Oxalert EPO Indication for Use
The FDA has the extremely difficult job of insuring that drugs and devices are both "Safe" and "Effective".
The FDA does not allow manufacturers of FDA-approved devices and drugs, even if they are safe, to make claims of effectiveness not supported by clinical evidence. Studies in humans proving effectiveness can be impossibly expensive and take many years. One estimate of the cost of approving a new drug was $800 million.
Manufacturers of pulse oximetry do NOT claim that patient harm can be avoided by monitoring alone. All they can really claim is that the device accurately measures oxygen levels and will not CAUSE harm to anybody. What patients or caregivers DO with that information about oxygen levels is not the responsibility or CLAIM of the manufacturer.
Neither does Med-Botics claim that its Oxalert EPO will prevent patient harm or save their lives. But currently available medical evidence strongly suggests that hypoxemia is commonly unrecognized, untreated, and is associated with poor outcomes.
FDA approval to market the Oxalert EPO depends on their assessment of potential risks and benefits to patients. As of October 18, 2019, the FDA designated the Oxalert EPO as a Breakthrough Medical Device for this proposed "Indication for Use":
"The device is intended to continuously monitor SpO2 in post-operative in-patients and home-users receiving opioids and to arouse them to breathe if SpO2 decreases below 90%. The device is not intended for single use."**
**Note: this does not constitute pre-market approval for the Oxalert to be sold as a medical device at this time.