By OMAR FORD
Medical Device Daily Staff Writer
EarlySense (Waltham, Massachusetts), a company devoted to proactive patient care solutions, reported the results of a post regulatory approval clinical and non-interventional prospective study supporting the effectiveness of the EarlySense contact-free patient monitoring system to accurately predict patient deterioration.
The clinical study data will be published in the October 2012 print edition of the Journal of Hospital Medicine in an article titled "Early Recognition of Acutely Deteriorating Patients in Non-Intensive Care Units: Assessment of an Innovative monitoring Technology."
"This study is focused on the ability to look at change in the patient and the ability to detect early warning signs of deterioration," Avner Halperin, CEO of EarlySense told Medical Device Daily. "This is kind of an advanced study beyond the ones that were published before."
According to EarlySense, the clinical study was performed in two different medical departments at two separate academic medical centers. Sensitivity and specificity in predicting deterioration was found to be 82% and 67%, respectively, for heart rate and 64% and 81%, respectively, for respiratory rates. For trend alerts, sensitivity and specificity were 78% and 90% for heart rate, and 100% and 64% for respiratory rates, respectively.
"So this data when you compare it to other monitoring technologies is extremely powerful in determining the early warning signs in deterioration with minimal level of false alarms," Halperin said.
Nearly 140 patients were evaluated in the study, the company said.
"This study supports the commonsensical idea that a robust system to non-invasively monitor patients' vital signs can catch signs of early deterioration potentially preventing embers from turning into fire storms," said Robert Wachter, Professor of Medicine at the University of California, San Francisco, one of the nation's top authorities on patient safety and a member of the EarlySense medical advisory board. "Given the challenges of 'alert fatigue', I was particularly heartened by the infrequency of false alarms seen in this study. This innovative technology is an important step forward in our efforts to keep patients safe."
The EarlySense system uses a sensor, placed under the mattress of a bed, and never touches the patient. It is designed to detect early warning signs of deterioration by continuously monitoring heart rate, respiratory rate, movement, bed exits and entries. The technology was designed to monitor non-ICU 'lower risk' patients on medical surgical floors who are usually monitored by on-duty nurses once every four to five hours. In the event of a change in a patient's status, the system immediately alerts on-duty nurses at the central nursing station, on large screens on the wall of the department and on their handheld devices. EarlySense's real time delivery of actionable data, coupled with comprehensive unit management tools, empowers the medical staff to identify critical situations early on and proactively respond.
The EarlySense system received FDA clearance back in 2010, with additional clearances for enhanced communication abilities and better sensing technologies in the middle of 2011. The device has also been cleared for sale in Europe and Canada.
"We've been developing this technology over eight years," Halperin told MDD. "It's a homegrown developed technology with over a 100 engineering years invested in it and one million patient monitoring hours collected in order to develop this it. It's truly a ground-breaking contact free patient monitoring technology, that I think has not been seen before."
In the future, Halperin said that he could see monitoring systems like EarlySense's becoming a permanent fixture in hospitals and care facilities. He added that although this isn't the case now, the shift to change this could happen in the next few years.
"Three or four years from now we'll say it's unbelievable that several years ago most of the patients were in the hospital beds were not monitored at all," he said. "[Monitoring technology] like our system is going to be more prevalent. When you talk to hospital administrators they all share our view that in the 21st century, it doesn't make sense for a patient at the end of a corridor to lie in bed and not be seen by a nurse for hours especially since there is clear evidence to the clinical and economic value of detecting the early warning signs [in time]."
Omar Ford, 404-262-5546;
Published September 24, 2012