HCLT Whitepaper: Traceability in Healthcare~ The Medical Device Industry as a Case in Point

Traceability In Healthcare - The Medical Device Industry as a Case in Point

N o v e m b e r 2 0 1 1

Traceability in Healthcare – The Medical Device Industry as a Case in Point | November 2011

© 2011, HCL Technologies. Reproduction prohibited. This document is protected under copyright by the author, all rights reserved.

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



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.



Abbreviations

Sl. No.

Acronyms

(Page

No.)

Full Form

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



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]



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



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



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.



Solution

Radio-Frequency Identification (RFID) in Tracking [9]

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.

http://en.wikipedia.org/wiki/Technology

http://en.wikipedia.org/wiki/Radio_waves



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.



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.



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.



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_Standard_Healthcare.pdf

9. FDA-Radio Frequency Identification http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm 10.http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htm

http://www.allcountries.org/health/counterfeit_medicines.html

http://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09

http://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09

http://www.sciencedaily.com/releases/2010/01/100120085348.htm

http://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.html

http://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.html

http://freepdfhosting.com/f60be7765c.pdf

http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=26366

http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285

http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698

http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698

http://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recalls

http://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recalls

http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdf

http://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdf

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htm



http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htm



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.

.

Hello, I’m from HCL’s Engineering and R&D Services. We enable technology led organizations to go to market with innovative products & solutions. We partner with our customers in building world class products & creating the associated solution delivery ecosystem to help build market leadership. Right now, 14500+ of us are developing engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor, Servers & Storage for our customers.

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About HCL

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HCLT Whitepaper: Traceability in Healthcare~ The Medical Device Industry as a Case in Point

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