ISO 14971: Defining Hazardous Situation

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Let's Talk Risk!

Let's Talk Risk!

Күн бұрын

ISO 14971 establishes definitions for important terminology including hazard, hazardous situation, and harm. In this video, Naveen Agarwal, Ph.D. defines the term hazardous situation, clarifies how it may be implemented for medical companies, and discusses potential problems with hazardous situations in the industry.
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Пікірлер: 1
@NN-tk7uw
@NN-tk7uw 11 ай бұрын
I agree with your examples. However ISO 14971:2019 Table C.3 provides examples of Hazardous Situations that encroach into the Harms territory. Their example of a Biological Hazard: Sequence of events: 1) Inadequate decontamination of anaesthesia tubing, 2) Contaminated tubing used during anaesthesia Hazardous situation: Bacteria released into airway of patient during anaesthesia Harm: bacterial infection If I understand your examples, it would be written as: Sequence of events: Inadequate decontamination of anaesthesia tubing, Hazardous situation: Contaminated tubing used during anaesthesia Harm: Bacteria released into airway of patient during anaesthesia leading to bacterial infection I would argue that the Hazardous Situation exists as soon as the contaminated tubing is available for use, without even coming into contact with a patient. Same logic for an exposed live wire or a wet floor. Thoughts?
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