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

Abstract

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) of an online e-commerce (e-comm) site and frequently purchase from the 1st few products listed. Whether the majority of personal ECG devices available on e-comm platforms in the United States are FDA cleared or validated is unknown. To characterize DTC personal ECG monitoring devices on a popular e-commerce website. The most popular U.S. e-commerce website, Amazon.com (Amazon.com, Inc., Seattle, WA), was searched for “personal ECG.” Results on the 1st SERP were ranked in order of position on the webpage. Non-heart monitoring devices & duplicates were excluded. Devices were analyzed for name, type of analysis offered, presence of an external website, presence of non-medical use disclaimers, and for FDA clearance statement in the e-comm device description or on an external website. Results were cross-referenced to the FDA 510(k) clearance database and to PubMed for validation studies. A total of 61 devices were listed on the 1st SERP, of which 21 (43%) were excluded. The remaining 40 devices were: 23 (58%) ECG-capable, 7 (18%) PPG-rhythm capable, and 10 (25%) heart-rate only. Seven (70%) of the 1st ten devices on the SERP could not be found in the FDA 510(k) database. Of the 30 ECG or PPG-rhythm capable devices, 14 (47%) were not listed in the FDA 510(k) database: 2 advertised FDA clearance on an external webpage but were not listed in the FDA 510(k) database, 11 (79%) offered rhythm analysis with 2 (14%) also offering automatic QTc, 6 (43%) had a clearly stated non-medical use disclaimer in the e-comm description. Of the 16 (53%) devices confirmed to have FDA 510(k) clearance, 4 (25%) stated this clearly in the e-comm description. Validation studies were found for 13 (81%) of FDA-cleared vs 1 (7%) of non-FDA-cleared devices. Nearly half of DTC “personal ECG” devices on the 1st SERP of a popular e-commerce site may not be FDA cleared, do not have non-medical use disclaimers and the majority do not have validation studies. Also, few FDA-cleared devices are clearly labeled as such on the site. This can be potentially confusing and misleading for patients and consumers. Education to increase awareness and health policies for regulation are needed for this issue.