In my opinion, it’s important to evaluate hazards and hazardous situations separately because they focus on different aspects of risk. Hazards are the potential sources of harm, like exposed electrical components or harmful chemicals, while hazardous situations occur when someone interacts with these hazards, such as a patient touching an exposed component. By considering them separately, it becomes easier to identify both the root causes and the specific scenarios where risks could arise, allowing for more precise and effective risk management strategies. This approach ensures that risks are addressed not only in the design but also in the real-world use of the device.

I completely agree that distinguishing between hazards and hazardous situations is key to effective risk management. Evaluating hazards helps us identify the inherent risks in the design or materials used, while assessing hazardous situations focuses on the interaction between the device, users, and environment.

For example, a hazard like exposed electrical components might be addressed through design controls (e.g., insulation or shielding), but evaluating hazardous situations ensures we also consider user training or environmental factors, like how the device is used in a wet environment. This separation ensures a more comprehensive risk evaluation process that captures both the "what" (hazard) and the "how" (hazardous situation).

For further discussion: When prioritizing risks, do you think teams should focus more on mitigating hazards or preventing hazardous situations, or is it always a balance between the two?

It’s important to look at hazards and hazardous situations separately because they happen at different stages of risk. A hazard is something that can cause harm, while a hazardous situation is when someone is actually exposed to that hazard. By separating the two, we can better understand where things can go wrong, whether it’s in the device design or how it’s used. This helps make sure we put the right safety measures in place to either remove the hazard or prevent people from being exposed to it.

I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention to stop the danger from ever happening in the first place. That's why regular maintenance is usually scheduled for medical devices and other types of machinery used, and other type of inspections to report when something that could become a hazard is found. Once a hazardous situation actually occurs, it becomes about having a plan to respond to it, not prevention. The most common example is active fires or devices failure during use, you can't stop it from happening, only following the appropriate emergency protocols, like planned evacuation to limit harm. Separating these two terms help distinguish clear plans for both preventing and reacting to potentially harmful situations. What are some ways companies can make sure that their plans for hazardous situations stay relevant and effective as they change, and new risks appear over time. 

I agree with your explanation — distinguishing between hazards and hazardous situations is essential because it helps clarify when and how a potential danger actually becomes a risk. A hazard on its own may not always lead to harm unless it’s paired with a specific circumstance that exposes someone to it.

In biomedical device development, this separation allows teams to design more effective controls. For example, knowing that an exposed wire (hazard) exists is only part of the picture; identifying that it could contact a patient during use (hazardous situation) helps engineers design insulation or fail-safes at the right point in the process. This level of detail strengthens both risk analysis and mitigation strategies, ensuring compliance with ISO 14971 and enhancing patient and user safety throughout the device’s lifecycle.

I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add is how time and device evolution should not blur the line between the two as technology becomes more advanced. A hazard for a device does not always begin as dangerous, but it becomes hazardous as it interacts with users and aging components. This transformation over time is emphasized in ISO 14971 as risk evaluation throughout the device’s lifecycle. 

For example, an insulin pump has an electrical battery and reservoir that are stable and safe when new. This makes them simply “hazards” in the risk file. However, as the pump undergoes multiple sterilization cycles, there can be seal degradation and microcracking. This could lead to insulin leakage and a hazardous situation that directly exposes the patient to danger. This is when a hazard turns into a hazardous situation. Similarly, with AI-based devices that are emerging in the market, algorithmic drift can turn safe behavior into unexpected hazardous situations if the model begins to make adjustments after exposure to new data. 

Evaluating hazards and hazardous situations separately at one moment in time is not enough. There needs to be dynamic linkage in the risk analysis in which engineers ask what is hazardous and when, and where the hazard can become a hazardous situation. This includes long-term testing and post-market surveillance to close the gap. 

Something else that is overlooked is human behavior drift. The most well-trained and experienced clinicians might take shortcuts in evaluation under pressure, leading to hazardous situations when hazards are ignored. That’s why I think teams should simulate misuse “workarounds” during development to understand exposure points. Additionally, this is why I think along with separating hazards and hazardous conditions, they should be streamlined into one as a separate point to mitigate as much risk as possible. 

Do you think future ISO 14971 revisions should require usage-dependent risk evaluations in which teams have to show how hazards evolve into hazardous situations? With the increasing use of AI and the feasibility of creating virtual systems to simulate real-life scenarios, would having long-term simulation be good for risk management? How else can hazards and hazardous situations be avoided and dealt with in the advancing times? 

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or mechanical hazards. A hazardous situation is when you are exposed to the hazard. Hazards can lead to hazardous situations which can lead to actual harm. As many users have said, knowing and evaluating the difference allows the identification of where risks may occur. They are not the same thing. Hazards are not the specific event that leads to someone being exposed to it. It is more of a root cause. Say for lysis buffer, for example, what type of hazards are there? The most common one is a chemical hazard. Step one was identifying the potential danger and for harm to users. Once again, hazards are not the interactions that lead to the exposure to the danger; the hazard is the danger. Step two is to identify what potential events can lead to the exposure of the hazard. It can simply be one event or it could be multiple. The hazardous situation with a chemical hazard is the exposure to the chemical hazard. With the lysis buffer example, the situation can include being exposed to the chemical via direct contact, ingestion, or inhalation. From here, we can see that this chemical can lead to multiple hazardous situations. These can lead to actual harm being skin and eye irritation, damage to the throat and stomach, as well as damage to the respiratory tract. In risk management, assessment, and analysis, it is important to consider these two aspects separately to identify the root cause of risk and the potential event that can lead to harm. Being able to identify these differences allow manufacturers to take extreme precautions, such as finding a way to implement that this chemical is dangerous. This would allow them to develop warning signs, tasks of handling, using and disposing of chemicals in a hazardous chemical handbook. 

To answer another question, I think that there is always a balance between mitigating hazards and preventing hazardous situations. Teams have to complete risk assessments, analysis, estimation, and evaluations. They use tools to deal with the risks, if necessary, and these include avoidance, mitigation, acceptance, and rarely, transference. It all depends on the probability and severity of the risk. There is a balance because in order to prevent hazardous situations, you need to look at the root cause to try to eliminate the hazard. In these assessments, removing the hazard completely is the best option, but sometimes it is not easy to do so, hence mitigating the hazard is also another option. Eliminating the hazard would lead to there being no hazardous situations to worry about. With mitigating the hazard, there are still some potential hazardous situations, but with implemented control and procedures to deal with the hazard, the chances of those situations decrease.

I think ISO 14971 revisions should include risk evaluations to show how hazards can turn into hazardous situations. That should already be a thing since again, you are looking at the root cause of something harmful and what kind of events would lead to the user to be exposed to the potential dangers of the device, leading to harm. In addition to AI, having simulations to show real-life scenarios of hazards and hazardous situations can be beneficial to observe the potential or possibilities of these events happening without the risk of harming another person in the works.