FDA News

FDA Clears MDN-CGS Intravenous Insulin Dosing Software

(Oct 18, 2007)-- Medical Decisions Network (MDN) announces Food and Drug Administration 510(k) clearance for the company's MDN-CGS IV Insulin Dosing Software. The MDN-CGS software is used by hospital nurses to quickly and accurately calculate the dosage of intravenous insulin administered to patients with elevated levels of blood glucose, the simple form of sugar the body converts to energy for survival.

More and more hospitals are adopting measures to control elevated glucose levels (commonly referred to as diabetes or hyperglycemia) in critical care units because studies have shown a resulting marked improvement in patient outcomes. These improvements include reduced mortality (death), length of stay, rate of infection, and a variety of other risks. According to Gary Stouder, MD, at Indiana's Hancock Regional Hospital, "Based on what we've seen so far, by automating our insulin dosing protocol with the MDN-CGS software, we expect to see a decrease in length of stay of 1 day and up to a 50% decrease in mortality in our hyperglycemic ICU patients."

Currently, hospitals rely on printed procedures to calculate IV insulin dosage based on hyperglycemic patients' varying glucose levels. More frequent glucose tests - as many as one or more per hour for tightly controlled ICU patients - burden the already overextended nurses. And referring to complicated paper protocols stresses clinical staff even more. Computerizing these calculations and providing automated patient reports may not only improve glucose control and save critical time and resources, but may reduce potentially dangerous dosing calculation errors as well.

The health benefits of this technology are hard to resist: MDN-CGS users have seen a stark reduction in the incidence of hypoglycemia, a potentially life-threatening severe drop in blood glucose. And it takes significantly less time to get a patient out of the danger zone and into the target glucose range(1).

According to Greg Menke, Medical Decisions Network's CEO, "We've seen technology make sweeping improvements in the quality and cost of healthcare. Our MDN-CGS Computerized Insulin Dosing Software is another major contributor to these improvements because it gives hospital clinicians the power to control hyperglycemia, a huge and growing health and cost burden in this country."

The MDN CGS is a networked application, accessible from any computer on a hospital's network. This means that clinicians can continue a patient's infusion progress even when the patient is moved to a new unit.

"This FDA 510(k) clearance will be important for clinical administrators who are considering the move to this beneficial technology and feel more comfortable with FDA's nod," says Menke. "It's an important step for all of us."

Share or bookmarklet this web page at: