Reuse & Renewal: The Rules and Value of Reprocessing Devices

Description

This session will provide an overview of the FDA's regulations on reuse of pacemakers and guidance on how to safely and legally export pacemakers. The session also includes a discussion of a real world example of a successful program.

Learning Objectives

1. Understand the US federal regulations on pacemaker reuse.
2. Gain knowledge of FDA's guidance on US and out of US reuse of pacemaker.
3. Learn the process to safely and legally export pacemakers for use outside of the United States.
4. Learn about a program that is providing reused pacemakers outside the United States.

Presenters

Kimberly A. Selzman, MD, MPH, FHRS
George E Wahlen VA Hospital, Salt Lake City, Utah

Captain Brian Lewis, MD, FHRS
US Food & Drug Administration, Silver Spring, Maryland

Thomas C. Crawford, MD, FHRS
University of Michigan, Ann Arbor, Michigan

Disclosures

K. Selzman: Nothing relevant to disclose.
B. Lewis: Nothing relevant to disclose.
T. Crawford: Nothing relevant to disclose.

Summary


Availability:	On-Demand


Cost:	FREE


Credit Offered:	No Credit Offered

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