministry of Health, Welfare and
Sport, RIVM has carried out a comprehensive review of the state-of-the-art and the possible health risks of nanotechnology
in medical applications. This technology is already starting to
have an impact on the diagnosis, treatment and prevention of
disease, especially by enabling early disease detection and
diagnosis, as well as precise and effective therapy.
Nanotechnology
Nanotechnology exploits the distinct technological
advances of controlling the structure of materials at a very
reduced dimensional scale approaching individual molecules and
their organized aggregates or supramolecular structures. Basically,
the nanometre-length scale opens the way for the development of
novel materials for use in highly advanced medical technology.
State-of-the-art in nanomedicine
The RIVM report reviews the state-of-the-art in nanotechnology
approaches in surgery, cancer diagnosis and therapy, bio-detection
of molecular disease markers, molecular imaging, implant
technology, tissue engineering, and devices for drug, protein, gene
and radionuclide delivery.
Many of these medical nanotechnology applications are still in
their infancy. However, an increasing number of new products are
currently under clinical investigation. Some products are already
commercially available, such as surgical blades and suture needles,
contrast-enhancing agents for magnetic resonance imaging, bone
replacement materials, wound dressings, anti-microbial textiles,
chips for in vitro molecular diagnostics, micro-cantilevers, and
micro-needles.
Possible risks to human health
While nanotechnology-based products are already in use,
further research is needed on the potential risks to human health
that could be associated with this new technology. Reducing
structure size to nanometre scale results in distinctly different
properties. As well as chemical composition, which largely dictates
the intrinsic toxic properties, very small size appears to be a
predominant indicator for toxic effects of particles.
Immobilized nanostructures inside or on surfaces of medical
devices, such as surgical implants, are expected to pose a minimal
risk provided they remain fixed. However, release due to continuous
chemical processes and/or mechanical stress at the interface of
implants and surrounding tissues might yield potential risks. For
medical applications utilising free nanoparticles or
nanostructures, such as novel drug delivery systems, the specific
toxicological properties have to be investigated.
A risk management strategy is a requirement for all medical
technology applications. This is considered sufficient for
nanotechnology approaches, provided all relevant stakeholders are
aware of the need for dedicated nanotoxicological risk
assessment.
Based on these conclusions, it is strongly recommended that
guidelines be developed at European level for the safety evaluation
of nanotechnology-based products applied in medical technology.
to reports:
Nanotechnology in medical
applications: State-of-the-art in materials and
devices
Nanotechnology in medical
applications: Possible risks for human
health
