PO-04-178 E-COMMERCE DIRECT-TO-CONSUMER RHYTHM MONITORING DEVICES: CLEARED FOR LANDING OR CLEAR AS MUD?

Direct-to-consumer (DTC) digital health products, especially personal ECG monitoring devices, have grown exponentially. Marketing studies show that ∼70% of consumers never click beyond the 1st search engine results page (SERP) an online e-commerce (e-comm) site and frequently purchase from few products listed. Whether majority devices available on e-comm platforms in United States are FDA cleared or validated is unknown. To characterize DTC a popular website. The most U.S. website, Amazon.com (Amazon.com, Inc., Seattle, WA), was searched for “personal ECG.” Results SERP were ranked order position webpage. Non-heart & duplicates excluded. Devices analyzed name, type analysis offered, presence external non-medical use disclaimers, clearance statement device description cross-referenced to 510(k) database PubMed validation studies. A total 61 listed SERP, which 21 (43%) remaining 40 were: 23 (58%) ECG-capable, 7 (18%) PPG-rhythm capable, 10 (25%) heart-rate only. Seven (70%) ten could not be found database. Of 30 capable 14 (47%) database: 2 advertised webpage but database, 11 (79%) offered rhythm with (14%) also offering automatic QTc, 6 had clearly stated disclaimer description. 16 (53%) confirmed clearance, 4 this Validation 13 (81%) FDA-cleared vs 1 (7%) non-FDA-cleared devices. Nearly half ECG” may cleared, do disclaimers Also, labeled as such site. This can potentially confusing misleading patients consumers. Education increase awareness policies regulation needed issue.