Dataset Information

Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps.

ABSTRACT: This retrospective study of 6426 hip replacement, coronary artery bypass graft, and colectomy surgeries across 23 US hospitals found that intravenous (IV) set designs that can be interchanged for use both in gravity-fed and automated pump delivery systems are replaced less frequently than IV sets designed for use primarily by one delivery method. Semistructured interviews with nurses highlighted the impact of set design on nursing workflow when moving between gravity-fed and pump-based administration. Use of interchangeable, single-design IV sets across gravity and automated infusions minimizes disruptions to closed systems, may reduce nurses being distracted from patients' clinical needs when replacing sets, and may yield supply cost savings.

SUBMITTER: Hedlund N

PROVIDER: S-EPMC5625969 | biostudies-literature | 2017 Jul/Aug

REPOSITORIES: biostudies-literature

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Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps.

Hedlund Nancy N Sarangpur Shishir S Kayler Shannon S OʼBrien Kathy K Beer Idal I

Journal of infusion nursing : the official publication of the Infusion Nurses Society 20170701 4

This retrospective study of 6426 hip replacement, coronary artery bypass graft, and colectomy surgeries across 23 US hospitals found that intravenous (IV) set designs that can be interchanged for use both in gravity-fed and automated pump delivery systems are replaced less frequently than IV sets designed for use primarily by one delivery method. Semistructured interviews with nurses highlighted the impact of set design on nursing workflow when moving between gravity-fed and pump-based administr ...[more]

PMID: 28682999

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Project description:BackgroundThe adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals.ObjectiveThis study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device.MethodsThe authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors.ResultsThe proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively.ConclusionsThe proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use.

Project description:BackgroundInfusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality.MethodsThis systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools.ResultsThe six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion.ConclusionsWe verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.

Project description:BackgroundReusing anaesthesia infusion-set components may reduce the climate impact from plastic waste and discarded medications. Infusion-set contents can be shielded from patient contact by single use of an infusion line fitted with dual antireflux valves, preventing retrograde entry of microorganisms, and eliminating the risk for patient-to-patient cross-contamination. However, infusion-set contamination from compromised aseptic handling could affect quality of care.InterventionsTo determine the prevalence of infusion-set bacterial contamination and compare the climate effects, we randomised operating rooms scheduled for total intravenous anaesthesia to handle procedures by infusion-set reuse or single-use. Both methods used dual single-use antireflux valves.OutcomesThe primary outcome was infusion-set bacterial contamination assessed by aerobic culture of infusion-set fluid collected after each procedure. The secondary outcome was CO 2 emissions (CO 2 -eq) estimated by life cycle assessment of component and medication use. To assess feasibility of detecting an inter-method difference in bacterial contamination, an interim analysis was planned after including at least 150 procedures per group.ResultsAfter allocating 54 operating rooms per method, 189 and 159 procedures of reuse and single use were included. Reuse permitted a median of three procedures per infusion set (range 1 to 8). Positive cultures occurred in two procedures per method [mean (95% CI)]; prevalence 1.15% (0.03 to 2.27); relative risk of reuse versus single use 0.84 (0.12 to 5.93), P = 0.861. As prespecified, inclusion was stopped due to futility. The median (95% CI) per-procedure climate emissions were 0.43 (0.41 to 0.47) and 1.39 (1.37 to 1.40) kg CO 2 -eq for reuse and single-use respectively; difference -0.96 (-0.99 to -0.93), P < 0.0005. The main sources for climate emissions were production of infusion-set components and waste handling.ConclusionsWe conclude that the prevalence of bacterial contamination was low for both methods. A much larger study would be needed to detect an inter-method difference. Reuse of infusion-set components allowed significantly reduced intravenous anaesthesia climate emissions.

Dataset Information

Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps.

Publications

Primary Intravenous Set Consumption Across 3 Branded Infusion Pumps.

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