@traceymraw I agree with you Tracey. You make some really interesting points in your reply. Some risk are necessary because they are unavoidable for the effectiveness of the product. The examples you used are great as well. Like the bone saw. You need something as strong as a saw to cut through bone because it is so dense and handling a saw or any sorts comes with risk. The most we could do in cases like these is make sure the person handling these instruments are properly trained.
@traceymraw I agree with you Tracey. You make some really interesting points in your reply. Some risk are necessary because they are unavoidable for the effectiveness of the product. The examples you used are great as well. Like the bone saw. You need something as strong as a saw to cut through bone because it is so dense and handling a saw or any sorts comes with risk. The most we could do in cases like these is make sure the person handling these instruments are properly trained.
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 risk in medical device development is incredibly different than many other industries and is handled differently because of that. There is no standardized criteria for the amount of risk a device or project can take on and that level of risk is ultimately determined by management and the project manager. I think risk in medical devices should be minimized as much as possible. If you think about defect rate (i.e. how often a product you make is to be a defect) the product and industry becomes paramount. For example, assuming a 1% defect rate for each product made, this might be acceptable in an industry like toy cars... however in medical devices this is very bad. If 1% of each medical device made is defective that would be horrendous both financially but also morally for a company. Due to this, I think medical devices should assume the least amount of risk possible in order to maintain that the devices that are being created are being as safe and effective as they can be.
Thanks,
Matt
I think the severity and occurrence of the risk should be analyzed first so that we know whether a risk should be accepted or not. Some risks have a very low severity, so they can be accepted as they cause little to no harm. Furthermore, as mentioned in the lecture, the product itself can be a risk such as a medical knife. There is always the risk of someone cutting themselves, but that is what the product is designed for. Hence, there is no specific guideline to when a risk should be accepted or not. Every risk should be analyzed to its particular case in order to decide.
An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because it is anticipated that there wont be enough produced by that time. This is an acceptable risk because the product not only gets use, but it gets buzz too. In addition to this, if it gets sold out, it looks even better for the product.
An example of a risk that can be instance where it would it be okay to accept the risk in medical device development is a risk that there wont be enough of the device to sell on the market because it is anticipated that there wont be enough produced by that time. This is an acceptable risk because the product not only gets use, but it gets buzz too. In addition to this, if it gets sold out, it looks even better for the product.
This depends solely on the circumstances of the medical device. For instance, some devices are created and are only used by professionals. For those specific ones, accepting risks isn’t necessary. The example of the surgical blade is on point when discussing this claim. Surgical blades are used by surgeons or licensed doctors and nurses. They are expected to have adequate knowledge of how to use the device. This doesn’t mean you ignore potential risks, but your approach is not as crucial as other risks. Drugs or other FDA-approved medication are left to the consumers, if the FDA approves it then the risks are manageable. The patient is responsible for the intake of the medication and any possible side effects.
Thanks.
In general, during medical device development it is acceptable to accept the risk if the benefit outweighs it. There are a few different weighs to track and identify risks. Common documents include the risk management plan, risk assessment, and risk report. Each of these documents play a crucial role in identifying the risk associated with a medical device. Additionally, the risk matrix classifies risk by severity and occurrence. Once every element of risk analysis and identification has been completed, next steps include avoidance, mitigation, acceptance, and transference. For the risk to be accepted for higher classifications of devices, clinical trials must demonstrate the performance of the device outweighs the risk and significantly benefits the user. Additionally, ethics is an important factor that should be considered when determining whether or not the risk of a medical device should be accepted.
When dealing with risk, there are some instances where it would it be okay to accept the risk in medical device development. When the benefit of the consumer is greater than that of the risk of releasing the product. An example can be how the vaccines for the pandemic were given special conditions that allowed them to be put out to the public. Testing was basically going on at the same time the vaccines were being administered.
Risk is an inevitable element of product development. Unfortunately, there is at the very least a low level of risk associated with each product that may or may not is known by a company/manufacturer. I think the best way to navigate risk via a risk profile is by rating each individual potential risk (known). The purpose of a risk management team is to investigate these elements. The result is a developed list of possible adverse effects; however, if a product has been tested and cleared for each raised concern, there is still a low-risk level for unforeseen circumstances.
There are risks associated with everything; however, it is important to determine if the benefits outweigh those risks enough to decide on if it would be worth it to accept the risks. With devices that have higher risks, I think it is important to do as much testing as possible in the planning phase in order to find the perfect parameters in which the probability of the risks are the lowest. Even if that is not possible, I still believe that accepting risks in medical device development can still allow for greater benefits.
