Evaluation Background: Continuous Positive Airway Pressure (CPAP) Units

December 30, 2019 | Evaluations & Guidance

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Here's background for our Evaluations of continuous positive airway pressure (CPAP) units, outlining the key considerations for making wise purchasing decisions. Learn how the technology is used, which specs are important and why, what factors we test for, costs of ownership, and more.

CPAP units are primarily used by patients in their homes to treat obstructive sleep apnea (OSA). They may also be used in the hospital or other clinical settings when brought from home by patients. If a patient requires CPAP but does not provide their own device, healthcare facilities may use other devices, such as low-acuity noninvasive ventilators, during the patient's stay.

To be considered in this category, a product must have the ability to maintain a constant pressure between 3 and 25 cm H2O. It must also have no expiratory valve—expired gas is vented passively from the mask—and be intended for personal use by one patient on a consistent basis.

CPAP technology is mature. The treatment was first developed in 1980, with the first commercial devices receiving FDA 510(k) clearance in 1984. Since then, advancements in the technology have focused on:

  1. Developing and improving algorithms to automatically detect sleep apnea and adjust the pressure setting according to the patient's needs (automatic positive airway pressure, also called AutoPAP or APAP)

  2. Capturing and transmitting data to the patient (via mobile apps), to the prescribing physician, and to the insurance provider

  3. Improving patient comfort by incorporating:

a) Ramp features that gradually increase the...

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