There are few medical device failures that could not conceivably result in harm-even a device that fails in a safe condition could result in a delay of treatment-but the “failure” vs. The failure of a device is only a hazard if it can cause harm to people, property, or the environment through a foreseeable sequence of events. A failure is not necessarily a hazard.Unlike the assessment of Severity, which is typically based on qualitative criteria used to describe the harm caused to people, property or the environment the estimation of the Probability of Occurrence of Harm is typically based on quantitative criteria (i.e., hard numbers derived from field experience and/or engineering studies) – but that doesn’t mean it’s any easier.įirst, there are a few things that you need to keep in mind: Risk is composed of two elements: Severity and the Probability of Occurrence of Harm. The Elements of the Probability of Occurrence of Harm If you have missed any of our previous articles in this series, you can find them on our website at here. This article addresses the other major element of risk, the Probability of Occurrence of Harm.
THREE DIMENSIONAL RISK PROBABILITY MODEL SERIES
In our last article, Part 5: Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and distinguishing between harms that occur as a direct result of the hazard/hazardous situation and harms that will only occur as the result of a potential series of subsequent events.
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