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

8/10/2019 HCLT Whitepaper: Traceability in Healthcare~ The Medical Device Industry as a Case in Point

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

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


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Traceability in HealthcareThe 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


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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 2751the 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.


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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


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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 mayaccount 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 hospitalsin 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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All of the challenges listed above have led to increasing demands for:

Visibility across thesupply chain

Greater assurance of quality and safety by consumer and law


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Market Trends/Challenges

Organizations should have the capability of tracing forward andbackward 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 bothsuppliers and third-party suppliers, spanning from picking andprocessing to the production of the final consumer product.Companies that do not have these processes and systems in place aresusceptible to serious legal and economic damages in case of a healthissue with any of their products.

Figure-1

Figure 1 illustrates the manufacturer-to-hospital/patient process, aswell as some of the challenges in maintaining traceability informationacross the multiple enterprises involved in the chain. Suppliersprovide manufacturers with the components used for manufacturingmedical devices. At this point, it is critical that all item attributes andcertifications be accurate, as that information must move with thepackage from this point forward. Certifications should be assigned toeach package, and a lot number associated with it. The package isalso assigned a unique shipment code. Quite often, this information isnot matched properly with an item, package and lot number. Theproblem becomes even more complex when products are made usingraw materials from different suppliers. When new items are created,the manufacturer typically assigns a new lot number for the devicethats manufactured in each plant. However, the componentshistorical information and quality certificates are often not maintained

appropriately. The product then typically moves to a set ofwholesalers, distributors, hospitals and/or pharmacies. Any one of theplayers in this chain of entities may rename or reassign and even re-brand the product. This necessitates that they, in turn, have to keeptrack of the original lot number and quality attributes. The productthen moves to a healthcare service provider who delivers the productto the end consumer. The final product, e.g. medical device, is eithersold as a unit that is comprised of multiple components, or it is soldas is to a consumer who use it in combination with other items.

Manufacturers are under constant pressure to provide accurate


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product information as quickly as possible in the event of a recall. Theability to successfully track device components received from globalsuppliers, 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, moderntraceability management system that integrates the supplier qualitysystem with their internal data in a seamless manner for effectivetracing. This necessitates that manufacturers develop faster, moretransparent and more comprehensive ways to communicate with theirsuppliers and customers.

RFID technology aids in collecting the data across supply chain in aquick and easy manner. It can help collect item data automaticallyand in real time.


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Solution

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

RFIDtechnology stores and transfers data usingradio waves from anelectronic 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 morewidely to track medical device packages, devices, and drugsthroughout the supply chain of distribution from manufacturers tohospitals.

When considering the use of RFID devices for implantable and othermedical devices, it is recommended that an information system usershould address four primary components of information security:Confidentiality, Integrity, Availability, and Accountability (CIAA).[10]

Confidentiality:data and information is disclosed only toauthorized persons, entities and processes at authorized times and inthe authorized manner.

Integrity:data and information is accurate and complete and thepreservation of accuracy and completeness is maintained throughoutthe process

Availability: data, information, and information systems areaccessible and usable on a timely basis in the required manner

Accountabilityis the application of identification andauthentication to assure that the prescribed access process is beingdone by an authorized user

Using RFID technology in the Healthcare field at all levels will improvepatient safety and deter counterfeiting efforts. Although there is someconcern (as yet, unfounded) about radioactivity in using the tags,

RFID technology will:

Ensure that patients receive the correct medications and medicaldevices

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 tofollow a standard naming convention for their products andlocations. Standard organizations such as GS1 play a major role increating traceability standards and best practices that can befollowed across the industry.
http://en.wikipedia.org/wiki/Technologyhttp://en.wikipedia.org/wiki/Radio_waveshttp://en.wikipedia.org/wiki/Radio_waveshttp://en.wikipedia.org/wiki/Technology


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Best Practices

GS1 System of Standards for Global Traceability inHealthcare[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 ContainerCode (SSCC), a generic standard case label template.


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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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Conclusion

The healthcare industry is a complex ecosystem, where collecting andsharing data between different entities is a significant obstacle inachieving full traceability in the supply chain. GS1 plays key role indeveloping and providing standards that are applicable across the

industry. Technology is a major enabler for data exchange toregulatory agencies and trade partners, as and when required.Developing an efficient healthcare traceability management systemwill provide a safer environment for supplies, manufacturers,providers and consumers. However, it is necessary to develop asystem that also maintains the privacy of data and ensures a higherdegree of safety for patients personal information.


