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Viral Disease
While not medical devices and not approved as such, there is sufficient evidence to consider off-label
usage for humanitarian purposes in the effort to ease the suffering and possibly reduce the mortality
rates associated with Ebola virus.
Pinson, AL, December 01, 2014 - Urgent
When electric fields are applied to smaller volumes or volumes that are in minimal
motion, then the strength of the fields can be reduced to a lower strength and applied more frequently
over a longer duration to achieve reasonable results.
This has been demonstrated under microscopic observation with bacteria, protozoa, and yeast, as wells
as with some fungi (3,4,5). These types of studies are not practical on virus due to the inability to
observe functioning virus under the microscope.
While these devices are not medical devices and have not received any approval as such, there is
sufficient evidence to have them considered to be used off-label for humanitarian purposes in the effort
to ease the suffering and possibly reduce the mortality rates associated with Ebola virus. The effects of
such usage in this application are unknown, however, the devices should be considered to be
inherently safe for the following reasons.
The output voltage is 10.0 volts or less and it operates on a 9 volt battery.
The output signal is current limited to a safe level so as not to risk any personal
injury.
The company has sold many thousands of these units to customers worldwide for the purpose of
investigating electric water purification. We note the off label use on humans may be relatively
common with no complaints of personal injury and no significant side effects other than what would be
found with the destructive inhibition of any large volume of microbial inhabitants in the human body.
While FDA approval has not been applied for, the FDA has investigated these products
and this company. In the case of this company, based on the information obtained by the FDA, in a
letter to the CEO of the company, the FDA found that these products should be considered to be Class 3
devices, capable of preserving human life, if and when used for the prevention or cure of disease or
illness. FDA approval has not been applied for because these devices are sold as experimental water
treatment devices, "for water not intended for human consumption
The unit would need to be applied to a patient for several hours a day, if not continuously, for the
duration of the illness.
The unit will generally run for 24 hours on a single 9 volt alkaline battery.
Para Systems, Inc., in private transaction, will provide 5 research units at cost plus shipping and
handling in consideration of the humanitarian nature of this issue.
Certain substantiating information is listed below. Kindly contact the writer for further private
discussion of the potential therapeutic benefits of this technology.
The most important point of this communication is that the off-label use of this water treatment device
has the potential of saving human lives as well as reducing the level of suffering associated with Ebola
and potentially other illnesses and this potential needs to be thoroughly tested.
The World Health Organization (WHO) stated, on August 12, 2014, that the panel reached
consensus that it is ethical to offer unproven interventions There was unanimous agreement that there is
a moral duty to also evaluate these interventions
http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en
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