JOINT BASE SAN ANTONIO –
For the first time in its 70-year history, the U.S. Army Institute of Surgical Research at Joint Base San Antonio-Fort Sam Houston has received 510(k) clearance from the U.S. Food and Drug Administration for a medical device developed at the USAISR.
The clearance for the Burn Resuscitation Decision Support System-Mobile, also known as BRDSS-M, was announced by Dr. Suzanne Schwartz, the FDA director of preparedness/operations and medical countermeasures, at the Center for Devices and Radiological Health, during the 2013 American Burn Association 45th Annual Meeting at Palm Springs, Calif., recently.
The FDA uses the 510 (k) premarket submission to ensure a medical device is safe for use on patients. A 510(k) submission (which is approximately 800 pages long) demonstrates that a new medical device is substantially equivalent, as safe and as effective as another medical device that has already been FDA cleared and is commercially available.
The approval process is arduous, expensive and can take several years to complete.
"This technology is the first of its kind algorithm-based decision assist system for use in managing fluid resuscitation of the severely burned patient," Schwartz said. "We consider this a milestone, but even more than that, a peek into what the future has in store for burn trauma management."
Jose Salinas, Ph.D., the USAISR research task area program manager for comprehensive intensive care research, helped develop the BRDSS algorithm which generates recommendations of fluid intake for burn patients.
It was designed to assist in avoiding problems related to over- or under-resuscitating by medical care providers who do not routinely care for burn patients. The original BRDSS technology was developed for use at the USAISR Burn Center Intensive Care Unit about seven years ago.
According to Salinas, it has been invaluable with assisting medical providers with resuscitation management and has been shown to improve patient outcomes.
"If you give a patient too much or too little fluid, the results can be fatal," explained Salinas, describing the complex care necessary for burn patients who are often dehydrated and require precise rehydration.
Maria Serio-Melvin, USAISR clinical program coordinator for computer decision support systems and co-chair of the integrated product team that is fielding the system, added that there are a lot of competing priorities when caring for burn patients.
"The goal is that this device will help keep medical providers on track with one of the most important things that they need to do - hourly fluid titration based on urine output," Serio-Melvin said.
The Burn Navigator, as the BRDSS-M is also known, is designed to be used in a deployed setting by non-burn experienced nurses and doctors. The software is in a mobile tablet that meets military specifications.
"An additional benefit of the system is that it's not only a decision support system; it's also a graphical interface of the trends of how the patient is doing," Salinas said.
"So even without the decision support part of it, medical providers can look at the display and see how the patient is progressing and use that to help better manage the burn patients."
The Burn Navigator is expected to be used soon by the Army at deployed combat support hospitals, which support overseas contingency operations.
The Burn Navigator technology was licensed to Arcos Medical, Inc. of Houston, which worked with the USAISR to submit the FDA 510(k) application with funding from the U.S. Army Medical Research and Materiel Command at Fort Detrick, Md.