http://www.hcltech.com/healthcare/overview~ More on Ecosystem The key challenge in the Healthcare industry is to trace items from manufacturer to end consumer in the supply chain. The recent fatalities in the food industry led to HR 2751 – the act mandating traceability in the supply chain to ensure quality and safety for the end consumer. In the Healthcare industry, counterfeit drugs pose a major challenge, and may account for 10-30% of the market in developing countries. In recent times, more than 600 medical device recalls were issued for a wide range of items, including implantable devices. This necessitates an efficient healthcare supply chain traceability solution to combat counterfeit drugs and to ensure drug and medical device safety as well as patient privacy. This paper will talk about the challenges related to traceability in Healthcare, and solutions adhering to GS1 standards.

1. Traceability In Healthcare - The Medical Device Industry as a Case in Point
November 2011

2. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
TABLE OF CONTENTS
Abstract ............................................................................................. 3
Abbreviations .................................................................................... 4
Introduction........................................................................................ 5
Market Trends/Challenges ................................................................ 7
Solution ............................................................................................. 9
Best Practices ................................................................................. 10
Conclusion....................................................................................... 12
Reference ........................................................................................ 13
Author Info ....................................................................................... 14
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3. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Abstract
The key challenge in the Healthcare industry is to trace items from
manufacturer to end consumer in the supply chain. The recent fatalities in
the food industry led to HR 2751 – the act mandating traceability in the
supply chain to ensure quality and safety for the end consumer. In the
Healthcare industry, counterfeit drugs pose a major challenge, and may
account for 10-30% of the market in developing countries. In recent
times, more than 600 medical device recalls were issued for a wide range
of items, including implantable devices. This necessitates an efficient
healthcare supply chain traceability solution to combat counterfeit drugs
and to ensure drug and medical device safety as well as patient privacy.
This paper will talk about the challenges related to traceability in
Healthcare, and solutions adhering to GS1 standards.
© 2011, HCL Technologies. Reproduction prohibited. This document is protected under copyright by the author, all rights reserved.

4. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Abbreviations
Acronyms
Sl. No. (Page Full Form
No.)
1. FDA Food and Drug Administration
2 PTI Produce Traceability Initiative
3 GTIN Global Trade Item Number
4 SSCC Serial Shipment Container Code
5 ASN Advance Shipment Notification
6 BOL Bill of Lading
7 POD Proof of Delivery
8 PO Purchase Order
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5. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Introduction
The key challenge in the Healthcare industry is to trace items from
manufacturer to end consumer in the supply chain. The recent
fatalities in the food industry led to the passing of the Food Safety
Modernization Act, which mandated traceability in the supply chain to
ensure quality and safety for the end consumer. In the Healthcare
industry, counterfeit drugs pose major quality control challenges,
taking a significant toll on human lives.
• Counterfeit drugs may account for 10-30% of the market in
developing countries[1]
• Fake drugs are behind an estimated 700,000 deaths from malaria
and tuberculosis, according to a 2009 report from the International
Policy Network[2]
• 150 patients were admitted to hospitals in Singapore after taking
counterfeit Tadalfil and herbal preparations that claimed to cure
erectile dysfunction (ED). Seven were comatose, as the drugs
contained a powerful drug used to treat diabetes; four subsequently
died.[3]
• Counterfeit Heparin has been linked to the deaths of 81 people, and
resulted in hundreds of allergic reactions in the United States.[4]
Pharmaceuticals and medical device recalls continue to rise, impacting
consumer confidence and economy.
• In 2010, there were nearly 500 Class I FDA-regulated recalls − a
160% increase over 2009.[5]
90% of the recalls were related to quality systems, 40% were
attributed to a manufacturing defect and 27% due to design issues.
Product recalls have a significant economic impact on companies due
to the cost of replacement/unsold inventory, as well as a reduction in
revenue as a result of the loss of credibility.
• The pharmaceutical industry incurs losses to the tune of $30 billion
annually because of diversion, counterfeiting and recalls. An estimate
by the pharmaceuticals industry indicates that the approximate cost
of return is $2 billion per annum[6]
• In January 2011, a pharmaceuticals, medical devices and consumer
packaged goods manufacturer announced a 12% year-over-year
decline in profit for the 4th quarter. This included after-tax charges of
$922 million in litigation settlements and other costs related to a hip
replacement device recall.[7]
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6. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
All of the challenges listed above have led to increasing demands for:
• Visibility across the supply chain
• Greater assurance of quality and safety by consumer and law
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7. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Market Trends/Challenges
Organizations should have the capability of tracing forward and
backward through the value chain, the items they manufacture,
distribute, and sell, as well as operating an effective recall program.
