Minneapolis, Minnesota, UNITED STATES

Clinical Surveillance & Quality Software Capability Due to "Landmark" Rule Will Assist Affordable Care Act Objective for Greater Value and Safety 

Improving Infection and Adverse Event Prevention, Patient Safety and Care, and Cost of Care Initiatives

MINNEAPOLIS, Oct. 24, 2013 (GLOBE NEWSWIRE) -- VigiLanz Corporation (, a digital healthcare technology company headquartered in Minneapolis, announced today that its Dynamic Monitoring System™ (DMS), a market-leading, real-time clinical surveillance and quality software-as-a-service (SaaS) platform, is fully compatible with the recent rule established and described as a "landmark step" by the U.S. Food and Drug Administration (FDA) requiring most medical devices sold in the U.S. to carry a Unique Device Identifier("UDI").  

The long awaited rule was announced in September with the intent, according to a statement by the FDA, of improving "the accuracy and specificity of adverse event reports " as well as "documenting device use in electronic health records and clinical information systems" such as VigiLanz' DMS.

"Our real-time cloud technology platform is ready right now to receive medical device UDI data," said David Goldsteen M.D., VigiLanz' president and chief executive officer.  "Our system is connected to a wide variety of data sources in our customer hospitals, including lab, microbiology, pharmacy, vital signs, surgery and radiology.  VigiLanz software supports thousands of hospital clinicians across the U.S. to assist in monitoring patients and clinical data on a real time basis, alerting them to the possibility of patient safety risks, potential infections, and other adverse events.  When the FDA's new UDI rule was announced, VigiLanz rapidly enabled its DMS software to monitor this additional data from medical devices in real-time as it becomes available from hospital providers."

As the Affordable Care Act continues its rollout this month, Dr. Goldsteen said valuable data derived from medical devices as well as other information systems sources will be delivered to hospital clinicians in real-time and will become essential components in value-based, quality patient care in hospital and outpatient clinics.

"The new UDI rule is an exciting development for VigiLanz because we are able to rapidly provide clinicians with key information in a variety of scenarios; for example, device use and costs, patient safety tracking, and the potential effect of various devices on the length-of-stay in the hospital," said Dr. Goldsteen.  "In addition, the heightened worldwide annual October focus on infection prevention, coupled with an increased emphasis on the need for electronically recorded UDIs will make it much easier for the VigiLanz DMS to identify potential infection."

VigiLanz ( is a privately held, emerging growth firm and a leading provider of clinical decision support software for hospitals, founded by David Goldsteen, M.D. and David Klass, M.D. in 2001. VigiLanz supports a community of hospital quality teams, infectious disease and control specialists, pharmacists, and other clinicians dedicated to patient care. VigiLanz is helping transform 21st century health care and assisting emerging Accountable Care Organizations better manage patient communities through real-time clinical information.


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