Air Force Lab Puts Medical Devices Through Their Paces
Peter Holstein, Air Force Surgeon General Public Affairs
“Well, maybe that’s not completely accurate,” Ritter clarified. “We don’t set out to break things, but sometimes that happens anyway.”
AFMESA’s mission is unique within the Air Force, and across the U.S. military. Their job is to test medical technology and devices to ensure they meet the needs of medical Airmen and survive the rigors of deployment. AFMESA is a crucial part of the procurement process for the Air Force Medical Service and vital to maintain ready medical forces.
“We get to play with stuff before the Air Force makes the final decision to buy a new piece of equipment or other technology,” said Lt. Col. Lewis Wilber, AFMESA deputy chief. “We perform what’s called ‘operational testing’ and make recommendations to acquisition teams to make sure devices the Air Force purchases for our medics can accomplish the mission in an operational environment.”
Situated at Fort Detrick, Maryland, AFMESA has its own testing site, complete with a 10-bed Expeditionary Medical Support Hospital (EMEDS +10), a 44,000 square foot test pad, and other on-site test facilities. AFMESA engineers work together with Air Force clinicians to put medical devices in simulated field environments.
“We start by running the device through a ‘functional verification test,’ which makes sure that it meets the manufacturer’s specifications,” said Ritter. “Then, we bring in actual users, medics, who deliver care in the field and in military treatment facilities, and let them interact with the device in a field setting.”
The test facilities at AFMESA simulate many of the conditions medical Airmen experience in the field. Having an EMEDS tent onsite is critical, since most of the equipment is used in that deployed setting, or one similar.
The AFMESA testers observe medics interacting with the devices and document where they experience problems or frustration using a device. Recording these interactions helps the test team identify which parts of the device to scrutinize issues more closely, to ensure the device will help medics accomplish their mission.
“Many of the devices we test have already been approved by the U.S. Food and Drug Administration,” said Wilber. “But the FDA doesn’t require the practical, hands-on testing that we perform. A device that works fine in a normal hospital setting may not work when Airmen use it in deployed environments. We make sure Air Force procurement teams have the right information to supply our medics with technology that works under stress.”
One example the AFMESA team highlighted was the evaluation of four patient-controlled analgesia pump devices. At first, each seemed to have similar capabilities, but when the team began high-temperature testing, something changed.
“One of the pumps had an aluminum case that covered some of the tubing,” said Ritter. “Our medics have to operate in temperatures up to 140 degrees, so that’s what we test to. As we turned up the heat, the aluminum melted the tubing, leaving the pump unusable.
That’s the type of thing you’d never learn from testing under ideal conditions. We know our medics rarely see ‘ideal conditions’ out in the field. If a piece of equipment breaks out there, that’s a life lost.”
Sometimes, AFMESA testing reveals fatal flaws in a device. Other times, the team may make a recommendation to correct a problem. One test was for an anesthesia machine to use during field surgery. When the team increased the temperature past 112 degrees Fahrenheit, they discovered the system was delivering more and more anesthetic to the simulated patient.
“It turns out the anesthetic agent boiled at 112 degrees,” said Ritter. “The gas was actually escaping into the test chamber, and delivering way too high a dose. We recommended changing to an agent with a higher boiling point, and the medical teams agreed. Now deployed Air Force surgical teams use that device in the field.”
What sets AFMESA apart from other military medical testing groups are the clinicians embedded in the organization. Their expertise and experience in the field allows AFMESA to identify points of failure that regular test engineers might not see.
“Clinician testing is our gem,” said Ritter. “We take medics who deploy downrange and train them to be testers. They know what really matters in the operational environment. It can be as simple as a device display that works just fine indoors, but can’t be read in bright sunshine, or knowing that special operations medics need to be able to turn off alarms and flashing lights for some missions.
Many of the devices medics use in the field today came through us first for testing. Our work directly affects the ability of Air Force Medicine to complete its medical mission.”
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