Chapter 41.
Human Factors and Medical Devices (continued)
Subchapter 41.3. Equipment Checklists in
Anesthesia
Events related to medical equipment can be divided into two
categories, user-error and equipment failure.43 Health device
inspection and preventive maintenance by biomedical or clinical engineering
departments have high face validity as an important patient safety practice in
reducing equipment failure.
There are many calls in the engineering literature to
standardize equipment maintenance.44-46,46 Standardization of
protocols is believed to help make the processes more efficient and reduce
errors.47 However, it has been difficult to standardize equipment
maintenance practices due to a lack of the appropriate units on which to base
measurement.46 Some authorities have suggested outcomes based on
engineering endpoints such as reliability and accuracy.48 Others have
tried to validate a set of maintenance outcome units based on cost or quality
metrics.44,45,49 Some engineers have suggested the incorporation of
clinical endpoints into medical equipment assessment.48,50
Notwithstanding differing views as to measurement of endpoints, experts
uniformly believe that standardization of engineering endpoints is vital to
ensure adequately inspected and maintained equipment.46 No studies to
date have developed a widely used standardized protocol for equipment
maintenance for clinical engineering departments, largely because the lack of
standardization of endpoints renders assessing the relative value of any
particular maintenance protocol impossible.44-46,48,50 Nonetheless,
equipment failure does result in a small fraction of clinical events and thus is
an important safety intervention. Hopefully, future studies will help delineate
the most effective practices for equipment maintenance processes.
Use of checklists is another practice that helps ensure
equipment readiness, particularly for equipment that is needed in critical
situations and/or where equipment failure may have dire consequences. For
example, a nurse at the beginning of each shift may use a checklist to ensure
the readiness of a hospital ward's resuscitation cart ("crash cart") should it
be needed (e.g., the defibrillator is plugged-in and charged, the back-up suction
pump works, medication is not past its expiration date). Similarly, a perfusion
technologist can use a checklist to ensure cardiac bypass circuit and back-up
equipment are ready before surgery. Published studies on the effectiveness of
equipment checklists largely relate to the use of preoperative checklists to
prevent anesthesia equipment failures since, to date, studies on the
effectiveness of equipment checklists in medicine have been limited to this
area.51-53,54 These studies are reviewed in Chapter 23.
Final Comment to Chapter
41
Human factors testing is yielding important data regarding safe
and effective medical device and alarm designs that take into account the users'
cognitive limitations. Machines can be designed and redesigned that enhance
patient safety, rather than compromise it.
Currently, there are no widely accepted standards for equipment
maintenance intervals and protocols. Maintenance endpoints that incorporate
clinical events as one component of the endpoint have been suggested. Until a
reliable and validated engineering endpoint metric is widely recognized it will
remain difficult to investigate the most effective maintenance practices.
Other than the pioneering work in anesthesiology, HFE has been
underutilized in medicine. Hopefully, in the near future, more attention will be
focused on integrating human factors engineering within all aspects of medical
training and practice, which will help create a culture of safety.
References
1. Handbook of Human Factors and Ergonomics. 2 ed. New York: John
Wiley and Sons, INC, 1997.
2. Sawyer D. Do It By Design: An Introduction to Human Factors in Medical
Devices. 1997. FDA.
3. Gosbee J, Lin L. The Role of Human Factors Engineering in Medical Device
and Medical Systems Errors. In: Vincent C, editor. Clinical Risk Management:
Enhancing Patient Safety. 2000.
4. Wiklund M, Gardner-Bonneau D, Carstensen P, Weinger M. Global
standardization of human factors for medical devices and systems. In:
Proceedings of the Human Factors and Ergonomics Society 44th Annual
Meeting. Santa Barbara, CA: Human Factors and Ergonomics Society, 2000:
533-536.
5. Cook RI, Woods DD, Howie MB, Horrow JC, Gaba DM. Case 2-1992.
Unintentional delivery of vasoactive drugs with an electromechanical infusion
device. J Cardiothorac Vasc Anesth 1992;6:238-244.
6. Cooper JB, Newbower RS, Kitz RJ. An analysis of major errors and equipment
failures in anesthesia management: considerations for prevention and detection.
Anesthesiology 1984;60:34-42.
7. Ludbrook GL, Webb RK, Fox MA, Singleton RJ. The Australian Incident
Monitoring Study. Problems before induction of anaesthesia: an analysis of 2000
incident reports. Anaesth Intensive Care 1993;21:593-595.
