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

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 <7 years) and pricing. Manufacturers were contacted to determine status of sellers and unregulated CIEDs using model/serial numbers.

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.

Keywords: Cardiac implantable electronic device (CIED); Defibrillator re-use; Global disparities; Implantable cardioverter-defibrillator; Pacemaker; Pacemaker re-use.

Figure 1

Number of unregulated online sale listings of verified cardiac implantable electronic devices (CIEDs) in the United States (per month) over the 6-month study period. Telephone icon signifies communication with manufacturers verifying the status of their listed CIEDs; magnifying glass icon signifies that new CIED listings were observed in the first 3 months of study (positive magnifying glass) but not in the last 3 months of study (negative magnifying glass). ICD = implantable cardioverter-defibrillator; PPM = permanent pacemaker.