Intel-GE Care Innovation's QuietCare resident monitoring system has received FDA 510(k) clearance as a Class I device. The QuietCare system is a network of infrared motion sensors placed in a senior living facility, which sends data to a Care Innovations server. An algorithm on the server analyzes motion data for potentially urgent situations such as falls and for significant changes in the user's daily routine, alerting a caregiver if necessary.
QuietCare was developed and originally manufactured by the Living Independently Group, a company that was acquired in late 2009 by GE Healthcare. The product was later moved under Care Innovation's umbrella when the joint venture launched in 2010.
The system has been deployed for some time in assisted living facilities, but the device was classified as a 510(k)-exempt Class II device. On the QuietCare website, Care Innovations states "[t]he QuietCare system is not an emergency response or alarm system and is not intended for providing medical care. Data from the QuietCare system should not be relied on as medical advice or clinical diagnosis."
Bonnie Norman, director of quality and regulatory affairs for Care Innovations, told MobiHealthNews that the FDA contacted Care Innovations saying they wanted to change QuietCare's classification from Class II to Class I. Although normally Class II devices require 510(k) clearance (while Class I devices need to be registered) QuietCare was a special case, Norman said. The FDA requested they file a one-time 510(k) because of a little-known regulation governing new technologies. She said future iterations of the device would most likely not require additional FDA filings.
"So putting a 510(k) package was a matter of going through existing files and putting a package together for them," said Norman. "...It was no big deal. We were happy to do it."
GE Healthcare competitor Philips has a PERS system called LifeLine, which is registered as a Class I device with the FDA, something that Philips notes on its website. Philip's device has a different form factor -- a pendant worn around the neck.
Norman said Care Innovations will mention the clearance in product descriptions, but has no intention of publicizing it beyond that.
"Using 510(k) clearance to market your device is inappropriate," she said. "I always raise my eyes at companies that trumpet that clearance as if it makes their product better than anyone else's. It's a data point. We will certainly mention it, but it's not a differentiator."
QuietCare has had its share of problems over the years. According to FDA documents, Care Innovations had to address product problems on at least two occasions. In June 2012, the FDA published a report about an August 2011 service outage which caused some alerts not to be sent. In May 2013, a problem caused users to receive duplicate alerts. Additionally, Laurie Orlov of Aging in Place Technology Watch wrote in 2010 about a botched rollout of the system in Fort Pierce, Florida which included a mandatory $200 extra charge per resident.
GE Care Innovations also received 510(k) clearance in September for their Connect RCM (Remote Care Management) software offering and subsequently rolled it out in the United States. Connect RCM is a cloud-based patient portal for Care Innovations' Guide platform, which previously required special hardware to access. By moving to a cloud-based software system, GE estimates the cost of deploying the system could be reduced by 50 percent. Just last week the company rolled Connect RCM out in Canada as well.