The FDA’s UDI System Creates the Foundation For Safer, More Cost Effective Medical Device Management

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UDITracker® is the first comprehensive medical device management system developed for hospitals.

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The leading medical device management system for hospitals

"Hospitals nationwide lose billions of dollars every year because of the limitations of their manual record keeping systems to accurately track their medical devices from delivery through use in patient care."

“The Food and Drug Administration’s Unique Device Identification (UDI) system for medical devices marks an historic turning point in patient safety and medical device management,” said Peter Casady, Chief Executive Officer of Champion Medical Technologies, a healthcare information technology company and leader in medical device management systems (MDMS) for hospitals.

“However, it will take the participation of hospitals to realize these benefits,” said Casady. The first phase of UDI implementation begins on September 24, when all Class III implantable, life-sustaining and life-supporting medical devices must carry UDI-compliant bar code labels.

“The UDI bar code labeling system will help to improve safety for patients who rely on medical device implants to improve their health and quality of life,” said Casady. “It also creates a huge opportunity for hospitals to improve business processes that can lead to lower medical device costs, increased revenue and will eventually inform better patient care with higher quality, accessible data.

“UDI is a powerful tool, but the benefits will only materialize when hospitals use the data as the foundation for comprehensive medical device management. This is a new concept for hospitals, but already, medical device management systems are in the market and available for use now because of UDI.”

Hospitals nationwide lose up to $5 billion every year due to obsolescence and loss because of the limitations of manual record keeping systems to accurately track their medical device implant inventory. September 24th marks the starting point for hospitals to streamline their medical device management processes, automate data entry and adopt the UDI labeling system.

“UDI creates the data base foundation, but it takes an enabling technology like UDITracker® to make the data useful. We’ve made significant investments in product development to provide hospitals with the tools to make the transition to an automated medical device management system.

“UDITracker® is a comprehensive medical device management system that captures, documents and shares medical device data. The system integrates regulatory compliance, inventory management, quality assurance and product recall inventory and patient matching into a single, streamlined medical device management system.”

About Unique Device Identification
In September 2013, the Food and Drug Administration established by law the Unique Device Identification system to provide a consistent way to track medical devices throughout their distribution and use. The rule will be phased in over seven years starting on September 2014, when most implantable devices and life-sustaining and life-supporting devices must carry UDI bar code labels.

The UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.

About Champion Medical Technologies
Champion Medical Technologies is a privately held, healthcare information technology company and leader in implantable medical device management systems for hospitals. Champion’s flagship system UDITracker® captures, documents and shares medical implant data between patient care and supply chain information systems, empowering hospitals with the insights they need to increase patient safety and drive down operating costs.

UDITracker® is a comprehensive medical device management solution that integrates regulatory compliance, inventory management, quality assurance and product recall inventory matching into a single, streamlined system. Using barcode scanners, smartphone apps and RFID storage units, users capture data once and record accurate information to ensure patient safety, produce inventory cost savings and to generate business-decision making analytics.

UDITracker® features interoperable interfaces to most electronic health record and inventory management systems, ensuring that medical devices can be uniquely identified, located in inventory, tracked during transfer from storage to the OR and traced directly to patients. Uniquely identified medical device information can be searched, sorted and shared within a single hospital or across a group of hospitals.

RecallConnect®, the only real-time recall inventory and patient matching system on the market, received a Chicago Innovation Award in recognition of its unique patient safety feature. It reduces from months to hours the amount of time it takes hospitals to identify patients and current inventory effected by a medical device product recall.

Founder and Chief Executive Officer Peter Casady established Champion Medical Technologies in 2006. Today, it serves more than 200 hospitals and major medical centers nationwide and is the market leader in tissue compliance and management.

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Bess Gallanis

Lisa Sipe
@ChampionMedTech
since: 03/2014
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