장기 및 인체조직 구득에 관한 공적 체계의 확립

김현철 이화여자대학교 생명의료법연구소 2014 생명윤리정책연구 Vol.8 No.2

Organs and human tissues are needed for the transplantation of organ and human tissue. However, organs or human tissues can be procured by essentially donations. Brain death and deaths donation therein is very important. And donation has ethical implications in itself because it is a manifestation of the spirit of sacrifice. So society to receive donations is responsible for honorable treatment of donors properly. For that, it is necessary to establish the public procurement system. In Korea, public procurement system has been introduced since 2003. However, in the current system “individual institutions centered procurement system” and “independent institutions centered procurement system” are mixed. In order to override this problem, it is needed to convert the paradigm of public procurement system into independent institutions centered procurement system. Then, there is a need for integration of laws to be divided into organs or human tissues for that. 장기이식과 인체조직이식을 위해서는 이식에 사용될 장기나 인체조직이 필요하다. 그런데 장기나 인체조직은 기본적으로 기증에 의해서 조달될 수 있다. 그 중에서 뇌사자와 사망자의 기증은 매우 중요하다. 그리고 기증은 그 자체로 윤리적 함의를 가지고 있고 희생정신의 발로이기 때문에, 기증을 받는 사회는 그 기증자를 적절히 예우할 책임을 진다. 그러기 위해서 필요한 것이 이른바 구득을 전담하는 공적 구득기관 제도이다. 우리나라에서는“장기등 이식에 관한 법률”에서 최초로 구득기관제도를 도입하고, 2015년부터 시행될“인체조직안전 및 관리등에 관한 법률”개정법에서 인체조직 분야에 독립적인 구득기관 제도를 도입할 예정이다. 그런데 현재 제도적으로“개별 기관 중심 구득체제”와“독립 기관 중심구득 체제”가 혼재되어 있다. 이를 기증정신과 구득의 효율성을 감안하여“독립기관 중심 구득 체제”로 제도의 패러다임을 전환해야 할 것이다. 그리고 이를 위해 장기와 인체조직으로 나뉘어 있는 법률의 통합이 필요하다.

Recommendations for SARS-CoV-2 testing and organ procurement from deceased donors in the Republic of Korea

Kim Si-Ho,Wi Yu Mi,문치숙,Kang Ji-Man,Kim Minhwa,Kim Jungok,김종만,Seok Hyeri,Shi Hye Jin,Lee Su Jin,Lee Ji Yeon,Jeong Su Jin,Choe Pyoeng Gyun,Huh Kyungmin,Lee Sang-Oh,Kim Sang Il 대한이식학회 2023 Korean Journal of Transplantation Vol.37 No.3

We present a summary of the evidence on testing for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and organ procurement from deceased donors and provide recommendations based on current clinical data and the guidelines from major transplant organizations. Because of the limited historical experience with coronavirus disease 2019 (COVID-19), certain recommendations in this document are based on theoretical rationales rather than clinical data. The recommendations in this manuscript may be subject to revision as subsequent clinical studies provide definitive evidence regarding COVID-19 in organ procurement.

인체조직법 개정의 의의와 법적 쟁점

김현철(Hyeon cheol KIM),윤이레(Erei Yoon) 이화여자대학교 생명의료법연구소 2015 생명윤리정책연구 Vol.9 No.2

2015년 1월부터 시행 중인「인체조직안전 및 관리 등에 관한 법률」은 국내 인체조직 기증 활성화를 위하여, 2005년 제정된 인체조직의 안전성 규제 중심의 법률에 대하여, 기증자에 대한 공적 관리를 강화하고 안전성 확보방안도 강화를하는 등 국내 인체조직 기증활성화를 위하여 큰 폭의 개정이 이루어진 법률이다. 그럼에도 여전히 규제기관의 이원화라는 점 및 기증에서부터 환자에게 전달되는 전체 프로세스의 완결성 미비라는 점에서 한계를 가지고 있으며, 이는 조직기증지원기관의 위상, 조직의 채취 및 조직의 분배구조와 환자 전달체계라는 법적· 제도적 측면에서 드러난다. 이를 위하여 인체조직 기증에서 이식에 이르는 전 과정을 구조적으로 체계화하는 입법 작업이 필요하며, 적어도 기증과정에 관한 한장기이식법과 인체조직법의 통합이 입법적으로 요청된다. The Safety and Management of Human Tissue Act, which has come into effect since January 2015, was revised for the original act focusing on regulation of human tissue safety enacted in 2005, in broad scope including to strengthen public management on donors and its guarantee of safety, in order to activate human tissue donation in Korea. Nevertheless, the act has limitations such as dual systems of regulatory agencies and incompleteness of the entire process from donation to patient, which have been seen in the legal and institutional perspectives such as appropriate role of TPO, recovery of human tissue, distribution structure of tissue, and delivery system to patients. For this, it is necessary to legislate to systematize structurally the entire process from donation of human tissue to its transplantation, and for the donation process at least, it is legislatively required to integrate both acts on organ transplantation and human tissue.

