Reuse & Renewal: The Rules and Value of Reprocessing Devices-Reuse and Renewal: The Rules and Value of Reprocessing Devices

Reuse and Renewal: The Rules and Value of Reprocessing Devices

Video Transcription

Video Summary

The video features presentations by Dr. Brian Lewis and Dr. Thomas Crawford on the topics of device reprocessing and reuse. Dr. Lewis discusses the legal export of reprocessed pacemakers, emphasizing that it can be accomplished by working with the FDA and following certain regulatory requirements. He highlights that meeting the safety and effectiveness bar is less stringent for exported pacemakers than for new ones approved for the US market. Dr. Crawford shares the University of Michigan's experience with pacemaker reuse. They aim to provide reconditioned devices to patients in developing countries where access to pacemaker therapy is limited. He details their reprocessing protocol, which involves cleaning, testing, and packaging the pacemakers before they are donated. Dr. Crawford mentions ongoing efforts to conduct a prospective trial comparing brand new devices with reconditioned ones. He also discusses the challenges of regulatory compliance and the need for collaborations to expand the program's reach. The video concludes by encouraging viewers to reach out with inquiries or comments.

Keywords

device reprocessing

legal export

reconditioned devices

pacemaker reuse

regulatory compliance

collaborations