Designing the design phase of critical care devices: A cognitive approach

Journal of Biomedical Informatics

Volumn 38, Issue 1, 2005, Pages 34-50

  Malhotra, Sameer ^a   Laxmisan, Archana ^a   Keselman, Alla ^a   Zhang, Jiajie ^b   Patel, Vimla L ^a  

^a Och Spine at New York Presbyterian Hospitals   (United States)

^b UNIVERSITY OF TEXAS   (United States)

Author keywords

Critical care; Decision making; Device engineering; Devices; Institutional decision making; Patient safety; Task analysis

Indexed keywords

ACCIDENT PREVENTION; COMPUTER SOFTWARE; DECISION MAKING; HUMAN COMPUTER INTERACTION; PATIENT TREATMENT;

CLINICAL CARE DEVICES; COGNITIVE TASK ANALYSIS; MEDICAL DEVICES; PATIENT MANAGEMENT;

BIOMEDICAL EQUIPMENT;

ARTICLE; COGNITION; COMPUTER PROGRAM; DECISION MAKING; HEALTH PRACTITIONER; HOSPITAL CARE; HUMAN; INTENSIVE CARE; MEDICAL ERROR; MEDICAL INSTRUMENTATION; PATIENT CARE; PRIORITY JOURNAL; SAFETY;

COGNITIVE SCIENCE; COMPUTER-AIDED DESIGN; CONSUMER PRODUCT SAFETY; CRITICAL CARE; DECISION SUPPORT TECHNIQUES; EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; EQUIPMENT SAFETY; MEDICAL ERRORS; SAFETY MANAGEMENT; TASK PERFORMANCE AND ANALYSIS;

EID: 13444267431     PISSN: 15320464     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbi.2004.11.001     Document Type: Article

References (45)