Analysis of factors involved in brain-death donor processing for face transplantation in Korea: How much time is available from brain death to transplantation?

Hong, Jong Won,Chung, Soon Won,Ahn, Sung Jae,Lee, Won Jai,Lew, Dae Hyun,Kim, Yong Oock Korean Society of Plastic and Reconstructive Surge 2019 Archives of Plastic Surgery Vol.46 No.5

Background Face transplantation has naturally evolved from reconstructive procedures. However, few institutions perform face transplantations, because it is time-consuming and it is necessary to justify non-vital organ transplantation. We investigated the process of organ donation from brain-dead patients and the possibility of incorporating face transplantation into the donation process. Methods A retrospective review was performed of 1,074 brain-dead patients from January 2015 to December 2016 in Korea. We analyzed the time intervals from admission to brain death decisions (first, second, and final), the causes of brain death, and the state of the transplanted organs. Results The patient base (n=1,074) was composed of 747 males and 327 females. The average period between admission to the first brain death decision was 8.5 days (${\pm}15.3$). The average time intervals between the first brain death decision and medical confirmation using electroencephalography and between the first brain death decision and the final determination of brain death were 16 hours 58 minutes (${\pm}14hours$ 50 minutes) and 22 hours 57 minutes (${\pm}16hours$ 16 minutes), respectively. The most common cause of brain death was cerebral hemorrhage/stroke (42.3%), followed by hypoxia (30.1%), and head trauma (25.2%). Conclusions When face transplantation is performed, the transplantation team has 22 hours 57 minutes on average to prepare after the first brain death decision. The cause of brain death was head trauma in approximately one-fourth of cases. Although head trauma does not always imply facial trauma, surgeons should be aware that the facial tissue may be compromised in such cases.

Analysis of factors involved in brain-death donor processing for face transplantation in Korea: How much time is available from brain death to transplantation?

홍종원,Soon Won Chung,안성재,이원재,유대현,김용욱 대한성형외과학회 2019 Archives of Plastic Surgery Vol.46 No.5

Background Face transplantation has naturally evolved from reconstructive procedures. However, few institutions perform face transplantations, because it is time-consuming and it is necessary to justify non-vital organ transplantation. We investigated the process of organ donation from brain-dead patients and the possibility of incorporating face transplantation into the donation process. Methods A retrospective review was performed of 1,074 brain-dead patients from January 2015 to December 2016 in Korea. We analyzed the time intervals from admission to brain death decisions (first, second, and final), the causes of brain death, and the state of the transplanted organs. Results The patient base (n=1,074) was composed of 747 males and 327 females. The average period between admission to the first brain death decision was 8.5 days (±15.3). The average time intervals between the first brain death decision and medical confirmation using electroencephalography and between the first brain death decision and the final determination of brain death were 16 hours 58 minutes (±14 hours 50 minutes) and 22 hours 57 minutes (±16 hours 16 minutes), respectively. The most common cause of brain death was cerebral hemorrhage/stroke (42.3%), followed by hypoxia (30.1%), and head trauma (25.2%). Conclusions When face transplantation is performed, the transplantation team has 22 hours 57 minutes on average to prepare after the first brain death decision. The cause of brain death was head trauma in approximately one-fourth of cases. Although head trauma does not always imply facial trauma, surgeons should be aware that the facial tissue may be compromised in such cases.

