GHX today announced it has partnered with PTC (Nasdaq: PTC) to offer a solution to help medical-surgical manufacturers meet both commercial and regulatory compliance needs, including the submission requirements of the U.S. Food and Drug Administration’s (FDA) new Unique Device Identification (UDI) rule.
The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices(1). By partnering with PTC, GHX broadens its existing UDI consulting and data services to include the PTC UDI Solution for creating, communicating, and tracking 21 Code of Federal Regulations Part 11-compliant Global UDI Database (GUDID) submissions. The FDA’s first UDI compliance deadline for high-risk Class III devices is September 24, 2014, less than five months away.
For more than a decade, GHX has worked together with hospitals and manufacturers to synchronize product data, helping build a foundation of greater accuracy for e-business transactions. Today, GHX operates the largest, most accurate and up-to-date product content repository in healthcare, helping to ensure GHX customers are always moving toward greater automation and efficiency. With the addition of the PTC UDI solution capabilities, GHX now offers manufacturers an even more comprehensive set of Global Data Standards compliance offerings, helping satisfy their product data standardization needs for both customers and regulators.
Developed in collaboration with the FDA and major medical device manufacturers, the PTC UDI solution generates the required Health Level 7 Structured Product Labeling-formatted submission data, transmits it to the FDA’s GUDID, and tracks FDA responses back to each submission to help manufacturers gain GUDID compliance across their complete product lines. It offers both submission-only technology and data staging technology, providing unique data management and synchronization capabilities to automatically keep GUDID submissions current as product attributes change, one of the key requirements of the FDA UDI rule. Specialized technology pre-validates each GUDID submission using the FDA’s own specification so manufacturers can identify and address issues prior to transmission.
This combined solution will help companies achieve value and new efficiencies while also moving toward compliance and highly secure electronic data management. These capabilities further enhance the existing GHX Global Data Standards solution set, which allows manufacturers to efficiently provide data feeds of critical product information for a variety of purposes. The GHX solution set includes:
“GHX is uniquely positioned to help healthcare realize the full value of UDI. Because we work with manufacturers that must comply with the rule, and their customers that must use the unique identifiers, we understand how to bring together these business partners to maximize value for both. Our expertise has grown over the nearly 15 years we’ve been accurately and efficiently sharing data among healthcare trading partners. GHX has built the trust necessary to be the industry’s primary solution for both UDI compliance and improved visibility across the supply chain,”said Tina Murphy, senior vice president, Global Product &Corporate Development, GHX. “Working together, PTC and GHX make this a perfect solution for our mutual customers and for the regulators and healthcare providers that depend on this data.”
(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.”
About GHX
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. For more information, visit www.ghx.com and The Healthcare Hub.
PTC, PTC UDI Solution and the PTC logo and are trademarks or registered trademarks of PTC Inc. or its subsidiaries in the United States and other countries