FDA Approves Ebola Test Machines Weeks After Dallas Needed Them

FDA Approves Ebola Test Machines Weeks After Dallas Needed Them

Several years ago the US Food and Drug Administration approved a small device that can quickly and accurately identify the Ebola virus, but despite its approval, US hospitals have been denied the use of the machine by the FDA until last week.

In fact, even though the Texas hospital that saw the first diagnosed case of Ebola in the US had the machine, it was prevented by the FDA from using it outside of medical research until October 25.

Sometime ago the FDA gave approval for a testing device named the FilmArray, produced by a company named BioFire. This little machine, the size of a toaster, gives very accurate results with a 90 percent certainty in less than an hour.

The US military is already using the $39,000 devices in Africa but the FDA didn’t let US hospitals use FilmArray for anything but medical research until recently.

This means that, even though Texas Health Presbyterian Hospital in Dallas has had the machine for two years, doctors were prevented from using the device on Ebola patient Thomas Eric Duncan or the two nurses who treated him and contracted Ebola.

But even as the FDA prevented hospitals from using the device outside of research, the US Defense Department gave BioFire a $240 million contract so that our soldiers could use the machine.

The FDA claims that they had not approved it because research devices have a lower safety and effectiveness threshold. Yet, FilmArray has been deemed safe enough for our soldiers.

The device could also be used in airports for travelers suspected of being infected with the disease.

The FDA has given the device “emergency use authorization” for Ebola screening and “has allowed hospitals to buy the necessary modifications to allowed their FilmArray systems to detect the virus.”

Follow Warner Todd Huston on Twitter @warnerthuston or email the author at igcolonel@hotmail.com


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