What the reboot of ISO 14971 means for medical device OEMs

Risk managementMedical devices, like physicians, should do no harm. That’s a given in the healthcare space, and ISO 14971 is an international standard that provides medical device manufacturers with a risk management tool to ensure that doesn’t happen. Jessica Lee, PhD, Director of Quality at Boston Scientific (Marlborough, MA), will discuss the 2012 “reboot” of ISO 14971 and how medtech OEMs can use it to reduce risk at a session during the Regulatory and Quality Update conference track at the forthcoming Medical Design and Manufacturing (MD&M) West event in Anaheim, CA. She shared some insights on this topic with PlasticsToday ahead of MD&M West, co-located with PLASTEC West, at the Anaheim Convention Center on Feb. 6 to 8.

The concepts of ISO 14971 are pretty basic, but it starts to get complicated once you dive into the weeds, says Lee, who has a doctorate in biomedical engineering in orthopedic biomechanics. “People often misinterpret risk—is it severity? Occurrence? In fact, it’s a combination of both, and once you have assessed that, the question becomes, what do you do about it?” says Lee.

Jessica Lee, Boston Scientific
Jessica Lee, PhD, Director of Quality at Boston Scientific.

The standard itemizes risk controls and evaluates their efficacy. For example, designing something into the product such as a hard stop is the most effective method, whereas providing training is on the other end of that spectrum “because it relies on humans remembering something,” explains Lee. Then it comes down to making an overall go, no-go decision based on a risk-benefit analysis.

Problems may arise when you come across obstacles in this process that are not discussed in the standard. “How do you proceduralize that for your company, for your device?” asks Lee. She will provide some helpful advice during her session at MD&M West.

One thing that medical device OEMs need to be especially aware of are “content deviations in the preamble to ISO 14971,” says Lee. These deviations are getting the attention of Notified Bodies, third-party compliance assessment organizations. For instance, you can no longer use instructions for use as a risk control measure. “What

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