지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
오류제보하기
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-inone 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.
목차
등록된 정보가 없습니다.
참고문헌 (9)
참고문헌 신청
Eugene A, Hessel II / 2015 / History of cardiopulmonary bypass (CPB) / Best Practice & Research Clinical Anaesthesiology 29(2):99~111
Andréia Cristina Passaroni / 2015 / Cardiopulmonary bypass: development of John Gibbon’s heart-lung machine / Rev Bras Cir Cardiovasc 30(2):235~245
David Zonies / 2017 / ECLS in Trauma: Practical Application and a Review of Current Status / World Journal of Surgery 41(5):1159~1164
2016 / ISO 7199:2016. Cardiovascular implants and artificial organs –Blood-gas exchangers (oxygenators)
2016 / ISO 15676:2016. Cardiovascular implants and artificial organs –Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
Andréia Cristina Passaroni / 2015 / Cardiopulmonary bypass: development of John Gibbon’s heart-lung machine / Rev Bras Cir Cardiovasc 30(2):235~245
David Zonies / 2017 / ECLS in Trauma: Practical Application and a Review of Current Status / World Journal of Surgery 41(5):1159~1164
2016 / ISO 7199:2016. Cardiovascular implants and artificial organs –Blood-gas exchangers (oxygenators)
2016 / ISO 15676:2016. Cardiovascular implants and artificial organs –Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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