Using failure mode and effects analysis to plan implementation of smart i.v. pump technology

American Journal of Health-System Pharmacy

Volumn 63, Issue 16, 2006, Pages 1528-1538

  Wetterneck, Tosha B ^a   Skibinski, Kathleen A ^b   Roberts, Tanita L ^c   Kleppin, Susan M ^d   Schroeder, Mark E ^a   Enloe, Myra ^e   Rough, Steven S ^f   Hundt, Ann Schoofs ^g   Carayon, Pascale ^g  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b UNIVERSITY OF WISCONSIN MADISON   (United States)

^c BEN TAUB GENERAL HOSPITAL   (United States)

^d Center for Drug Policy   (United States)

^e Elder Care of Wisconsin   (United States)

^f UWHC   (United States)

^g University of Wisconsin Madison   (United States)

Author keywords

Computers; Devices; Dosage; Drug use; Errors, medication; Hospitals; Injections; Methodology; Team; Technology; Toxicity

Indexed keywords

ARTICLE; COMPUTER PROGRAM; DRUG USE; FAILURE MODE AND EFFECTS ANALYSIS; HOSPITAL PHARMACY; HUMAN FACTORS RESEARCH; INFUSION PUMP; INFUSION SYSTEM; MEDICAL AUDIT; MEDICAL TECHNOLOGY; MEDICATION ERROR; OUTCOME ASSESSMENT; PATIENT SAFETY; PRIORITY JOURNAL;

EID: 33748562195     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp050515     Document Type: Article

References (42)