Analysis of Factors Affecting Emergency Physicians’ Attitudes toward Deceased Organ & Tissue Donation

Lee Dong Eun,Kim Hyun,Park Kwi Hwa,Park Song Yi,박승민,Jung Yong Hun,Jeong Wonjoon,Park Kyung Hye 대한의학회 2021 Journal of Korean medical science Vol.36 No.49

Background: This study aimed to investigate differences in knowledge, and attitudes toward deceased organ and tissue donation of emergency physicians. Additionally, we analyzed factors affecting the attitudes toward deceased organ and tissue donation. Methods: We conducted a survey of specialists and residents registered with the Korean Society of Emergency Medicine in December 2020. The respondents’ sex, age, position, personal registration for organ donation, experience of soliciting organ donation, participation in related education, knowledge, and attitude about brain death organ donation, and attitude toward stopping life-sustaining treatments were investigated. According to the characteristics of the respondents (specialists or residents, experience and education on organ and tissue donation), their knowledge and attitude toward deceased organ donation were compared. Stepwise hierarchical multiple regression analysis was used to investigate the factors affecting the attitudes toward deceased organ and tissue donation. Results: Of the total 428 respondents, there were 292 emergency medicine specialists and 136 medical residents. Specialists and those who registered or wished to donate organs had higher knowledge and attitude scores regarding deceased organ and tissue donation. Those who had experience recommending organ and tissue donation more than 6 times had higher knowledge scores on deceased organ and tissue donation and higher overall scores in attitude. Those who received education from the Korean Organ Donation Agency had higher knowledge scores. Specialists, and those who wished to donate or had registered as organ donors and had a higher life-sustaining treatment attitude score and knowledge about deceased organ and tissue donation, had more positive attitudes toward deceased organ and tissue donation. Conclusion: For more potential deceased organ and tissue donors to be referred for donation, there should be continuous education for emergency physicians on brain-dead organ and tissue donation-related knowledge and procedures. In addition, institutional or systematic improvements that can lead to organ donation when deciding on the withdrawal of life-sustaining treatment should be considered.

Barriers to the identification of possible organ donors among brain-injured patients admitted to intensive care units

Abdul Jabbar bin Ismail,Nor Diyanah Ahmad,Chong Si Ching,Cheah Siew Lean,Tony Tan Beng Keong,Mohd Izzwan Zaini,Cheah Phee Kheng 대한이식학회 2023 Korean Journal of Transplantation Vol.37 No.2

Background: Improving organ donation rates requires better detection of possible organ donors, which in turn necessitates identifying barriers preventing the identification of possible organ donors. The objectives of this study were to determine the actual rate of possible deceased organ donors among nonreferred cases and to identify barriers to their identification as possible donors. Methods: This retrospective observational study used 6 months of data collected from two intensive care units (ICUs). Possible organ donors were defined as patients with a Glasgow Coma Scale score <5 and evidence of severe neurological damage. Barriers that led to the nonidentification of these patients as possible organ donors were also identified. Results: Fifty-six of 819 patients admitted to the ICUs during the study period were detected as possible organ donors, representing a 6.83% possible organ donor detection rate. Nonclinical barriers to the identification of possible organ donors were found to be more significant than clinical barriers (55% vs. 45%, respectively). The most significant nonclinical barrier was an unknown reason, despite patients being medically suitable for deceased organ donation and fulfilling the criteria for possible organ donor classification. Unresolved sepsis was the main clinical barrier. Conclusions: The significant rate of unreferred possible deceased organ donors found in this study reveals the need to increase awareness and knowledge among clinicians of the proper detection of possible donors at an early stage to avoid the loss of possible deceased organ donors, and thereby increase the deceased organ donation rate in Malaysian hospitals.

해외 주요 국가와 비교 고찰을 통한 인체조직기증 활성화 방안

현윤정(Yun-Jung Hyun),이난영(Nan Young Lee),김동자(Dong Ja Kim) 한국산학기술학회 2020 한국산학기술학회논문지 Vol.21 No.12

