2. 2
Contents
Abstract 01
Evolution – IMDRF and
U.S. FDA’s Role
01
UDI Requirements,
System Establishment
02
Global Impact of UDI
Implementation
03
Target Dates in USA for UDI
Implementation
04
Challenges at the
Organizational Level
05
Benefits to All the
Stakeholders
05
One-Stop Full Solution
by Cyient
06
Conclusion 07
Authors 07
References 07
About Cyient 08
3. 01
Abstract
The healthcare industry has witnessed a
complete transformation in the last couple of
years in all areas starting from the providers,
payers and medical device manufacturers, to
outsourced service providers. The change
has resulted in improved, safe, and efficient
devices with better patient outcomes.
With the safety and integrity of medical
devices becoming a strategic priority, the
ability to track and trace these devices at a
global level has gained higher significance.
Although there are few systems in place
already, the Unique Device Identification
(UDI) system aims to adopt a modern and
harmonized approach of tracking with the best
use of technology. The U.S. Food and Drug
Administration (FDA) led the global initiative to
put this together.
The stipulated legislation for UDI is expected
to herald a new era in improved patient safety
and healthcare business processes, enabling
easy tracking of medical devices. This will
result in improved post-market surveillance
through rapid and precise identification of a
device and key attributes that affect its safe
and effective use. UDI can fundamentally
change and improve the way we order,
purchase, distribute, and use medical devices.
Its implementation, however, calls for a
structured approach between all healthcare
stakeholders. This will enable healthcare
providers to leverage the information
for electronic patient records, adverse
event reporting, product recalls, inventory
management, and other applications related
to positive identification of medical devices.
There are benefits for manufacturers in the
form of collaboration with a reliable vendor.
Product engineering service providers with
expertise in automation and technologies
background in medical devices engineering can
help manufacturers in faster implementation.
This whitepaper outlines the evolution, current
scenario, and future of UDI implementation.
It also describes challenges to global impact
and offers suggestions on out-of-the- box and
cost-effective Cyient approach.
Evolution – IMDRF and
U.S. FDA’s Role
Before UDI there was no single global
regulation for uniquely identifying medical
devices in the supply chain which made
recalling devices a less efficient and complex
process. In 1999, the landmark Institute of
Medicine (IOM) report, “To Err is Human:
Building a Safer Health System” stated that
between 44,000 and 98,000 patients die in US
hospitals each year due to preventable medical
errors1
.
In 2004, the FDA released the Pharmaceutical
Barcode Rule addressing medication error, a
type of preventable medical error. The rule
requires drug and biological products to have
linear bar codes on their labels containing the
drug’s National Drug Code (NDC). The rule was
intended to encourage adoption and use of
information systems to support the reduction
of medication error in patient care settings2
.
At that time, the FDA also entertained the
thought of a similar rule for medical devices,
but the lack of a unique identifier for devices
precluded further action. FDA Amendments
Act of 2007 directed the FDA to create a
unique device identification system for
medical devices. The UDI proposed rule
underwent a period of public comment until
November 7, 2012. On November 19, the FDA
released an amendment to the UDI proposed
rule in response to provisions within the FDA
Safety and Innovation Act.
The Unique
Device
Identification
(UDI) system aims
to adopt a modern
and harmonized
approach of
tracking the
medical devices
with the best use
of technology.
4. 02
In the meantime, IMDRF (International Medical
Device Regulatory Forum), a voluntary group
of medical device regulators from around
the world, came together to accelerate
international medical device regulatory
harmonization and convergence. It sponsored
a new work item focused on the adoption of a
common structured set of device identifiers
and key descriptive elements to support
electronic regulatory submission of device
information.
U.S. FDA led the global initiative to put
together the UDI system in the end. IMDRF’s
current members include Australia, Brazil,
Canada, Europe, Japan, U.S.A., China, and
Russia.
