Prevention of Opioid-Induced Respiratory Depression and Death
The Oxalert EPO (Enhanced Pulse Oximeter) 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 patients are deaf or sedated, escalating safe but arousing electrical stimuli are given through electrodes contacting the wrist to encourage breathing and to wake up if necessary to self-medicate or get help.
The Oxalert's "enhancements" to traditional pulse oximetry use a method patented by Board-Certified anesthesiologists. Anesthesiologists are recognized experts and the original practi- tioners of critical care medicine and resuscitation. In a 2011 Clinical Trial technology recently adapted by the Oxalert EPO was 100% successful in keeping oxygen levels safely above 90%.
The Oxalert EPO device packages this technology into a wearable device.
**Under legislative authority granted by the Twenty-First Century Cures Act
This does not yet constitute FDA pre-market approval, which is pending a Clinical
Trial of the Oxalert EPO and an FDA submission. See:
https://www.fda.gov/media/108135/download for FDA Guidance and
definition of Breakthrough Devices.
10/18/2019--FDA designates the Oxalert EPO
a Breakthrough Device for use in postoperative
in-patients and home-users receiving opioid therapy.**