We’ve not covered many telemedicine tales recently for the reason that we’re device guys and the arguments seem to be more about embracing a “tele culture” than the tools it is demanding. This one took our fancy however, because it follows FDA’s 2011 classification guidelines for tele-health technology.
California’s InTouch Health describes itself as the world’s premier provider of acute care telemedicine solutions. The company has issued a press release announcing that it has received FDA 510(k) clearance with expanded indications for use for its range of Remote Presence devices which includes RP-7i®, RP-Lite®, RP-Vantage® and RP-Xpress® as well as VisitOR1® which is sold by and is a registered trademark of Karl Storz.
What’s telling in the approval is that this expansion of the indications for use clears the devices to be used for active patient monitoring in high acuity environments where immediate clinical action may be required and indeed specifically allows use for pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations. As an active patient monitoring technology it is defined as Class II by FDA rather than simply a medical device data system.
FDA has made it pretty clear how to classify devices which are likely to be prefixed with the word “tele” in its February 14, 2011 announcement regarding Medical Device Data Systems (MDDS).
The MDDS final rule provides clarification on the critical difference between the handling of medical device data intended simply for documentation versus that of active patient monitoring, classifying the former as Class I, the latter as a fully fledged Class II device and as such not an MDDS and therefore requires more stringent manufacturer controls.
In other words any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action (defined as active patient monitoring) by a health care professional is not an MDDS.
So, rules explained, what about InTouch and its Remote Presence devices?
InTouch Health integrates what it calls end-to-end telemedicine solutions, 24×7 technical support and clinical consulting services in its novel InTouch(R) Telemedicine System which it says enables physicians to perform highly reliable, real-time consultations with patients. Through a single portal, physicians can access a host of purpose-built, FDA-cleared telemedicine devices to provide care anywhere across the continuum, from Emergency Departments, ICUs, procedure rooms and patient wards to clinics, ambulances and homes.
The company’s telemedicine network is powered through its SureConnect® cloud-based infrastructure providing unparalleled connection quality and reliability, interoperability, workflow imaging and documentation, and services and support.
If you were to give the company and its system a strapline it would read something like “Wherever access to medical expertise is limited, InTouch Health’s Remote Presence telemedicine solutions can effectively extend the physician’s reach to manage patient care, thereby removing critical time and distance barriers”.
The Company already has more than 500 hospital locations on six continents enrolled in its Remote Presence network for the delivery of telemedicine services such as stroke, critical care, cardiology, trauma, pediatrics, neonatology, behavioural health, language translations, and clinical education and surgical/procedure mentoring.
“With these expanded indications for use, InTouch Health’s platform of telemedicine devices now has clearance for active patient monitoring in high acuity clinical environments with specific language clarifying the allowance of clinical applications of importance to customers in our core TeleStroke and TeleICU markets,” said Dr. Yulun Wang, Chairman and CEO of InTouch Health. “This clearance raises the bar for regulatory compliance in acute care markets and we are proud to have achieved this regulatory objective. We are absolutely committed to stringent regulatory compliance, and we are pleased to provide customers the assurance of knowing that our telemedicine solutions have withstood vigorous testing and are fully compliant with FDA regulations.”
SOURCE: InTouch Health, Business Wire