When dealing with risks for medical devices, there is always going to be an instance where risk is accepted. Any device has to accept some risks when a device is released for use. But you always want the benefits to outweigh the risk. A good example of a medical device that has accepted risk is IUD for birth control in women. The IUD has several side effects for women but it is believed that the benefit of stopping conception outweighs the risks associated with the device.
When deciding if risk is acceptable, I think you should consider the following to see if it’s worth the risk. Risk cannot be completely eliminated, so sometimes you have to take the best of the worst. Even when taking the best of the worst, you should discern which is worse. The following listed below should help decipher and be taken into consideration when deciding.
Severity of harm: is categorized into three levels, each of which includes a duration component. The three levels are medical device-related deaths or serious injuries, medical device-related non-serious adverse events, and medical device-related events without reported harm.
1.Medical device-related deaths and serious injuries include those events (including procedure related complications) that may have been or were attributed to the use of the medical device and that cause or contribute to a death or injury or illness that is life-threatening, results in permanent impairment or damage to the body, or requires medical or surgical intervention to prevent permanent harm to the body.
2.Medical device-related non-serious adverse events include those events (including 11 procedure related complications) that may have been or were attributed to the use of the medical device and that cause or contribute to minor, temporary or medically reversible injuries that do not meet the criteria for classification as a medical device-related serious injury.
3.Medical device-related events without reported harm include medical device nonconformities which have no related harm, medical device malfunctions which have no related harm, procedure related complications with no related harm, and instances where a nonconformity or regulatory noncompliance was observed at the medical device manufacturing facility and no defective devices were released to the market. A medical device nonconformity or malfunction can include the failure of a medical device to meet its performance specifications even though the device still performs adequately to meet the needs of a given patient.
Likelihood of risk: considers risk factors related to the potential number of patients at risk of experiencing harm: the likelihood that a medical device will have problems, the likelihood of a patient experiencing harm, and the total number of patients exposed. We encourage manufacturers wishing to provide data and calculations for use in evaluating this factor to contact FDA regarding what information may be relevant and appropriate to the issue being assessed.
Distribution of nonconforming devices: includes whether nonconforming product has been distributed and if so, how many nonconforming devices are on the market.
Duration of exposure to population: is the length of time between initial patient exposure to the device with the identified risk of harm and the point at which the risk of harm is successfully addressed.
False-positive or false-negative results: are important risk factors for diagnostics. If a diagnostic medical device gives a false-positive result, the patient might, for example, be incorrectly diagnosed with a serious disease and receive an unnecessary treatment, incurring all the risks that accompany that treatment. If a diagnostic medical device gives a false-negative result, the patient might not be diagnosed with the correct disease or condition and might not receive an effective treatment (thereby missing out on the benefits that treatment would confer). The risks associated with false positives and false negatives can be multifold, but are considered by FDA in light of probable risks.
Patient tolerance of risk: is the level of concern that patients have regarding harm or potential harm caused by the device. Patient tolerance of risk may take into account both the patients’ willingness and unwillingness to use a nonconforming medical device, to use a device manufactured by a non-compliant manufacturer, or to tolerate harm (both probable and actual).
Risk tolerance: varies among patients, and affects individual patients’ decisions as to whether risks associated with the medical device’s technology are acceptable in exchange for the benefit. Risk tolerance may also vary with risk severity (e.g., there may be special subpopulations in which risk severity is higher). Patients may not understand device-related risks for all types of devices. For prescription devices, a patient’s assessment of risk would be appropriately informed by information from his or her clinician. Risk factors for healthcare professionals or caregivers may be considered when the risk may have an adverse impact on the clinician or caregiver.
All in all, I do believe there are instances where we can allow risk, we just have to make sure we are choosing the best risks to accept.
I think accepting risk is a case-by-case basis. With most things, there is always a level of risk. In medical device risk, it should not put the end user's life in danger. It should also be used by someone who is trained. These steps should be taken in order to minimize and reduce risk. I believe it is acceptable if the risk can potentially save someone's life, which is usually in the case of surgery.
In terms of medical device development, I think it is okay to accept the risk in situations when not accepting them will impede the purpose and use of the device. Also when the risks of a certain device are low I believe it is okay to accept them. Even when the risks are medium or high, it is okay to accept them in the case when the benefits greatly outweigh the risks and lives will not be put in danger. An example is the use of surgical tools. We have to accept the risks of these devices because they are a necessity in surgery.
