Risk acceptance essentially is acknowledging but taking no action towards a risk based on certain criteria. Risk acceptance may create a higher probability of risk, but it will not guarantee the risk will occur. Rather, there are factors taken into account to determine the implications and consequences of allowing a certain risk to occur. The purpose of the risk matrix is to determine the severity and occurrence of potential risks. This matrix can help companies gauge how to address risk, whether it is to mitigate, avoid, or accept. Low risks are likely to be accepted as they are not frequent or minor. Another way to determine whether to accept a risk is to perform a risk-benefit analysis. One major factor to consider is costs: would the risk mitigation or avoidance methods be an unreasonable financial burden? Another factor to consider is the direct impact it would have on the patient: would this impact have major health consequences or minor side effects such as minimal, one-time pain?

The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and approaches should be taken to minimize the damage it may cause. So, within the acceptance phase, the organization need to access if the risk aligns with their objectives and regulations. Most of this is done using a cost-benefit analysis in industry where the company will look at the cost of addressing/fixing the issue and see if it outweighs the impact of that particular risk. The famous example is for the Ford Pintos who had the problem of blowing up if it ever got into a rear accident. Ford decided not to take action because the chances of getting a rear-ended accident is pretty low. However, this can be applied to medical devices because there are regulatory compliance considerations and human lives at stake. So, at best, the organization should monitor the risks they accept and have a response plans prepared in case the risk materializes

I think risk acceptance does not increase the risk nor does it keep it the same. It decreases the risk, because you know it is there. If you know there is a chance it might rain. Do you bring an umbrella? There is a chance it might rain or might now. So, you might end up using or not using the umbrella. But, if it does rain. You won't get wet, because you have your umbrella right? For that reason, the risk definitely decreases. 

Risk acceptance does indeed imply a higher probability of encountering the risk, as it involves acknowledging the risk without taking any specific action to avoid or mitigate it. This approach is typically chosen when the cost or effort of other risk management strategies (avoidance, mitigation, transference) is considered to be greater than the impact of the risk itself. However, it's crucial to understand that risk acceptance doesn't always lead to negative outcomes. It can be a viable strategy when the risks are well-understood, the probability of occurrence is low, the impact is minor, or when the potential benefits outweigh the risks. The key to successful risk acceptance lies in careful planning and thorough accounting for the possible consequences. For instance, in the development of a new product, a company might accept the risk of a small feature not appealing to a certain segment of their market. They might do so because the feature enhances appeal to a larger or more lucrative market segment, or because the costs of redesigning the feature are prohibitive. So, in summary, risk will only outweigh the reward when it is carefully planned for and accounted for. This means thoroughly evaluating the potential impacts and ensuring that the benefits of accepting the risk – whether in terms of cost savings, time efficiency, or strategic advantage – clearly and significantly exceed the potential negative consequences.

I don't think that accepting risk has any effect on the probability of harm. Logically, the only way to affect the probability of harm is to avoid or mitigate the risk, decreasing the probability of harm. Accepting that there is a risk and doing nothing about it does not increase or decrease the probability of harm. The only way that acceptance can lead to a decrease in harm probability is if the user is made aware of the risk and taught how to stay safe. Even if this step isn't taken, the probability of harm still does not increase just by simply accepting a risk. Risk acceptance should only be done for low occurrence or low severity risks. Avoidance and mitigation are both better methods for dealing with risk. 

Risk acceptance is a risk management strategy in which an organization consciously decides to accept a risk without taking proactive steps to avoid or mitigate it. Therefore, to answer the question above, risk acceptance can technically lead to a higher probability of risk because the organization isn't completely eliminating the risk, but it does not change the probability of the occurrence of the risk. If anything, it decreases the overall harm of the risk because the organization is still aware of the potential occurrence of the risk. In most cases, organization will choose risk acceptance when the risk has a low probability/impact and a cost-benefit balance. When an organization chooses to accept a risk they are typically accepting a risk that is unlikely to occur or, if it does, has a minimal impact. This makes it very manageable while major operations are conducted. Furthermore, another reason an organization may choose to accept a risk is because the cost of mitigating the risk might be higher than the potential loss if the risk materializes. Rather than spend the resources on preventing the risk from happening, it makes more sense to accept it. This, however, brings into question when the risk could potentially outweigh the reward. The point at which risk outweighs the reward in risk acceptance depends on factors like the risk’s potential impact, the organization's risk tolerance, and the resources required to manage it if it materializes. Generally, if the cost or damage of the risk occurring surpasses the benefits gained by accepting it, or if it threatens critical operations or safety, it may no longer be worth the risk.

While risk acceptance can be a valid strategy in risk management, it must be approached with caution when developing medical devices. Only hazards that pose a low risk of occurrence and have minimal impact should be considered for acceptance. Risks that are likely to occur, could cause serious harm to patients, or violate regulations should never be accepted, regardless of potential benefits. A thorough cost-benefit analysis should be conducted to evaluate whether a risk can be taken on, with patient safety and legal compliance being the highest priorities.

Several others have made very valid points already in that using an Acceptance approach doesn't necessarily increase risk. However, I think its very important to distinguish that using the Acceptance method generally implies there is very low risk to begin with OR that there isn't an alternative. Acceptance is understanding that the probability of that risk occurring is low. Its also used often in high stakes situations--say for example your astronauts are stranded on the ISS and you must retrieve them within a certain time frame. Certain risks need to be taken in that scenario as the alternative of not moving forward could be equally disastrous or worse as the possibility of that risk occurring. 

When analyzing the risk vs reward, companies may use tools such as cost analysis and severity of the harm taking place-would it be worth pursuing?

As I mentioned in another post, sometimes what we do not know... we may not know as there are endless possibilities in the world. Unfortunately with many things in the past, with new research, they are now bad for you, like how lead paint was considered safe many years ago and is now unsafe. I do believe acceptance happens when there is very little risk, not an outright one. I personally believe the best way to deal with risk management is mitigation to try and decrease the risk from some to as little as possible or none. The reality of this is that there may be none now, but some in the future with developing technology.

I don't think acceptance changes the probability of risk in a situation. I believe it just means that you are ok with that probability combined with the severity of a situation. This process was mentioned in the lecture as not having any real guidelines legally, other then being able to defend the decision you made.