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中国器官捐献与移植法律框架(中)
时间:2026-05-28来源:中国反邪教网 作者:南山 王海波 黄洁夫 桑梓(编译)
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逝世后器官捐献与获取流程

根据中华医学会器官移植学分会组织器官移植和器官捐献相关专家制定发布的中国公民逝世后器官捐献流程和规范(2019版),中国公民逝世后器官捐献流程遵循8个主要步骤:报名登记、捐献评估、捐献确认、器官获取、器官分配、遗体处理、人道救助、捐献文书归档[52–57]。

报名登记

中国公民依法享有逝世后无偿捐献器官的权利,根据公民的健康状况,报名登记可分为生前报名登记和逝世后捐献申请两类。

• 生前报名登记:可在户籍所在地、居住地或住院地的人体器官捐献办公室、登记站或器官捐献网站(中国人体器官捐献管理中心http://www.rcsccod.cn/;中国器官移植发展基金会“施与受”器官捐献志愿者登记网站http://www.savelife.org.cn)完成器官捐献登记手续。在人体器官捐献办公室或登记站获取并填写由中国人体器官捐献办公室统一制作的《中国人体器官捐献登记表》,填写完毕可邮寄、传真或面交至人体器官捐献办公室或登记站。人体器官捐献办公室或登记站向报名登记者颁发统一制作的“中国人体器官捐献卡”,将自愿捐献者相关资料录入中国人体器官捐献登记管理系统并保存原始资料。

• 逝世后捐献申请:由外伤或疾病导致不可逆脑损伤或脑死亡的公民,生前未表达器官捐献或未表达不同意器官捐献意愿,其直系亲属(配偶、成年子女、父母)可通过住院地所属器官获取组织( Organ Procurement Organization,OPO)或人体器官捐献办公室表达器官捐献意愿,填写《中国人体器官捐献登记表》并签署意见,同时提供能说明捐献者与直系亲属关系的证明材料。人体器官捐献协调员负责协助办理相关捐献手续。

捐献评估

一旦临床上怀疑出现不可逆性脑损伤或脑死亡,脑死亡判定专家组应根据主管医师的请求诊断脑死亡或不可逆性脑损伤。若确诊为脑死亡或诊断为不可逆性脑损伤,该患者即可被视为潜在器官捐献者。在向其亲属告知上述诊断结果后,主管医师可征询亲属是否愿意捐献器官,或通过人体器官捐献协调员,以尊重公民逝世后自愿捐献器官的权利为前提。如果亲属有捐献器官的意愿,主管医师或人体器官捐献协调员将主动联系医院所在服务区域的器官获取组织(OPO),申请捐献者评估专家对捐献者的主要器官功能及全身状况进行评估与维护。人体器官捐献协调员会仔细评估亲属捐献器官意愿的真实性与可行性,并协助亲属完成器官捐献相关手续。红十字会工作人员将在器官捐献流程中提供帮助。如果潜在捐献者所在的医院不具备判定脑死亡、诊断不可逆性脑损伤以及评估和维护器官与全身功能的能力,红十字会可协调具备脑死亡判定资质的专家及OPO评估团队,为医院提供必要的协助。

撤除维持生命治疗(WLST)适用于正在接受机械通气且出现严重神经功能损害或器官功能衰竭、极有可能导致死亡的不可逆性脑损伤患者。这包括预计在撤除生命支持后60分钟内死亡的患者,以及虽被诊断为脑死亡但因文化或法律因素须待心脏停搏后才宣告死亡的患者。这一过程必须在合适的临床环境中进行,并严格遵循机构相关规程。参与器官移植或获取工作的人员,包括器官获取组织(OPO)成员及手术团队成员,均不得在这一过程中在场。如果供者在撤除WLST后存活时间较长(目前各国指南规定的最长可接受时间为180分钟),则不建议继续实施捐献后循环停止(DCD)流程[57]。

撤除治疗后,必须采用临床和有创方式持续监测患者的生命体征。用于判定心肺功能停止的推荐指标包括:无脉搏、无自主呼吸、无血压、无心音;无法测得有创动脉压;脑干反射消失(例如瞳孔固定且散大);以及确认处于深度昏迷状态。

为确认循环停止的永久性,必须在循环功能停止后进行一段绝对的观察期。根据现有文献及国际指南,需要至少2分钟、上限为5分钟的最低观察期。在此期间,不得实施任何复苏干预措施。这与美国麻醉医师学会的建议类似:“5.c 在经过至少两分钟且不超过五分钟的建议观察期后宣告死亡。”[58]

死亡必须由两名完全独立于器官获取组织(OPO)和移植团队的在场医师正式宣告。这种分离机制确保了判定过程的客观性、公正性以及法律与伦理上的完整性。

死亡的确切时间必须在病历中予以精确记录,整个过程应进行视频记录,以提供透明度、质量保证及法律验证。在临终关怀期间,主管医疗团队须将捐献者的舒适与尊严置于首位。死亡判定必须完全独立自主地进行,任何与器官捐献相关的行为均不得影响或加速患者的死亡进程。

