A new white paper drafted by a special AAMI working group lays out six principles – developed jointly by industry and the U.S. Food and Drug Administration – to guide the management of risk of medical devices in the postmarket setting.
The complimentary paper seeks to offer a “shared understanding” of risk principles, an important milestone in the ultimate goal of having better coordination and interaction between manufacturers and regulators when it comes to postmarket activities.
The six risk principles are:
- Informed judgment in risk and benefit evaluations
- Loss-of-benefit assessment
- Populations
- Use environment and clinical assessment
- Communication
- Risk control and recovering loss of benefit
The paper covers specifics for each risk principle, and it includes a long list of factors to consider when applying those risk principles, such as complexity of use, software dependency, clinical impact on patients, and risks with alternative choices.
The complete white paper, which includes a list of the working group members, can be downloaded here.