Failure mode effect analysis use and limitations in medical device risk management

Abstract

This study aims to investigate the application of risk analysis techniques in the medical device industry and the techniques most utilised to address compliance with ISO 14971:2019 with a view to assessing the challenges of risk management. Failure Mode Effect Analysis (FMEA) and its limitations as a tool are also investigated, as well as the risk management competencies that may contribute to effective risk management implementation. Qualitative interviews were conducted with risk management experts to gain insights into current risk management practices and challenges. The study found that FMEA is the most utilised risk analysis tool by the medical device industry but does not meet all risk analysis requirements per ISO14971:2019. FMEA focuses on device functionality and risk of failure and does not account for safety risks during normal device usage. It is the first focussed study on FMEA limitations in the medical device risk assessment process, and the study can be utilised to inform regulatory policy and industry best practices. Benchmarking the pros and cons of FMEA as a tool can strengthen Risk management thinking and deployment. This study is also novel in relation to the analysis of risk analysis requirements per ISO 14971, as well as looking at risk management competency gaps in Medtech in terms of risk analysis.