Software is an integral component of medical devices, more now than at any other point in history. Modern medical devices are a marvel of engineering and perform every function from diagnostics to treatment. Mechanical and electrical parts come with their own set of risks, and management strategies and software are no exception. Software failure carries a heavy risk, as it is considered to have a 100% probability of failure in the event that it happens.
There are basic steps to good medical device risk management that allow for planning, assessment, mitigation, and response. Acknowledging the probability of software failure is the first step to managing it. Below, you’ll find a brief overview of four different types of medical device software risk management
1) Identify and Categorize
To begin, familiarize yourself with the regulatory documents and bodies that govern medical software.
- ISO 14971 – This serves as the international standard for all medical devices.
- IEC 62304 – Another international standard governing medical device software and life-cycle requirements. This is a companion to ISO 14971. It lays out various processes, documentation procedures, and activities required to maintain medical device software.
During the identification phase, you’ll determine where the risk originates and begin developing a response strategy. This includes categorizing the type and severity of the risk.
Categorization requires a basic risk assessment and yields one of the multiple possible results. Use these results to make a risk index. When creating a risk index, a software hazard analysis example could be:
- An acceptable level of risk or no risk of causing a hazardous situation.
- An unacceptable level of risk of a non-serious hazardous situation.
- An unacceptable level of risk of a very serious hazardous situation, such as injury or death.
When making this particular assessment, use your worst-case scenario for the determination. Use the IEC 62304:2015 to guide your assessment and subsequent documentation procedures. Whether a device is capable of threatening humans is a critical component in risk assessment for medical software.
2) Response
Once possible software failures and risks have been identified, each potential failure needs a response. In typical software risk assessment, there are a few response options that aren’t present for medical software. For instance, you should not put off the risk to a third party should the software fail.
With medical software, your response might involve an avoidance strategy, which entails avoiding the potential risk that a failure could cause.
You could also opt for mitigation, which decreases risk and still involves an active response to the issue. There are different potential mitigation strategies that offer varying levels of success. Each has its own pros and cons, and the correct response will depend on the risk and problem.
- Mitigating via informing the user on screen
- Mitigating through the development process
- Mitigating through software
- Mitigating through hardware
Another response strategy is active acceptance. This entails accepting that the risk will or is happening and developing a plan of action to respond to it.
3) Planning
During the planning stage, create plans that focus on limiting, decreasing, or completely preventing the risks associated with software failure in the medical device in question. If complete prevention isn’t possible, focus on decreasing the risk and putting measures in place to identify failure as soon as possible. The response strategy attached to a failure should activate as soon as possible to limit the associated risk.
4) Monitoring and Documentation
Routine checks should be performed on all equipment. Generate reports regularly and review for any changes to risk level or needed updates. If any new risks are identified, immediately initiate all prior steps to properly respond to them. Identify, generate responses, plan, and return to monitoring. The IEC 62304 lays out certain documentation processes for medical software that must be followed, too.
Conclusion
Risk analysis is a crucial part of developing and maintaining software for medical devices. There are regulations that must be followed, and failure to do so puts lives at great risk. Many medical devices that physicians, medical staff, and patients depend on rely on working software so the importance of risk analysis and management cannot be overstated. Follow the best practices and guidelines laid out in the available international standards.
