What is a hazard? Glad you asked!

At first glance, the term?hazard?appears quite intuitive to understand. According to the dictionary, it is the source of danger. But it is not so easy to precisely define it when doing risk analysis for your medical device in the context of ISO 14971.?The result is a lot of confusion and mistakes!

A simple statement about the term hazard in this recent LinkedIn post led to a lot of discussion and comments. In this article, I will summarize some of the key comments with the goal of continuing the discussion.

ISO 14971 defines the term hazard simply as a "potential source of harm".

But what does that mean? Is it a thing, an action or activity, an event or a condition?

According to one comment, everything could be a hazard!

Walking on the beach could be a hazard. Your smartphone could be a hazard. The seemingly fresh vegetables you got from the specialty organic store could be a hazard!

It is not that the definition of hazard in ISO 14971 is incorrect. The problem is that this definition is not sufficiently precise to be useful in practice.

Under certain conditions, walking on the beach could be hazardous. Under certain conditions, your smartphone could be hazardous. And yes, under certain conditions even vegetables that seem so nice and fresh could be hazardous.

So, an object or activity could be hazardous under certain conditions. However, these are not, by themselves, a hazard.

Why does it matter, you ask?

The main reason is that if we don't correctly identify hazards associated with our medical device in both normal and fault modes, then we can't effectively identify and implement appropriate risk control measures.

As a result, we can't be confident of our risk analysis and control measures to claim that we have mitigated all known and potential risks to an appropriate level.

That is why we have to be more precise about hazard(s) associated with our medical device, which are relevant in a hazardous situation where exposure to these hazard(s) could lead to one or more harms.

In my practice, I have seen a lot of confusion about basic terminology such as hazards, sequence of events and hazardous situations. This is the main reason why I created my risk management fundamentals course, which can help you build a solid understanding of 25 key terms and basic concepts used in the risk management of medical devices according to ISO 14971.

Here are a few insightful comments from my LinkedIn post

This is the magic of LinkedIn! We can learn so much from our colleagues. Here are 3 comments which I think provide more clarity on the term hazard.

Jim Kershner ?shared this insight:

?? "This has been an ongoing (vigorous? heated?) discussion for years in my career. Granted, the term "potential source or harm" is not particularly helpful. So for a long time I have been coaching others to think of a hazard as "the thing that actually hurts you" in this context. For example, high voltage is a hazard. A speeding bullet is a hazard. Gamma radiation is a hazard. Falling rocks are a hazard."

?David Grilli ?shared this insight based on his experience in both aerospace and medical device industries

?? "In going between 882 (Ericsson) and 14971, I'm not sure I've found a 14971 equivalent of mishap. I've equated "Hazardous Situation" to Ericsson's definition of Hazard and 14971's definition of "Hazard" to Ericsson's description of a hazard source which is just a piece of a hazard. In my opinion, 14971 misses the notion of a hazard transitioning into a mishap once the causal factors are realized."

?John Walters ?shared a very practical tip

?? "I have used a practice where I start at the injury/exposure and then work backwards to the initiating cause through a series of "due to's" (contact with/exposure to X due to A due to B due to initiating cause). This helps me focus on all 3 of these items - the exposure that results in the harm and helps me bin the hazardous situation and the correct hazard(s), the sequence of events which can help me group and organize similar hazardous situations near one another for more consistent analysis, and the true initiating cause which can help me identify fault types (single fault, multiple fault, correct use, use error, software, etc.) as well as help with identifying risk controls."

Learn more in this free, on-demand Hazard Analysis Made Easy webinar!

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Thank you to everyone who contributed to the discussion! Please continue the conversation below and share your insights.