Medical device development: The challenge for ergonomics

Applied Ergonomics

Volumn 39, Issue 3, 2008, Pages 271-283

  Martin, Jennifer L ^a   Norris, Beverley J ^b   Murphy, Elizabeth ^a   Crowe, John A ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^b NATIONAL PATIENT SAFETY AGENCY   (United Kingdom)

Author keywords

Medical device; Patient safety; User requirements

Indexed keywords

ERGONOMICS; PATIENT TREATMENT; PROFESSIONAL ASPECTS; REQUIREMENTS ENGINEERING; SAFETY FACTOR;

MEDICAL DEVICES; PATIENT SAFETY; USER REQUIREMENTS;

BIOMEDICAL EQUIPMENT;

COGNITION; DEVICE; ERGONOMICS; FOOD AND DRUG ADMINISTRATION; PATIENT SAFETY; REVIEW;

EID: 38149030896     PISSN: 00036870     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.apergo.2007.10.002     Document Type: Review

References (42)

1. AAMI HE74, 2001. Human Factors Design Process for Medical Devices.
2. Anderson G.J. Shaping the future: using voice of the customer methodology to develop inhaler design. Resp. Drug Del. 8 (2002) 1-10
3. Barrett J., and Kirk S. Running focus groups with elderly and disabled elderly participants. Appl. Ergon. 31 (2000) 621-629
4. Batavia A.I., and Hammer G.S. Toward the development of consumer-based criteria for the evaluation of assistive devices. J. Rehabil. Res. Dev. 27 (1990) 425-436
5. Blackburn T., and Sadler C. The role of human patient simulators in health care training. Hosp. Med. 64 (2003) 677-681
6. BS 7000-6, 2005. Design Management Systems. Managing Inclusive Design.
7. Buckle P., Clarkson P.J., Coleman R., Lane R., Stubbs D., Ward J., Jarrett J., and Bound J. Design for Patient Safety: A System-wide Design-led Approach to Tackling Patient Safety in the NHS (2003), Department of Health Publications, London. 1-84182-7657
8. Buckle P., Clarkson P.J., Coleman R., Ward J., and Anderson J. Patient safety, systems design and ergonomics. Appl. Ergon. 37 (2006) 491-500
9. Cimino J.J., Patel V.L., and Kushniruk A.W. Studying the human-computer-terminology interface. J. Am. Med. Inf. Assoc. 8 (2001) 163-173
10. Coble, J.M., Karat, J., Kahn, M.G., 1997. Maintaining a focus on user requirements throughout the development of clinical workstation software. In: Proceedings of the 1997 Conference on Human Factors in Computing Systems, CHI, March 22-27, 1997. ACM, New York, NY, USA, Atlanta, GA, USA, p. 170.
11. Cohen M.R. Preventing errors associated with PCA pumps. Nursing 23 (1993) 17
12. De Angeli A., Athavankar U., Joshi A., Coventry L., and Johnson G.I. Introducing ATMs in India: a contextual inquiry. Interact. Comput. 16 (2004) 29-44
13. Doherty, E., Cockton, G., Bloor, C., Benigno, D., 2001. Improving the performance of the Cyberlink mental interface with the "Yes/No program". Conference on Human Factors in Computing Systems CHI 2001 Anyone, Anywhere, March 31-April 5, 2001. Seattle, WA, p. 69.
14. Garmer K., Liljegren E., Osvalder A.L., and Dahlman S. Arguing for the need of triangulation and iteration when designing medical equipment J. J. Clin. Mon. Comput. 17 (2002) 105-114
15. Garmer K., Liljegren E., Osvalder A., and Dahlman S. Application of usability testing to the development of medical equipment. Usability testing of a frequently used infusion pump and a new user interface for an infusion pump developed with a Human Factors approach. Int. J. Ind. Ergon. 29 (2002) 145-159
16. Garmer K., Ylven J., and Karlsson I.C.M. User participation in requirements elicitation comparing focus group interviews and usability tests for eliciting usability requirements for medical equipment: a case study. Int. J. Ind. Ergon. 33 (2004) 85-98
17. Gould J.D., and Lewis C. Designing for usability: key principles and what designers think. Commun. ACM 28 (1985) 300-311
18. Holtzblatt K., and Beyer H. Making customer-centered design work for teams. Commun. ACM 36 (1993) 93-99
