This blog is excerpted from its original post at Today's Medical Developments.
The U.S. medical device industry continues to innovate, producing sophisticated, life-saving products for the nation’s most at-risk patients, developing cutting-edge treatments to improve the quality of life for those with chronic conditions, and offering tried-and-true approaches for common, everyday ailments. Information about medical devices, particularly those that are needed to save lives, should be clear, accurate and easy to find. This is especially critical to foster recalls or to identify contaminated products; yet sharing information about medical devices throughout the supply chain, and directly with the patient, is needlessly complex.
Lack of consistent device identifiers in healthcare has been
a long-standing problem, yet is one that is solved with the adoption of
consistent global identification standards across the industry and the
implementation of systems to provide accurate data throughout the healthcare
system.
In late September 2013, the U.S. Food and Drug
Administration issued its highly anticipated final rule establishing a unique
device identification (UDI) system that provides a platform for communicating
accurate, reliable information about medical devices to all recipients who need
information about the device. The new regulation will affect how manufacturers
label their products and publish device identifiers to a centralized database
(see www.gs1us.org/hcudi for more information). It comes after many years of industry
collaboration and input, and marks a turning point in healthcare. Its impact
will be felt across all of healthcare, from the different points in the healthcare
supply chain to clinicians, payors and members of the public – all of whom will
be able to rely on consistent, publicly accessible standardized information
regarding medical devices, thus increasing patient safety and improving supply
chain efficiency and security.
This
UDI system is comprised of the UDI code, application of the UDI to device
labeling and packaging, and a related, centralized database that will serve as
a one-stop shop of sorts for information related to all the medical devices
being developed and/or on the market. The system will enable many benefits that
will ultimately improve patient safety, including:
- Faster and easier product recalls
- Improved traceability
- More effective counterfeit detection and abatement
- Increased accuracy in electronic transactions and information
sharing
- Reduced supply chain costs
- Increased access to product information for members of the
public and the medical community
Perhaps
more importantly, the UDI rule has implications beyond the U.S. healthcare
supply chain, as it supports global alignment efforts to use data standards that
provide global product visibility
and can identify recalled products that need to be removed from a supply chain
that crosses international borders. Any manufacturer located anywhere in the
world that sells products in the U.S. is required to comply with the new rule.
The components
of the FDA UDI system are:
- The UDI – a unique numeric or alphanumeric
code that includes a device identifier (DI), which is specific to a device
model, and a production identifier (PI), which includes the current production
information for that device, such as the lot or batch number, the serial number
and/or the expiration date (including year, month and day).
- The label – the UDI must appear on the label in
human readable format as well as in a manner that can be read by automatic identification and data
capture (AIDC) technology, such as a linear or 2D DataMatrix barcode, for
example. A UDI must be applied to the base package and higher levels of
packaging.
- The database – Manufacturers must submit the UDI to
the FDA Global UDI Database (GUDID), and include a standard set of basic
identifying attributes for each UDI. The GUDID
will store information about all medical devices, and providers, patients, and
members of the public will be able to access the information when needed, leading
to better decisions concerning patient care. Using consistent, global standards
will also enable providers to harness data for longer-term goals, such as
comparative effectiveness, outcomes research and population health management.
The
proposed effective dates for UDI requirements are based on risk class after
publication of final rule, which occurred on September 24, 2013:
- Class III – 1 year (by September 2014)
- Class II implants and
life-supporting/life-sustaining devices – 2 years (by September 2015)
- The rest of Class II – 3 years (by September
2016)
- Class I – 5 years (by September 2018)
GS1, a leading standards organization, was named by the FDA
as an accredited issuing agency for UDIs. Healthcare’s 11ptst
manufacturers, distributors, leading IDNs, and GPOs are already using GS1
Standards to improve patient safety, supply chain efficiency, and prepare
for regulatory requirements such as FDA UDI. GS1 Standards, specifically
the Global Trade Item Number® (GTIN®), are recognized across the healthcare
industry as a unique identifier of medical/surgical products for every level of
packaging and supports UDI regulation.
