What You Need to Know for an Effective Risk Assessment

Two concepts to ensure patient safety and device quality

Historically, risk management has been a complex and polarizing subject, with various stakeholders assigning different values on the probability and severity of harm. In the medical device industry, risk management’s high importance has led to the publication of standards such as ISO 14971, offering guiding principles using a universal risk management framework applicable to all types of medical devices and processes throughout the entire product life cycle, from design and development through manufacturing and into post-market activities.

In December 2019, an updated version of the standard ISO 14971:2019 was released, bringing impactful changes to the medical device industry. Although many of the changes were minor, there are key updates to processes and best practices that medical device companies should understand and keep top of mind.

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Comments

Improbable Medium Risk

Hello,

Thank you for the article.

Often, especially during audits and inspections, potentially life-threatening risks are seen as always of the highest risk level, no matter how improbable they are. And there is a case to make, that just because something is highly unlikely, the consequences remain life-threatening and therefore, the risk should be treated as if it occured more regular and thus be categorized as "high risk".

Assuming all risk managers somewhat use the principle of worst-case, it's hard to grasp how a critical (per articles definition life-threatening) risk can be a low risk, just because you may only harm 1 in a million. I think it would make sense to have any foreseeable permanent damage to be at least "medium" risk and all life-threatining risks as "high" risk category.

That ISO14971 fails to define this, once and for all in its current revision, is a mistake, in my honest opinion. This is, where true standardization in this industry could have happened, but instead some formalities were changed. The request for more Benefit/Risk analyses will never be heard, when even potentially fatal consequences can be a low-risk topic.

daniel