The use of fault reporting of medical equipment to identify latent design flaws C.J. Flewwelling a,b,⇑ , A.C. Easty a,c , K.J. Vicente d , J.A. Cafazzo a,b,e a Institute of Biomaterials and Biomedical Engineering, University of Toronto, Rosebrugh Building, RM 407, 164 College Street, Toronto, ON M5S 3G9, Canada b Healthcare Human Factors, University Health Network, 4th Floor R. Fraser Elliot Building, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada c HumanEra, University Health Network, 4th Floor R. Fraser Elliot Building, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada d Department of Mechanical and Industrial Engineering, University of Toronto, 5 King’s College Road, Toronto, ON M5S 3G8, Canada e Institute of Health Policy, Management and Evaluation, University of Toronto, Health Sciences Building, 155 College Street, Suite 425, Toronto, ON M5T 3M6, Canada article info Article history: Received 2 December 2013 Accepted 7 April 2014 Available online xxxx Keywords: No Fault Found No problem found No trouble found Clinical engineering Human factors Medical device design abstract Background and purpose: Poor device design that fails to adequately account for user needs, cognition, and behavior is often responsible for use errors resulting in adverse events. This poor device design is also often latent, and could be responsible for ‘‘No Fault Found’’ (NFF) reporting, in which medical devices sent for repair by clinical users are found to be operating as intended. Unresolved NFF reports may contribute to incident under reporting, clinical user frustration, and biomedical engineering technologist inefficacy. This study uses human factors engineering methods to investigate the relationship between NFF report- ing frequency and device usability. Material and methods: An analysis of medical equipment maintenance data was conducted to identify devices with a high NFF reporting frequency. Subsequently, semi-structured interviews and heuristic evaluations were performed in order to identify potential usability issues. Finally, usability testing was conducted in order to validate that latent usability related design faults result in a higher frequency of NFF reporting. Results: The analysis of medical equipment maintenance data identified six devices with a high NFF reporting frequency. Semi-structured interviews, heuristic evaluations and usability testing revealed that usability issues caused a significant portion of the NFF reports. Other factors suspected to contribute to increased NFF reporting include accessory issues, intermittent faults and environmental issues. Usability testing conducted on three of the devices revealed 23 latent usability related design faults. Conclusions: These findings demonstrate that latent usability related design faults manifest themselves as an increase in NFF reporting and that devices containing usability related design faults can be identi- fied through an analysis of medical equipment maintenance data. Ó 2014 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). 1. Introduction Evidence suggests that adverse events associated with medical devices are more often the result of use error than device malfunction [1]. One study found that 82% of all preventable errors involving anaesthesia devices were due to use error [2], while a study of infusion pump errors found that use errors were the most frequent cause of patient harm [3]. In some cases medical devices have poorly designed and difficult to use human system interfaces [4]. As a result, there is an increasing interest in incorporating human factors engineering (HFE) principles in the design and eval- uation of medical devices. However, the use of HFE principles within healthcare is still not widespread [5]. There remain instances in which usability related design flaws are identified by users as a device malfunction. When investigated, conclusions of ‘‘No Fault Found’’ or ‘‘cannot replicate problem’’ are often reached. These outcomes cannot be used to mitigate the situation and may contribute to user frustration and incident under-reporting. In this study, we sought to identify devices that contain latent usability related design flaws using medical equipment maintenance data and human factors techniques. http://dx.doi.org/10.1016/j.jbi.2014.04.009 1532-0464/Ó 2014 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). Abbreviations: NFF, No Fault Found; UHN, University Health Network; WRHA, Winnipeg Regional Health Authority; NSAHO, Nova Scotia Association of Health Organizations; VIHA, Vancouver Island Health Authority; BMET, biomedical engi- neering technologist; HFE, human factors engineering. ⇑ Corresponding author at: Healthcare Human Factors, University Health Net- work, RFE 4th floor, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada. E-mail address: christopher.flewwelling@uhn.ca (C.J. Flewwelling). Journal of Biomedical Informatics xxx (2014) xxx–xxx Contents lists available at ScienceDirect Journal of Biomedical Informatics journal homepage: www.elsevier.com/locate/yjbin Please cite this article in press as: Flewwelling CJ et al. The use of fault reporting of medical equipment to identify latent design flaws. J Biomed Inform (2014), http://dx.doi.org/10.1016/j.jbi.2014.04.009