A Hazard Analysis of Class I Recalls of Infusion Pumps

Abstract

Background The 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. Objective This 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. Methods 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. This dataset does not include cases involving illegal factors. Results The 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. Conclusions The 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.

Investigation and analysis of four countries’ recalls of osteosynthesis implants and joint replacement implants from 2011 to 2021

“…The recall of medical device is caused by four factors (Fig. 1 ), including manufacturer, hospital, supervision administration and the environment [ 1 , 9 , 12 – 14 , 21 ]. The manufacturer is responsible for the design and manufacture of the medical devices.…”

“…In 2008, Rich [ 13 ] listed 3 disturbing human factors that lead to medical device recalls, namely user expectations, device design and environment. And Gao et al established a human–machine–environment interaction model to analyze the recalls of infusion pump [ 14 ]. Adverse events of medical device place a significant burden on the health of patients and the reputation of manufacturers [ 3 , 15 ].…”

“…Adverse events of medical device place a significant burden on the health of patients and the reputation of manufacturers [ 3 , 15 ]. The analysis of recall events helps to control the risk of medical devices, protect the health of patients and provide some further insights into the better management of medical devices [ 14 , 16 ].…”

Compilation About Adverse Events Recorded in FDA/ USA and ANVISA/Brazil Databases Through Models Available in the Literature Concerning Analysis and Prioritization of Actions for Medical Devices

“…4 These events can occur because the medical device environment is a complex system of human-machine interaction that requires understanding the environment and identify risk factors. 5 Every year, the Food and Drug Administration (FDA/ USA) receives many thousand reports of suspected medical device-associated injuries, deaths, and malfunctions. 6 The FDA uses these reports to detect potentially related safety issues, monitor device performance, and contribute to benefit-risk assessments of these products.…”

“…10,11 The third piece of equipment is the Infusion Pump (IP), which perfuses medications or nutrients to the patient at a controlled amount; a health professional programs the rate and duration of fluid delivery using the equipment's software. 5,12 Fourth is the Physiological Monitor (PM), which is a device connected to the patient, able to identify clinical emergencies when vital signs like heart rate, blood pressure, and oxygenation exceed preset thresholds; in this case, alarms are activated. 13 The fifth is the Pulmonary Ventilator (PV), which involves a breathing tube placed in the patient's windpipe, connected to the mechanical ventilator, which delivers oxygenated air.…”