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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 2008http://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 Healthcarehttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdf

9. FDA-Radio Frequency Identificationhttp://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.htmlhttp://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09http://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09http://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09http://www.sciencedaily.com/releases/2010/01/100120085348.htmhttp://www.sciencedaily.com/releases/2010/01/100120085348.htmhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://freepdfhosting.com/f60be7765c.pdfhttp://freepdfhosting.com/f60be7765c.pdfhttp://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=26366http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=26366http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=26366http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698http://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdfhttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdfhttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdfhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072141.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/ElectromagneticCompatibilityEMC/ucm116647.htmhttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdfhttp://www.gs1.org/docs/gsmp/traceability/Global_Traceability_Standard_Healthcare.pdfhttp://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://www.sagefoodsafety.com/2011/02/the-economic-impact-of-recallshttp://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=656698http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=45285http://pharmtech.findpharma.com/pharmtech/author/authorInfo.jsp?id=26366http://freepdfhosting.com/f60be7765c.pdfhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://www.safemedicines.org/counterfeit-heparin-blamed-for-worldwide-deaths.htmlhttp://www.sciencedaily.com/releases/2010/01/100120085348.htmhttp://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09http://www.marketwatch.com/story/internet-drug-scams-can-make-you-sick-2011-03-09http://www.allcountries.org/health/counterfeit_medicines.html


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Author Info

Pala Bushanam Janardhan (Jana) PracticeManager, ERS-Practice-Practice-CAM

Janahas over 23 years of experience andcurrently leads the manufacturing practice ofthe Engineering and R&D services businessline at HCL Technologies, Ltd. He has beenassociated with HCL since April 2006, providingdomain consultancy for regulated industries.Prior to joining HCL, he served the regulatedindustries (pharmaceuticals, phytochemicals,nutraceuticals and speciality chemicals) invarious capacities for over 18 years, including

process technology development, technologytransfers regulatory compliance, supply chainmanagement, outsourcing and businessdevelopment..

Saravanan JeyaramanProject Manager, ERS-Practice-Practice-CAM

Saravanan has over 12 years experience inmanufacturing execution systems (MES),engineering data analytics (EDA), enterprisemanufacturing intelligence (EMI), equipmentautomation and Microsoft Technologies. Hebrings strong experience in implementation,integration and maintenance of MESapplications, developing SPC applications,internal traceability in the shop floormanufacturing process and tool automation. Heis a PMP and Microsoft Certified TechnicalSpecialist responsible for architecting .NETbased track and trace solutions adhering toGS1 standards.


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Hello, Im from HCLs Engineering and R&D Services. We enabletechnology led organizations to go to market with innovative products &solutions. We partner with our customers in building world class

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Visit our website http://www.hcltech.com/engineering-services/

About HCL

About HCL TechnologiesHCL Technologies is a leading global IT services company, workingwith clients in the areas that impact and redefine the core of theirbusinesses. Since its inception into the global landscape after its IPO in1999, HCL focuses on 'transformational outsourcing,' underlined byinnovation and value creation, and offers integrated portfolio of servicesincluding software-led IT solutions, remote infrastructure management,engineering and R&D services and BPO. HCL leverages its extensiveglobal offshore infrastructure and network of offices in 26 countries toprovide holistic, multi-service delivery in key industry verticals includingFinancial Services, Manufacturing, Consumer Services, Public Servicesand Healthcare. HCL takes pride in its philosophy of 'Employee First,

Customer Second' which empowers our 77,046 transformers to createa real value for the customers. HCL Technologies, along with itssubsidiaries, had consolidated revenues of US$ 3.5 billion (Rs. 16,034crores), as on 30 June 2011 (on LTM basis). For more information,please visit www.hcltech.com

About HCL EnterpriseHCL is a $6 billion leading global technology and IT enterprisecomprising two companies listed in India - HCL Technologies and HCLInfosystems. Founded in 1976, HCL is one of India's original IT garagestart-ups. A pioneer of modern computing, HCL is a globaltransformational enterprise today. Its range of offerings includesproduct engineering, custom & package applications, BPO, ITinfrastructure services, IT hardware, systems integration, anddistribution of information and communications technology (ICT)products across a wide range of focused industry verticals. The HCLteam consists of over 85,000 professionals of diverse nationalities, whooperate from 31 countries including over 500 points of presence inIndia. HCL has partnerships with several leading global 1000 firms,including leading IT and technology firms. For more information, pleasevisit www.hcl.com

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

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