The U.S. FDA has granted marketing authorization for the Masimo SafetyNet Opioid System, a monitoring device intended to recognize and respond—by a series of escalating notifications—when an individual may be experiencing opioid-induced respiratory depression (OIRD) due to opioid use or overdose.
The device monitors several physiological markers to detect the impairment of oxygenation due to opioid use and uses software that can notify personal contacts and/or trigger a wellness call to the device user by an Emergency Medical Service dispatch when a person may be experiencing opioid-induced respiratory depression, to help ensure they receive necessary treatment intervention, such as naloxone.
Opioid-induced respiratory depression, the primary cause of opioid-induced death, is the neural depression of respiratory drive which, together with a decreased level of consciousness and obstructive sleep apnea, cause ventilatory insufficiency. Variability of responses to opioids and individual differences in physiological and neurological states add to the risk. (1)
The Masimo SafetyNet Opioid System is intended for individuals 15 years of age and older at risk. It can be used in a hospital or in-home setting for individuals taking prescribed opioid medications, or those using opioids illicitly.
Masimo is a global medical technology company that develops, manufactures, and markets a variety of noninvasive patient monitoring technologies, hospital automation solutions, home monitoring devices, ventilation solutions, and consumer products.
References:
- “Mechanisms of opioid-induced respiratory depression” https://link.springer.com/article/10.1007/s00204-022-03300-7
