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Responding to Ventricular Assist Device Recalls

An Ethical Guide for Mechanical Circulatory Support Programs

Kirkpatrick, James N.*,†; Mahr, Claudius*; Beckman, Jennifer*; Bjelkengren, Jason*; Dudzinski, Denise M.

doi: 10.1097/MAT.0000000000001005
Original Article: PDF Only
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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.

From the *Division of Cardiology, University of Washington, Seattle, Washington

Department of Bioethics and Humanities, University of Washington, Seattle, Washington.

Submitted for consideration December 2018; accepted for publication in revised form March 2019.

C.M.: Consultant/Investigator: Abbott, Medtronic, and Abiomed. J.B.: Consulting relationships with Abiomed, Abbott, and Medtronic. The remmaining authors have no conflicts of interest to report.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.asaiojournal.com).

Correspondence: James N. Kirkpatrick, University of Washington Medical Center, 1959 NE Pacific St, Seattle, WA 98195. Email: kirkpatj@uw.edu.

Copyright © 2019 by the American Society for Artificial Internal Organs