I think it should be acceptable to accept a risk that won’t cause harm to patients or harm to the one’s using it. If it’s something small like a cosmetic design error, or an inevitable risk, then it should be accepted. Like it the device is something like a needle. There’s a risk that a person could be stabbed, but that is the purpose of the device, the inject (or stab) it into a person. In this instance, the risk has to be accepted because it is the purpose of the device. I think the risk is acceptable, if it doesn’t harm a patient or operator if used properly. If the risk comes from improper use, then that’s not something that should stop a device from making it to market.
I am not sure if there is a right time to accept the risk when developing a medical device. However, this must happen in some cases because without taking the risk you would not know the impact It has on a patient or how well it works with people who have different health backgrounds. I do not think it is worth the risk involving safety because most medical devices are made to help one’s health. Sometimes you must accept the risk to understand the impact but only if its safe to do so.
I think with most medical devices, there is already a baseline level of risk established, since you do not know if that device will always perform as it was intended. Some devices might be quite aggressive and abrasive to the human body in order for it to be used properly and have the desired outcome. Without that high potential risk factor, results may not be satisfactory. So yes, I do think if the risk is reasonable, it can be acceptable.
Risk management in healthcare comprises the clinical and administrative systems, processes, and reports employed to detect, monitor, assess, mitigate, and prevent risks. By employing risk management, healthcare organizations proactively and systematically safeguard patient safety as well as the organization’s assets, market share, accreditation, reimbursement levels, brand value, and community standing.
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 that there are many medical devices that are used whose benefits outweigh the possible harm it could inflict on people. As a mother, when delivering my children I opted for an epidural. This in my opinion is one of the most invasive devices that could pose a significant amount of damage to a patient. However, this is given as an option for delivering mothers or even sometimes is the only option, and if done correctly alleviates some of the pain. The risk of damage is minimal for these procedures, but as with anything we do, eat, or use there are associated risks to be aware of and ultimately its up to the person if the use of the medical device is truly worth it.
@salston I couldn't agree more! I often think about the devices that we currently have in the medical field. At some point a risk assessment team thought about the "what ifs" and took a chance on a device because of its benefits. With almost every medical device there has been some marginal negative effects that some people have unfortunately experienced. However, on a grand scale most of the time the benefits far outweigh the risks associated with the medical device.
I don't know that there is ever a time when excepting risk is okay, because even if the risk is small someone will get hurt or suffer side effects. Realistically though, there is no way to ever fully guarantee no risk. So, I would think the best thing to do is, to get the risk level as low as possible. For example, if less than one percent of people suffer a side effect, then I think that amount of risk is okay. Now, I also think that if the risk is minor than that is ok. For example, if the risk is ten percent of people may develop a slight rash that will go away on its own in a few days. That is also an acceptable amount of risk.
I think that accepting some risks is vital while developing x-ray devices. They are necessary for doctors to direct medical staff while they implant catheters, stents, or other devices within the body, treat tumors, remove blood clots or other blockages, and help diagnose disease and monitor treatments. Since everyone uses this device, I'm willing to take a chance.
Thats a good question. This has to go into risk evaluation section because you really have to compare between the risks and benefits. If you're able see that the benefits are worth the risk then go for it; however, that's a big gamble to take. Anything could happen and medical devices can fail. You're responsible if that medical device fails, and when it does fail, you're subject to possible financial consequences or termination.
Risk is involved in any and everything meant to benefit health or increase the quality of life. The COVID-19 vaccine is a prime example of instance where it be okay to accept the risk. The benefits far outweighed the risks by a 1000x fold. Still, people are hesitant to accept the risks associated with the COVID-19 vaccine but the magnitude of benefits - i.e. treatment, recovery, and protection are life-saving . I think the risks are worth accepting considering the mortality and morbidity rates from the pandemic reveal a chilling tale. Although, we are still in the early stages of monitoring the effects of the vaccines across the population, I think longitudinal studies will reveal the patient impact of the life-saving measure.
When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?
Accepting risk is inevitable, despite the risk levels present in a medical device during development. It depends on the risk, however, when deciding if accepting is worth it and how to proceed if it's not. In instances where a risk level is low or moderate in both severity and probability, it's likely worth accepting for the simple fact that the risk, should it occur, will be of little harm to the consumer. When there's a high severity risk or high probability of being affected by a risk, that's the time to determine if said-risk is worth accepting. Sometimes a risk like death is present, and while high in severity, could be extremely low in probability. Because we're in the medical field, this is a perfect example that occurs frequently, but the higher the probability, the lower the decision to accept the risk should be.
In medical device development, there are always some levels of risk that must be assessed. Conducting a proper risk analysis will allow all parties involved to determine, what types of risks are involved, as well as associated costs, and potential failures that could occur. Once all risks have been identified, the company can now decide if it is worth the risk to proceed with the project and mitigate challenges as they arise or not to proceed. I believe that a lot of drug and medical device companies put products on the market with known adverse effects and high risks simply because they know that they will make millions or billions long before the appropriate studies come out against their product. By that time, they can afford to pay the settlements. We have seen this over and over. It would not be my business model, but I do see how companies rationalize the risks.
@ljatta I agree with you completely. From what I have read and understand, the vaccine was created to minimize the incidence of death from contracting the virus, not to prevent an individual from catching it all together. There was a lot of misinformation surrounding that purpose. Additionally, the vaccine is a lipid-soluble product which means there are a particular set of effects that occur with all lipid-soluble substances including injection site redness, muscle soreness or myalgia, and the actual Humoral and Cell-mediated effects from mounting an immune response when the inoculation is given. These were all normal side effects of any vaccine. I, for one, mounted a pretty robust immune response with my second shot and I didn't question it for a second because I fully understood what my immune system was doing. For a person without a science background, I could see how troubling it must have felt; however, to date, I have not had the covid virus and I like to think even if I do my body is primed to protect me from serious illness or death. I absolutely agree with you that the benefits far outweigh the risks.
@justinwilliams I concur, x-ray was the sole way I could see the spine when I was in practice as a previous physical rehab director at a medical office. I ordered an x-ray on every new patient because even though a detailed medical history was obtained and a thorough physical exam was performed things get missed. I was always surprised by the number of patients that seemingly forgot they had metal rods or screws in their joints. The x-ray was a way to "look under the hood" so to speak and the minimal amount of radiation emitted was worth the risk to prevent serious injury. We also used leaded gonadal and thyroid shields to prevent over-exposure of sensitive tissues and we shrank the x-ray view to capture on the absolute necessary areas we wanted to visualize. Always trust, but verify. X-ray imaging certainly allows for that type of verification.
@zandrews We live in a world full of risk. Just waking up in the morning and walking out the house is a risk because we don't know what can happen. Driving a car, riding a bike, even walking across the street can be risky. I believe that risk is just inevitable part of life and should be proceed with precautions. With this being said each individual must take a risk assessment and risk management in our daily lives. When it comes to a career moves and tough decisions that have to be made. It's all about what are the pros and cons of the risk and is the risk worth taking in the first place.