潜在捐献者采用ABC-HOME评估方法分两个阶段进行评估:首先进行基本评估(ABC),随后开展更详细的评估(HOME;表1)。

 

表1 潜在器官捐献者 ABC-HOME 评估方法

初步评估(ABC)

进一步评估(HOME)

年龄

脑损伤、脑死亡

禁忌证

循环

病史

器官功能

用药

内环境

<65 岁

GCS 评分≤5 分

自主呼吸 <

12 次 / 分

昏迷原因明确

艾滋病

颅外恶性肿瘤

全身性感染

收缩压、平均

动脉压

中心静脉压

心肺复苏时

间、次数

药物成瘾史

高血压病史

糖尿病史

ICU住院时间

肝肾功能

尿量

超声检查

X 线胸片

血管活性药

利尿脱水药

电解质

pH 值

血红蛋白

白蛋白

GCS 评分为格拉斯哥昏迷评分;ICU 为重症监护室

来源:中华医学会器官移植学分会《中国公民逝世后器官捐献流程和规范(2019版)》

捐献确认

评估完成后,若所有直系亲属均同意捐献,他们必须签署相关表格:中国人体器官捐献登记表和人体器官捐献知情同意书。这些表格必须在捐献协调员和(或)红十字会工作人员在场的情况下签署,且由工作人员确认其真实性。

协调员会通过官方文件(如身份证、户口本、结婚证或出生证明)核实捐献人与家属之间的关系,并收集副本归档。如遇缺少文件的情况,可提供协助获取所需材料。一旦核实与归档工作完成,确认程序即正式完成。

器官获取流程

一旦确认捐献,主治医师与捐献者的家属或其代表须签署“终止治疗同意书”。若接受脑死亡作为判定死亡的标准,则必须先确认脑死亡,并获得在该条件下获取器官的同意。如果家属更倾向于在循环死亡后进行器官获取,也可同意在循环死亡后采用体外膜肺氧合(ECMO)技术以维持器官功能,并签署相应的同意书。

在任何器官获取之前,器官获取组织(OPO)必须向医院的伦理委员会提交文件以获得批准。伦理委员会在脑死亡后捐献的患者器官获取前,以及在循环死亡后捐献/脑-心双死亡后捐献患者的终止维持生命治疗(WLST)前被告知。获得批准后,将根据捐献者的意愿进行获取,由捐献协调员和(或)红十字会工作人员见证,并妥善保存准确的手术记录。根据国际标准,循环死亡后捐献的待命时间至少为5分钟,而脑-心双死亡后捐献的待命时间至少为2分钟[56,58]。

器官分配与共享

所有捐献的器官均须通过COTRS进行分配。OPO在获取器官前,会将捐献者的医疗数据录入系统,以触发预分配程序。若捐献者病情恶化,则立即启动紧急分配机制。获取器官后,OPO通过“绿色通道”协调运输,确保器官及时送达移植医院。移植完成后,捐献协调员将填写并存档捐献登记表,并向省级办公室提交相关文件。

遗体处理流程

捐献者遗体在器官获取后会得到尊重的对待:手术切口将被缝合,缺失的组织将被替换,外貌得以恢复。如果表达了全身捐献意愿,器官获取组织或红十字会将与接收机构进行协调。若未表达此意愿,则遗体将在相关机构的支持下移交至殡仪馆。

人道救助

器官捐献者的家属可从红十字会以及民间或其他慈善机构获得人道主义救助。救助范围包括丧葬费用、与器官捐献住院相关的自付医疗费用、交通费用、务工损失费用,以及对低收入家庭的扶助。家属可凭相关证明文件提出申请。社区所采取的社会支持措施还包括就业支持、教育帮扶及法律援助。

文件与归档

OPO负责汇编所有与捐献相关的完整档案。这包括捐献者信息、同意书、临床记录、伦理审批文件、见证人证明以及脑死亡或循环死亡的医学证据。若采用体外膜肺氧合技术(ECMO),还需纳入其同意书及操作记录。其他相关文件亦需一并归档。具体要求因死亡是脑相关、心脏相关,还是两者兼有而异。

死亡声明

如上文所述,经诊断为脑死亡或循环死亡后,患者即被宣告死亡,并须出具死亡原因医学证明[57],以供伦理委员会进行评估。证明出具后,该死亡事件须经公安机关正式登记,由公安机关更新逝者的户籍档案,从而依法终止其民事身份。此项登记是后续各项法律和行政程序的先决条件,包括继承权主张及遗产清算等。 (未完待续)

(本文作者:南山,医学博士、哲学博士[1,2];王海波,医学学士、理学硕士、公共卫生硕士[1,3];黄洁夫,医学博士、哲学博士[4])

 

延伸阅读:

 中国器官捐献与移植法律框架(上)

 

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