• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• Journal of Chest Surgery
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• 제34권4호
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• pp.356-360
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• 2001

일시적 혹은 단기간의 심폐보조는 여러 형태의 심부전에서 널리 이용되어 왔다. 이 중 체외막산소화장치는 고식적 치료에 반응없는 환자에서 주로 사용되는데, 소아에서는 자주 이용되어 왔으나 성인에서는 그 적응증이 명확하지 않았으며 결과도 만족스럽지 못했다. 환자는 승모판 협착증을 가진 32세의 여자로 제왕절개술후 발생한 폐부종으로 내원하였다. 내원시 환자는 쇽상태로 강심제, 폐혈관확장제, 이뇨제등에 반응이 없었다. 우측 대퇴정-동맥캐뉼라를 통하여 14시간동안 체외막산소화장치를 이용하였으며, 환자상태는 가동 즉시 호전을 보였다. 이후 양측판막치환술을 시행하였고 수술 후에도 체외막산호화장치를 지속하였다. 체외막산호화장치는 수술시간을 포함하여 모두 62시간동안 가동하였으며, 이탈(weaning)은 안정된 혈류역학, 호전된 폐부종, 기저질환의 교정등을 통하여 성공적으로 이루어졌다. 환자는 판막수술 후 30일째 특별한 합병증없이 퇴원하였다.

• Tuberculosis and Respiratory Diseases
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• 제82권4호
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• pp.328-334
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• 2019

Background: Although the frequency of respiratory viral infection in patients with pulmonary acute respiratory distress syndrome (ARDS) is not uncommon, clinical significance of the condition remains to be further elucidated. The purpose of this study was to compare characteristics and outcomes of patients with pulmonary ARDS infected with influenza and other respiratory viruses. Methods: Clinical data of patients with pulmonary ARDS infected with respiratory viruses January 2014-June 2018 were reviewed. Respiratory viral infection was identified by multiplex reverse transcription-polymerase chain reaction (RT-PCR). Results: Among 126 patients who underwent multiplex RT-PCR, respiratory viral infection was identified in 46% (58/126): 28 patients with influenza and 30 patients with other respiratory viruses. There was no significant difference in baseline and clinical characteristics between patients with influenza and those with other respiratory viruses. The use of extracorporeal membrane oxygenation (ECMO) was more frequent in patients with influenza than in those with other respiratory viruses (32.1% vs 3.3%, p=0.006). Co-bacterial pathogens were more frequently isolated from respiratory samples of patients with pulmonary ARDS infected with influenza virus than those with other respiratory viruses. (53.6% vs 26.7%, p=0.036). There were no significant differences regarding clinical outcomes. In multivariate analysis, acute physiology and chronic health evaluation II was associated with 30-mortality (odds ratio, 1.158; 95% confidence interval, 1.022-1.312; p=0.022). Conclusion: Respiratory viral infection was not uncommon in patients with pulmonary ARDS. Influenza virus was most commonly identified and was associated with more co-bacterial infection and ECMO therapy.