title: The use of fault reporting of medical equipment to identify latent design flaws.
abstract: OBJECTIVE
  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 reporting frequency and device usability.
  
  
  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 identified through an analysis of medical equipment maintenance data.
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Rosebrugh Building, RM 407, 164 College Street, Toronto, ON M5S 3G9, Canada; Healthcare Human Factors, University Health Network, 4th Floor R. Fraser Elliot Building, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada. Electronic address: christopher.flewwelling@uhn.ca.
authors.forename: C J
authors.initials: CJ
authors.lastname: Flewwelling
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Rosebrugh Building, RM 407, 164 College Street, Toronto, ON M5S 3G9, Canada; HumanEra, University Health Network, 4th Floor R. Fraser Elliot Building, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada.
authors.forename: A C
authors.initials: AC
authors.lastname: Easty
authors.affiliation: Department of Mechanical and Industrial Engineering, University of Toronto, 5 King's College Road, Toronto, ON M5S 3G8, Canada.
authors.forename: K J
authors.initials: KJ
authors.lastname: Vicente
authors.affiliation: Institute of Biomaterials and Biomedical Engineering, University of Toronto, Rosebrugh Building, RM 407, 164 College Street, Toronto, ON M5S 3G9, Canada; Healthcare Human Factors, University Health Network, 4th Floor R. Fraser Elliot Building, 190 Elizabeth Street, Toronto, ON M5G 2C4, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Health Sciences Building, 155 College Street, Suite 425, Toronto, ON M5T 3M6, Canada.
authors.forename: J A
authors.initials: JA
authors.lastname: Cafazzo
mesh_terms: D057225:Data Mining / Q000379:methods; D016208:Databases, Factual; D004867:Equipment Design / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000379:methods* / Q000706:statistics & numerical data; D004864:Equipment and Supplies / Q000145:classification*; D008283:Maintenance / Q000379:methods / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data
keywords: Clinical engineering; Human factors; Medical device design; No Fault Found; No problem found; No trouble found