• 제목/요약/키워드: Medical device failure

검색결과 76건 처리시간 0.026초

Single-pigtail plastic stent made from endoscopic nasobiliary drainage tubes in endoscopic ultrasound-guided gallbladder drainage: a retrospective case series

  • Koichi Soga
    • Clinical Endoscopy
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    • 제57권2호
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    • pp.263-267
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    • 2024
  • Technical failure of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is often attributed to device failure. To rectify this problem, we developed a single-pigtail plastic stent (SPPS) for EUS-GBD. We retrospectively reviewed the cases of four patients who underwent EUS-GBD for acute cholecystitis. To prepare the SPPS, a 7.5-Fr endoscopic nasobiliary drainage tube was cut to an appropriate length. The use of SPPS during EUS-GBD was successful from both technical and clinical standpoints. The SPPS spontaneously detached 57 days after the procedure in patient 4 and 412 days after the procedure in patient 1. Patient 1 developed cholecystitis after 426 days and was managed with antibiotics. The other three patients did not develop any complications after surgery. In conclusion, we designed a new SPPS dedicated to EUS-GBD and established its technical feasibility and clinical effectiveness.

소아용 보조인공심장의 모의순환 실험에 관한 연구 (In Vitro Test of Seiong Pediatric Ventricular Assist Device)

  • 권혁남;박표원
    • 대한의용생체공학회:의공학회지
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    • 제12권1호
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    • pp.29-34
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    • 1991
  • Ventricular assist device(VAD) has been clinically applied as a temporary circulatory sup- porting system in the patients with severe heart failure, but small sized VAD for infant is not available. The purpose of tilis paper is to introdIAce small sized VAD and presents the result of in vitro test. Sejong VAD is diaphragmatic type of pneumatic pump and stroke volume is 11cc. Cardiac outputs of the Sejong VAD were measured by overflow tank under variable conditions of driving parameters. The cardiac output was 1.3 1/min at the heart rate of 120 per minute, left atrial pressure of $15cmH_2O$, percent systole of 43%, driving pressure of 240 mmHg, vacuum pressure of -40 mmHg, and mean aortic pressure of 70 mmHg. No mechanical problem was developed during the continuous in vitro test for 3 months.

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전기적 자극방식 삼킴 보조 치료기의 장비관리/안전진단 매뉴얼 개발 (Development of Device Management and Safety Diagnosis Manual for Electrical Stimulating Swallowing-Assist Equipments)

  • 허서윤;최봉근;이근민
    • 재활복지공학회논문지
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    • 제8권2호
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    • pp.79-88
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    • 2014
  • 국내에서 전기적 자극방식 삼킴 보조 치료기는 높은 보급률과 사용빈도를 가진 전문 의료기기임에도 불구하고 기기에 대한 관리체계가 전무하여 유지 보수의 측면에 있어서도 매우 큰 취약성을 노출해 왔다. 이에 본 연구는 전기적 자극방식 삼킴 보조 치료기의 장비관리 및 안전진단 매뉴얼 개발에 목적을 두고 프로그램을 개발하였다. 이를 위하여 국제전기기술위원회(International Electrotechnical Commission, IEC)등의 기관에서 공시한 표준화된 프로그램 수집과 문헌고찰을 통해 매뉴얼 개발의 근거를 마련하고, 프로토콜을 개발하여 제시하였다. 완성된 알고리즘과 프로토콜, 지표 등의 자료를 전문가 및 현장 실무자의 자문을 통하여 수정 및 보완하고 유지보수 워크시트(Maintenance Worksheet)의 5지표 18항목, 삼킴 보조 전자 의료기기 장비관리/안전진단 절차 매뉴얼(Equipment Procedure Manual)에서 4개 지표 32항목으로 구성된 점검 매뉴얼을 최종적으로 완성하였다. 완성된 지표는 장비의 고장률을 줄이고 의료기록 문서화의 체계성 제고에 도움을 줄 것이며, 의료서비스의 효율성, 적절성을 유지하는데 기여할 수 있을 것이라 생각된다.

