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:
"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.