This article was originally published in the February issue of HealthLeaders Magazine.
For just a second, obstetrics doctors and nurses would recognize the streaming waves undulating across the tablet as those from a fetal heart rate monitor at a patient’s bedside.
With this app, AirStrip Remote Patient Monitoring, providers can view these waves from wherever they happen to be—while treating another patient or attending a soccer game. With mobile access on the iPad or iPhone, or any mobile device, they can see trouble as it starts, both historic and in real time.
The developer, AirStrip Technologies, decided to classify the software as a medical device, similar to a pacemaker, hearing implant, or imaging test. In so doing, it subjected the technology to review for safety and efficacy by the U.S. Food and Drug Administration.The company decided that its software did not just send information from one source to another, like calling up the Stedman’s Medical Dictionary online.
Rather, because AirStrip renders a visual interpretation of that wave-form data “and makes sure that we’re maintaining the proper mathematical ratios and graphically plotting that out in a way that’s accurate and reliable, that makes it a medical device” says Bruce Brandes, AirStrip’s chief sales officer.
The FDA cleared the application in July 2010. Now the software is being adapted for cardiology and critical care applications, postanesthesia care, and telemetry units at hundreds of hospitals. It is being used by paramedics to transport 12-lede ECG tests from the field to the base hospital before transporting the patient, Brandes says.
In seeking oversight from a federal agency for an app, AirStrip Technologies is unusual, although it is not the first. Richard Katz, MD, director of the division of cardiology at George Washington University School of Medicine in Washington, DC, echoed the sentiments of many physicians developing and using mobile medical applications in calling the field “entering uncharted territory.”
“We’re very early in the game, and there aren’t a lot of apps that have been widely tested or validated,” he says.