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Jon Speer

Health Care

The Importance of Managing and Controlling Risk in the Medical Device Industry

Knowing where to prioritize is key to successful mitigation

Published: Tuesday, September 8, 2020 - 11:02

Imagine you’re a patient going in for any medical procedure. You probably think very little about the risks of the medical device being used on you. Generally, patients trust clinicians’ expertise and seldom wonder if the products being used have undergone rigorous testing and are proven to be safe and effective. Patients also, often unknowingly, accept the risks associated with the device.

This is precisely why risk management is so essential to the medical device industry.

Risk management activities can be tedious but are essential for ensuring a device functions as intended to save lives. There are many factors to consider when managing the risk of a medical device, with risk controls as one of the most important. Risk controls are defined in ISO 14971:2019, the international standard for medical device risk management, as the measures taken to reduce identified risks to acceptable levels.

Let’s take a look at some key details of risk controls and how you can leverage the best QMS software solutions to streamline risk activities and ensure compliance throughout the risk management process.

Prioritizing risk control options

As previously stated, risk controls are meant to reduce the risk of a medical device to acceptable levels. Establishing sound risk-control procedures will have the most substantial impact against the chance of harm occurring.

Risk controls have a variety of options but should be prioritized, in order, using the following criteria:
• Apparent safety by design
• Protective measures for the medical device or manufacturing process
• Safety information, like labeling and instructions for use

It’s best practice to include multiple risk controls to ensure maximum risk reduction and to identify design outputs, verification, and validations as additional risk-control measures.

Manually, this process can be tedious, but by using a modern medical-device quality management system (MDQMS) solution, teams can gain actual control of risks by establishing connections between risk management and design control activities.

Risk control verification and residual evaluation

After risk controls are identified and put in place, those identified risks must be reevaluated to determine whether they are acceptable. Utilize the same aforementioned criteria for occurrence, risk levels, severity, and risk acceptability.

Pending any risks found to be unacceptable, a benefit-risk analysis (BRA) can be conducted to determine whether the medical benefits of the medical device outweigh the residual risk. A BRA must be well documented within your MDQMS to provide objective evidence as to why the benefits outweigh any unacceptable risks. The completed BRA should be included as part of your risk management report.

One important note to keep in mind is that some individuals following the European Union’s Medical Device Regulation claim a BRA is required for any risk. The logic behind this idea is that any risk should be reduced as much as possible and is something to consider when putting together a risk management plan.

Final considerations

Once all risk controls have been implemented, verified, and reevaluated, there is one final twist you may encounter. Ask yourself, “Did my risk controls create new hazards or hazardous situations?” If this is the case, you must identify any known potential risks and repeat the same risk management process.

Risk controls can seem like a tedious part of the risk management process, but they’re worth the time and effort that goes into them. In the past, this process was managed using paper and filing cabinets. With modern MDQMS solutions that have risk management software workflows built in, there’s no reason to take on any additional risks when these systems manage the entire process from start to finish.

Protecting patients and end users is the ultimate objective for medical device professionals, and proper risk controls are a critical component of attaining that goal.


About The Author

Jon Speer’s picture

Jon Speer

Jon Speer is the founder and vice president of quality assurance and regulatory affairs at Greenlight Guru, a software company that produces the only medical device quality management software solution. Device makers in more than 50 countries use Greenlight Guru to get safer products to market faster. Speer has served more than 20 years in the medical device industry and helped dozens of devices get to market. As a thought leader and speaker, he regularly contributes to numerous industry publications. He is also the host of Global Medical Device Podcast.