8. Bogner MS. Designing medical devices to reduce the likelihood of error.
Biomed Instrum Technol 1999;33:108-113.
9. Human Factors Implications of the New GMP Rule.
http://www.fda.gov/cdrh/humfac/hufacimp.html. 4-22-1998.
10. Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule;
Quality System Regulation. http://www.fda.gov/cdrh/humfac/frqsr.html 61[195],
52601-52662. 10-7-1996. Food and Drug Administration.
11. American National Standards Institute AftAoMI. Human factors
engineering guidelines and preferred practices for the design of medical
devices (ANSI/AAMI HE-48). Arlington, VA: Association for the Advancement of
Medical Instrumentation, 1993.
12. Brown SL, Bogner MS, Parmentier CM, Taylor JB. Human Error and
Patient-Controlled Analgesia Pumps. Journal of Intravenous Nursing 1997;20:311-316.
13. Lin L. Human Error in Patient-Controlled Analgesia: Incident Reports and
Experimental Evaluation. In: Proceedings of the Human Factors and Ergonomics
Society 42nd Annual Meeting. Santa Barbara, CA: Human Factors and Ergonomics
Society, 1998:1043-1047.
14. Lin L, Isla R, Doniz K, Harkness H, Vicente KJ, Doyle DJ. Applying human
factors to the design of medical equipment: patient-controlled analgesia. J
Clin Monit Comput 1998;14(4):253-263.
15. Aucella A, Kirkham T, Barnhart S, Murphy L, LaConte K. Improving
ultrasound systems by user-centered design. In: Proceedings of the Human
Factors and Ergonomics Society. Santa Barbara, CA: Human Factors and
Ergonomics Society, 1994.
16. Sawyer D. Medical device requirements, human factors, and the food and
drug administration. In: Proceedings of the Human Factors and Ergonomics
Society 44th Annual Meeting. Santa Barbara: Human Factors and Ergonomics
Society, 2000: 526-527.
17. Claus P, Gibbons P, Kaihoi, BH, Mathiowetz M. Usability lab: A new tool
for process analysis at the Mayo Clinic. In: HIMSS Proceedings. Chicago:
Healthcare Information Management Systems Society, 1997:149-159.
18. Gosbee J. Human Factors Engineering is the Basis for a Practical
Error-in-Medicine Curriculum. First Workshop on Human Error in Clinical Systems.
http://www.dcs.gla.ac.uk/~johnson/papers/HECS_99/Gosbee.html. 1999.
19. Casarett D, Helms C. Systems error versus physicians' errors: Finding the
balance in medical education. Acad Med 1999;74:19-22.
20. Frey B, Kehrer B, Losa M, Braun H, Berweger L, Micallef J et al.
Comprehensive critical incident monitoring in a neonatal-pediatric intensive
care unit: experience with the system approach. Intensive Care Med 2000;26(1):69-74.
21. Woods D. The Alarm Problem and Direct Attention in Dynamic Fault
Management. Ergonomics 1995; 38(11):2371-2393.
22. Samuels SI. An alarming problem. Anesthesiology 1986;64(1):128.
23. Finley GA, Cohen AJ. Perceived urgency and the anaesthetist: responses to
common operating room monitor alarms. Can J Anaesth 1991;38(8):958-964.
24. Loeb RG, Jones BR, Leonard RA, Behrman K. Recognition accuracy of current
operating room alarms. Anesth Analg 1992;75(4):499-505.
25. Momtahan K, Hetu R, Tansley B. Audibility and identification of auditory
alarms in the operating room and intensive care unit. Ergonomics 1993;36:1159-1176.
26. Patterson R, Milroy R. Auditory warnings on civil aircraft: the learning
and retention of warnings. Final Contract Report 7D/S/0142. 1980. Cambridge, MRC
Applied Psychology Unit.
27. Simons D, Frederiks T, Tappel J. The evaluation of an auditory alarm for
a new medical device. In: Proceedings of the Human Factors and Ergonomics
Society 41st Annual Meeting. Santa Barbara: Human Factors and Ergonomics
Society, 1997: 777-781.
28. Edworthy J, Stanton N. A user-centered approach to the design and
evaluation of auditory warning signals: 1. Methodology. Ergonomics 1995;38:2262-2280.
29. Leung YK, Smith S, Parker S, Martin R. Learning and Retentiono of
Auditory Warnings. www.icad.org/Web siteV2.0/conferences/icad97/leung.pdf. 2001.
