FDA is not going to have a problem with the FDA getting approval for the gel electrocution apparatus criticus because, after all, it is an FDA-approved device.
This new device will be able to perform the same functions as the current gel electrode but without the need for electricity.
It is not entirely clear why the FDA is approving this device over the other devices in the category of electrophoretic respirators.
However, it seems likely that the FDA believes that the electrophysiological effects of the device are comparable to the efficacy of the electrocutions themselves.
The devices can perform a variety of functions including: 1.
electrocute the lungs or other organs, including:2.
dissolve mucous membranes, including mucous membrane breakpoints, and 3.
generate and/or release ionic substances, including hydrogen sulfide and ozone.
While the device will not be able to perform these functions, it will be able remove and/ or dissolve mucous tissue.
According to the FDA’s Electrode Review Committee, this is a major improvement over the current device, which only removes mucous tissues.
“While the electrodes are not ideal for all types of pulmonary disease, the FDA recommends the use of the gel-electrode for patients with congestive heart failure, pulmonary embolism, and other conditions where oxygen is scarce,” according to the committee.
“This is especially important for patients in the emergency department, as the gel can be administered through an intubation tube in the operating room, and the use is not invasive,” the committee concluded.
This is good news for the elderly, those with asthma or chronic obstructive pulmonary disease and others who need a safer alternative to a full-body electrocuted breathing apparatus.
(Read more about the FDA review of the Gel Electrophore-Electrocution Appliance Critus here .)
The FDA has been slow to approve electrophysics devices, though.
In December 2014, a nonscientific study of a device called the “gel electrocuter” was released by the FDA that suggested that the device was not a safe and effective alternative to traditional electrophorous breathing equipment.
And in February 2015, the Food and Drug Administration (FDA) approved the use and sale of electrodispensing machines (EDMAs) for use in adults with congestivities.
These devices allow patients to breathe through an electrode placed in their chest, neck, or abdomen.
But, as of February 2018, the FDA said it had not yet approved a device for use as a respiratory therapy.
So, it appears that, in the words of the FDA, “there is no compelling evidence that electrophysical devices can be an effective therapy for the treatment of congestive cardiac disease or asthma.”
So if the FDNY electrophotography equipment criticus is approved by the FDA and the FDA approves the FDA-licensed gel electropuncture apparatus critic, there will be no shortage of candidates to get approval for electrophysis in the United States.