While
the FDA UDI regulation is now a reality, it is important to remember that
organizations representing all aspects of the supply chain have been working
together for many years to support UDI capabilities, not only in anticipation
of the law, but because it is the right thing to do for patient safety. In
addition, clean, consistent and global data has immeasurable value for any
organization that decides to implement standards. A UDI system accessed and
leveraged by all constituents in the U.S. supply chain will improve the speed
and accuracy for product recalls as well as adverse event reporting, among
other benefits. The time is now – the industry is able to implement UDI to the
benefit of patients, healthcare providers and manufacturers here in the U.S.
and around the world.
MJ Wylie is the Sr. Director of Healthcare for GS1 US, leading US healthcare trading partners to actively engage, adopt, and use the GS1 standards to improve their business and supply chain operations, with a clear passion to support the FDA’s Unique Device Identification (UDI) regulation to enhance patient safety. Ms. Wylie is a certified Global Regulatory Affairs Compliance Professional (GRACP).
Additional
Resources
UDI Implementation for Manufacturers
To
support UDI implementation using GS1 Standards, I recommend that manufacturers
take the following approach:
1. Assess how your company currently identifies
and marks its products in terms of the UDI requirements (e.g., identification
numbers, labeling, barcodes). Does your company know where the FDA-requested
data attributes reside? Do you know how your products are classified?
This
step could take several weeks, even months, and perhaps is the most time and research-intensive
of all the steps, so get started right away.
2. Determine the responsible party within your
organization for assignment of:
·
UDI / GTINs (usually those responsible
for packaging)
·
GUDID: data aggregation, submission,
and maintaining the data to the FDA’s database
·
Work with your regulatory affairs to
manage updates to both the UDI and GUDID
3. Join GS1 US to obtain a GS1 Company Prefix,
which is the foundation for creating GS1 identification numbers (i.e. GTINs)
for UDI requirements. You may also need to identify your locations with Global
Location Numbers (GLNs) to meet customer requirements.
4. Assign GTINs and design your approach to
production information for your products.
5. For smaller to mid-sized manufacturers, select
a solution provider partner and/or use the online GS1 US Data Driver® tool to generate
your GTINs.
6.
Prepare notification of adoption of standards for product and location
identification. There are a host of useful tools to help manufacturers get
started on UDI, including visuals, a GTIN Quick Start Guide and a UDI
“Frequently Asked Questions” at www.gs1us.org/hcudi
7.
Begin marking products with barcodes containing GTIN plus, if applicable, the secondary
information, such as expiry date, serial number and such.
8.
Load GTIN and GTIN data attributes, if applicable, into the Global Data
Synchronization Network (GDSN) to submit to the US FDA GUDID. The GDSN is currently used by the
industry to share standardized healthcare product information across supply
chain partners, and may also be used to populate the FDA GUDID.
Create
and use a cross-reference file between the old identification numbers and GTINs.
9.
Communicate with your customers about any new packaging, labeling and usage in
procurement and contracting efforts.
About GS1 Standards
The
GS1 System of global supply chain data standards has revolutionized efficiency,
accuracy and cost-effectiveness in a broad range of industries. Recognizing the
impact that industry-wide adoption of a common language can have, GS1
Healthcare US has set out to apply these same standards to helping the
healthcare industry improve efficiency and quality for lower costs, more
streamlined care delivery and better patient safety.
Global Location Number (GLN): Location
Identification
This
number is an industry-wide, standardized location identifier that replaces
custom account and location numbers.
Global Trade Item Number (GTIN):
Product Identification
Manufacturers
are moving toward adopting a standardized product identifier to
ensure accuracy of product information at every level of packaging, throughout
the supply chain.
Global Data Synchronization Network
(GDSN)
The
GDSN is an authoritative source of standardized healthcare product information.
With this network, all supply chain partners will be able to access identical,
up-to-date, reliable product data efficiently. The GDSN plays an integral role
in the adoption of GTINs. Healthcare organizations can use the network to
create and store product information for faster standardization and better
communication across the industry.
Source: November 2013 Healthcare
Implementation Workshop: AHRMM, HSCA, SMI, GS1 Healthcare US