Malfunctions of Medical Devices Due to Electrostatic Occurrences Big Data Analysis of 10 Years of the FDA’s Reports

Kohani, Mehdi; Pecht, Michael

doi:10.1109/access.2017.2782088

Cited by 24 publications

(12 citation statements)

References 10 publications

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“…It is well established that medical devices such as ICP monitoring systems may malfunction due to electrostatic discharges (ESDs) [86,87]. All parts of the ICP measurement system, including sensor, cable, transducer and display, may represent potential sites of origin for baseline pressure errors (BPEs).…”

Section: Electrostatic Dischargesmentioning

confidence: 99%

Measuring intracranial pressure by invasive, less invasive or non-invasive means: limitations and avenues for improvement

Evensen¹,

Eide²

2020

Fluids Barriers CNS

112

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Sixty years have passed since neurosurgeon Nils Lundberg presented his thesis about intracranial pressure (ICP) monitoring, which represents a milestone for its clinical introduction. Monitoring of ICP has since become a clinical routine worldwide, and today represents a cornerstone in surveillance of patients with acute brain injury or disease, and a diagnostic of individuals with chronic neurological disease. There is, however, controversy regarding indications, clinical usefulness and the clinical role of the various ICP scores. In this paper, we critically review limitations and weaknesses with the current ICP measurement approaches for invasive, less invasive and non-invasive ICP monitoring. While risk related to the invasiveness of ICP monitoring is extensively covered in the literature, we highlight other limitations in current ICP measurement technologies, including limited ICP source signal quality control, shifts and drifts in zero pressure reference level, affecting mean ICP scores and mean ICP-derived indices. Control of the quality of the ICP source signal is particularly important for non-invasive and less invasive ICP measurements. We conclude that we need more focus on mitigation of the current limitations of today’s ICP modalities if we are to improve the clinical utility of ICP monitoring.

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Section: Electrostatic Dischargesmentioning

confidence: 99%

Measuring intracranial pressure by invasive, less invasive or non-invasive means: limitations and avenues for improvement

Evensen¹,

Eide²

2020

Fluids Barriers CNS

112

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“…This study provides a comprehensive evaluation of use error adverse events decomposed by several key event attributes to address the gaps in the availability of industrywide statistics. Past work has used MAUDE data to examine adverse events associated with specific devices (Hill et al, 2017;Hur et al, 2019;Krouwer, 2018;Shlofmitz et al, 2019) and specific malfunctions (Kohani & Pecht, 2018). The work presented in this paper sought to evaluate adverse events across all devices, specifically for use error.…”

Section: Introductionmentioning

confidence: 99%

An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Knisely

Levine

Kharod

et al. 2020

Proceedings of the International Symposium on Human Factors and

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Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

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“…Roll-to-roll (RtR) manufacturing has been one of the most employed processes in the production lines of many industries because of its high processing speeds to achieve large production volumes [1][2][3][4]. RtR manufacturing is an ideal method for developing thin and flexible web or sheetbased products, including printed electronic displays, solar cells, packaging film, and nonwoven products [1][2][3]5]. However, RtR manufacturing could result in the quick buildup of electrostatic charges, resulting in exceptionally high electrostatic potential and electrostatic discharge (ESD) if the induced electric field condition is satisfied for breakdown in air [3,[6][7][8].…”

Section: Introductionmentioning

confidence: 99%

“…For instance, ESD results in defects in light-sensitive photographic-film products. In the electronic and medical device industries, electrostatic charge generation, accumulation, and discharge can induce dust contamination and electronic device malfunctions [3,5,[12][13][14]. In a given situation, the discharge results in a large amount of energy that can ignite an explosion or fire [7,11,15].…”

Section: Introductionmentioning

confidence: 99%

Self-Induced Localized Electric-Field-Enhanced Electrostatic Electron Emission in Polypropylene Surface-Based Roll-to-Roll Manufacturing

2020

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The roll-to-roll (RtR) Manufacturing can produce a large amount of electrostatic charges. In terms of industrial safety, a large amount of energy can be released via electrostatic discharge (ESD) that can cause severe shocks, which can be a risk to automated machines, operators, and merchandise. In this study, the ESD associated with the existing nonwoven Polypropylene (PP) manufacturing is minimized by designing and introducing a sharp-edge metal bar with a radius of curvature of ~100 µm as a passive electrostatic charge dissipation system next to the PP winding stock roll. The coulombic force from the deposited charges on PP can induce a highly localized electric field (up to ~10 6 V/cm) between the grounded metal edge and the nanoscale surface of the nonwoven PP fabric that reduces the potential barrier, causing electrostatic electron/ion emission or discharge from the insulating PP winding surface to the ambient air, especially along the metal edge. Further, the level of static charge associated with the RtR process is characterized using a noncontact electrostatic field (E-field) meter without contaminating and interrupting the production lines. Furthermore, the three-dimensional finite element method (FEM) is used to obtain an accurate electrostatic charge distribution based on the actual size of the winding stock roll, providing a comprehensive understanding of the self-induced E-field-assisted ESD during operation. The experiment and simulation indicate that ~75% of the effective stored charge density is transferred through the air. Therefore, the induced field emission structure is cost effective for dissipating the electrostatic charges and minimizing the ESD hazards. INDEX TERMSElectrostatic discharge, Electron emission, Electric field, Polypropylene, Roll-to-roll manufacturing KHOMSAN RUANGWONG received the B.Sc. Degree in electrical engineering from the Faculty of Electrical Engineering, Kasetsart University Sriracha Campus, Thailand in 2016. He previously worked in High-voltage system in Mitsubishi Electric Thai Auto-Parts Co., Ltd. and Fuji Tusco Co., Ltd during 2016 to 2018. He is currently pursuing the M.Sc. degree in the Department of Electrical Engineering with the focus of high voltage and electric field applications, including corona discharge plasma, electrostatic discharge in manufacturing and insulator and dielectric phenomena in high voltage system. CHAYAPORN THAMMANIPHIT received the B.Sc. Degree in electrical engineering from the Faculty of Electrical Engineering, Kasetsart University, Thailand in 2019. She is currently pursuing the M.Sc. degree in the Department of Electrical Engineering. She is a Research Assistant with the Electrons and Semiconductor Laboratory. Her research interests include nonthermal plasma discharge processes and innovation plasma applications, electron and electrostatic discharges. SIWAPON SRISONPHAN. (M'13) received the B.S. degree in electronic engineering from King Mongkut'

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Malfunctions of Medical Devices Due to Electrostatic Occurrences Big Data Analysis of 10 Years of the FDA’s Reports

Cited by 24 publications

References 10 publications

Measuring intracranial pressure by invasive, less invasive or non-invasive means: limitations and avenues for improvement

Measuring intracranial pressure by invasive, less invasive or non-invasive means: limitations and avenues for improvement

An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Self-Induced Localized Electric-Field-Enhanced Electrostatic Electron Emission in Polypropylene Surface-Based Roll-to-Roll Manufacturing

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