Assessment of Operational Risk for Medical Equipment
Calin Corciova*
Associate Professor, Department Medical Sciences, Medical Bioengineering Faculty, “Grigore T. Popa” University of Medicine and Pharmacy, Iasi, Romania
*Corresponding Author: Calin Corciova, Associate Professor, Department Medical Sciences, Medical Bioengineering Faculty, “Grigore T. Popa” University of Medicine and Pharmacy, Iasi, Romania.
Published: September 29, 2025
DOI: 10.55162/MCET.09.296
Abstract
Assessing operational risk for medical equipment is a cornerstone of providing safe and reliable medical services. This short article summarizes methods and practices reported in the literature between 2015 and 2024 and compares them with international standards (ISO 14971:2019; IEC 80001‑1:2021). A structured search was conducted in PubMed, IEEE Xplore, and Scopus using keywords such as “operational risk”, “medical device”, “FMEA”, “FTA”, “Bayesian network”, and “medical technology management”. Inclusion criteria covered English-language peer-reviewed studies describing methods, comparisons, or case applications for operational risk of medical equipment; purely financial or market risk papers were excluded. The findings indicate that FMEA and FTA remain the most widely used tools, but they may underrepresent the dependencies between failure modes and face higher-order uncertainties. Hybrid and probabilistic approaches (e.g., Bayesian networks, Markov models, Monte Carlo simulation) address some of these gaps but require richer data sets and validation. Cyber security risks and interoperability challenges in IT networks that incorporate medical devices are inconsistently integrated into current practice. We conclude that combined methodologies, explicit treatment of uncertainty, and comparative empirical studies are needed to advance operational risk assessment and support patient safety and system resilience.
Keywords: operational risk; medical equipment; risk management; patient safety; standards; FMEA; FTA; Bayesian networks