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systems model

Event Reviews

Whether it is near-miss events that continue to occur, an adverse event that was too close for comfort, or a serious safety event that must never happen again, human factors engineering offers a unique systems perspective to a traditional root cause analysis.

Healthcare systems are complex, consisting of policies, medical devices, information systems, processes, and physical environments. At the center of this system are people: physicians, nurses, technicians, transporters, and a host of other specializations that provide the resilience of the healthcare system. When an unwanted event occurs, two actions are imperative: 1) understand why the event occurred, because if it made sense to one person to perform a particular action in one case, it will make sense to someone else to perform that action at a later time, and 2) develop a strategy to address the true root causes of an event. Too often, the resulting action after a root cause analysis is to implement a new policy or provide additional training. Unfortunately, research has demonstrated repeatedly that these are the least effective and least sustainable solutions to adverse events.

To understand why an event occurred, we need to examine the difference between “Work as Imagined” vs. “Work as Performed.” When people are doing things ‘wrong’, why is that the case? If policies are not being followed, we need to examine why. What are the work-arounds or shortcuts? We need to examine and address difficulty, complexity, variety, ambiguity, and sequence. Working through a systems analysis of the events will identify a healthcare system’s strengths and inform opportunities for improvement.

Healthcare Safety Strategies can send a review team to your facility to perform an independent review or you may choose to have a seasoned human factors engineer join your team during the review process. Contact us for more information.


Healthcare Safety Strategies offers presentations, workshops, and class series regarding the application of human factors engineering to healthcare. Dr. Vicki R. Lewis, the Principal Human Factors Engineer at Healthcare Safety Strategies, has presented Human Factors related workshops, webinars, and countless invited presentations to hospital leadership, medical device design and manufacturing firms, clinical professional societies, and other organizations. She is currently providing private class series to multiple organizations. Contact Vicki for a one-time speaking engagement or to develop training that meets the needs of your organization. Training may be provided on site or via internet to best meet your timeframe and training budget.

Usability Services

Healthcare Safety Strategies provides usability consultation and testing throughout the medical device design and development process to keep your products on track for regulatory approval. Healthcare Safety Strategies applies FDA Human Factors guidance, IEC 62366 and 60601, and HE75.

Regardless of your need, Healthcare Safety Strategies will put together a customized plan for you. From a few hours of consultation to advise your product developers to assembling a team to conduct all formative and summative validation studies, to working with your regulatory contractor, Healthcare Safety Strategies works with your product development timeline. Healthcare Safety Strategies will obtain all clinical and patient participants for testing.