Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws,  taking away the dangerous aspect of the tool would also remove the ability for the tool to perform as it is needed. In these cases, I think it is worth accepting for the surgeons to be able to perform the tasks required for various procedures. Though this risk should be accepted, it is also necessary to include training and instructions to ensure that the tool is being used as safely as possible to minimize risk. 

All drugs contain a level of risk to the user. Many of these chemicals are labeled safe by the FDA only in instances where a licensed physician may see fit for their patient. However, in devices that require drug delivery, the risks brought along by the drug in question may not apply unless the drug is specifically built into the design of this medical device. It is again up to the physician to decide patients with the highest risk/benefit ratio for these devices.

Posted by: @traceymraw

Similar to the scalpel example in the lecture, I think there are many surgical tools where the risk must be accepted. For tools such as bone drills and saws,  taking away the dangerous aspect of the tool would also remove the ability for the tool to perform as it is needed. In these cases, I think it is worth accepting for the surgeons to be able to perform the tasks required for various procedures. Though this risk should be accepted, it is also necessary to include training and instructions to ensure that the tool is being used as safely as possible to minimize risk. 

I completely agree. You have to understand that the surgeons using these instruments are highly trained individuals that obviously know what they are doing. In most cases, they want the sharpest scalpels/saw blades/drills/etc. as those will allow them to complete the necessary steps in the procedure as accurately and quickly as possible. They go through years of training using these instruments in medical school and in cadaver labs prior to actually using them in surgery, so by the time they are using them in surgery, they are pros. If their hand were to slip in surgery and they were to cut themselves, they wouldn't blame the company for designing a saw blade that's too sharp, since that is exactly what they want the saw blade to be. This is just a risk that is accepted by both the company and the surgeon with the understanding that these instruments need to be sharp in order to perform the associated steps of the procedure. 

One instance I can see accepting risk being okay is with vaccines. Now I don't align with anti-vax principles at all, but I am pretty sure there is a 1 in a million chance that there's an adverse effect in vaccines. That doesn't mean that people shouldn't use vaccines because of this risk, because it is nearly infinitely small and the risk of disease if vaccines are not used is much worse! Other instances I can think of would be blood transfusion, plenty of drugs that are prescribed and available over the counter, and surgical equipment. You can probably make the argument for any medical device, even a bandage, that there are risks in the device. What if someone puts a bandage on the wrong way and cuts circulation to a limb? That's why companies relinquish liability for what happens to users when their product is used outside of the directions given to the user. 

Yes, I believe it is worth accepting the risk as some devices can not work if we remove the risk aspect of it, for example, a bone drill or a painkiller (when thinking of drugs). It's just that the consumer needs to know how to manage the device.

In the medical device industry risks are identified by the residual safety risk zone for each risk identified to determine it's acceptability. They may be identified into 3 zones. Zone 1 is when the risk are usually acceptable and do not need any further analysis. However, zone 2 are partially acceptable and require further analysis and are considered acceptable only if adequate actions are identified to mitigate the risk. Finally the zone 3 risks are unacceptable if required action cannot be taken to get them into the zone 1 or 2.

In agreement with some of the replies above, some residual risk is acceptable if it is necessary for the function of the device. In these cases, it is important to consider who will be using the device. For the example of the scalpel, we expect that the person who will be using the scalpel is trained in using it. We may consider designing a cover for the blade which will stay on the scalpel until it is about to be used so that it is not mishandled by someone who is not properly trained to use it. One of the devices that I have worked on is a blood oxygenator set that is used during cardiopulmonary bypass with a heart lung machine. Since this device provides critical life support, any major failures can result in fatality of the patient. However, much of the residual risk that cannot be designed out or safe-guarded is accepted because of the fact that it is used by cardiac surgeons and certified perfusionists (people trained to operate heart lung machines during cardiopulmonary bypass), so if any issues arise they are trained to deal with it right away. 