UDI Requirements, System
Establishment
The fundamental concepts in the final
guidance for a globally harmonized UDI system
include few parameters:
• Must have a specified set of standards
• Should be globally acceptable and comply
with the UDI requirements set by its
regulatory authority
• No national or local identification numbers
should be accepted as a substitute for UDI
• Regulatory authorities should not specify the
procedure for modifying these UDI standards
• The UDI core elements should not be
modified
• The UDI should use the Health Level Seven
International (HL7) structured product label
(SPL), and web-based interface for data
submission
• Every medical device needs to be identified by
a UDI, unless it is exempted
The US FDA
led the global
initiative in
collaboration
with the IMDRF.
The latter worked
on the adoption
of a common
structured
set of device
identifiers and
key descriptive
elements to
support electronic
regulatory
submission
of device
information.
Fig. 2 | IMDRF UDI stakeholdersFig. 1 | Timeline showing the progress on UDI guideline
2005: US FDA UDI project
conceptualization begins
2008: Draft guidance on UDI system
concept initiated by the GHTF
2011: IMDRF UDI workgroup takes
over the drafting of the guidance
2012: US FDA UDI proposed
regulations published
2013: US FDA UDI final ruling
U.S.A
Europe
Australia
Global Database Providers (GS1, HIBCC)
Medical Device Industry Representatives
Regional Harmonization Models
Russia
Japan
China
Canada
Brazil
5. 03
The UDI directive
and system aim to
help users safely
select the correct
medical device
for a patient.
It would also
help regulatory
agencies to
quickly identify
product problems
in adverse event
reports and better
target recalls.
Global Impact of UDI
Implementation
The standardization of a common UDI
mandate increases visibility and improves the
quality of information in adverse event reports
of medical devices, improves traceability and
security within the supply chain, and reduces
potential medical errors through consistent,
unambiguous, harmonized data. Additionally,
UDI also facilitates the storage, exchange,
and integration of data and systems between
suppliers and providers.
Establishing a UDI system is a three-step process followed by adoption and implementation:
The true value of a UDI system lies in its
broad adoption and subsequent use by
manufacturers, distributors, providers,
patients, and other stakeholders with
important roles throughout the medical device
life cycle. UDI is expected to achieve this by
providing electronic access to critical patient
safety information relating to each medical
device stored in a public database. The directive
and proposed system aim to not only help
users safely select the correct medical device
for a patient but also the regulatory agencies
to quickly identify product problems in adverse
event reports and better target recalls.
Fig. 3 | Approach to UDI system establishment
Step 1:
UDI
Have a standardized
system to develop
the UDIs
DI (Static data)
PI (Variable data)
Place the UDI in human
readable format on
either a device or its
label, or both
AIDC (Machine-readable)
HRI (Clear text)
Create and maintain the
UDI database
Database with static
data access via UDI
Step 2:
UDI Carrier
Step 3:
UDID
UDI : Unique Device Indentifier
DI : Device Identifier
PI : Product Identifier
AIDC : Automatic Identification and Data Capture
HRI : Human Readable Interpretation
6. 04
While the rule is a great reassurance for both
patients and anyone who needs to use a
medical device to improve health outcomes,
the manufacturing and labeling industry is
finding it a daunting task to prepare for and
change their current processes in time.
FDA in September 2013 announced the final
ruling on UDI. It mandates manufacturers to
enumerate devices with a unique numeric or
alphanumeric code. This includes a device
identifier specific to the device model and
a production identifier, which includes the
current production information for that
specific device—such as the lot or batch
number, the serial number, and/or expiration
date. The FDA has stated that it will allow
manufacturers to use one of two ISO 15459
standard-compliant devices: the GS1 Global
Trade Item Number (GTIN) or Health Industry
Business Communications Council (HIBCC)
Labeler Identification Code (LIC).
Target Dates in USA for UDI
Implementation
The FDA used a risk-based compliance
timeline. Manufacturers of Class III devices
were required to comply within one year of
the final rule (2014); manufacturers of Class
I or II devices categorized as “implantable,
life-saving, and life sustaining” were due
to be compliant within two years (2015);
manufacturers of Class II devices to be
compliant within three years (2016); and
manufacturers of non-exempt Class I devices
are required to be compliant by 2018. For
those devices requiring direct part marking,
manufacturers can add one year to the class
effective date. For example, manufacturers of
implantable Class III devices would be required
to comply within two years of the final rule
(2015).
