A risk assessment model with dependent failure modes for the manufacturing and design processes of medical equipment

The reliability of medical equipment is paramount for surgical success. Manufacturers are continuously exploring risk assessment and improvement strategies to prevent equipment malfunctions during surgery. Failure mode and effects analysis (FMEA) can primarily be divided into two types: DFMEA (Design FMEA) and PFMEA (Process FMEA). Traditional FMEA serves as a practical tool for identifying and prioritizing key failure modes (FMs). However, past FMEA research has overlooked the interdependencies among FMs, treating them as independent entities, which does not align with real-world operations. This paper introduces a groundbreaking risk dependency assessment model aimed at addressing the influential relationships among FMs. The modified technique for defining the influential relationship of failure modes (modified TEDIR-FMs) is developed to compute the relative risk scores of different FMs accurately. At its core, this paper integrates concepts from multiple criteria decision-making (MCDM) techniques into FMEA, with a particular focus on the interdependencies of failure modes in the manufacturing and design manufacturing processes of medical equipment. The model’s application is demonstrated through a case study on a medical device for hernia surgery. The introduction of modified TEDIR-FMs not only enhances the accuracy of risk assessments but also offers a fresh perspective on risk management within the design and manufacturing processes. The research results indicate that the three failure modes with the highest risk are “adhesive does not deploy or only partially deploys from the dispenser,” “the mesh does not adhere to the adhesive,” and “the adhesive drips from the tip.” In the manufacturing and design processes of this device, greater attention should be given to improving the adhesive components.