Risk Identification – ISO 14971
27 June 2011
Over the last few weeks, this blog has explored the components of risk management and how it is a key component to quality management systems. But what about potential risks and the best practices for manufacturers to follow?
The first step all manufacturers should take is to identify any hazards that may occur due to characteristics or properties of the medical device during normal usage or foreseeable misuse. Criteria for determining acceptable risk levels must be established and implemented. Why? After hazards are identified, risks are evaluated, deemed acceptable or unacceptable, and need to be addressed based on a set criteria. These hazards may be pulled from a variety of sources, including:
- Analysis of the manufacturer's experience with similar medical devices;
- Research on currently accepted risk levels by regulators, users, or patients, given the benefits derived from diagnosis or treatment with the device;
- Published standards;
- Scientific technical data;
- Field data and published incidents from similar devices in use;
- Usability tests of typical users;
- Clinical evidence;
- Investigative results;
- Expert opinions; and
- External quality assessment.
As thorough identification of hazards is difficult, ISO 14971 provides a number of aids, including Annex C which provides device characteristics that may impact safety, and Annex H which provides information on in vitro diagnostic devices.