Their information systems should capture and maintain information
about suppliers’ quality certificates and lot numbers used by both
suppliers and third-party suppliers, spanning from picking and
processing to the production of the final consumer product.
Companies that do not have these processes and systems in place are
susceptible to serious legal and economic damages in case of a health
issue with any of their products.
Figure-1
Figure 1 illustrates the manufacturer-to-hospital/patient process, as
well as some of the challenges in maintaining traceability information
across the multiple enterprises involved in the chain. Suppliers
provide manufacturers with the components used for manufacturing
medical devices. At this point, it is critical that all item attributes and
certifications be accurate, as that information must move with the
package from this point forward. Certifications should be assigned to
each package, and a lot number associated with it. The package is
also assigned a unique shipment code. Quite often, this information is
not matched properly with an item, package and lot number. The
problem becomes even more complex when products are made using
raw materials from different suppliers. When new items are created,
the “manufacturer” typically assigns a new lot number for the device
that’s manufactured in each plant. However, the components’
historical information and quality certificates are often not maintained
appropriately. The product then typically moves to a set of
wholesalers, distributors, hospitals and/or pharmacies. Any one of the
players in this chain of entities may rename or reassign and even re-
brand the product. This necessitates that they, in turn, have to keep
track of the original lot number and quality attributes. The product
then moves to a healthcare service provider who delivers the product
to the end consumer. The final product, e.g. medical device, is either
sold as a unit that is comprised of multiple components, or it is sold
“as is” to a consumer who use it in combination with other items.
Manufacturers are under constant pressure to provide accurate
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8. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
product information as quickly as possible in the event of a recall. The
ability to successfully track device components received from global
suppliers, along with the required quality information and certificates,
will ensure competitiveness among all entities along the supply chain.
Medical device manufacturers need to adopt an effective, modern
traceability management system that integrates the supplier quality
system with their internal data in a seamless manner for effective
tracing. This necessitates that manufacturers develop faster, more
transparent and more comprehensive ways to communicate with their
suppliers and customers.
RFID technology aids in collecting the data across supply chain in a
quick and easy manner. It can help collect item data automatically
and in real time.
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9. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Solution
[9]
Radio-Frequency Identification (RFID) in Tracking
RFID technology stores and transfers data using radio waves from an
electronic tag, called an RFID tag. RFID readers (emitters) send out
radio waves to detect tags and read the data stored inside those tags.
RFID is a rapidly growing technology. It may soon be used more
widely to track medical device packages, devices, and drugs
throughout the supply chain of distribution from manufacturers to
hospitals.
When considering the use of RFID devices for implantable and other
medical devices, it is recommended that an information system user
should address four primary components of information security:
Confidentiality, Integrity, Availability, and Accountability (CIAA).[10]
• Confidentiality: data and information is disclosed only to
authorized persons, entities and processes at authorized times and in
the authorized manner.
• Integrity: data and information is accurate and complete and the
preservation of accuracy and completeness is maintained throughout
the process
• Availability: data, information, and information systems are
accessible and usable on a timely basis in the required manner
• Accountability is the application of identification and
authentication to assure that the prescribed access process is being
done by an authorized user
Using RFID technology in the Healthcare field at all levels will improve
patient safety and deter counterfeiting efforts. Although there is some
concern (as yet, unfounded) about radioactivity in using the tags,
RFID technology will:
• Ensure that patients receive the correct medications and medical
devices
• Prevent the distribution of counterfeit drugs and medical devices
• Facilitate device recalls in case of an event
Furthermore, RFID will support hospitals and healthcare facilities to:
• Manage assets such as hospital equipment
• Track patients
• Provide data for electronic medical records systems
As a best practice, each stakeholder in the supply chain needs to
follow a standard naming convention for their products and
locations. Standard organizations such as GS1 play a major role in
creating traceability standards and best practices that can be
followed across the industry.
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10. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Best Practices
GS1 System of Standards for Global Traceability in
Healthcare[8]
GS1 standards provide its healthcare members the process standard
for traceability, allocating the corresponding GS1 numbering for
devices and location, and other required standard parameters for
effective communication across the supply chain.
