Responding to Ventricular Assist Device Recalls: An Ethical Guide for Mechanical Circulatory Support Programs.

摘要: We discuss the ethical responsibilities of mechanical circulatory support (MCS) programs in context cardiac device recalls, particularly near-simultaneous recalls Abbott HeartMate 3 left ventricular assist (VAD) and Medtronic HVAD devices 2018. consider MCS programs' toward patients who already have VADs their caregivers, as well impact on informed consent shared decision-making under consideration for new VADs. Timely communication to affected is imperative throughout recall process. are required notify existing VAD about nature likelihood risk. A press release from manufacturer or other reports may occur before teams learn recall. This leads a disclosure gap, where actively deciding an appropriate action plan while simultaneously fielding patient concerns. From ethics standpoint, if all users owed information manufacturer, treating team. The question what disclose specifically, how.