Risk acceptance does not necessarily increase the probability that a risk will occur. Risks are typically accepted rather than mitigated when they cannot be further reduced through design changes, when the overall benefits of the device outweigh the potential harms, and when their probability and severity are both low. It’s important to note that for a risk to be accepted, both its probability and severity must fall within the company’s predefined risk acceptance criteria. Risks are often accepted when they are inherent to the device’s intended use, especially when eliminating them would compromise the device’s functionality. A common example of this is orthopedic surgical tools such as saws, drills, and mallets. These instruments inherently carry the possibility that a user could injure themselves or damage unintended tissue on a patient. However, with proper training and technique, the likelihood of these events becomes low. For example, attempting to redesign a surgical saw to fully eliminate the risk of cutting the user would render the device incapable of performing its intended purpose. Risk acceptance ensures devices are effective and functional while acknowledging that some level of inherent risk is unavoidable.

Accepting risk, to a certain extent, should be the case especially when the need is urgent and there are too many factors to consider as individual risks but there can be an overall calculated risk. In all cases, risk should be reduced as much as possible. But there are cases where risk is worth the reward, especially when the outcome is in a sense inevitable. For example, someone with an incurable stage 4 cancer (who will also only have 2 months to live) might be offered some type of treatment that may not have been used before and have high risk. In this case, since the person may not live much longer, the risk may be worth the reward, especially if there is decent science to back it even if it has not been fully tested. These are the types of cases where the risk should not play as much of a factor as long as its reasonable risk (not like a 99% failure rate, something like a 50/50 or above may serve as a safer range, but it is individual dependent). Acceptance, in this case is fine. However, acceptance in cases that are not like this does create more risk because then medical device creators might not consider certain risks if they are just "accepted" or have been in the past. This can create the misconception that it is okay to not fully test their devices, and this would create a horrible market environment because then there is lots of uncertainty with devices.

Risk acceptance does always involve acknowledging a higher probability of harm compared to avoidance or mitigation, but it does not mean the decision is careless or unsafe. In medical device development, risk is only accepted when it has been reduced as far as reasonably possible and when the clinical benefit clearly outweighs any remaining risk. This is common with devices like insulin pumps, pacemakers, or implantable sensors where eliminating all risk would make the device unusable or delay access to important therapy. The point at which risk outweighs the reward is when the residual risk can no longer be justified through clinical benefit, available alternatives, or patient need. In other words, risk acceptance is appropriate only when it is evidence based, justified, and transparent, not when it is used to shortcut safety or quality requirements.