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의료용 할로겐램프의 가속수명시험에 관한 연구 (A Study on Accelerated Life Test of Halogen Lamps for Medical Device)

  • 정재한;김명수;임헌상;김용수
    • 품질경영학회지
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    • 제41권4호
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    • pp.659-672
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    • 2013
  • Purpose: The purpose of this study was to estimate life time of halogen lamps and acceleration factors using accelerated life test. Methods: Voltage was selected as an accelerating variable through the technical review about failure mechanism. The test was performed at 14.5V, 15.5V and 16.5 for 4,471 hours. It was assumed that the lifetime of Halogen lamps follow Weibull distribution and the inverse power life-stress relationship models. Results: Mean lifetimes of pin and screw types were 19,477 hours and 6,056 hours, respectively. In addition, acceleration factor of two items are calculated as 4.8 and 2.2 based on 15.5V, respectively. Conclusion: The life-stress relationship, acceleration factor, and MTTF at design condition are estimated by analyzing the accelerated life test data. These results suggest that voltage was very important factor to accelerate life time in the case of halogen lamps and the life time of pin type is three times longer than screw type lamps.

End-of-Life Care for End-stage Heart Failure Patients

  • Ju-Hee Lee;Kyung-Kuk Hwang
    • Korean Circulation Journal
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    • 제52권9호
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    • pp.659-679
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    • 2022
  • Efforts to improve end-of-life (EOL) care have generally been focused on cancer patients, but high-quality EOL care is also important for patients with other serious medical illnesses including heart failure (HF). Recent HF guidelines offer more clinical considerations for palliative care including EOL care than ever before. Because HF patients can experience rapid, unexpected clinical deterioration or sudden death throughout the disease trajectory, choosing an appropriate time to discuss issues such as advance directives or hospice can be challenging in real clinical situations. Therefore, EOL issues should be discussed early. Conversations are important for understanding patient and family expectations and developing mutually agreed goals of care. In particular, high-quality communication with patient and family through a multidisciplinary team is necessary to define patient-centered goals of care and establish treatment based on goals. Control of symptoms such as dyspnea, pain, anxiety/depression, fatigue, nausea, anorexia, and altered mental status throughout the dying process is an important issue that is often overlooked. When quality-of-life outweighs expanding quantity-of-life, the transition to EOL care should be considered. Advanced care planning including resuscitation (i.e., do-not resuscitate order), device deactivation, site for last days and bereavement support for the family should focus on ensuring a good death and be reviewed regularly. It is essential to ensure that treatment for all HF patients incorporates discussions about the overall goals of care and individual patient preferences at both the EOL and sudden changes in health status. In this review, we focus on EOL care for end-stage HF patients.

치과용 임플란트에 대한 ISO 14971 기반의 리스크관리 (Application of Risk Management for Dental Implants Based on ISO 14971)

  • 윤지훈;김영진;전계록;정창모
    • 한국안전학회지
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    • 제27권2호
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    • pp.92-97
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    • 2012
  • Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.

Development of a Transcutaneous Optical Information Transmission System for Total Artificial Heart Using Near Infrared Laser

  • 이정훈;김욱은;최재순;안재목;민병구
    • 대한의용생체공학회:학술대회논문집
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    • 대한의용생체공학회 1997년도 춘계학술대회
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    • pp.64-67
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    • 1997
  • In the total artificial heart(TAH), a transcutaneous information transmission system(TITS) is vely important to monitor the TAH status and detect the device failure, and repair the possible problems. First of all, the communication channel(skin) and method were simulated in terms of transmittance, scattering, reflection and absorption, then the system was designed with size reduction including low power consumption and reliability compared to the previous one. The informations are transmitted through the skin(approximately 1cm in depth) by frequency modulated near infrared(NIR) pulses using 780nm laser diodes as transmitters and photodiode as receiver with high speed and high spectral sensitivity. The logic high and low frequencies are 3MHz, 1MHz respectively. The system is a bidirectional data link for more than 38.4Kbps data rate, full-duplex with a bit error rate of less than $10^{-5}$.

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전기-기계식 이식형 좌심실 보조 시스템의 개발 및 평가 (Development and Evaluation of a Novel Electro-mechanical Implantable Ventricular Assist System)

  • 조한상;김원곤;이원용;곽승민;김삼성;김재기;김준택;류문호;류은숙
    • 대한의용생체공학회:의공학회지
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    • 제22권4호
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    • pp.349-358
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    • 2001
  • A novel electro-mechanical implantable ventricular assist system is developed as a bridge to transplantation or recovery for patients with end-stage heart failure. The developed system is composed of an implanted blood pump, an external monitoring system which stores data, and a wearable system including a portable external driver and a portable power supply system. The blood pump is designed to be implanted into the left upper abdominal space and provides blood flow from the left ventricular apex to the aorta. The pulsatile blood flow is generated by a double cylindrical cam. There was mo excessive heat emission from the blood pump into the temperature-controlled chamber in the heat test and no stagnated flow within the blood sac by the observation in the flow visualization test. Animal experiments were performed using sheep and calves. The maximum assist flow rate reached 7.85L/min in the animal experiment. The evaluation results showed that the developed system was feasible for the implantable ventricular assist system. The long-term in vitro durability test and mid-term in vivo experiments are in progress and mow the modified next model is under development.