현대 사회는 장기 및 인체조직기증에 대한 요구도가 높아지고 있으나, 우리나라에서 인체조직기증에 대하여 인식도와 기증률이 낮아 기증 활성화를 위한 현실적인 방안에 대한 연구가 필요할 것으로 사료된다. 본 연구는 국내외 관련 문헌고찰 및 나라별 이식 등록기구 홈페이지 자료를 참조하여, 인체조직기증과 관련한 국내 법률과 운영 제도 현황을 분석하였으며, 해외 주요 국가와 비교 고찰하였다. 본 연구를 통하여 국내 인체조직기증 활성화 방안으로 법률적 측면에서 이원화된 장기와 조직이식에 관한 법체계의 통합화, 제도 운영적 측면에서 과도한 압력이 없는 국가의 장기기증에 대한 추정적 동의 방식인 Opt-out 제도의 활성화와 사회 문화적 측면에서 대국민 홍보 활성화를 제시하였다. 그러나 추정적 동의 방식은 다양한 사회적 공론화 단계가 필요하며, 거부 의사를 위한 등록체계 운영사항에 대해 국내 실정에 맞는 이해가 있어야 할 것이다. 결론적으로 외국에 비하여 낮은 장기 및 인체조직기증을 활성화하기 위한 법적 제도정비가 요구되며, 기증에 대한 긍정적 인식 전환, 대중 홍보 및 사후 기증자와 가족에 대한 지원 등이 필요할 것으로 사료된다. In modern society, there is a growing demand for human tissue donation along with organ donation. However, the awareness of tissue donation and actual donation rates remain very low in South Korea. This study was undertaken to evaluate the current status of domestic laws and systems, and to compare them with the operation systems of major foreign countries, by reviewing literature and web sites of organ donation and registration. The authors present three measures to promote human tissue donation in Korea: integration of a dual legal system in a legal aspect, vitalization of the Opt-out system in terms of system operation, and activation of public relations in terms of social and cultural aspects. The Opt-out system, in particular, is the most effective way to activate transplants in the form of presumed consent of countries without undue pressure. However, the presumed consent method requires various stages of social public debate, and the requirement is a proper domestic understanding of the registration system for rejection. In conclusion, we believe the solution towards a positive inclination for organ donation is a public policy to increase the supply for organs and human tissue transplants, and positive perception of donations, public promotion, and support for postmortem donors and their families.

국내 장기기증 현황과 기증감소의 해결방안

조원현 대한이식학회 2018 Korean Journal of Transplantation Vol.32 No.3

Deceased organ donation in Korea has increased steadily after legislation of transplantation law. Since last year, however, several obstacles resulting in a decrease in organ donation have been experienced. Among them, the reduced reporting of potential brain death from large size hospitals and reduced consent rate of medically available deceased donors are two main hurdles. The consent rate of organ donation was 41.9% in 2017 but has dropped to approximately 10% than 2016. Other strong family members overrode approximately 10% of donations initially consented by their next of kin. In addition to the medical points, difficulties in labor shortage are being experienced during donor management, testing and organ recovery in the hospital. Some end stage patients who are candidates as organ donor give up further management and decide to withdrawing life sustaining treatment, which deprive the chance of donation. Moreover, the national mortality rate of cerebrovascular and traffic accidents, which occupy a major part of brain death, have decreased over the recent 10 years. All of these events can cause a decrease in brain death development so it is important to find solutions to overcome all of them. Revising transplant law and donation system should be led by government. Efforts to increase the consent rate, procurement rate, and transplant rate and decrease the organ discard rate are all the responsibility of the medical team. Public awareness and a positive attitude towards organ donation are the most important basic requirements for increasing organ donation. A comprehensive task force team to overcome all of these problems is requested.

Trends in Deceased Organ Donation and Utilization in Korea: 2000-2009

민상일,김성엽,박양진,민승기,김연수,안규리,김상준,하종원 대한의학회 2010 Journal of Korean medical science Vol.25 No.8

Continuous efforts have been made by the organ donation and transplantation community in Korea to increase organ donation by the deceased. The authors detailed trends of organ donation and utilization over the past 10 yr using data provided by the KONOS. The yearly number of deceased donors has grown gradually since 2003. The number and percentage of old donors (≥50 yr) and donors dying from intracranial hemorrhage has increased continuously. Therefore, the percentage of standard criteria donors (SCD) has been declining significantly, from 94% in 2000 to 79.2% in 2009. The number of organs transplanted per donor (OTPD) has also declined slightly since 2007, from 3.28 in 2007 to 2.95 in 2009. This decline may be attributable to increases in the number and percentage of extended criteria donors (ECD) and donors after cardiac death (DCD), since the OTPD was 2.25 for DCD, 2.5 for ECD, and 3.09 for SCD in 2009. In summary, the makeup of donors has changed significantly. There is an urgent need for establishment of an institutional framework including an independent organ procurement organization and for improvement for the National Transplant Act to increase deceased donor pool and to optimize management of ECD and DCD.