30. Edworthy J, Loxley S, Dennis I. Improving auditory warning design:
relationship between warning sound parameters and perceived urgency. Hum
Factors 1991;33:205-231.
31. Stanford L, McIntyre J, Hogan J. Audible alarm signals for anaesthesia
monitoring equipment. Int J Clin Monit Comput 1985; 1:251-256.
32. Burt JL, Bartolome DS, Burdette DW, Comstock JR. A psychophysiological
evaluation of the perceived urgency of auditory warning signals.
Ergonomics 1995;38:2327-2340.
33. Loeb RG. A measure of intraoperative attention to monitor displays.
Anesth Analg 1993;76:337-341.
34. Gurushanthaiah K, Weinger MB, Englund CE. Visual display format affects
the ability of anesthesiologists to detect acute physiologic changes. A
laboratory study employing a clinical display simulator. Anesthesiology
1995;83:1184-1193.
35. Jungk A, Thull B, Hoeft A, Rau G. Ergonomic Evaluation of an Ecological
Interface and a Profilogram Display for Hemodynamic Monitoring. J Clin
Monit 1999;15:469-479.
36. Kestin IG, Miller BR, Lockhart CH. Auditory alarms during anesthesia
monitoring. Anesthesiology 1988;69:106-109.
37. Sanderson P, Seagull FJ. Cognitive Ergonomics of Information Technology
in Critical Care: Contexts and Modalities for Alarm Interpretation. Available
at: http://www.detir.qld.gov.au/hs/ergo97/sanderso.pdf. Accessed June 20, 2001.
38. Xiao Y, Mackenzie F, Seagull J, Jaberi M. Managing the monitors: an
analysis of alarm silencing activities during an anesthetic procedure. In:
Proceeding of the Human Factors and Ergonomics Society 44th Annual
Meeting. Santa Barbara: Human Factors and Ergonomics Society, 2000: 250-253.
39. Bliss JP, Gilson RD, Deaton JE. Human probability matching behavior in
response to alarms of varying reliability. Ergonomics 1995;
38(11):2300-2312.
40. Rheineck-Leyssius AT, Kalkman CJ. Influence of pulse oximeter lower alarm
limit on the incidence of hypoxaemia in the recovery room. Br J Anaesth
1997;79(4):460-464.
41. Makivirta A, Koski EM. Alarms-inducing variability in cardiac
postoperative data and the effects of prealarm delay. J Clin Monit 1994;10:153-162.
42. Rheineck-Leyssius AT, Kalkman CJ. Advanced pulse oximeter signal
processing technology compared to simple averaging. II. Effect on frequency of
alarms in the postanesthesia care unit. J Clin Anesth 1999;11:196-200.
43. Hyman WA. Errors in the Use of Medical Equipment. In: Bogner MS, editor.
Human Error in Medicine. Hillsdale, New Jersey: Lawrence Erlbaum Associates,
1994:327-347.
44. Cohen T, Bakuzonis C, Friedman SB, Roa RL. Benchmark indicators for
medical equipment repair and maintenance. Biomed Instrum Technol 1995;29:308-321.
45. Cohen T. Validating medical equipment repair and maintenance metrics: a
progress report. Biomed Instrum Technol 1997;31:23-32.
46. Shaffer MJ. Biomedical equipment: maintenance factors, units of
measurement, and standards. Med Instrum 1985;19:268-272.
47. Leape LL. Error in medicine. JAMA 1994;272:1851-1857.
48. James PJ. Equipment management risk rating system based on engineering
endpoints. Biomed Instrum Technol 1999;33:115-120.
49. Cohen T. Validating medical equipment repair and maintenance metrics,
Part II: Results of the 1997 survey. Biomed Instrum Technol 1998;32:136-144.
50. Keil O, Widmann DE. Assessment of the impact of medical devices on the
quality of care. QRB Qual Rev Bull 1984;10:278-280.
51. Caplan RA, Vistica MF, Posner KL, Cheney FW. Adverse anesthetic outcomes
arising from gas delivery equipment: a closed claims analysis.
Anesthesiology 1997;87:741-748.
52. Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia
mishaps: a study of human factors. Anesthesiology 1978;49:399-406.
53. Cooper JB. Toward prevention of anesthetic mishaps. Int Anesthesiol
Clin 1984;22:167-183.
54. March MG, Crowley JJ. An evaluation of anesthesiologists' present
checkout methods and the validity of the FDA checklist. Anesthesiology
1991;75:724-729.
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