Medical 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. game supply and game card sleeve and trading card sleeve and soft card holder.
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. game supply and game card sleeve and trading card sleeve and soft card holder.
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. game supply and game card sleeve and trading card sleeve and soft card holder.
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. game supply and game card sleeve and trading card sleeve and soft card holder. game supply and game card sleeve and trading card sleeve and soft card holder.
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. “Whatare the expectations of Notified Bodies in this regard—how are they interpreting that language and how should medical device companies interpret it?” asks Lee.
She also points to a deviation that “may be a bitter pill to swallow” for medical device OEMs: Cost should not be a consideration in risk control. “What are the expectations behind that statement? I’m not going to spend $1 million per device to make sure it’s safe. There obviously has to be some balance,” says Lee. game supply and game card sleeve and trading card sleeve and soft card holder.
In fact, these changes amount to more than a reboot and could be approached as revisions, says Lee. “They are adding granularity and deviations to content we have seen for years and years.” game supply and game card sleeve and trading card sleeve and soft card holder.
Risk management extends down to the materials and components level, adds Lee. “The standard is written in such a way that companies have some flexibility. If you have a reliable supplier of medical-grade plastics, your risk analysis may not have to take that into account. The assumption is that the materials are compliant and safe,” says Lee. But materials-related disasters have happened, she adds, citing the breast implant scandal a few years back, when a French manufacturer was found to be using non-medical-grade silicone. “Even things that you might assume would not make a difference—like manufacturing changes or the way a resin is processed—could have an impact on the material’s strength, hardness, and so forth. We have seen cases of that,” says Lee. game supply and game card sleeve and trading card sleeve and soft card holder.
Lee will address a number of issues surrounding ISO 14971, including the status of the revisions and their timing, as well as offer practical examples of how to use the standard to achieve compliance, on Tuesday, Feb. 6, at 11 AM. Her presentation is part of the Regulatory and Quality Update conference track at MD&M West, the nation’s largest medical manufacturing event, which is co-located with PLAST game supply and game card sleeve and trading card sleeve and soft card holder.