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May 24, 2011

InTouch Complies with FDA''s Regulations Regarding Medical Device Data Systems

The Food and Drug Administration (FDA) made an announcement recently regarding Medical Device Data Systems (MDDS) after which InTouch Health confirmed that it complies with regulations issued by the agency.

In a release, Dr. Yulun Wang, Chairman and CEO for InTouch Health said, “The evolution of two-way audio and video communications systems used by health care professionals have transitioned from distance learning and hospital administrative applications to more comprehensive patient diagnosis. As health care providers now adapt these systems for real time physician consults, the industry must accept higher levels of responsibility to insure the safety and effectiveness of these devices.”

“From the time of the FDA’s Proposed Rule, InTouch Health recognized its responsibility as a medical device manufacturer and thus sought and received FDA class II 510(k) clearance in 2008,” Wang added.

The regulations concern the use of hardware and software in the healthcare information technology space. The MDDS Final Rule offers details on the critical difference between the handling of medical device data intended only for documentation purposes and that which is used for active patient monitoring. The FDA has made it clear that MDDS classified devices can be used only to transfer, store, convert from one format to another according to preset specifications, or to display medical device data, said officials.

The Final Rule emphasizes that being an FDA class I device, an MDDS cannot be used in connection with active patient monitoring as in real time, active or online patient monitoring. It stipulates that any device that transmits, stores, converts, or displays medical device data that is used to take immediate clinical action by a health care professional is not an MDDS. Active patient monitoring devices are classified as FDA class II medical devices that have to go through more stringent manufacturer controls.

Stephen R. Sidwell, Director of Regulatory Affairs and Quality Assurance for InTouch Health said, “The Final Rule is a signal to industry that the FDA is transitioning from ‘regulatory discretion’ where the FDA takes a wait-and-see approach to nascent markets, to pursuing ‘enforcement discretion’ to actively regulate new market segments.”

He pointed out that the company has put in more time and energy to design, validate and test all products standard procedures and processes in accordance with guidelines provided by the FDA.

Recently InTouch Health launched RP-Xpress at the American Telemedicine Association’s 16th Annual International Meeting and Exposition in Tampa, FL. The RP-Xpress is a portable telemedicine device designed for use in clinical environments using standard 802.11 Wi-Fi, enabling physicians to deliver real-time patient consults into hospitals and clinics.

Shamila Janakiraman is a contributing editor for HealthTechZone. To read more of Shamila’s articles, please visit her columnist page.

Edited by Rich Steeves

Shamila Janakiraman is a contributing editor for HealthTechZone. To read more of Shamila’s articles, please visit her columnist page.

Edited by Rich Steeves
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