Risks in the Implementation and Use of Smart Pumps in a Pediatric Intensive Care Unit: Application of the Failure Mode and Effects Analysis

Manrique-Rodríguez, Silvia; Sánchez-Galindo, Amelia; López‐Herce, Jesús; Calleja‐Hernández, Miguel Ángel; Peinado, Irene Iglesias; Carrillo-Álvarez, Ángel; Sáez, María Sanjurjo; Fernández-Llamazares, Cecilia M.

doi:10.1017/s0266462314000051

Cited by 20 publications

(36 citation statements)

References 28 publications

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“…In infusion pumps, nuisance alarms can take the form of frequent air-in-line alarms as a result of microbubbles; occlusion alarms as a result of kinked administration sets or positional intravenous catheters; hold, expired, or inactivity alarms; and battery alarms. Evidence suggests that increased training and education can help reduce the number of nuisance alarms 3,7,21,27. In a study involving a pediatric ICU, Manrique-Rodríguez et al27 found that providing user training and support tools, as well as continuously monitoring results, decreased the number of unnecessary pump alarms and that alarms that sounded were taken more seriously.…”

Section: Discussionmentioning

confidence: 99%

“…Evidence suggests that increased training and education can help reduce the number of nuisance alarms 3,7,21,27. In a study involving a pediatric ICU, Manrique-Rodríguez et al27 found that providing user training and support tools, as well as continuously monitoring results, decreased the number of unnecessary pump alarms and that alarms that sounded were taken more seriously. Kurnat-Thoma and Shah3 characterized pump alarms and associated nurse perceptions across 6 care units, concluding that there was a need to improve staff education specific to clustering tasks around medical device alarms.…”

Section: Discussionmentioning

confidence: 99%

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Perceptions of Infusion Pump Alarms

Vitoux

Schuster

Glover

2018

Journal of Infusion Nursing

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Between 1983 and 2011, equipment-related alarms in critical care have increased from 6 to 40 different alarm types. As nurses become overwhelmed, distracted, or desensitized by alarm noise, they may miss critical alarms that could result in patient harm. The findings of an infusion pump alarm survey indicated that nurses overwhelmingly agree that infusion pump nuisance alarms occur frequently and disrupt patient care. But nurses' perceptions of pump alarms are different from those previously reported for clinical alarms in general. It may not be appropriate to broadly apply general alarm management recommendations to infusion pump alarms at this time.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Perceptions of Infusion Pump Alarms

Vitoux

Schuster

Glover

2018

Journal of Infusion Nursing

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“…In the pediatric context, implementing new IP smartpumps, when assessed through analysis of modes and failures, several points of risk during the implementation and use process were also found by its users (25) . However, improvements were suggested through the role of the staff itself, such as introducing capital letters to help users differentiate names of similar drugs, promoting more safety in the use of equipment and improvements in care practice.…”

Section: Resultsmentioning

confidence: 99%

Usability of volumetric infusion pumps in pediatric intensive care

Oliveira

Silva

Arruda

et al. 2021

Rev. esc. enferm. USP

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Objective: To analyze the usability of two infusion pump models in a Pediatric Intensive Care Unit. Method: This is a cross-sectional study of exploratory descriptive quantitative approach. A task was carried out in a controlled environment using infusion pump with 72 nursing staff members from August to September 2018. The Methodological Guideline for Medical Care Equipment Assessment Studies and the quality model proposed by NBR ISO/IEC 9126-1 were followed. Descriptive statistical analysis was used applying Fisher’s exact test, binomial test and Mann-Whitney test. Results: 91.7% of tasks were completed. The infusion pump-2 model was associated (p < 0.001) with operationalization, tasks accomplished with non-conformities, use of a manual calculator (measure effectiveness) and task accomplishment time (measure efficiency). Conclusion: Efficacy and efficiency measures can evidence a better context of usability of IPs and identify interaction failures with the nursing staff to be improved in care practice.

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“…15,16 It has also been considered an excellent tool for the evaluation of patient safety after the implementation of information technologies (ITs) like computerized physician order entry (CPOE) and smart pumps. 17,18 However, given the scant evidence about the reliability and validity of FMECA, 19 it would not be appropriate to recommend its use alone as a tool for preventing patient harm. To overcome this limitation, we combined risk analysis using FMECA methodology with the objective measures of a traditional cross-sectional medication error rate study.…”

Section: Introductionmentioning

confidence: 99%

Risks and medication errors analysis to evaluate the impact of a chemotherapy compounding workflow management system on cancer patients’ safety

Marzal-Alfaro¹,

Rodríguez-González²,

Escudero‐Vilaplana³

et al. 2020

Health Informatics J

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A failure modes, effects and criticality analysis was supported by an observational medication error rate study to analyze the impact of Phocus Rx®, a new image-based workflow software system, on chemotherapy compounding error rates. Residual risks that should be a target for additional action were identified and prioritized and pharmacy staff satisfaction with the new system was evaluated. In total, 16 potential failure modes were recognized in the pre-implementation phase and 21 after Phocus Rx® implementation. The total reduction of the criticality index was 67 percent, with a reduction of 46 percent in material preparation, 76 percent in drug production and 48 percent in quality control subprocesses. The relative risk reduction of compounding error rate was 63 percent after the implementation of Phocus Rx®, from 0.045 to 0.017 percent. The high-priority recommendations defined were identification of the product with batch and expiration date from scanned bidimensional barcodes on drug vials and process improvements in image-based quality control. Overall satisfaction index was 8.30 (SD 1.06) for technicians and 8.56 (SD 1.42) for pharmacists ( p = 0.655). The introduction of a new workflow management software system was an effective approach to increasing safety in the compounding procedures in the pharmacy department, according to the failure modes, effects and criticality analysis method.

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Risks in the Implementation and Use of Smart Pumps in a Pediatric Intensive Care Unit: Application of the Failure Mode and Effects Analysis

Cited by 20 publications

References 28 publications

Perceptions of Infusion Pump Alarms

Perceptions of Infusion Pump Alarms

Usability of volumetric infusion pumps in pediatric intensive care

Risks and medication errors analysis to evaluate the impact of a chemotherapy compounding workflow management system on cancer patients’ safety

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