Should we treat it as a hazard, a hazardous situation or a harm?

A diagnostic device gives a false or invalid result causing a delay in diagnosis and therapy. The software controlling a medical device crashes during setup or during surgery. A patient monitor fails to alarm in a critical condition causing a delay in urgent, potentially life-saving, medical intervention.

Delayed therapy, prolonged procedure, additional unplanned interventions, or an aborted procedure are all reasonably foreseeable scenarios resulting from a medical device malfunction or use-error. As a result, it is very important to adequately analyze and control the risks arising from these scenarios.

In practice, it often becomes quite challenging. One reason is that there are so many different scenarios and outcomes that need to be considered. If we are not careful, it can quickly become an endless game of what-if. 

An important question to answer first is whether we should treat it as a hazard, or a hazardous situation or a harm? 

Recently, we posed this question on LinkedIn in a quick poll. We received a wide range of responses and opinions reflecting a range of diverse practices in the medical device industry. The chart below summarizes the 119 responses received as of this writing:

Although a majority of the respondents selected hazardous situation (50%), a significant number chose hazard or harm (43%). It is also important to note that about 6% selected "Other" as their answer. 

It may be useful to first review how these terms are defined in ISO 14971:2019, the International Standard for application of risk management to medical devices. 

Hazard: potential source of harm

Hazardous Situation: circumstance in which people, property or the environment is/are exposed to one or more hazards

Harm: injury or damage to the health of people, or damage to property of the environment.

A lot of good comments provided excellent context to understand these results. Let us review a few of these comments below:

 In short, it depends!

 That is why our perspective is that there is no right or wrong answer. It is more important to define an approach that clearly identifies the linkages between device or use related events that initiate a sequence of events, which then lead to a hazardous situation where the user and/or the patient is exposed to one or more hazards. This linkage is important to understand the type and severity of harm that may occur. 

This linkage is illustrated in the figure below, which also offers an important insight. The link between a trigger event and eventual harm is not always linear. Any medical or surgical intervention, may by itself, lead to another sequence of events and a different hazardous situation. 

We believe that this analysis should be rigorously and consistently applied when analyzing all risks, not just those arising from delayed treatment. 

In this context, delay in treatment could be an initiating event or a hazardous situation that leads to additional intervention, which then leads to additional sequence of events and another hazardous situation. As a result, one or more harms of different severities may occur. 

Let us consider different ways to handle delay in treatment and discus.

When delay in treatment is analyzed as a hazard

If we can link delay in treatment, clearly and directly, as one of the main sources of the harm(s) experienced by the patient, then it makes sense to consider it as a hazard. The hazardous situation is the surgery itself, which is then prolonged as a consequence, and where the patient is exposed to the general hazards of surgery. 

In our practice, we have facilitated this approach by creating a distinct hazard type corresponding to delay in treatment. This hazard type can be associated with one or more potential device failure modes, or reasonably foreseeable misuses. This allows a very easy way to consider all possible initiating events that may lead to a hazardous situation. 

Another benefit of this approach is that it helps separate device and/or use-error related hazards from other hazards associated with the surgical procedure itself. In the big picture, a goal of medical device risk management is to control device and use related hazards, not necessarily surgery-related hazards. Those hazards must be controlled through good surgical practices, infrastructure and competent healthcare professionals. 

When delay in treatment is analyzed as a hazardous situation

A hazardous situation, by definition, involves the presence of one or more hazards to which the patient is exposed. If we consider delay in treatment as a hazardous situation, then we should also identify, as clearly as possible, the associated hazards. It should be clear that these applicable hazards may be different in different types of delay in treatment. 

In our view, this approach is somewhat challenging because it requires a different hazard mapping in each situation. It can be done, but it requires an extra step of collecting all device failure modes and reasonably foreseeable misuses associated with a certain kind of delay in treatment, and then identifying all applicable hazards. 

When delay in treatment is analyzed as a harm

A harm, by definition is injury or damage to health of people. Therefore, if we consider delay in treatment as a harm, we need to clearly estimate its severity. Remember, risk of each harm is the combination of its probability of occurrence and its severity. 

In our view, this approach is very challenging, because it is difficult to define a severity level of the actual harm experienced by the patient with high certainty. It may range from a minor inconvenience to a life-threatening situation and even death. It depends. 

As a result, a common industry practice is to classify delay in treatment either as clinically significant or insignificant. An alternate approach is to identify 3-4 levels of delay in treatment based on the amount of delay. As an example, delay less than 15 minutes, delay more than 30 minutes, delay more than an hour etc. Based on the amount of delay, a severity level is assigned. But this may not always be accurate. Depending on the circumstance, a patient can die within minutes if delay occurs at the most critical stage during the procedure. 

In summary

Delay in treatment is a reasonably foreseeable scenario with the use of medical devices which can lead to harm. As a result, we must analyze the risk of harm appropriately and adequately. Our poll on LinkedIn illustrates a considerable difference in how it is treated in the industry. While we continue to believe that there is no right or wrong approach, we have typically considered it as a hazard in our practice. The main reason is that it helps us facilitate an easier way to link device failure modes and reasonably foreseeable misuses with sequence of events, hazardous situation and harms.

 Finally, we just had an awesome discussion in our recent Interactive Q&A session on this topic. A full recording of our discussion is available to members of our free Knowledge Sharing Forum. Register here for free if you are interested. See this post for an introductory video clip to learn more about our monthly Interactive Q&A sessions.