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TOSHA B. WETTERNECK, M.D., is Associate Professor, Department of Medicine, University of Wisconsin School of Medicine and Public Health (UWSMPH), Madison. KATHLEEN A. SKIBINSKI, M.S., is Clinical Assistant Professor, and Associate Dean for Student Affairs, University of Wisconsin School of Pharmacy. TANITA L. ROBERTS, M.S., PHARM.D., is Ambulatory Pharmacy Operations Manager, Ben Taub General Hospital, Houston, TX; at the time of writing, she was Pharmacy Administrative Resident, University of Wisconsin Hospital and Clinics (UWHC), Madison. SUSAN M. KLEPPIN is Deputy Director, Center for Drug Policy, UWHC. MARK E. SCHROEDER, M.D., is Associate Professor, Department of Anesthesiology, UWSMPH. MYRA ENLOE, R.N., M.S., is Director of Program Operations, Elder Care of Wisconsin, Madison; at the time of writing, she was Patient Safety Officer for Nursing and Patient Care Services, UWHC. STEVEN S. ROUGH, M.S., is Director of Pharmacy, UWHC. ANN SCHOOFS HUNDT, PH.D., is Research Scientist, Center for Quality and Productivity Improvement (CQPI), University of Wisconsin–Madison. PASCALE CARAYON, PH.D., is Director, CQPI, and Procter & Gamble Professor in Total Quality, Department of Industrial and Systems Engineering, University of Wisconsin–Madison.
Address correspondence to Dr. Wetterneck at the Department of Medicine, University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, J5/222b CSC, MC 2454, Madison, WI 53792 (tbw{at}medicine.wisc.edu).
Summary. A multidisciplinary team conducted a FMEA to guide the implementation of a smart i.v. pump that was designed to prevent pump programming errors. The smart i.v. pump was equipped with a dose-error reduction system that included a pre-defined drug library in which dosage limits were set for each medication. Monitoring for potential failures and errors occurred for three months postimplementation of FMEA. Specific measures were used to determine the success of the actions that were implemented as a result of the FMEA. The FMEA process at the hospital identified key failure modes in the medication process with the use of the old and new pumps, and actions were taken to avoid errors and adverse events. I.V. pump software and hardware design changes were also recommended. Thirteen of the 18 failure modes reported in practice after pump implementation had been identified by the team. A beneficial outcome of FMEA was the development of a multidisciplinary team that provided the infrastructure for safe technology implementation and effective event investigation after implementation. With the continual updating of i.v. pump software and hardware after implementation, FMEA can be an important starting place for safe technology choice and implementation and can produce site experts to follow technology and process changes over time.
Conclusion. FMEA was useful in identifying potential problems in the medication-use process with the implementation of new smart i.v. pumps. Monitoring for system failures and errors after implementation remains necessary.
Index terms: Computers; Devices; Dosage; Drug use; Errors, medication; Hospitals; Injections; Methodology; Team; Technology; Toxicity
Purpose. Failure mode and effects analysis (FMEA) was used to evaluate a smart i.v. pump as it was implemented into a redesigned medication-use process.
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