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FDA Guidelines Restrict Use of Ebola Scanning Device at Hospitals

It took a Dallas hospital two days to diagnose the first Ebola patient in the US, but doctors reportedly had a machine that could have provided test results in under an hour.
October 22, 2014, 1:37am
Photo via Flickr

It took two days for the US Centers for Disease Control and the Texas Department of State Health Services to confirm that Thomas Eric Duncan, the first patient to be diagnosed with Ebola in the US during the current outbreak, had in fact tested positive for the hemorrhagic fever. For a virus that claimed the 42-year-old Liberian national's life in less than two weeks, two days might have made all the difference — and it appears that a device in Texas Health Presbyterian Hospital's arsenal could have turned around the results in less than an hour.

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The device is called the FilmArray, a sleek diagnostic scanner that can identify more than a dozen different viruses and bacteria. With the right kit, these capabilities include testing for Ebola. In fact, healthcare workers at Emory University Hospital in Atlanta used the device to diagnose US aid workers Dr. Kent Brantley and Nancy Writebol after they contracted the disease in Liberia.

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Another proponent of the device is the US military, which has funded the company behind the machine, BioFire, to tailor the device for testing diseases like Ebola — an investment that has proven worthwhile considering the military is utilizing the FilmArray as apart of its Ebola response efforts in West Africa.

BioFire confirmed to DefenseOne that the Dallas hospital does in fact have a FilmArray in its arsenal, begging the question as to why it wasn't used to test Duncan during his emergency room visit, instead of sending his samples to a CDC-sanctioned lab in Texas and the agency's Atlanta headquarters.

First and foremost, the hospital would have needed a special Ebola panel for the device — a panel that most hospitals probably don't have, Dr. Stephen Morse, an epidemiology professor at Columbia University, told VICE News. But perhaps the biggest obstacle is the fact that, despite military backing and high profile cases of use, the device is not technically approved by the Food and Drug Administration for diagnosing Ebola.

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Currently, FilmArray is approved for diagnosing gastrointestinal and respiratory problems, but when it comes to Ebola the scanner must get special approval by the FDA, an allowance which falls under the agency's "research use only" guidelines. This means that even if the FDA gave a hospital the green light to use the Ebola panel for the FilmArray, it would have to be strictly for research, not simply for determining whether a patient has the disease.

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According to Morse, once the hospital is given permission to use a device under the research guidelines, it would be up to clinicians to determine what that means — leaving a definite gray area in which testing could be done.

In the case of a potential Ebola patient, it may seem reasonable for healthcare workers to cite an emergency situation and use the diagnostic test. But Dr. Peter Jacobson, a health law and policy professor at the University of Michigan, told VICE News that using the test could open a hospital up to liability issues.

"If you're a hospital, before you use a device, you ask the FDA for a waiver because if you don't and you get it wrong, you have a liability issue," he said. "In an emergency situation, you've got to give healthcare administrators leeway, but you have to be careful and justify why it's an emergency."

Jacobson said there is a strong defense for allowing emergency use of FilmArray for Ebola diagnosis.

'Particularly with this device, one argument could be that the only way to actually find out if it works is to use it during an outbreak.'

"Unchecked Ebola has obviously dire consequences," he said, explaining that if you can argue that something would work to prevent the spread of Ebola or cure someone, you would have a strong defense. "Particularly with this device, one argument could be that the only way to actually find out if it works is to use it during an outbreak." Jacobson noted an important caveat: FilmArray should not be used exclusively — its results should be backed up by other testing methods.

The FDA said it has been reaching out to commercial companies in order to encourage them to develop rapid diagnostic tests for Ebola, in addition to acknowledging the importance of such technologies. As Morse points out, diagnostic tests are especially important for tackling the outbreak at its source West Africa. He explained that rapid diagnostic capabilities are important on the ground in order to differentiate between Ebola and diseases with similar symptoms, especially Malaria, which is very common in the region.

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Early diagnostics also help to jumpstart contact tracing efforts, ensuring that resources are not used to follow the contacts of someone who doesn't actually have the virus.

Regardless of the fervor surrounding the outbreak, the FDA sticks by its current use guidelines for FilmArray. The agency said it works to quickly decide on these cases once they receive a request.

"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," the FDA said in a statement.

According to Jacobson, the FDA is constantly under attack for being to slow to respond or to slow to approve pharmaceutical and medical devices.

"But there's a reason why we have the FDA," he said. "FDA approval needs to be systematically thorough and robust so we don't have devices on the market that don't work and/or that cause more harm."

Jacobson said the debate brings up larger issues that the government will have to resolve going forward.

"We know that we need some type of policy to deal with this kind of outbreak," he said. "The way Ebola spreads and the fear it induces suggests we need to think differently about devices and pharmaceuticals in an outbreak."

The Fight Against Ebola. Watch the VICE News documentary here.

Follow Kayla Ruble on Twitter: @RubleKB

Photo via Flickr