GHX shares key lessons learned to successfully prepare and publish data to the FDA’s GUDID
One day before the U.S. Food and Drug Administration's (FDA) deadline for medical device companies to submit Class III product data to the FDA's Production Global UDI Database (GUDID), GHX announced that in August its UDI solution and services practice 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 its 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 tomorrow's 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 is tomorrow, September 24, 2014.
Only approximately 10 percent of products fall under the first deadline for Class III products, with the remaining 90 percent of medical devices sold in the U.S. yet to be impacted by the regulation. Next September, 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.
GHX is already helping manufacturers prepare for future deadlines, which will cover significantly more medical devices. 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.
"UDI is a watershed opportunity for the industry, but there are a lot of lessons to be learned navigating this new regulatory requirement," said Tina Murphy, senior vice president, Global Product & Corporate Development at GHX. "Trust, but verify is important advice for any organization submitting to the FDA's GUDID. GHX uses a submission simulator to help identify the issues before officially submitting. This saved critical time because the FDA can take several days to review and return failed submissions. It is often something simple like a wrong phone number or format issue that creates a failure. The simulator helps us to catch those errors before they caused a problem."
Through its work with regulatory agencies, standards organizations and device manufacturers and its success submitting device data, GHX has developed the following guidance for other organizations on key lessons learned when preparing and publishing data to the FDA's Global UDI Database (GUDID):
Lessons Learned and Mistakes to Avoid Submitting to the FDA UDI GUDID:
1. Thinking it's easy: Many manufacturers believe the labeling requirements for UDI are the greatest challenge and product data submission to the GUDID is the easy part. The reality is that GUDID submission is much more complex than many originally thought. In most companies, data is spread across multiple departments and stored in dispersed locations with varying degrees of availability so the process of locating and compiling data can be especially challenging. Another challenge is that the format required for GUDID data submission is critical and not intuitive, and acknowledgements back from the FDA on whether a submission has been successful can be difficult to decipher. Furthermore, systems and processes used to submit data to the GUDID must be validated to comply with the part 11 of Title 21 of the FDA Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) and ensures compliance to Parts 820 and 830. UDI compliance is not a simple matter of gathering and submitting data. It requires a well thought out implementation strategy.
2. Waiting to start: Because Class III manufacturers are first required to comply with the FDA's UDI rule, some manufacturers of products in other classes and categories have chosen to take a "wait and see" approach. The problem is that UDI preparedness takes a lot longer than most realize. During UDI readiness engagements, the GHX Consulting 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 their UDI implementations. Additionally, major U.S. health systems are setting their own deadlines for receiving standardized product data from their suppliers, with some requiring manufacturers to supply product attribute data via a Global Data Synchronization Network (GDSN) certified data pool by the end of this year. With thousands of manufacturers required to comply with the FDA UDI rule through 2018, and increasing demands from healthcare provider organizations for standardized product data, it's in a manufacturer's best interest to begin their UDI preparedness efforts now.
3. Believing regulated data is the same as commercial data: Manufacturers that have enumerated their products with GS1 Global Trade Item Numbers (GTINs) and are sharing this data with customers and business partners through a GDSN-certified data pool may believe they can submit the same data in the same format to the FDA's GUDID. The reality is that GDSN and GUDID data submissions are worlds apart. There are vast differences in the required data attributes, how they are formatted and the processes for submission.
4. Taking a piecemeal approach: With industry attention on the FDA's long-awaited UDI rule, some manufacturers are choosing to focus their time, resources and efforts solely on how they can draw the necessary data out of their systems for a one-time submission to the FDA's GUDID. What many have failed to realize is that the UDI rule is just one of many emerging global regulatory and industry demands for standardized product data. The FDA envisions broad applications for UDI and is planning to use it to improve the visibility and identification of medical devices across the Center for Devices and Radiological Health (CDRH). This is just the beginning, UDI will soon become THE way the FDA and other global regulatory bodies identify devices. In our work with medical device manufacturers to prepare for GUDID data submission, GHX has found those that implement more holistic, sustainable master data management strategies designed to not only meet their current needs but also address future requirements get the most out of their UDI investments in terms of greater operational efficiency and lower costs.
5. Thinking that a one-time technology implementation is all that needs to be done: Some suppliers join a data pool or UDI solution expecting that the technology will solve the issue; but that is only part of the challenge. Through our years of experience GHX knows that data pool and UDI technology solutions are vital to success, but the strategies surrounding their implementation are equally, if not more important. Adopting a new technology is arguably the easiest part of UDI implementation. The real challenge lies in being able to effectively and efficiently manage the data attributes, inter-company connectivity and sustainable processes that generate the subject matter being submitted to a data pool or the FDA. The longest duration will be establishing the related processes, data identification management, and implementation strategy that will be used to optimize the data pool/UDI technology. Manufacturers that will be most successful in their UDI implementations are those that view GUDID submission as a long-term strategy. This includes change management processes for managing the status of submissions, maintaining an archive with a complete audit trail and maintaining the accuracy of their data end-to-end over time.
"To meet all of the requirements for medical device manufacturers to manage and publish their product attribute data to their commercial trading partners and global regulatory bodies, GHX has leveraged its existing resources, developed new services and solutions, and partnered with other healthcare technology leaders to bring a best-of-breed solution set to the industry," said Denise Odenkirk, senior director, Industry Solutions at GHX.
"At GHX we manage regulatory submissions within a validated system, have the ability to verify data prior to submission, are able to track, manage and interface submission status, and have the database structure to support submissions to multiple regulatory agencies," added Odenkirk. "What makes GHX unique is our proven technology solution backed by a consulting team with expertise helping organizations avoid the common pitfalls implementing UDI processes."
GHX UDI Solutions
The full suite of GHX best-of-breed solutions is comprised of GHX Health ConneXion(SM) GDSN-certified Data Pool, GHX UDI Solution and GHX Consulting Services. This solution set enables medical device manufacturers to meet multiple demands for standardized product data. It is designed to help manufacturers establish a complete master data management strategy whereby they can publish UDI data to the FDA GUDID, to other global regulators per the format they require, business partners (via GDSN) allowing them to address a broad range of global industry, ecommerce and regulatory requirements.
By publishing data to the GHX Health ConneXion data pool, manufacturers can synchronize product data with multiple parties using a single data source (or single pipe) and route changes to all data consumers in one step. This approach enables a manufacturer to garner incremental business benefit from its UDI investment in the form of greater operational efficiency and over time as adoption grows will help lower costs throughout its supply chain.
The GHX UDI Solution is the most comprehensive and robust on the market. It generates the required HL7 SPL-formatted submission data, transmits the message to the FDA's GUDID, and tracks the FDA responses back to each submission. The solution includes data staging technology providing unique data management and synchronization capabilities to help automatically keep GUDID submissions current as product attributes change, which is one of the key requirements of the FDA UDI rule. The solution is also validated to comply with 21 CFR Part 11 requirements and ensures compliance to Parts 820 and 830
(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. For more information, visit www.ghx.com and The Healthcare Hub
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