• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of Chest Surgery
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• v.55 no.3
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• pp.197-205
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• 2022

Background: The integrated design of the HeartMate 3 (Abbott Laboratories, Chicago, IL, USA) affords flexibility to place the pump within the pericardium or thoracic cavity. We sought to determine whether the presence of a left ventricular assist device (LVAD) in either location has a meaningful impact on overall patient outcomes. Methods: A retrospective cohort study was conducted of all 165 patients who received a HeartMate 3 LVAD via a median sternotomy from November 2014 to August 2019 at our center. Based on operative reports and imaging, patients were divided into intrapleural (n=81) and intrapericardial (n=84) cohorts. The primary outcome of interest was in-hospital mortality, while secondary outcomes included postoperative complications, cumulative readmission incidence, and 3-year survival. Results: There were no significant between-group differences in baseline demographics, risk factors, or preoperative hemodynamics. The overall in-hospital mortality rate was 6%, with no significant difference between the cohorts (9% vs. 4%, p=0.20). There were no significant differences in the postoperative rates of right ventricular failure, kidney failure requiring hemodialysis, stroke, tracheostomy, or arrhythmias. Over 3 years, despite similar mortality rates, intrapleural patients had significantly more readmissions (n=180 vs. n=117, p<0.01) with the most common reason being infection (n=68/165), predominantly unrelated to the device. Intrapleural patients had significantly more infection-related readmissions, predominantly driven by non-ventricular assist device-related infections (p=0.02), with 41% of these due to respiratory infections compared with 28% of intrapericardial patients. Conclusion: Compared with intrapericardial placement, insertion of an intrapleural HM3 may be associated with a higher incidence of readmission, especially due to respiratory infection.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2012.10a
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• pp.495-497
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• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• Proceedings of the KOSOMBE Conference
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• v.1998 no.11
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• pp.106-107
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• 1998

To minimize the failure rate of medical devices, the maintenance records for general X-ray, R/F X-ray, mobile X-ray, artificial dialyzer, ventilator, and automatic chemistry analyzer was analysed with regard to the cause of the failure. The parts responsible for the most frequent system failure was then worked intensively during the preventive maintenance. After this procedure, the faliure of the systems in a month decreased from 1.8 on average to 0.3.

• Korean Journal of Digital Imaging in Medicine
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• v.16 no.1
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• pp.61-67
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• 2014

The demand of cyclotron for PET (positron emission tomography) has rapidly grown as the more use of PET or PET-CT equipment requires the increased amount of radioactive isotopes for clinical positron emission. While research on failure statistics of medical equipment used in medical centers has continued to be done, the analysis and study on failure statistics of cyclotron have rarely been conducted. However, the growing demand shows the urgency of systematical management guideline and countermeasures for device failure to minimize any supply delay of radiopharmaceuticals occurred by such failure and complains from waiting patients for PET-CT diagnosis. Therefore, this study aims to analyze the failure report from Minitrace equipped in cyclotron which is owned by the department of nuclear medicine at Yeungnam University Medical Center and draws on the data to build effective management system for cyclotron.

• Journal of Korean Critical Care Nursing
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• v.7 no.2
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• pp.34-44
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• 2014

Purpose: The purpose of this study was to determine the factors related to airway failure during endotracheal intubation among patients with and without predicted airway difficulty. Methods: Medical records were examined retrospectively. 329 patients who were admitted to the general ward and underwent endotracheal intubation were included. The incidence of airway failure in the two groups was investigated. Results: The group predicted to have airway difficulty consisted of 79 patients (24.0%) and the group without airway difficulty, 250 (76.0%). The number of cases of airway failure was 50 (15.2%). The factors that were associated with airway failure in the group with predicted airway difficulty were the jaw relaxation score, Cormack-Lehane score, and the device of the first endotracheal intubation attempt. The factors that were associated with the airway failure in the group predicted not to have airway difficulty were the induction agent, jaw relaxation score, Cormack-Lehane score, level of training of the personnel with the first endotracheal intubation success, and the device of the first endotracheal intubation attempt. Conclusion: The prediction of airway difficulty during endotracheal intubation was not effective; however, it was meaningful from the perspective of patient safety.

• Journal of Industrial Technology
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• v.33 no.A
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• pp.9-14
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• 2013

Reliability plays a pivotal role in the development of medical instruments. A hyperbaric oxygen chamber, as a medical/health device, is known to help medical therapy for diversity of diseases through provision of high purity oxygen. The use of hyperbaric oxygen chamber is expected to increase in the future and study to examine reliability and safety is needed. We have performed reliability assessment for a newly developed hyperbaric oxygen chamber in this study. We first briefly discussed the system structure and mechanism. We then performed FMEA (Failure Mode and Effect Analysis) for the chamber. We drew major failure modes affecting the system performance and performed in depth analysis for measuring the expected effects.

• Journal of Chest Surgery
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• v.46 no.6
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• pp.391-401
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• 2013

Mechanical circulatory support (MCS) in the pediatric heart failure population has a limited history especially for infants, and neonates. It has been increasingly recognized that there is a rapidly expanding population of children diagnosed and living with heart failure. This expanding population has resulted in increasing numbers of children with medically resistant end-stage heart failure. The traditional therapy for these children has been heart transplantation. However, children with heart failure unlike adults do not have symptoms until they present with end-stage heart failure and therefore, cannot safely wait for transplantation. Many of these children were bridged to heart transplantation utilizing extracorporeal membranous oxygenation as a bridge to transplant which has yielded poor results. As such, industry, clinicians, and the government have refocused interest in developing increasing numbers of MCS options for children living with heart failure as a bridge to transplantation and as a chronic therapy. In this review, we discuss MCS options for short and long-term support that are currently available for infants and children with end-stage heart failure.

• Journal of Chest Surgery
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• v.54 no.6
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• pp.543-546
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• 2021

A 55-year-old woman who had received an implantable left ventricular assist device 3 months earlier presented with dyspnea and a low-flow alarm of the device. Computed tomography and log-file analysis of the device system suggested inflow cannula obstruction. Since the patient had cardiogenic shock due to pump failure, venoarterial extracorporeal membrane oxygenation (ECMO) was initiated. With ECMO, surgical exchange of the pump was considered. However, the obstruction spontaneously resolved without surgical intervention. It turned out that an obstructive thrombus was washed out by rebooting the pump. Moreover, the thrombus was embolized in the patient's left subclavian artery. The patient underwent heart transplantation 4 months after the pump obstruction accident and continued to do well.

• Journal of Chest Surgery
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• v.57 no.3
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• pp.315-318
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• 2024

The HeartWare Ventricular Assist Device (HVAD) was widely used for mechanical circulatory support in patients with end-stage heart failure. However, there have been reports of a critical issue with HVAD pumps failing to restart, or experiencing delays in restarting, after being stopped. This case report describes 2 instances of HVAD failure-to-restart during heart transplantation surgery and routine outpatient care. Despite multiple attempts to restart the pump using various controllers and extensions, the HVAD failed to restart, triggering a hazard alarm for pump stoppage. In one case, the patient survived after receiving a heart transplantation, while in the other, the patient died immediately following the controller exchange. These cases highlight the rare but life-threatening complication of HVAD failure-to-restart, underscoring the importance of awareness among clinicians, patients, and caregivers, and adherence to the manufacturer's guidelines and recommendations for HVAD management.