The FDA has
specified a risk-
based compliance
timeline for
medical device
manufacturers to
comply with the
final rule for UDI.
Fig. 5 | FDA compliance timeline
Fig. 4 | Global approach for UDI databases
Global UDI
Database
Regional UDI
Database
US FDA UDI
Database
EU UDI
Database
2013 2014 2015 2016 2017 2018 2019 2020
2013-09-24
Final FDA Rule
* Implantables and life-sustaining and life supporting | **Multi-use devices that are intended to be reprocessed before each use
UDI
Database
Class III
Class III Class II Class I
Class I-II* Class II
remainder
Class I
remainder
Label &
Packaging
Direct
Marketing**
7. 05
ChallengesattheOrganizationalLevel
While federal regulation deadline is indeed the
biggest driver for manufacturers, all device
manufacturers face the challenge of being
equipped in time to comply with regulatory
guidelines. Besides this, other major challenges
faced by the medical device manufacturers are
described as below:
Benefits to All the Stakeholders
Although there are many challenges for
UDI implementation system, the system is
poised to bring various benefits to all the
stakeholders (manufacturers, healthcare
providers and patients).
• For the medical device manufacturer
- Enhanced device traceability
- Improved post-market surveillance with
the ability to rapidly and precisely identify
a device and key attributes that affect its
safe and effective use
- Better security of devices through more
effective detection, which in-turn, could
lead to the removal of counterfeit devices
- Empowered data systems for relevant
device information
- Enhanced visibility and effective tracking,
leading to better preparedness for medical
emergencies in disasters and shortages/
substitutions
- Using UDI data for additional purposes
beyond the FDA’s Global Unique Device
Identification Database (GUDID), such as
product registration tracking, effective
recall track and traceability, and
mitigating risks
• For the healthcare provider and patient
- Enhanced access to important information
about device characteristics for
comparative effectiveness (e.g. in product
registries)
- Improved visibility of information leading to
reduction of medical errors that result from
misidentification of a device or confusion
concerning its appropriate use
- Ensuring use of the intended device toward
the treatment of a patient and phasing
out similar devices that may not fully
meet the requirements of the healthcare
professional who ordered its usage
- Consistent coding for product
identification (with manufacturers,
distributors, clinics) leading to wider use
of automated inventory management
systems, thereby reducing inventory cost
and the expense of consignment stocks
In spite of the
challenges
to the UDI
implementation
system, the
system is poised
to bring various
benefits to all
the stakeholders
(manufacturers,
healthcare
providers, and
patient).
Manufacturer
#458G
Manufacturer
12345
Distributor
#943G
Distributor
12345
Healthcare
Provider
#672G
Healthcare
Provider
12345
Currect
State
Future
State
Different for each country market
Same for all
Fig. 6 | Major challenges faced by the medical device
manufacturers
Fig. 7 | Consistent coding for product identification
For the entire organization
Looking at entier organizationDocument
Control
Product
Development
Manufacturing
Regulatory
ERP System
Updates
Other Affected
Business Units
• SOP revisions
• Specifications change
• Version control and data integrity
• Content creation (labels, inserts,
IFUs, product data, DHF etc.)
• Labels
• Direct marketing
• Compliance issued guidelines
• Data compliation
• Submission to GUDID
• Mapping workflow processes
• Review and approval managemnt
• Finance (budgets)
• Supplies, marketing and sales
• Services
8. 06
One-Stop Full Solution by Cyient
As per the guidelines issued by FDA, every
medical device manufacturer in U.S. is
following a time bound deadline to label
their products for UDI compliance. To deliver
impactful results, different business functions
and organization layers require a structured
approach.
Manufacturers can benefit by collaborating
with a reliable outsourcing engineering service
partners to accelerate the implementation.
We, at Cyient, with our unique expertise in
medical devices can provide proven framework
and processes to implement the required
changes in the quality management system
and the engineering documentation. We have
built an automated method of converting
legacy documentation to the latest industry
standard. Our tailored QMS approach is based
on our core expertise on ISO13485 and FDA 21
CFR Part 820 from design to manufacturing of
medical devices. On the vision of “Designing
Tomorrow Together”, we have developed
the approach “One stop: full solution” which
can help manufacturers to get SMEs and
consultants from different cross functions,
required for UDI implementation.
