Abstract
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.
Highlights
Infusion Pumps Continuous intravenous delivery of drugs with short half-lives, such as inotropic agents and vasodilators, is a recommended technique in acute care [1]
The 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
The proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA
Summary
Infusion Pumps Continuous intravenous delivery of drugs with short half-lives, such as inotropic agents and vasodilators, is a recommended technique in acute care [1]. A syringe pump is a device that intravenously infuses fluids, drugs, or nutrients in the patient [2]. The use of infusion pump is helpful as it helps in reducing nurses’ workload and in improving accuracy and efficiency in terms of delivery of drugs or fluids. The purpose of using a syringe pump in clinical settings is to administer an accurate http://humanfactors.jmir.org/2019/2/e10366/ XSLFO RenderX. JMIR HUMAN FACTORS amount of drug or fluid over a relatively long duration, and it can be especially favorable for continuous infusion of very small amounts such as 0.1 mL/hour [3]. With the development of the related technologies and market, the number of adverse events has 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
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