The Importance of Risk Management in Medical Devices

My first day as a medical device engineer changed my life. I started the day excited about a new job, but with no particular understanding of the gravity of that job. As I watched one of the training videos, it began to hit me. Like most who work in the medical device industry, I had a moment of clarity about the importance of my job. The devices I designed and developed could one day be used by my mom, my sister, my day I might need to use one of these devices. If you’re working in medical devices and haven’t had this moment yet, it might be time for a gut check.

Risk and Medical Devices

The dictionary definition of “risk” is the possibility...

Detectability and Medical Device Risk Management

The role of detectability in medical device risk management is often discussed and debated. If you are clinging to the argument that detectability should be a component of evaluating and assessing product risks, it is time to stop.

Move to ISO 14971 Risk Management

ISO 14971 provides a very clear definition of risk: RISK - combination of the probability of occurrence of harm and the severity of that harm No mention of detectability or detection. ISO 14971 has been in existence for many, many years. The 2007 version has been harmonized for quite some time. This means that ISO 14971 is the medical device industry's go to standard for medical device risk management. Bottom line: Your risk management process must conform to ISO 14971. It is also possible that you might be clinging to the value of detectability...

FMEA is NOT ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to abandon FMEA as the risk management tool of choice. Let me tell you why. Here is the definition of "risk management" as defined in ISO 14971.

Risk Management - systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk

And to be fair, I'll also share with you a definition / description of FMEA from ASQ

Failure Modes and Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.

Risk Management & My First Clinical Experience

I had my first real experience with medical device risk management 15 years ago, yet I didn't realize it at the time. I was a product development engineer, designing airway devices, central venous catheters, and other critical care devices. I inherited a project that had been passed from one new engineer to the next. I was thrilled to receive it. I was young. Hungry. The purpose of the project was to redesign a double-lumen catheter introducer, used to monitor pressure while offering a working channel to place a Swan-Ganz catheter. The advantage of the introducer would provide an extra lumen, or channel for fluid infusion and pressure monitoring.

Journey into Design Controls

As I mentioned, the company already had an existing double-lumen introducer on the market. However, the product had a few issues and was not...