When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
When dealing with risk , the only time we can accept the risk is before the clinical trial . We want to maximize the revenues and minimize the risks for a better sell and production . And to avoid to to be sue or taking to court.
Within the risk management process, there are four stages which include analysis, evaluation, management, and measurement. Once we have identified and categorized each risk in the analysis, assigned probability of occurrence and considered severity in the evaluation, we move into managing the risks. This is basically an open ended question of, well, what are you going to do about it? At this time, a decision must be made to either avoid, mitigate, or accept the risk (as transference does not occur in MDD). In the case of accepting a risk, this would be done when avoiding or mitigating is not possible. Design changes should first be considered, as well as the addition of safeguards. It is hard to say in a general sense of when a risk should be accepted, but in any case, it is always important to consider the risk verse reward. This may answer the question of if the risk is worth accepting. For instance, one risk of a stent implant can be that restenosis, or the re-narrowing of arteries, can occur and actually does happen quite frequently. Research in the field has not presented a definitive root cause as to why this occurs, but it is hypothesized that the outward force of the stent on the arterial wall causes cell migration and proliferation mechanisms to be initiated. This risk cannot be avoided or mitigated because such efforts would comprise the intended function of the stent, to hold the artery open. Therefore, this would have to be an accepted risk. But when considering the reward having a stent implant, such as the necessary restoration of blood flow, the acceptance of this risk can be justified.
Generally speaking, I think since the transference way is not available as risk management tool for medical device, the acceptance should not be considered in medical device unless avoidance and mitigation options are impossible to be selected. However, some cases that mentioned in the posted comments show how the acceptance is taken, and I agree with most of them. Nowadays, the COVID-19 vaccine will force the nation to accept the risk with this pandemic
In terms of acceptance, I think that acceptance should only be implemented if none of the other risk management options can be used. There will always be cases in which acceptance is necessary since without the risk, there is sometimes no function to the device. The scalpel example professor had provided is a perfect representation of this. In fact, many surgical tools would also need acceptance. For example, like the scalpel, surgical scissors would be useless if they were not sharp. Some of the other cases in which acceptance may be used is when the risk has low severity and low frequency. For these types of risk, a simple warning label, which goes along with acceptance, would suffice. Therefore, although acceptance should be the last risk management option to be considered, there are plenty of instances in which acceptance would be the best risk management option.
It is worth accepting the risk in cases where the user is aware of the consequences of the risk and is provided with all the safety manuals. It is always not the best idea to accept the risk but there are few cases where you cannot overcome this process. The scalpel example mentioned in the lecture is the best example to explain this. The surgeon is aware of all the risks associated with using the scalpel or any other medical equipment related to surgeries but they have to use it to perform surgery.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
I think the risk is worth the effort if the potential benefit of the device drastically outweighs the risk. For instance, if a new face covering medical device was being developed for hospital workers that work in the COVID section of hospitals there is a risk that the device material could irritate the skin of the workers or be generally uncomfortable. However, the potential benefit of these devices warrant the time spent to develop and distribute them.
In my opinion, I do not believe it is ever okay to accept any amount or level of risk when it comes to medical device development. This is a very specific area of device development that involves the health and, in some cases the life, of people. With such dire uses and needs not only should be manufactured correctly with no risk, they should also be under regular control and maintenance like calibration. This risk is not worth accepting because it can lead to lawsuits, loss of businesses and reputation damage.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
Some risks must be accepted when considering what the device is, but I think that tends to be when the job cannot be done without that device. For example, scalpels, suctions, saws, and other such devices/ tools, can be dangerous. In these situations it is vital that the user exercises extreme caution. Lasers might also fit into this category. They have the ability to cause severe burns if used improperly, bu they are needed for various dermatologic treatments.
Similar to pharmaceutical drugs that are being implemented for human consumption there is inherent risks associated with medical device development but there is also this idea of scaling risk, scaling for the level of severity or harm or the probability of which versus the overall benefit of the use of the device. We know medical drugs have side effects and within those side effects, the severity of harm is called question. By seeking the suggestions physicians and clinicians who have experience in treating patients that will use a particular device will tell you based on the medical condition associated if the severity of harm is low compared to the benefit of using the device. If the risk of harm is relatively low compared to the overall benefit, it may be worth noting that the harm of use scale aligns with an acceptable level of risk in the development of a medical device. This calculation is based on probability but should remain relatively low in order to meet regulatory guidelines and to be widely marketed as a safe device.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
When dealing with risks, according to the FDA it is okay to use medical devices that have not been approved only under the EUA (Emergency Use Authorization). Marcus Schabacker, president and CEO of Emergency Care Research Institute, stated "If these EUAs get revoked, and hospitals continue to use ] devices with an EUA, they're out of compliance. They're seeing liability risks. They're essentially using a non-approved, non-authorized device. And if anything happens to the patient, their liability risk would go dramatically up." Overall devices should not be used unless it is under the EUA although I personally feel that if a device was not already approved by the FDA then you are indeed taking risks. I also feel that the patient should be allowed to give consent on using a risky device to treat their condition. Regardless of the amount of harm that could be caused, all patients should be aware.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
I would say anything with pointy or sharp ends, electricity, or ventilators, etc. All of these play a major role in the development of health. But it is a risk every time it is used. We are risking electrocution, death, and scars just to name a few. Although we are taking a risk each time these devices are used.. they tend to do more good than bad. In this case, I would definitely say it is a risk worth accepting because it was created to help more than hurt so most times the risk is not really on your mind as much as the help it is providing.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
In medical device development, accepting risks is common, as the risks are usually directly related to the device benefits. If most medical devices are used improperly, they put the user and sometimes the administrator at risk, but if they are used properly, they are of great benefit. In this instance, the risks are worth accepting because if used properly, the benefits outweigh the potential for risks. To reduce these risks, it's important to thoroughly educate and train anyone using medical devices.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
In the medical field from the developer side an instance when accepting the risk would be okay to develop the medical device is when you know there is a treat market who needs the device and there is a high chance the FDA will approve it because there is such limited treatment for the disease that you are developing it for.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
I do believe that once a device maker has weighed the risk-benefits profile extensively that then they are able to make a informed and well thought out decision on the device. Once they truly know the ends and the outs of the device itself and what it is truly capable of then they can move forward. I do believe that this what is looked at so that the risk are known and that benefits outweigh the risk. I believe that with any product that there will be risks to it but the benefits should always be more.