1. R.I. Cook, and D.D. Woods Operating at the sharp end the complexity of medical error. Chapter 13, Human Error in Medicine 1994 Lawrence Erlbaum Hillsdale, NJ
2. DW Bates, M. Cohen, L.L. Leape, J.M. Overhage, M.M. Shabot, and T. Sheridan Reducing the frequency 609 of errors in medicine using information technology J Am Med Inform Assoc 8 2001 299 308
3. Bria WF, Shabot MM. The electronic medical record, safety, and critical care. Critical Care in Clinics (2005) [Article in press]
4. Ash JS, Lyman JA, Carpenter J, Fournier L. A diffusion of innovations model of physician order entry. In: Proceedings of the AMIA annual symposium; 2001. p. 22-6
5. V.L. Patel, K.N. Cytryn, E.H. Shortlife, and C. Safran The group collaborative effort health care team: role of individual and group expertise Teach Learn Med 12 2000 117 132
6. J. Orasanu, and E. Salas Team decision making in complex environments H.J. Klein J. Orasanu R. Calderwood C.E. Asambok Decision making in action: models and methods 1993 Ablex Norwood, NJ 327 345
7. V.L. Patel, and J.F. Arocha The nature of constraints on collaborative decision making in health care settings E. Salas G. Klein Linking expertise and naturalistic decision making 2000 Lawrence Erlbaum Mahawah, NJ 383 485
8. L.L. Leape A systems analysis approach to medical error J Eval Clin Pract 3 1997 213 222
9. L.L. Leape, D.W. Bates, and D.J. Cullen Systems analysis of adverse drug events JAMA 274 1 1995 35 43
10. T.A. Brennan, L.L. Leape, and N.M. Laird Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I N Engl J Med 324 1991 370 376
11. D.W. Bates, N. Spell, and D.J. Cullen The costs of adverse drug events in hospitalized patients JAMA 277 4 1997 307 311
12. L.L. Leape, T.A. Brennan, and N. Laird The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II N Engl J Med 324 1991 377 384
13. D. Bates, D.J. Cullen, and N. Laird Incidence of adverse drug events and potential adverse drug events JAMA 274 1 1995 29 34
14. Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999
15. Kaganov AL. Ann Thorac Surg. Medical device development: innovation versus regulation. April; 29(4):331-5
16. Cross reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.4 Design input
17. Fleck PD. Five insights for improving product development cycle success. Humanizing technology; Cooper interaction design
18. Design control guidance for medical device manufacturers this guidance relates to FDA 21 CFR 820.30 and sub-clause 4.4 of ISO 9001 March 11, 1997
19. Tufts center for the study of drug development. Impact report: analysis and insight into critical drug development issues, vol. 2. March 2000
20. Food and Drug Administration. Human Factors Implications of the New GMP Rule. Overall Requirements of the New Quality System Regulations. Available from: http://www.fda.gov/cdrh/humfac/hufacimp.html [2000, June 27]; 1998.
21. Sawyer D, Aziz KJ, Backinger CL, Beers ET, Lowery A, Sykes SM, et al. Do it by Design: an Introduction to Human Factors in Medical Devices. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health; 1996
22. Dion R, "Process Improvement and the Corporate Balance Sheet," IEEE Software, July 1993. p. 2835
23. V.L. Patel, J.F. Arocha, and D.R. Kaufman A primer on aspects of cognition for medical informatics J Am Med Inform Assoc 8 2001 324 343
24. Patel VL, DSC, Kushniruk AW, Yang S, Yale JF. Impact of a computer-based patient record system on data collection, knowledge organization, and reasoning. JAMIA, vol. 7. Number 6 Nov/Dec 2000 p. 569-85
25. J. Zhang, T.R. Johnson, V.L. Patel, D.L. Paige, and T. Kubose Using usability heuristics to evaluate patient safety of medical devices J Biomed Inform 36 1-2 2003 23 30
26. V.L. Patel, and D.R. Kaufman Cognitive science and biomedical informatics E.H. Shortliffe J.J. Cimino Biomedical informatics: computer applications in health care and biomedicine 2004 Springer-Verlag New York
27. A.W. Kushniruk, and V.L. Patel Cognitive and usability engineering methods for the evaluation of clinical information systems J Biomed Inform 37 1 2004 56 76
28. J. Preece, Y. Rogers, H. Sharp, D. Benyon, S. Holland, and T. Carey Human-computer interaction 1994 Addison-Wesley New York
29. K.J. Vicente Cognitive work analysis: toward safe, productive and healthy computer-based work 1999 Lawrence Erlbaum New York
30. J. Rasmussen On information processing and human-machine interaction: an approach to cognitive engineering 1986 Elsevier Amsterdam
31. V.L. Patel, D.A. Kaufman, and J.F. Arocha Emerging paradigms of cognition and medical decision making J Biomed Inform 35 2002 52 75
32. M.C. Beuscart-Zepir, J. Bender, R. Beuscart, and I. Menager-Depriester Cognitive evaluation: how to assess the usability of information technology in healthcare Comput Methods Programs Biomed 54 1-1 1997 19 28
33. J. Zhang, V.L. Patel, K.A. Johnson, J.W. Smith, and J. Malin Designing human centered distributed information systems IEEE Intell Syst 2002 42 47
34. Do It By Design-An Introduction to Human Factors in Medical Devices (Dick Sawyer et al, 3)
35. V.L. Patel, and D.W. Bates Cognition and measurement in patient safety research J Biomed Informatics 36 1-2 2003 1 3
36. A. Keselman, V.L. Patel, T.R. Johnson, and J. Zhang Institutional decision-making to select patient care devices: identifying venues to promote patient safety J Biomed Inform 36 1-2 2003 31 44
37. M.B. Miles, and A.M. Huberman Qualitative data analysis: an expanded sourcebook 1994 Sage Thousand Oaks, CA
38. A Strauss, and J. Corbin Grounded theory methodology-an overview N.K. Denzin Y.S. Lincoln Handbook of qualitative research 1994 Sage Publications Thousand Oaks 273 285
39. R.C. Bogdan, and S.K. Biklen Qualitative research for education 1992 Allyn & Bacon Needham Heights, MA
40. Laxmisan A, Malhotra S, Keselman A, Johnson TR, Patel, VL. Decisions about Critical Events in Device-Related Scenarios as a Function of Expertise. Prepublication Manuscript for J Biomed Inform; July 2004
41. P.H. Chung, J. Zhang, T.R. Johnson, and V.L. Patel An extended hierarchical task analysis for error prediction in medical devices Proc AMIA Symp 2003 165 169
42. M.H. Wholey, and J.D. Haller An introduction to the Food and Drug Administration and how it evaluates new devices: establishing safety and efficacy Jt Comm J Qual Saf 29 11 2003 598 609
43. J. Horsky, D.R. Kaufman, M.I. Oppenheim, and V.L. Patel A framework for analyzing the cognitive complexity of computer-assisted clinical ordering J Biomed Inform 36 2003 4 22
44. Gillan, DJ, Schvaneveldt RW. Applying cognitive psychology: Bridging the gulf between basic research and cognitive artifacts. In: Durso FT, editor. Handbook of applied cognition; 1999. p. 3-31
45. D.A. Norman Things that make us smart: defending human attributes in the age of the machine 1993 Addison-Wesley Reading, MA