Applied Soft Computing 32 (2015) 322–334 Contents lists available at ScienceDirect Applied Soft Computing j ourna l ho me page: www.elsevier.com/locate /asoc A comprehensive fuzzy risk-based maintenance framework for prioritization of medical devices Afshin Jamshidi a,∗ , Samira Abbasgholizadeh Rahimi a , Daoud Ait-kadi a , Angel Ruiz b a Department of Mechanical Engineering, Laval University, QC, Canada b Faculty of Business Administration, Laval University, QC, Canada a r t i c l e i n f o Article history: Received 26 October 2014 Received in revised form 3 December 2014 Accepted 30 March 2015 Available online 8 April 2015 Keywords: Medical devices FMEA Criticality prioritization Risk-based maintenance Hospitals Multi criteria decision making a b s t r a c t Medical equipment such as infant incubator, infusion pump, CT scanner, etc. should be maintained properly to meet adequate standards of reliability in healthcare services. This paper proposes a new comprehensive risk-based prioritization framework for selecting the best maintenance strategy. The framework encompasses three steps. In the first step, a fuzzy failure modes and effects analysis (FFMEA) method is applied by considering several risk assessment factors. In the second step, seven miscellaneous dimensions such as use-related hazards, age, and utilization are applied to consider all aspects of hazards and risks in prioritization of medical devices. Finally, a simple method is introduced in the third step in order to find the most suitable maintenance strategy for each device according to the scores produced by the previous steps. A numerical example illustrates the proposed approach and shows that, through the method introduced in this paper, managers can easily classify medical devices for maintenance activities according to their criticality scores. Implementation of this framework could increase the availability of high risk machines in healthcare industries. Moreover, this framework can be applied in other critical industries such as aviation by modifying some criteria and dimensions. © 2015 Elsevier B.V. All rights reserved. 1. Introduction Nowadays, safety of medical device and the hazards associated with utilization of them is one of the critical issues for healthcare organizations across the world [1]. Medical devices are instruments or machines that are used to diagnosis, monitor, treat, or pre- vent disease or other conditions. Degradation in the performance of critical medical devices and inadequately maintained medical equipment create an unacceptable risk of patient injury. In addi- tion, there are risks of injury to clinical staff from simple, direct hazards, such as accidental contact with electrified parts or from mechanical failures within the device [3], for example defects in ultrasound machines, defective artificial cardiac valves, leakage of insulin pumps [4], and high number of errors in CT scans which leads to patients receiving 10 times the intended dose of radiation in some cases. Thus, the maintenance of medical devices is fun- damental and it calls for an effective and efficient framework to prioritize medical devices for maintenance activities based on key criteria and choose the best maintenance policy for each device. ∗ Corresponding author. Tel.: +1 581 777 0555. E-mail address: afshin.jamshidi.1@ulaval.ca (A. Jamshidi). Clinical engineering departments in hospitals have been devel- oping programs such as Medical Equipment Management Program (MEMP) to reduce risks associated to medical devices and to pro- mote the safety of medical devices in support of patient care. Some risk based MEMP methods have been presented for assessment of devices and are currently in use. These models consider risk in terms of maintenance requirements of medical device, function of medical device, and physical harm/risk. However, other important criteria such as the number of patients served, economic loss, mean time to repair (MTTR), and use-related hazards, among others are overlooked. Rice [5] in his paper mentions that, “although these methods do reduce risks, they are not near optimal”. Besides, in most of the proposed models equal risk levels are assigned to sim- ilar devices and the operational and environmental conditions and independently of the hospital’s mission statement are overlooked. This could lead to misclassifying devices, such as steam sterilizers, as low risk [6]. This paper presents a novel fuzzy multi-criteria decision making (FMCDM) approach to the medical device prioritization problem within a risk-based maintenance (RBM) framework. This compre- hensive approach first prioritizes medical devices based on their criticality and then propose a diagram for selecting appropriate maintenance strategy in healthcare organizations. The two objec- tives of this research are (1) to revisit and reassess the major criteria http://dx.doi.org/10.1016/j.asoc.2015.03.054 1568-4946/© 2015 Elsevier B.V. All rights reserved.