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Boston area startup tackles ECRI's #1 Medical Technology Hazard


November 21, 2016 ( Newswire) Last week the ECRI Institute, the highly respected medical technology watchdog organization, ranked infusion pumps as #1 on its list of the "Top 10 Health Technology Hazards for 2017." As ECRI states in its executive brief, "ECRI Institute continues to learn about and investigate incidents of infusion errors involving pump or administration set failures, staff unknowingly defeating a safety mechanism, or incorrect infusion programming. Such errors- particularly those that result in the uncontrolled flow of medication to the patient, known as "IV free ow"-can lead to patient harm and even death.

In fact, these pumps are associated with 54% of potential adverse drug events, 56% of medication errors and 61% of serious and life-threatening events. The FDA receives more reports of adverse infusion pump incidents annually than for any other medical technology. From 2005 to 2009, 56,000 recorded pump issues resulted in 710 patient deaths.

"If airline mishap rates were comparable to infusion pump mishap rates, far fewer people would fly." That's how moderators at an FDA 2016 conference summed up the poor safety record of the infusion pump, ubiquitous throughout today's hospitals.

"The risks to healthcare are enormous because the majority of patients receive an infusion during a hospital stay," comments Stuart Randle, CEO of Ivenix, a Boston area technology startup focused on bringing infusion therapy into the modern age. Infusion pumps have had little change in core technology for the past 20 years.

Ivenix saw this as a significant business opportunity and a chance to deliver a higher standard of patient care. In the process it is challenging the dominance of three major medical technology giants that virtually own the $2.6 billion U. S. large volume pump market.

Randle explains that the industry has been rife with FDA recalls and advisories, acquisitions and resistance to change. As he observed, improvements were more like retrofits-adding a modern steering system to an old 1970s car-not developing integrated new solutions that address underlying problems. Ivenix's intelligent infusion system is designed to significantly enhance dose accuracy, reduce the chance of medication errors and boost clinician workflow. Innovations include a uniquely accurate and efficient pneumatic fluid delivery system and simple smartphone-like interface to prevent user errors.

"The system has bi-directional electronic medical record (EMR) communication and uses patient, pump and drug library data to help ensure appropriate device settings, infusion delivery and safety checks. It also provides clinicians, wherever located, with timely infusion information, as the pump truly enters the digital age," says Randle. "In the future connected hospital, that platform will help share pump information with other devices and systems to further eliminate manual processes and enhance quality of care."

Last year, Ivenix received a $42 million round of financing. After hours of development and extensive testing, the next milestone will be FDA submission, expected shortly. The company hopes to be the first infusion system to comply with the FDA's 2014 Infusion Pumps Total Product Life Cycle Guidance for Industry, intended to improve the quality and safety of infusion pumps.


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