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119구급대의 활성화 방안에 관한 연구 (A Study on Activation device of 119 Emergency Care)

  • 고재문;김경완;정용태
    • 한국응급구조학회지
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    • 제11권1호
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    • pp.27-40
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    • 2007
  • Even now, 119 rescue services have dissatisfactory aspects in operation, system and equipments as discussed above, It is the most urgent subject to systemize rescue services so that they can be suitable for our status, for we will make 21C welfare state come true before long. So, this author suggest that the followings have to be raised to activate 119 rescue service. 1) Bring up experts and offer high-quality rescue service 2) Prepare more up-to-date equipments 3) Operate transfer joint organizations 4) Promote the ability to meet with a press at the time of rescue service activities 5) Adjust regulations related to rescue services 6) Make up for a countermeasure to traffic accidents of ambulances 7) Adjust regulations making it mandatory to establish heliport at the target on hospitals more than a defined scale 8) Install more rescue service teams 9) Educate and train officials belonging to briefing rooms, where the officials with long experiences are arranged 10) Minimize the time for rescue team to reach fields 11) Establish legal protection system for rescue the team Nowadays, our country operates the department of fire fighting and rescue services without great difficulty, even though the circumstances are bad - insufficient members and the inferior circumstances. All of the fire fighting officials are given heavy duties in bad circumstances, and so are the team of rescue service. The rescue service team, taking charge of some emergency medical system, do a fire fighting inspection as a non-duty service, though they are scanty of sleep due to prevention and protection services of the fire fighting service team. But, they can not engage in rescue services completely and have to deal with miscellaneous duties. So they can not offer professional emergency medical services. But now, almost every fire fighting organization, belonging to National Emergency Management Agency, are separating rescue services, which shows a lot of good results. People recognize rescue services to get better and better gradually and the demands for this rescue services increase. So, this is the best time when rescue service teams should offer qualitative services rather than quantitative services. The people will recognize this rescue service team to be an organization sacrificing and serving for them. However well institutes and operation systems should be established, the rescue service team can not come true their aim without strong wills that they will serve and sacrifice themselves for people from their hearts. In addition, it is essential for the officials in charge of policies about emergency medical services to have a concernment on and practice the policy without failure.

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Early Outcomes of COVID-19 Lung Transplantation Recipients in Korea: A Single-Center Study

  • Shi A Kim;Jae Kwang Yun;Geun Dong Lee;Dong Kwan Kim;Sehoon Choi
    • Journal of Chest Surgery
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    • 제56권1호
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    • pp.6-13
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    • 2023
  • Background: Coronavirus disease 2019 (COVID-19) has been found to cause life-threatening respiratory failure, which can progress to irreversible lung damage. Lung transplantation can be a life-saving treatment in patients with terminal lung disease (e.g., acute respiratory distress syndrome caused by infection). This study aimed to present the clinical course and results after initial lung transplantation in patients with severe COVID-19 who did not recover even with optimal medical care. Methods: From August 2019 to February 2022, this study enrolled 10 patients with COVID-19 (5 men; median age, 55.7 years) who underwent lung transplantation at a single center in Korea. All patients' characteristics, clinical pathway, overall survival, complications, and operative data were collected and analyzed. Results: Veno-venous extracorporeal membrane oxygenation or an oxygenator in a right ventricular assist device circuit was applied to 90% of the patients, and the median length of extracorporeal life support before operation was 48.5 days. There were no cases of mortality after a median follow-up of 372.8 days (interquartile range, 262.25-489 days). The major complications included the requirement for postoperative extracorporeal membrane oxygenation support in 2 cases (20%), re-transplantation in 1 case (10%), and re-exploration due to bleeding in 2 cases (20%). During the follow-up period, 3 out of 10 patients died. Conclusion: Excellent early outcomes were observed for patients who underwent lung transplantation. Thus, lung transplantation can be an effective and feasible treatment for patients with end-stage lung disease caused by COVID-19.