Opportunities

The Need for New Technology

Infusion pump manufacturers are subject to challenging regulatory pressures, in large part as the result of safety concerns. With the FDA's Infusion Pump Improvement Initiative, focus on the industry will intensify. As Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said upon the new initiative's announcement, "These pumps often provide critical fluids to high-risk patients, so failures have significant implications. It is time for a more comprehensive approach than we've taken to date." Xhale's XSensor PPG™ technology addresses issues discussed in this initiative by introducing a comprehensive level of safety to new and existing infusion pump platforms.

Between 2005 and 2009, 56,000 adverse events involving infusion pumps were reported to the FDA. Pumps can be mis-programmed, malfunction, and not respond to a patient's physiological responses to medications and underlying medical conditions. Whatever the cause, healthcare professionals need an innovative solution that will immediately alert them when dangerous events occur, especially in instances where the patient's medical condition deteriorates rapidly.

An Innovative Solution for Infusion Pump Safety

The XSensor PPG™ technology is now in a prototype stage, and is being readied for human trials. The first generation is being designed to monitor and alert healthcare professionals before adverse events occur and could automatically slow or stop drug infusion. It could be a stand-alone monitor for any existing infusion pump system, or it could be incorporated into a third party's next-generation infusion pumps.

Later generations of the technology could offer further features in correlating patient vital signs data to pump infusion rates, offering increased patient care and pump safety advancements for the healthcare professional.