FDA halts Dallas hospital from using Ebola-screening device

The Dallas hospital that treated Thomas Eric Duncan had a version of the Ebola-screening device used by the U.S. military in West Africa sitting on a shelf, but FDA guidelines prohibited staff from using it on the patient.

A $39,000 machine called FilmArray was available to the Dallas Presbyterian Hospital when Duncan came in with a fever. The device has a high success rate for detecting Ebola in less than one hour, but sat idly because current federal guidelines prevented the hospital from obtaining a specific “kit” needed for screening, the military website Defense One reported Thursday.

“It will take the Ebola cells, break them open, expose the [ribonucleic acid] in the Ebola and match those with a target we’ve identified,” a representative from BioFire Diagnostics, which produces the device, told the website.

The company told Defense One that BioFire Dallas Presbyterian Hospital was in possession of FilmArray for up to two years.

In short, current FDA guidelines limit the machines to “research use only,” the website reported. Hospitals that do receive FDA approval to use the devices to diagnose patients must then wait up to 20 days before using it in such a capacity, the website reported.

The FDA responded to Defense One’s story with the following statement:

• “The FDA understands the importance of quickly diagnosing Ebola cases in the U.S. and abroad. We are committed to working with BioFire and other companies in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola for emergency use during this epidemic. The FDA works extremely rapidly to make a determination on an Emergency Use Authorization once the information is submitted to the agency for review. The FDA may not authorize the use of a diagnostic test before reviewing data about its performance in detecting Ebola virus in human specimens and determining that the standard for authorization is met. Doing so would also be irresponsible and potentially unsafe.”

Update: BioMérieux spokesperson Suzanne Jones reached out to The Washington Times on Monday and added that the company “is working closely with FDA to determine if the FilmArray Ebola assay might qualify for an [Emergency Use Authorization]” of its product, which was developed “solely for use in environmental surveillance.”