AAMI News March 2019
Q&A with Tina Krenc: The Importance of Risk Management
Tina Krenc is the lead instructor for AAMI’s industry training course, Integrating Risk Management into the Product Life Cycle. She recently worked with AAMI to update the course in light of the Food and Drug Administration’s announcement that it planned to move its focus toward the quality management standard ANSI/AAMI/ISO 13485, as well as to incorporate the current state of the risk management standard ANSI/AAMI/ISO 14971 and the Medical Device Single Audit Program (MDSAP) audit structure.
Krenc, who has worked in the medical device industry for nearly 40 years, is the principal consultant for KTA Compliance Consulting in Bensenville, IL, and a member of the AAMI Board of Directors, where she is the vice chair of education.
Q: What drew you to the medical device industry?
It started in high school, when I got a job after school in a hospital laboratory. I saw people running tests and making slides—with very early medical technology—and thought it was really interesting. After that, I worked as a nurse’s assistant at night while I went to college. I worked with a lot of medical devices and saw both how they could improve patients’ health and what could go wrong with them. I decided that I wanted to go back into the hospital lab, and eventually began working at a large medical device company. Every time I went into work, I knew that I was trying to make someone’s life better.
Q: Why is risk management important to the medical device industry?
Risk management is a cornerstone for much of the work that’s done in the industry. It’s one of the things we can do to make products safer for patients and for users. People are often making risk-based decisions, they just don’t always have a process to follow to ensure that it’s done well. That’s where standards like ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485, which the FDA intends to use to replace its quality systems regulation, can help.
From the minute you decide that you’re going to develop a product, you have to think about the potential hazards or issues that could cause harm to the user or the patient and try to minimize those situations. The risk management process is used throughout the entire quality system and, in the best situation, is used from cradle to grave for that device. When you make decisions, such as recalling a product or releasing a new version, the decisions you make are based on your understanding of the associated risk.
Q: What key principles should be followed for effective risk management?
First, use consistent terminology. That runs from the early concept phases to research and development to when the device is on the market. You don’t want to be unintentionally saying different things to those in your company, to regulators like the FDA, and to auditors.
Second, maintain up-to-date documentation at all times. That data helps you understand the risks of your product at any point in time. You want to make decisions based on as much data as you can.
Third, ensure that your organization—from the management level all the way to the person on the line—supports risk management. They should understand the risk associated with every decision they make and the impact of that decision on the medical device or quality system.
Q: How can AAMI’s industry training course, Integrating Risk Management into the Product Life Cycle, help?
We look at risk management from beginning to end, following the product life cycle. We talk about how to identify and mitigate hazards at each step, beginning from early development to manufacturing, postproduction, and retirement.
We updated the course in late 2018 to pull in concepts from ISO 13485:2016, the newest quality management standard. We’re also including quite a few new tools to go beyond failure modes and effects analysis. Finally, we’ve added MDSAP, so you’ll be prepared for how your auditing organization will talk about risk management in all the different quality systems. It’s all integrated in this new course.