For low severity I believe I would choose either acceptance or mitigation. This is because with low severity there is a potential harm but not a large one so it is not the biggest risk. There needs to be note of if the benefits outweigh the potential risks but overall in this situation it can be accepted or mitigation of the risk can be easily implemented. For a high severity of risk, it would need avoidance or mitigation. In medical devices, the risk needs to be minimum or at the very least manageable because the reason for a medical device is to improve a certain part of someone's life not cause another issue. So in the instance of high severity, the risk needs to be reevaluated and managed to decrease the severity.
Transference does not really reduce the risk level in total but rather pushes it onto someone else. And like the example in class, insurance would be a prime example of transference because for cars there is a large risk but if anything does happen, the insurance company takes care of a majority of it. It does not decrease how risky it can be but rather moves the consequences to someone else.
For risks of low severity, as there is minimal threat, risk acceptance may be the best option. Depending on the threat posed, one may choose risk mitigation if it is worth the cost however it is optional. For risks of high severity, I would choose mitigation to bring the risk down from high severity to intermediate or low severity. In my opinion, avoidance and transference each do not reduce the risk level in risk management. While avoidance does seem to "avoid" the causes and source associated with the risks, it does not reduce the risk itself. An example of using risk avoidance would be an organization limiting the input of patient information into an instrument or system to avoid the chance of interception in a cyberattack While it avoids the risk altogether, it does not reduce it. As mentioned in lecture, an example of using risk transference would be insurance. In this instance, the risk is given to a third party that is better equipped to deal with the risk.
I believe that acceptable would be considered as a low severity of a risk. For example, if a bandage would not work as intended, i.e. a lack of adhesion, then that would be something that can be an aid like adding medical tape to help in the adhesion. In that scenario, the hazard would be acceptable. A high severity would be mitigation or would require more detailed documentation of the effects. Avoidance wouldn't be sufficient enough. For example, breast implants would fall into this category as they can potentially harm the patient due to the rupturing aspect. Acceptance would not reduce the level of risk and I would use it in producing nicotine packages.
Medical Device Risk Management is a systematic approach of identifying, analyzing, evaluating, controlling, and monitoring all kinds of risk for a medical device from its design stage to end of life as per the standards. Low severity risk should be mitigated. However, it can be considered trivial which will make the product a faulty design. Some companies can overlook intermediate severity hazards by putting insurance. High severity hazards must be prevented entirely. And FDA won’t approve a product with high severity hazards.
If a risk has a low severity level, the best option would be to accept it, as the cost and effort required to mitigate or avoid the risk may be greater than the potential harm caused by the risk. For risks with high severity levels, mitigation would be the best option, as it can help reduce the impact of the risk to an acceptable level.
Transference may not necessarily reduce the risk level, as it simply transfers the risk to another party or entity. It should only be used when the receiving party has more expertise or resources to manage the risk effectively, or if it aligns with the organization's risk management strategy. Acceptance should also be used with caution, as it does not eliminate the risk but simply acknowledges it. It should only be used for risks with low severity levels or risks that cannot be avoided or mitigated.
For low severity I would choose acceptance. If the risk is not too harmful and rare it is easier to understand and process that the outcome will not have a major impact. I feel like acceptance is for situations where good outweighs the bad or the purpose is more important.
For low severity, I would choose acceptance. I am accepting the risk because that's is my best option. In the lecture on Risk Management, the example used for accepting risk was a scalpel. The best option is to accept the risk of the scalpel. You can avoid the risk but you can mitigate the risk by using safety measures. For high severity risk, I would avoid it or transfer the risk. For example, if there is a medical device that may give off electric shocks, I would avoid the risk by using another medical device. I would transfer the risk by requesting the company of the medical device to test the device before use.
I think acceptance, avoidance, and transference do not reduce the risk level. The extent of the risk still exists in these options. I would use acceptance when there is little to no option to lessen the risk. I would use mitigation when there is some ways to lessen the risk. I would use avoidance when there are other options to achieve the same end goal. I would use transference when there another party to take on the risk.
