Unregulated online sales of cardiac implantable electronic devices in the United States: A six-month assessment.

TLDR: There does exist a public online market for unregulated CIED sales in the United States, but this specific market seems to be small and unlikely to significantly expand with active monitoring by manufacturers and regulators.

Abstract: Background An estimated 1 million patients require cardiac implantable electronic devices (CIEDs) but go without annually. This disparity exists in low-to-middle-income nations largely owing to the cost of CIED hardware. Humanitarian reuse of CIEDs has been shown to be safe and feasible. However, recent publications have raised concern that promotion of CIED reuse may foster a CIED "black market," to the dismay of manufacturers, regulators, and clinicians alike. Objective To determine if unregulated CIED sales for potential human use is a real issue by investigating unregulated public online CIED sale listings in the United States of America. Methods An observational study was undertaken over 6 months using multiple internet search engines from May 1 to November 1, 2019. We cataloged usable CIEDs (still in packaging, manufactured Results In total, 58 CIEDs—47 implantable cardioverter-defibrillators and 11 permanent pacemakers—from 4 manufacturers were listed for sale on 3 websites. During the study period, 8 of 11 pacemakers and 37 of 47 implantable cardioverter-defibrillators were sold (price range: $100–$1500 [US dollars]). No new listings were seen in the last 3 months of observation, possibly owing to concomitant industry investigation. Conclusion There does exist a public online market for unregulated CIED sales in the United States. This specific market seems to be small and unlikely to significantly expand with active monitoring by manufacturers and regulators.