The U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) rule is expected to greatly improve patient safety, post market surveillance and the efficiency of supply chain operations by requiring manufacturers to assign standard identifiers to medical devices, label products with those identifiers and provide additional data to the FDA’s Global UDI Database (GUDID). Achieving these benefits – and shedding more light on the cost and quality of care – requires UDI adoption in clinical, financial, administrative and procurement systems. The first UDI compliance deadline (for Class III devices) has already passed, with the next major deadline scheduled for Sept. 24, 2015.
The GHX Business Consulting Services team has found it takes manufacturers an average of nine months to prepare product data for submission to the GUDID, with some global manufacturers spending years on UDI implementations. This September, all implantable products, along with other products deemed to be life-saving and life-sustaining, regardless of class that were not covered under the first deadline, must comply, with the largest class of products, Class II representing more than 40 percent of medical devices, slated for compliance in September 2016.
“Meeting UDI regulatory requirements demands a multi-functional effort within supplier organizations and creation of sustainable processes and validated systems to ensure ongoing compliance,” said Karen Conway, executive director, industry relations for GHX. “The time to act is now.”
As more UDIs are assigned to medical devices, GHX is seeing an uptake in usage of the standard identifiers in supply chain transactions, but usage is higher among suppliers than providers. According to Conway, “The real value of UDI will come when providers are using UDIs to improve visibility to the products used in patient care.”
To help suppliers and providers prepare for these realities, GHX’s Conway, an industry thought leader on the UDI rule, will lead a panel session entitled, “UDI and Health IT: Key to Unlocking Medical Quality and Cost,” at the HiMSS15 Annual Conference (April 12-15, Chicago). The UDI session will take place on Wednesday, April 15, from 2:30 p.m.-3:30 p.m. CT in room S401.
Conway will be joined by an elite group of panelists who are both intimately knowledgeable on the UDI rule and seasoned in real-world best practices to help organizations realize its benefits. The session will help attendees understand how to best utilize UDIs by identifying the necessary system and process changes, and evaluating the clinical and financial benefits of better medical device tracking. Panelists include:
The GHX UDI solution and services practice has successfully submitted UDI data attributes in the required Health Level 7 Structured Product Label (HL7 SPL) format to the GUDID. GHX Business Consulting Services has been helping numerous medical device manufacturers prepare for UDI for many years, and last year the company’s UDI technology solution was able to submit data for Class III devices for one of the industry’s largest medical device companies well in advance of the 2014 deadline. Now the company is working with customers to prepare for the upcoming September 2015 deadline.
The FDA’s UDI rule passed in September 2013 aims to considerably reduce the instances of patient injury and death that result from the misidentification of medical devices(1). The UDI rule requires healthcare manufacturers to label covered products with a unique device identification code and provide additional information about their products to a UDI database. The first UDI compliance deadline for high-risk Class III devices was September 24, 2014.
In September 2015, all implantables, as well as products determined to be life-saving and life-sustaining devices, regardless of class must be in compliance, with all remaining Class II devices the following year. Non-exempt Class I devices must comply by September 2016.
The GHX solution helps ensure the device data (including both the device identifiers and required product attributes) meet the FDA’s specifications, leverages PTC (Nasdaq: PTC) to submit the data first to a staging environment to verify data and address any data issues, and then verifies that data was submitted to the FDA’s test environment, and finally to the FDA production GUDID.
(1) Federal Register /Vol. 78, No. 185 /Tuesday, September 24, 2013 /Rules and Regulations page 58786 “Reduce Medical Errors. The presence of a UDI that is linked to device information in the GUDID will facilitate rapid and accurate identification of a device, thereby removing a cause of confusion that can lead to inappropriate use of a device. Using a device’s UDI, you will be able to use the GUDID to positively identify the device and obtain important descriptive information, preventing confusion with any similar device which might lead to misuse of the device. Health care providers will no longer have to access multiple, inconsistent, and potentially incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information.”
Global Healthcare Exchange, LLC (GHX) is driving costs out of healthcare by transforming the healthcare supply chain. Working with providers and suppliers, GHX is accelerating change by providing a faster, more efficient and collaborative supply chain that will take billions of dollars out of the cost of healthcare. In November 2014, GHX acquired Vendormate, a leader in vendor credentialing and procurement cycle management software and services for healthcare providers and suppliers. For more information, visit www.ghx.com and The Healthcare Hub.
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