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.”
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.
Copyright Business Wire 2014