A staff physician at Boca Raton (Fla.) Regional Hospital has created an innovative new iPad-driven method, called a remote-K-viewer, for adjusting and managing patients' pacemakers. While the technology isn't a direct connect--it actually requires two-way communication between the physician on an iPad and a nurse on a mobile computer cart at the patient's bedside--it does enable real-time patient management, and shrinks the time for adjusting a pacemaker from hours to just a few minutes according to Dr. E. Martin Kloosterman, the device's creator.
"The remote-K-viewer concept is a new software/hardware communication system and the first step into an inevitable direction, real time remote device management," Kloosterman, the hospital's electrophysiology laboratory director and chief of cardiology, said in a statement. "If we can control a robot in Mars we can certainly control remotely a cardiac device in Boca Raton."
Here's how the system works: A nurse or other clinician wheels the K-viewer cart to the patient's bedside. The physician logs into the system through an iPad and can see the patient's pacemaker readings onscreen. Talking with the nurse, the physician walks the clinician through the process of re-programming the patient's implanted device, Kloosterman explained in a statement late last week.
The process most hospitals use is a bit more clunky. It requires a representative from the device manufacturer to bring a computer to the patient's bedside, gather the data, and then send or call in the findings to the cardiologist. And that's just for a device check, let alone having to actually adjust the pacemaker itself, according to Kloosterman.
No word yet, though, on how the new technology might be viewed by U.S. Food and Drug Administration regulators. Pacemakers, and mobile technology that can actually affect how they function, are likely to fall in the higher-risk categories, such as Class III, FDA expert and attorney Bradley Thompson of Washington, D.C.-based firm Epstein Becker Green tells FierceMobileHealthcare. Full-scale clinical trials and FDA oversight of the device's marketing could mean a long road to market for the system.
Note: Once the systems' creators begin the trial process, they'll need to be ultra-careful with in their implementation. An FDA panel late last week denied approval of CardioMEMS' Champion HF Monitoring System, an implantable device for detecting heart failure. The reason: Panel members saw bias in the way the trial had been conducted. Regulators confirmed the device was safe, but weren't as sure that it was more effective than other treatments, reports Bloomberg Businessweek.