Dealing with risk
I would like to agree with a previous comment that vaccines are a case where the benefits outweigh the risks. I believe that all drugs and medical devices have risks. However, in the case of the recent pandemic, I believe it is far more detrimental to the human population to not take those risks. I would also think that organ transfers also run a large risk, but with greater benefits. It is possible that the organ will not take, but if it does, it can save a patient's life.
I believe that risk is acceptable in situations where a patient’s health is in question. For instance, if someone is experiencing symptoms that are associated with a stroke, completing an MRI is very beneficial and crucial to potentially saving a patient’s life. If the company who manufactured this device decided that the risk was too great to move forward with manufacturing the device, millions of people could have gone undiagnosed or treated due to this. It’s important for companies to asses the benefits and risks, to ensure that the benefits outweigh the risk prior to moving forward with production.
Yes, I like many others believe that many risks are worth accepting in the medical device field. Any type of surgery offers up a large risk that it may not be successful, for example, hip and knee replacement. In many of these and other medical cases, the risk of not doing it will exceed the risk of the device itself. Many drugs and devices have been or were supposed to be studied extensively in both animals and humans looking for different risks that can occur and judging how severe and frequent they happen. I think that any medical device, from implants to drugs, should be looked at by each recipient separately in a case-by-case basis; the risk to one patient may be different from the risk to others. Different drugs, implants, and vaccines can affect each person differently. Some medical devices offer up more risks than others, but at times for different people that are facing life-and-death situations, this may be worth it, whereas to the public it would be considered too risky. Overall, I think there is no other way than to accept the risk with many different devices and mitigate it as much as you can.
Even the simplest of products have risks associated with them, like a band-aid. The main risk posed by a band-aid is the pain associated with removing that band-aid if users aren’t careful in the process, and sometimes, not even being careful helps with the pain. I think that risks are inevitable for certain products, and a large part of this depends on how customers use these products. I agree with previous responses that by eliminating risks completely, a product, like the band-aid, won’t be able to perform its desired function correctly. For example, if we were to eliminate the band-aid glue to reduce pain, then the band-aid will never stick to the skin and cover the wound. However, some risks can lead to very dangerous situations even without the customer using the product incorrectly. For example, if a drug is composed of a substance that has proven to cause severe life-threatening side effects, then that risk should be eliminated and the drug removed or substituted. Therefore, risks can be worth accepting depending on how severe that risk is without the customer using it and whether or not it interferes with the overall purpose and function of a device.
As someone who works primarily on post-market surveillance of medical imaging equipment, it is my responsibility to determine the root cause when a system is not functioning properly. Imaging is commonly a part of a clinicians medical decision making process, therefore if any of the equipment being used is not working there is the potential to do more harm than good - either through a misdiagnosis, missed findings, or putting the patient at risk due to unnecessary radiation exposure. When faced with multiple down equipment, my team and I practice risk management tools such as failure mode effects analysis in deciding which issues require the most immediate attention. We typically determine how an equipment fails by first analyzing the problem, attempting to reproduce the issue, and evaluating its impact based on the severity (the number of patients and types of patients that could potentially be impacted) and probability (how frequently the issue occurs; intermittent or constant). We then take corrective and preventative actions to manage risks and monitor the units performance to measure/gauge the effectiveness of the solutions we implement. We also conduct preventative maintenances, safety testings, calibrations, as well as print warning labels for specific equipment or provide training within the departments we work with to avoid and mitigate future issues from repeating themselves.
As others have said in this thread, there are many instances where risk will need to be accepted in medical device development. Many times, these devices are highly invasive to the human body and the surgical procedure needed to implant them will pose a high-risk threat. This kind of risk is unavoidable and must be accepted as part of the design of the device. During the procedure, it will depend greatly on the surgeon or whoever is operating the tools being used and their knowledge of how to implant the device. It is ideal to accept the least amount of risk possible but in some scenarios, zero risk will be impossible. This means that lots of thought and brainstorming on how to minimize the risk will be key in medical device development.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
This is a great question; it should never be okay to accept the risk of something that may affect someone's life. However, there is always risk in the real world, especially if it is a life-dependable device like a pacemaker. If one accepts the chance that it may stop functioning after two years, you are gambling with someone's life, which is unacceptable. However, if you are dealing with a tongue depressor and the risk is that it is too pointy, for example. I believe it is okay to take that risk because you will not be harming the person severely in that case. Only minimal disturbance may occur, which is okay with most patients.
An instance where the risk is worth acceptance is when dealing with biologics in medical device development. While biologics such as vaccines, gene therapies, and therapeutic therapies each have specific functions that may be beneficial to the human body, each comes with a list of risks associated. Biologics are notorious for increasing the risk of infection due to a weakened immune system. While these risks are posed, the reward of these biologics oftentimes outweigh the risks associated.
When developing medical devices, especially devices that might be classified as Class III by the FDA, I think there must be a level of risk you have to accept, considering the standing of the device is already one of high risk. Obviously, you need to mitigate any obvious risks, such as electrical risks for class III devices such as pacemakers, etc. However, examples such as pacemakers will be the cause of mortalities for various reasons, that are not directly a result of the device, but of the body the device is attached to. With device development that gets approved by the FDA, a majority of these devices are more so improvements on predicates than they are new ideas. As a result, in order to make an improved, risky medical device, one must take and accept much of the risks associated with the device and especially its predicates.
I also agree with others that in our lecture it is mentioned that surgical tools which has some risks but due to ensure it's performance we have to accept that risks. Also, with almost every drug there are some risks or side effects but if is FDA approved and prescribed by doctors at a certain dose it is safe to consume so we have to accept that risk and understand when and how to use that.
I agree with the previous discussion that many medical devices tend to have a risk, even if they are approved. And almost all of the drugs have some off-target effects or side effects. I totally agree with the example given in the lecture about scalpels, that if we avoid all the risks that this equipment poses then the equipment will have no function. Therefore, the risk of cutting/clamping or getting injured need to be ignored. However, the risk can be mitigated by educating the user. And that's what the risk management system does.