From the Department of Medicine, Division of Cardiology, University of Washington, Seattle, Washington.
Department of Bioethics and Humanities, University of Washington, Seattle, Washington.
ASAIO J. 2020 Apr;66(4):363-366. doi: 10.1097/MAT.0000000000001005.
We discuss the ethical responsibilities of mechanical circulatory support (MCS) programs in the context of cardiac device recalls, particularly the near-simultaneous recalls of Abbott HeartMate 3 left ventricular assist device (VAD) and Medtronic HVAD devices in 2018. We consider MCS programs' ethical responsibilities toward patients who already have VADs and their caregivers, as well as the impact of recalls on informed consent and shared decision-making in patients under consideration for new VADs. Timely communication to affected patients is imperative throughout the recall process. MCS programs are required to notify existing VAD patients about the nature and likelihood of risk. A press release from the device manufacturer or other press reports may occur before MCS teams learn about the recall. This leads to a disclosure gap, where the programs are actively deciding on an appropriate action plan while simultaneously fielding patient concerns. From an ethics standpoint, if all device users are owed the recall information from the manufacturer, all patients are owed the information from their treating team. The question is what to disclose specifically, and how.
我们讨论了机械循环支持 (MCS) 项目在心脏设备召回背景下的道德责任，特别是在 2018 年 Abbott HeartMate 3 左心室辅助装置 (VAD) 和 Medtronic HVAD 设备几乎同时召回的情况下。我们考虑了 MCS 项目对已经拥有 VAD 的患者及其护理人员的道德责任，以及召回对考虑使用新 VAD 的患者的知情同意和共同决策的影响。在整个召回过程中，及时向受影响的患者进行沟通至关重要。MCS 项目有责任通知现有 VAD 患者有关风险的性质和可能性。设备制造商的新闻稿或其他新闻报道可能会在 MCS 团队了解召回之前发布。这导致了披露差距，即项目在积极制定适当的行动计划的同时，还在处理患者的担忧。从伦理学的角度来看，如果所有设备使用者都有权从制造商那里获得召回信息，那么所有患者都有权从他们的治疗团队那里获得信息。问题是具体披露什么，以及如何披露。
