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A932
October 19, 2009 2:00 PM - 4:00 PM Room Area M |
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| Use of Failure Modes and Effects Analyses To Guide the Design of an Infusion Pump User Interface | ||||||||||||||||||||||||||||||||||||||||||
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David Liu, B.Eng., Daniel J. Pulsipher, B.S., Noah D. Syroid, B.S., Ken B. Johnson, M.D., Dwayne R. Westenskow, Ph.D. Department of Anesthesiology, University of Utah, Salt Lake City, Utah |
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Introduction
: Many adverse drug events are related to infusion pump use
1
but can be mitigated or prevented with smart infusion technology
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. Failure Modes and Effects Analyses (FMEA) have been used to improve the drug administration process
3,4
. However, their mitigation strategies usually focus on process improvements (e.g. staff training) rather than improving pump technology. We performed FMEAs on two pumps (syringe and volumetric) to help guide the design of an improved interface.
Methods : A committee of eight experts in anesthesiology, bioengineering, human factors, computer science, and design was assembled. The committee identified tasks where the anesthesiologist interacts with infusion pumps in the OR, listed each step in the workflow (including data entry into AIMS), and identified potential failure modes and mitigation strategies. The Severity, Probability, and Detectability of each failure mode was scored individually on a modified scale from 1 (mild) to 3 (severe) 5 . The three scores were averaged across the committee, multiplied to generate a Risk Priority Number (RPN), and ranked to identify high priority issues.[table1] Results : The committee investigated 19 tasks (with 164 steps) across the two pumps (see Table 1, above). There were 108 potential failure modes identified and mitigation strategies were suggested for all failure modes. The five highest-priority failure modes for the syringe pump are shown in Table 2, below. Conclusions : The FMEA found keypad entry errors to be the greatest risk to patient safety. The mitigation strategies will be implemented in an ongoing study that will prototype and evaluate a new user interface for infusion pumps. References : 1. Husch M, Sullivan C, Rooney D, et al. Qual Saf Health Care 2005;14:80-6. 2. Wilson K, Sullivan M. Am J Health-Sys Pharm 2004;61:177-83. 3. Apkon M, Leonard J, Probst L, et al. Qual Saf Health Care 2004;13:265-71. 4. Wetterneck TB, Skibinski KA, Roberts TA, et al. Am J Health-Sys Pharm 2006;63:1528-38. 5. ECRI. Health Devices 2004;33:233-43.[table2] From Proceedings of the 2009 Annual Meeting of the American Society Anesthesiologists. |
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