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Medical devices are required to be safe and effective before they are commercially marketed. However, there have been reports of adverse events, even deaths, due to unforeseen design efforts. How can biomedical engineers minimize potential hazards to users and operators? Risk management is an essential engineering skill that all biomedical engineers should understand and use aggressively. Risk management is the systematic application of management policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risk. In this article, I will briefly outline the general steps you would take to anticipate failures, make safer products, and reduce liability costs. Regulatory bodies have also recognized the value of risk management. The FDA's Quality System Regulations and the EC's Medical Device Directive require risk management. There are also international standards for how to conduct risk management. One of the most useful is "AAMI/ISO 14971 Risk Management - Application of risk management to medical devices " which can be obtained through www.aami.org. The process outlined in this article follows this standard.
Engineering in Medicine and Biology Magazine, IEEE (Volume:22 , Issue: 4 )
Date of Publication: July-Aug. 2003