San Francisco, California – The U.S. Food and Drug Administration (FDA) recently sent a warning letter to iRhythm Technologies regarding issues related to their Zio AT mobile cardiac telemetry device. The letter, dated May 25, was made public on the agency’s website on June 6, shedding light on various concerns the FDA had with the company’s practices.
One of the key issues pointed out in the FDA’s letter was iRhythm’s failure to report two patient deaths and other violations related to medical device reporting (MDR) within the required 30-day timeframe. Additionally, the FDA highlighted that iRhythm marketed the Zio device under unapproved indications, failed to follow proper submission procedures for device changes, and did not address numerous customer complaints.
During a visit to iRhythm’s headquarters in California, the FDA uncovered a substantial number of complaints related to a transmission limit issue that affected data transmission accuracy. This issue was classified as a nonconformance by the FDA due to its frequent occurrence hindering the device’s intended purpose of transmitting electrocardiogram data. The FDA discovered that this transmission limit issue led to the oversight of significant arrhythmias, resulting in two patient deaths that were not reported promptly.
Another critical point raised in the warning letter was that iRhythm marketed the Zio device for uses not approved by the FDA. While the device is authorized for long-term monitoring of arrhythmia events in non-critical care patients not requiring real-time monitoring, iRhythm’s promotional materials suggested capabilities for near real-time monitoring for high-risk patients – a claim not supported by FDA approval.
Despite issuing responses to the FDA addressing some of the violations, iRhythm was advised to take further action to ensure compliance with FDA regulations. The FDA acknowledged some of iRhythm’s responses as satisfactory but indicated that additional changes and reporting may still be necessary to address the identified issues. The warning letter serves as a reminder to medical device companies of the importance of adherence to regulations for the safety and well-being of patients.