Risk Management Mentor Program



The first part of the applications module includes information on medical device management and root cause analysis (RCA). It defines medical devices and the Safe Medical Device Act, discusses the key components of a medical device management program, and examines the process of handling malfunctioning medical devices. Education on root cause analysis includes an explanation of the formal RCA process, the components of an action plan, and reporting of RCA findings. A sample RCA also is reviewed.

The second part of the applications module covers three topics: (1) FMECA, (2) environment of care and emergency response, and (3) cybersecurity. The FMECA portion examines the process of FMECA (failure mode effects and criticality analysis), including a review of a sample FMECA. FMECA’s importance in mitigating potential risk exposures through an organization also is demonstrated. The environment of care and emergency response portion covers the risk management role in an organization’s environment of care. It identifies potential environmental risks to an organization; demonstrates how to recognize steps in preparation for, and response to these risks; and specifies recovery efforts following an environmental event. The cybersecurity portion presents tips on protecting information technology systems. The importance of cybersecurity to a healthcare organization is described, and key points of a cybersecurity preparedness plan are also presented. Cyber breaches are examined using an enterprise risk management approach, including reporting requirements. Learning to recognize vulnerable medical device systems also is included.


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