ISO 14971 defines harm as
“injury or damage to the health of people, or damage to property or the environment”.
According to ISO 14971, the harms are usually impairments of body structure (e.g., cut) or body function (e.g., ability to move, ability to see, capability to cleanse blood). To assess the risks, we must know the harm our medical devices can cause. ISO 14971 defines risks as
“the combination of the probability of occurrence of harm and the severity of that harm”.
Here, we run into a difficulty: there is not just one harm, but a whole chain of causes in which each link is a harm in the sense of the definition. For example:
Each element of this causal chain meets the definition of ISO 14971 because each represents a physical injury or damage to health. However, each element will occur with a different probability and thus represent a different risk in ISO 14971.
Most manufacturers do not look at the chain of causes in such detail. Accordingly, they estimate the risks incompletely and incorrectly. As the picture above suggests, these chains of causes are usually complex and not linear. The following illustration makes it clear:
If you want to conduct a risk analysis, specifically to investigate this last part of the causal chain, you need a doctor. There is no other way. Additionally, you need a risk manager who documents the doctor’s output in the risk management file consistently and in accordance with the requirements of ISO 14971.
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