San Francisco, California – The U.S. Food and Drug Administration (FDA) recently issued a warning letter to iRhythm Technologies over violations related to its Zio AT mobile cardiac telemetry device. The letter, published on the FDA’s website, outlined various concerns, including the company’s failure to report patient deaths and other violations within the required timeframe.
The FDA’s inspection of iRhythm’s California headquarters uncovered several issues, such as a significant number of complaints regarding a transmission limit that compromised the device’s ability to transmit electrocardiogram data accurately. This led to missed arrhythmias, including two patient deaths, which were not reported promptly to the FDA.
Additionally, the warning letter highlighted that iRhythm marketed the Zio device for unapproved indications, claiming it could provide near real-time monitoring and immediate notifications for high-risk patients. However, the device is only approved for long-term monitoring in non-critical care patients where real-time monitoring is not necessary.
During the inspection, the FDA found that iRhythm made changes to the device without following the required procedures, committed labeling violations, and failed to address issues raised in customer complaints. The agency emphasized that it is the company’s responsibility to ensure compliance with FDA regulations to maintain the quality and safety of its products.
iRhythm Technologies has responded to the FDA’s findings, acknowledging some violations and disputing others. The company claimed that the transmission limit issue was a design limitation rather than a nonconformance, despite it resulting in missed significant arrhythmias and patient deaths. While some of iRhythm’s responses were deemed satisfactory by the FDA, further improvements and reporting may still be necessary to address the identified violations.
The warning letter serves as a reminder of the importance of adhering to regulatory standards in the medical device industry to protect patient safety and maintain trust in healthcare products. iRhythm Technologies will need to take corrective actions to address the FDA’s concerns and ensure compliance with applicable laws to prevent future violations.