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An FDA-designated Breakthrough Medical Device
for use in patients receiving opioid therapy.**
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Oxalert apd
(APNEA PREVENTION DEVICE)
Prevention of Opioid-Induced Respiratory Depression and Hypoxemia
The Oxalert Apnea Prevention Device (APD) is a breakthrough in patient safety at the point-of-care. It is a truly interactive monitor of oxygen levels: a wrist-worn, battery-powered pulse oximeter and arousal device that restores life-saving conscious control of breathing to overly-sedated patients.
Respiratory depression and sleep apnea cause hypoxemia (low blood oxygen). When the Oxalert detects hypoxemia it verbally prompts the user to breathe.
If users are deaf or sedated, escalating safe but arousing electrical stimuli are given through electrodes contacting the wrist to encourage breathing and to wake up, and if necessary self-medicate or get help.
The Oxalert's uses reflectance (no finger probe) pulse oximetry with an arousal system patented by Board-Certified anesthesiologists. Anesthesiologists are recognized experts and the original practitioners of critical care medicine and resuscitation. In a 2011 Clinical Trial technology recently adapted by the Oxalert was 100% successful in keeping oxygen levels safely above 90%.
The Oxalert APD packages all this technology into a convenient wearable device.
**Under legislative authority granted by the Twenty-First Century Cures Act.
This does not yet constitute FDA clearance, which is pending.
See the FDA Guidance document for a description of Breakthrough Devices:
https://www.fda.gov/media/108135/download