19. Horsky J., Zhang J., and Patel V.L. To err is not entirely human: complex technology and user cognition. J. Biomed. Inf. 38 (2005) 264-266
20. ISO 13407, 1999. Human-Centred Design Processes for Interactive Systems.
21. ISO 14971, 2000. Medical Devices-Application of Risk Management to Medical Devices.
22. IEC 60601-1, 2004. General Requirements for Safety of Electrical Medical Equipment.
23. IEC 60601-1-6, 2004. General Requirements for Safety of Electrical Medical Equipment Collateral Standard: Usability.
24. IEC 60601-1-8, 2006. Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems.
25. Kaufman D.R., Patel V.L., Hilliman C., Morin P.C., Pevzner J., Weinstock R.S., Goland R., Shea S., and Starren J. Usability in the real world: assessing medical information technologies in patients' homes. J. Biomed. Inf. 36 (2003) 45-60
26. Lane J.P., Usiak D.J., Stone V.I., and Scherer M.J. Voice of the customer: consumers define the ideal battery charger. Assis. Technol. 9 (1997) 130-139
27. Leape L.L. Error in medicine. JAMA 272 (1994) 1851-1857
28. Liljegren, E., Osvalder, A., Dahlman, S., 2000. Setting the requirements for a user-friendly infusion pump. In: Proceedings of the XIVth Triennial Congress of the International Ergonomics Association and 44th Annual Meeting of the Human Factors and Ergonomics Association, 'Ergonomics for the New Millennnium', July 29-August 4, 2000. Human Factors and Ergonomics Society, San Diego, CA, USA, p. 132.
29. Lin L., Isla R., Doniz K., Harkness H., Vicente K.J., and Doyle D.J. Applying human factors to the design of medical equipment: patient-controlled analgesia. J. Clin. Mon Comput. 14 (1998) 253-263
30. Mello S. Right process, right product. Res. Technol. Manage. 44 (2001) 52-58
31. Militello L.G. Learning to think like a user: using cognitive task analysis to meet today's health care design challenges. Biomed. Instrum. Technol. 32 (1998) 535-540
32. Obradovich J.H., and Woods D.D. Users as designers: how people cope with poor HCI design in computer-based medical devices. Hum. Factors 38 (1996) 574-592
33. Patel V.L., and Kaufman D.R. Medical informatics and the science of cognition. J. Am. Med. Inf. Assoc. 5 (1998) 493-502
34. Rishel, K.C., Grindstaff, R., Beckman, O., 2000. Understanding the needs of international customers: applying the contextual inquiry method in Asia. In: Proceedings of the XIVth Triennial Congress of the International Ergonomics Association and 44th Annual Meeting of the Human Factors and Ergonomics Association, 'Ergonomics for the New Millennnium', July 29-August 4, 2000. Human Factors and Ergonomics Society, San Diego, CA, USA, p. 662.
35. Salvemini A.V. Challenges for user-interface designers of telemedicine systems. Telemed. J. 5 (1999) 163-168
36. Sawyer, D., 1996. Do it by design: an introduction to human factors in medical devices. US Department of Health and Human Services Food and Drug Administration (Center for Devices and Radiological Health).
37. Shefelbine S., Clarkson P.J., and Farmer R. Good Design Practice for Medical Devices and Equipment-Requirements Capture vol. 1 (2002), University of Cambridge Engineering Design Centre/University of Cambridge Institute of Manufacturing
38. Stanton N.A., and Young M.S. Is utility in the mind of the beholder? A study of ergonomics methods. Appl. Ergon. 29 (1998) 41-54
39. Wald D.S. Bureaucracy of ethics applications. Biomed. J. 329 (2004) 282-284
40. Webb R.K., Russell W.J., Klepper I., and Runciman W.B. The Australian Incident Monitoring Study. Equipment failure: an analysis of 2000 incident reports. Anaesth. Intensive Care 21 5 (1993) 673-677
41. Wilson J.R. Fundamentals of ergonomics in theory and practice. Appl. Ergon. 31 (2000) 557-567
42. Zhang J., Johnson T.R., Patel V.L., Paige D.L., and Kubose T. Using usability heuristics to evaluate patient safety of medical devices. J. Biomed. Inf. 36 (2003) 23-30