How Effective Is The Approval Process For HSAT Devices?

Sleep labs are not going out of style, but consumers clearly want more home sleep apnea testing (HSAT) devices. As demand goes up, so too has the problem of consistent standardized development and verification procedures.

Researchers analyzed the approval process for HSAT devices as performed by the U.S. Food and Drug Administration (FDA) from September 1, 2003, to September 1, 2023—with a primary focus on ensuring safety and clinical effectiveness. The research recently appeared in the prestigious science journal Journal Nature.

HSAT devices have gained significant traction, particularly following the COVID-19 pandemic, which has underscored the need for accessible home-based health monitoring solutions. From 2003 to 2023, there has been a notable increase in FDA clearances for these devices, with a particular surge observed in Type-3 HSAT devices. These devices are pivotal in diagnosing sleep apnea, a condition characterized by repeated interruptions in breathing during sleep, which can lead to serious health issues if left untreated.

Key metrics used to evaluate these devices include the apnea–hypopnea index (AHI), which measures the severity of sleep apnea, and the accuracy of sleep stage analysis. The study emphasizes the importance of compliance with electrical safety and biocompatibility standards, referencing international standards such as those set by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO).

Clinical trials play a critical role in the validation of these devices. The article reports that a substantial proportion of devices have undergone rigorous clinical testing, comparing their performance with established polysomnography (PSG) systems, predicate devices, and CO-oximeters. PSG remains the gold standard for sleep studies, and many HSAT devices are validated against it to ensure they provide reliable and accurate measurements.

Looking forward, the study advocates for the establishment of more comprehensive guidelines and performance criteria to further enhance the reliability and clinical utility of HSAT devices. The increasing number of FDA clearances indicates a growing confidence in these devices, but ongoing improvements in technology and regulatory oversight will be essential to maintain and build upon this progress.

Source: Chris Vu, ASBA

To access the article FDA-cleared home sleep apnea testing devices, click here