Automating FMEA with Model Based Systems Engineering

The reliability of medical devices such as alarms is critical for patient safety, with standards such as IEC 60601-1-12 mandating high-priority alarms like the "high-pressure alarm." Traditional approaches to ensuring these alarms' functionality involve complex logical reasoning within Failure Mode & Effect Analysis (FMEA) and Hazard Analysis, which are prone to logical errors.

Objective: This study introduces an innovative workflow utilizing a Model-Based Systems Engineering (MBSE) model to validate the effectiveness of the Method of Control (MOC) for each potential failure, ensuring high-priority alarms function correctly even under single-fault conditions.

Methods: By integrating fault injection within the MBSE model, we simulate each failure scenario detailed in the fault tree. This process verifies the alarm's response across various ventilator settings, patient categories, and medical complications, providing evidence of the intended behavior.

Results: The proposed MBSE-verified FMEA workflow significantly reduces the risk of logical errors compared to traditional manual methods. Implementing this workflow at early design stages makes it possible to ensure a safer design and mitigate costly safety-related design issues later in the product lifecycle. The demonstration highlights the workflow's efficacy with fault injection and simulation results, offering a promising direction for future safety engineering in medical device development.

Please allow approximately 45 minutes to attend the presentation and Q&A session. We will be recording this webinar, so if you can't make it for the live broadcast, register and we will send you a link to watch it on-demand.