Our holistic approach helps manufacturers
in data segregation, engineering change
management, data management, and data
collection for post-market surveillance.
Some of the key areas in which we can play
a role in implementation of UDI system at
organization level are:
• Automation to achieve higher accuracy
• Automated legacy conversion
• Faster implementation
• Enable the medical device manufacturer to
do more with less cost-effective solutions
• Potentially reduce implementation cost by
up to 50%
• Better utilization of talent; manufacturer can
focus on product innovation while Cyient can
provide support on UDI compliant products
• Best practices to capture lessons learnt
• Comprehensive long-term benefits
Our proven
framework and
processes to
implement the
required changes
in the quality
management
system and
engineering
documentation
can help you
speed up the
process of
implementing
UDI.
Fig. 8 | Approach for UDI implementation “One stop: full solution”
Ideate
Design/Engineer/
Build/Test
Analyze/Maintain
Data management Dossier management
Labeling management Go live
Envision Change management Post market review/analysis
Prepare roadmap
Manufacturing
process creation
CAPA (if required)
Verification/Validation
Develop product
understanding
Carry out assessment
9. 07
Conclusion
The healthcare industry as a whole has never
adopted technology at a faster rate than the
last decade. The penetration of smart phones
and demand for higher utilization of high value
assets has created new segments like IoT
medical devices, health related mobile apps,
home healthcare devices, as well as remote
monitoring for moving surgery vehicles.
UDI will accelerate the innovation by clearly
defining an early regulatory path to the
innovators and avoid past challenges in
choosing right classification. Use of latest
technology and openness to build a data
repository accessible to larger population will
not only benefit manufactures but also enable
public to stay more educated and informed.
UDI will create a universal language for better
understanding of the medical devices as well as
harmonize the global standards. It has already
vastly improved understanding of devices
through a variety of focused and effective PMS
activities, including longitudinal studies. This will
allow for better understanding of the long-term
safety and effectiveness of specific devices,
their overall risk profile, and the use of devices
in specific patient populations. And when
problems do arise, quick identification and
communication with the affected patients will
be possible in ways that did not exist earlier.
However, all of this requires change. It requires
device manufacturers to appropriately apply
and use UDI on their device(s) as well as
everyone else involved in any aspect of device
distribution and use to adopt and implement
systems for managing devices at their level.
At Cyient, we are looking forward to collaborate
with medical device manufactures in their
journey to quickly implement the changes and
provide higher value to their customers.
Authors
Kuldeep Tyagi is Deputy General Manager
in Medical unit. He joined Cyient in 2012 and
is based out of New Delhi, India. He is well-
experienced in product development, system
value engineering, and innovative technology
development projects in the Medical industry.
He has expertise in various Medical segments,
including:
• Medical devices: Orthopedic, Cardiovascular,
Spine, and Trauma
• Medical equipment: Diagnostic Imaging
(MRI, X-Ray, Ultrasound and CT), Ultra Low
Temperature Freezers, In-vitro-diagnostics,
Patient Monitoring, Sterilization, and
Endoscope Re-processors
Naveen Dhawan is quality and regulatory affairs
specialist in Medical business unit at Cyient.
He is a certified Value Engineer and ISO 13485
internal auditor. Naveen has experience in the
areas of product design and development, and
system value engineering. He has delivered
various projects in the therapeutic areas
including spine, orthopedics, and extremities.
Naveen holds a Bachelor’s degree in Mechanical
Engineering.
References
1
IOM (Institute of Medicine). 2000. To Err is
Human: Building a Safer Health System.
Washington, DC: National Academy Press
2
Barcode Label Requirements for Human Drug
Products and Biological Products; Final Rule.
Federal Register;69(38):9120-71
U.S. Food and Drug Administration. About
FDA. http://www.fda.gov/aboutfda/whatwedo/
Federal Register. Unique Device Identification
System Proposed Rule.
https://www.federalregister.gov/arti-
cles/2012/11/19/2012-28015/
unique-device-identification-system
UDI will quicken
the process by
defining an early
regulatory path
to the innovators
and avoid past
challenges in
choosing the right
classification.