Much of what we have learned about risk management uses terms like "minimize" and "as much as possible" due to the nature of risk. Risk is something that can never completely go away. Some amount of risk will be present in any product development project. Risk is even present in something as simple as walking in a straight line. So when potentially dangerous medical devices are being developed it is obvious that there will be a significant amount of risk involved. So for this reason, there are techniques and methods used for identifying and minimizing potential risks. But inevitably, for the product to be used, there will always need to be some acceptance of risk. When this risk is at a sufficient level to accept is somewhat of a judgement call and circles back to the idea of minimizing risk as much as possible.

As we all know, X-ray devices have a lot of risks if the person was expose to high radiation levels, but having the X-ray was huge deal in the medical history. Some risks we need to accept for the greater good especially if it is the device primary mode of action and there is no other way to reduce some risks but it can still save people life.on the other hand, if we do not accept the risks the amount of the medical devices in the market will be reduced to less than 10% as each device have it is own risks. 

Project risk management is the process of identifying, analyzing and then responding to any risk that arises over the life cycle of a project to help the project remain on track and meet its goal. Risk management isn’t reactive only; it should be part of the planning process to figure out risk that might happen in the project and how to control that risk if it in fact occurs.

A risk benefit analysis can be done to determine whether the risk outweighs the overall benefit to the patient. As mentioned above, vaccines are a good example since the overall immunity you get has more benefit where the alternative is getting the disease. If the percent effectiveness is high then it reduces risk even more. Side effects are common however they might be less severe than the consequences you could face from getting the disease you would be vaccinated against. For sharp items that have high risk for users, risk can be mitigated with proper training for the users. Covers for the sharp portions can be implemented when the item is not in use. Labeling and proper disposal procedures should be followed. A combination of the controls mentioned and more would help mitigate the risk enough for it to be considered acceptable. 

A Risk Matrix can also be used to assess risk and see whether or not the risk should be accepted. For a medical device with high severity of risk, it may be acceptable if the occurrence is occasional, since that puts the overall risk at a low level. Therefore, in the case of the scalpel, on top of accepting risk due to its functionality being sharp, one could also accept risk of the surgeon being cut if the severity is minor and occurrence is occasional. Of course, training and proper precautions would decrease the occurrence of such events, thus it is important for medical device companies to be fully transparent on the possible risks and it is critical for the users to be educated or trained on medical devices. 

Dealing with risk, there are certain steps to follow. To start with, a risk register must be created. A risk register is basically a spreadsheet that includes areas to put information about the description of the risks, the likelihood of happening, impact on the project, appropriate response, etc. In other words, it is basically like a playbook to be filled. After that, the risks must be identified. This can be difficult according to a project, and it's highly likely not all the risks can be foreseen before it can happen. Still, it is an important step to identify a high percentage of the risks that might happen. Then an identification of the positive risks and opportunities must be made. This is basically including all the events that might happen to the project and estimating what impact it can have on the project. Following that, determining the likelyhood of the identified risks is the next step to be done. Whatever risks there may be, it is not certain that It will happen or not. In other words, there is a statistical chance it can happen or not. Determination of this can help in which risks must be focused on to reduce its likelihood of happening. After this process, an estimation of the cost for each risk must be identified. If the risk becomes a reality, what is/are the cost/costs to the project is a question that must be answered. After that deciding the workforce for the identified risks is another logical step to take. This way, a specialized unit will deal with that specific risk if it happens most efficiently. These teams will also be responsible for reporting the risks if it happens. This can also help reduce the likelihood of the risk happening in the future, according to the risk management units report's feedback. Lastly, periodic meetings must be held to review the risks and maybe identify new ones along with the project. This will maximize the efficiency of the risk management procedure.

This is a great question. In terms of medical devices, I feel like there are a lot of examples of devices in which we need to accept the risks. For example, as stated in the lecture with surgical tools, we need to accept the risks of cutting/clamping/sucking/etc. or else, if we avoided these risks or designed them out, the device would be unable to do its job. Another example I was thinking of was a defibrillator. There is a high risk of electrocution if the instructions aren't followed carefully. The job of the person using it is to follow these directions. If the designers decided to lower the voltage cap of the defibrillator, it may not be effective for its purpose. I believe that all of these acceptance of risk are worth it and necessary.