The multidisciplinary application of science at the nanoscale is bringing new insights into the understanding of cell biology including protein formation and operation, and other key processes.
While this will result in new approaches to imaging, diagnosis, drug design and delivery, regenerative medicine and the development of novel biomedical materials, the nanoscale behaviour of materials may present novel hazards and associated risks, and give rise to new risk management challenges.
Therefore, in tandem with the development of new nanomedical approaches and therapies, it is essential that work in analysing and estimating these risks, in reducing them as far as practicable, in communicating them, and in balancing risks against benefits is undertaken in a systematic manner.
Risk management may be thought of as a process comprising a number of separate but interrelated activities. These include:
- hazard identification
- risk estimation
- risk evaluation
- risk control
- determining the acceptability of risk
- risk/benefit analysis
- risk communication
- post production and post treatment monitoring
The process is an iterative one. For instance, if new information comes to light at any stage in the process, including at application stage, it is fed back into the process resulting in an expanding level of knowledge and continual refinement at each stage.
While there are some specific variations in approaches to risk management in the medical field resulting from the different models of regulation applied, e.g. in medical devices and pharmaceuticals, the general principles as described above always apply and it is important that any novel hazards and risks associated with nanoscale properties are identified, eveluated, assessed and controlled.