To implement traceability, regardless of technologies used by various
stakeholders across the healthcare supply chain, GS1 provides a
business process standard which is globally accepted, that uniquely
identifies an item and all of the associated events and required
records to provide complete traceability.
Organizations around the globe have their own limitations and goals
for achieving traceability. There are various factors such as
geographical location, their role in the supply chain, and the business
they are involved in that could influence traceability. Little awareness
exists currently to enable parties to respond immediately in case of a
faulty situation. Given the current scenario, GS1 plays a major role in
providing global traceability standards and best practices. The
primary challenge is in implementing a generic healthcare traceability
system that is acceptable to all parties in the supply chain, regardless
of their level or size.
GS1 organizes and categorizes products by assigning a unique Global
Trade Identification Number (GTIN). Similarly, to standardize the
shipment process label, GS1 has created Serial Shipment Container
Code (SSCC), a generic standard case label template.
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11. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Figure-2
Figure 2 depicts a generalized traceability system. To perform
traceability across a supply chain, it is mandatory for the traceability
partner to share the set data. This will help in the identification
processes and link the product transformation at various levels.
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12. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Conclusion
The healthcare industry is a complex ecosystem, where collecting and
sharing data between different entities is a significant obstacle in
achieving full traceability in the supply chain. GS1 plays key role in
developing and providing standards that are applicable across the
industry. Technology is a major enabler for data exchange to
regulatory agencies and trade partners, as and when required.
Developing an efficient healthcare traceability management system
will provide a safer environment for supplies, manufacturers,
providers and consumers. However, it is necessary to develop a
system that also maintains the privacy of data and ensures a higher
degree of safety for patients’ personal information.
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13. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Reference
1.US Department of Health; The World Health Organization,
http://www.allcountries.org/health/counterfeit_medicines.html
2.Internet drug scams can make you sick, by Val Brickates Kennedy
March 9, 2011
http://www.marketwatch.com/story/internet-drug-scams-can-make-
you-sick-2011-03-09
3. Counterfeit Internet Drugs Pose Significant Risks and Discourage
Vital Health Checks - January 21, 2010
http://www.sciencedaily.com/releases/2010/01/100120085348.htm
4.Counterfeit Heparin Blamed for Worldwide Deaths - Janaury 2008 to
May 2008 http://www.safemedicines.org/counterfeit-heparin-blamed-
for-worldwide-deaths.html
5. A Delicate Balance: FDA and the Reform of the Medical Device
Approval Process, Ralph F Hall – April 13, 2011
http://freepdfhosting.com/f60be7765c.pdf
6. Resist the Rain Check: ePedigree Solutions Have Immediate Value,
Feb 17, 2010, by: John Danese, Arvindh Balakrishnan ,
http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?
id=656698
7. The Economic Impact of Recalls by Gale Prince on February 12,
2011 , http://www.sagefoodsafety.com/2011/02/the-economic-
impact-of-recalls
8. Global Traceability Standard for Healthcare
http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Stan
dard_Healthcare.pdf
9. FDA-Radio Frequency Identification
http://www.fda.gov/Radiation-
EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/u
cm116647.htm
10.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
/GuidanceDocuments/ucm072141.htm
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14. Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011
Author Info
Pala Bushanam Janardhan (Jana) Practice
Manager, ERS-Practice-Practice-CAM
Jana has over 23 years of experience and
currently leads the manufacturing practice of
the Engineering and R&D services business
line at HCL Technologies, Ltd. He has been
associated with HCL since April 2006, providing
domain consultancy for regulated industries.
Prior to joining HCL, he served the regulated
industries (pharmaceuticals, phytochemicals,
nutraceuticals and speciality chemicals) in
various capacities for over 18 years, including
process technology development, technology
transfers regulatory compliance, supply chain
management, outsourcing and business
development..
Saravanan Jeyaraman
Project Manager, ERS-Practice-Practice-CAM
Saravanan has over 12 years experience in
manufacturing execution systems (MES),
engineering data analytics (EDA), enterprise
manufacturing intelligence (EMI), equipment
automation and Microsoft Technologies. He
brings strong experience in implementation,
integration and maintenance of MES
applications, developing SPC applications,
internal traceability in the shop floor
manufacturing process and tool automation. He
is a PMP® and Microsoft Certified Technical
Specialist responsible for architecting .NET
based track and trace solutions adhering to
GS1 standards.
.
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