1. Bates DW, Cullen DJ, Laird N et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. JAMA. 1995; 274:29-34.
2. Kaushal R, Bates DW, Landrigan C et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001; 285:2114-20.
3. Committee on Quality of Health Care in America, Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press; 2001.
4. Eskew JA, Jacobi J, Buss WF et al. Using innovative technologies to set new safety standards for the infusion of intravenous medications. Hosp Pharm. 2002; 37:1179-89.
5. Institute for Safe Medication Practices. "Smart" infusion pumps join CPOE and bar coding as important ways to prevent medication errors. www.imsp.org/MSAarticles/Smart.htm (accessed 2005 Oct 7).
6. Leape LL, Bates DW, Cullen DJ et al. Systems analysis of adverse drug events. JAMA. 1995; 274:35-43.
7. ECRI. General purpose infusion pumps. Health Devices. 2002; 31:353-87.
8. Rothschild JM, Keohane CA, Cook EF et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med. 2005; 33:533-40.
9. Bates DW. Variability in intravenous medication practices: implications for medication safety. Jt Comm J Qual Patient Saf. 2005; 31:203-10.
10. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000.
11. Battles JB, Keyes MA. Technology and patient safety: a two-edged sword. Biomed Instrum Technol. 2002; 36:84-8.
12. Cook RI. Safety technology: solutions or experiments? Nurs Econ. 2002; 20:80-2.
13. Nadzam DM, Macklis RM. Promoting patient safety: is technology the solution? Jt Comm J Qual Improv. 2001; 27:430-6.
14. Cohen MR, Senders JJ, David NM. Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm. 1994; 29:319-30.
15. Wachter RM, Shojania DG, Duncan BW et al. Making health care safer: a critical analysis of patient safety practices. Rockville, MD: Agency for Healthcare Research and Quality, 2001; AHRQ publication no. 01-E058.
16. Smith MJ, Carayon-Sainfort P. A balance theory of job design for stress reduction. Int J Ind Ergon. 1989; 4:67-79.
17. American Society for Quality Control Statistics Division. Glossary and tables for statistical quality control. Milwaukee, WI: ASQC Quality Press; 1983.
18. Stamatis DH. Failure mode and effects analysis: FMEA from theory to execution. Milwaukee, WI: ASQC Quality Press; 1995.
19. American Society for Healthcare Risk Management. Strategies and tips of maximizing failure mode and effects analysis in your organization. Chicago: American Society for Healthcare Risk Management; 2002.
20. Spath P. Get more out of your FMEAs: the five stages of FMEA implementation. Hosp Peer Rev. 2004; 29:13-6.
21. Grissinger M, Rich D. JCAHO: meeting the standards for patient safety. Joint Commission on Accreditation of Healthcare Organizations. J Am Pharm Assoc. 2002; 42(5, suppl 1):S54-5.
22. McNally KM, Page MA, Sunderland VB. Failure-mode and effects analysis in improving a drug distribution system. Am J Health-Syst Pharm. 1997; 54:171-7.
23. Burgmeier J. Failure mode and effect analysis: an application in reducing risk in blood transfusion. Jt Comm J Qual Improv. 2002; 28:331-9.
24. Apkon M, Leonard J, Probst L et al. Design of a safer approach to intravenous drug infusions: failure mode effects analysis. Qual Saf Health Care. 2004; 13:265-71.
25. Adachi W, Lodolce AE. Use of failure mode and effects analysis in improving the safety of i.v. drug administration. Am J Health-Syst Pharm. 2005; 62:917-20.
26. Wetterneck TB, Skibinski K, Schroeder M et al. Challenges with the performance of failure mode and effects analysis in healthcare organizations: an IV medication administration HFMEA. In: Proceedings of the Human Factors and Ergonomics Society 48th Annual Meeting. Santa Monica, CA: Human Factors and Ergonomics Society; 2004; 1708-12.
27. Capunzo M, Cavallo P, Boccia G et al. A FMEA clinical laboratory case study: how to make problems and improvements measurable. Clin Leadersh Manag Rev. 2004; 18:37-41.
28. Willis G. Failure modes and effects analysis in clinical engineering. J Clin Eng. 1992; 17:59-63.
29. DeRosier J, Stalhandske E, Bagian JP et al. Using health care failure mode and effect analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002; 28:248-67.
30. Carayon P, Wetterneck TB, Hundt AS et al. Assessing nurse interaction with medication administration technologies: the development of observation methodologies. In: Khalid HM, Helander MG, Yeo AW, eds. Work with computing systems (WWCS). Kuala Lumpur, Malaysia: Damai Sciences; 2004:319-24.
31. Carayon P, Wetterneck TB, Hundt AS et al. Observing nurse interaction with medication administration technologies. In: Advances in patient safety: from research to implementation. Rockville, MD: Agency for Healthcare Research and Quality; 2005:349-64. AHRQ publication no. 050021-2.
32. HF: Safe Medication Administration through Technologies and Human Factors: FMEA study. http://cqpi2.engr.wisc.edu/smarthf/fmea.html (accessed 2006 May 30).
33. Lin L, Vicente KJ, Doyle DJ. Patient safety, potential adverse drug events, and medical device design: a human factors engineering approach. J Biomed Inform. 2001; 34:274-84.
34. Carayon P, Karsh B. Sociotechnical issues in the implementation of imaging technology. Behav Inf Technol. 2000; 19:247-62.
35. Carayon P, Smith P, Hundt AS et al. Implementation of an electronic health records (EHR) system in a small clinic. Behav Inf Technol. In press.
36. Schroeder ME, Wolman R, Wetterneck TB et al. Tubing mislead allows free flow event with smart intravenous infusion pump. Anesthesiology. In press.
37. Vicente KJ, Kada-Bekhaled K, Hillel G et al. Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability. Can J Anaesth. 2003; 50:328-32.
38. Vicente KJ. What does it take? A case study of radical change toward patient safety. Jt Comm J Qual Saf. 2003; 29:598-609.
39. Hundt AS, Carayon P, Wetterneck TB et al. Evaluating design changes of a smart IV pump. In: Tartalgia R, Bagnara S, Bellandi T et al., eds. Proceedings of the International Conference-HEPS 2005. London: Taylor & Francis; 2005:239-42.
40. Institute for Healthcare Improvement. Risk priority number (from failure modes and effects analysis). www.ihi.org/IHI/Topics/PatientSafety/ MedicationSystems/Measures/ Risk+Priority+Number+%28from+Failure+Modes+and+Effects+Analysis%29.htm (accessed 2005 Sep 25).
41. Woodhouse S, Burney B, Coste K. To err is human: improving patient safety through failure mode and effect analysis. Clin Leadersh Manag Rev. 2004; 18:32-6.
42. Kieffer RG. Validation and the human element. PDA J Pharm Sci Technol. 1998; 52:52-4.