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Big Data Analytics In M2M

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Medical Devices - Implementation of Unique Device Identification (UDI)

Big Data Analytics In M2M

WHITE PAPER

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Table of Contents

Abstract ............................................................................................. 3

Abbreviations .................................................................................... 3

Glossary ............................................................................................. 3

Market Trends and Challenges ......................................................... 4

Scope ................................................................................................. 5

UDI Format ........................................................................................ 6

Technical Requirements.................................................................... 6

UDI Compliance Dates for Medical Devices ...................................... 8

UDI Implementation – Process Approach ......................................... 9

UDI Compliance in Warehouse Operations .................................... 10

GUDID Requirements ...................................................................... 11

GUDID Data Submission Methods .................................................. 12

HCL’s GUDID Data Submission Approach ....................................... 13

UDI Issuing Agencies ....................................................................... 13

General Exceptions ......................................................................... 14

Benefits of UDI Implementation ..................................................... 14

Conclusion ....................................................................................... 15

References ...................................................................................... 15

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Abstract Unique Device Identification (UDI) is a new regulation from the U.S. FDA, which requires that the label

and device package of each medical device include a UDI. On September 24, 2013, the FDA published a

final rule (the UDI Rule), establishing the UDI system. U.S. FDA Code of Federal Regulation (CFR) parts

801.55, 830.10, 830.100, 830.110, 830.120, and 830.130 of the rule came into effect on October 24,

2013; the remaining parts came into effect on December 13, 2013.

As part of the UDI final rule, labelers of medical devices must submit information concerning their

devices to the Global Unique Device Identification Database (GUDID).

This paper is intended to provide information to the medical device industry concerning the FDA’s UDI

system, and gives an overview of HCL’s implementation of UDI processes for medical devices and the

corresponding business impact.

Abbreviations Sl. No Acronyms Full Form

1 AIDC Automatic Identification and Data Capture

2 GMDN Global Medical Device Nomenclature

3 GS1 Global Standards/Solutions

4 GUDID Global Unique Device Identification Database

5 HIBCC Health Industry Business Communications Council

6 ICCBBA International Council for Commonality in Blood Banking Automation

7 PHS Public Health Service

8 PMA Premarket Approval

9 RFID Radio-Frequency Identification

10 XML Extensible Markup Language

Glossary Device Identifier (DI): A mandatory, fixed portion of a UDI that identifies the specific version or model of

a device and the labeler of that device.

Global Unique Device Identification Database (GUDID): The database that serves as a repository of

information that facilitates the identification of medical devices through its distribution and use.

Labeler:





http://www.hcltech.com/lifescience-healthcare/medical-devices


1. Any person who causes a label to be applied to a device with the intent that the device will be

commercially distributed without any intended subsequent replacement or modification of the

label; and

2. Any person who causes the label of a device to be replaced or modified with the intent that the

device will be commercially distributed without any subsequent replacement or modification of the

label, except that the addition of the name of, and contact information for, a person who distributes

the device, without making any other changes to the label, is not a modification for the purposes of

determining whether a person is a labeler.

Production Identifier (PI): A conditional, variable portion of a UDI that identifies one or more of the

following when included on the label of the device:

1. The lot or batch within which a device was manufactured

2. The serial number of a specific device

3. The expiry date of a specific device

4. The date when a specific device was manufactured

Unique Device Identifier (UDI): An identifier that adequately identifies a device through its distribution

and use by meeting the requirements of 21 CFR 830.20. A unique device identifier is composed of (1) a

device identifier, and (2) a production identifier.

Market Trends and Challenges Traceability is currently not regulated by the Medical Device Directives. The lack of unambiguous

identification of medical devices or the inaccessibility to critical device-related information, significantly

impacts the healthcare supply chain, patient safety, and treatment processes. The tracking mechanisms

for post market safety of medical devices due to incident reporting, recalls or adverse events, targeted

field safety corrective actions, and monitoring by competent authorities, are not efficient.

Therefore, the Food and Drug Administration Amendments Act (FDAAA) mandated the U.S. Food and

Drug Administration (FDA) to establish a unique device identification system which enables easy tracking

and identification of medical devices throughout their lifecycle i.e. from production through use in

clinical practice. The best way to ensure effective traceability of medical devices in the Union is to

develop a UDI system. The UDI will function as the key that can be used to obtain critical information

from the GUDID about the medical devices. It will allow the FDA, health care providers, and industries to

more rapidly extract useful information and effectively monitor the devices in the market.






The Results of UDI Non-Compliance

Here are a few complaints impacting patient safety due to a lack of data traceability.

Figure 1: Issues faced due to lack of device traceability

Scope

UDI applies to the devices and their accessories, as illustrated below:

• Medical Devices – these are instruments, apparatus, implants, in vitro reagents, and similar or

related articles that are used to diagnose, prevent, or treat disease or other conditions, and do not

achieve their purposes through chemical action within or on the body.

• Active Implantable Medical Devices – are active medical devices that are intended to be totally or

partially introduced, surgically or medically, into the human body or by medical intervention into a

natural orifice, and that are intended to remain there, after the procedure

• In Vitro Diagnostic Medical Devices – are devices, whether used alone or in combination, intended

by the manufacturer for the in-vitro examination of specimens derived from the human body solely

or principally to provide information for diagnostics, monitoring, or compatibility purposes. These

include reagents, calibrators, control materials, specimen receptacles, software, and related

instruments or apparatus or other articles.

A UDI must also be placed directly on devices (but not on all implants) that are likely to be separated

from their label over time, such as:

Adverseevents-2007

66,000

60% lacked product identifier

25% wrong manufacturer name

10% No product brand name

US Defense department findings in product brochures

HIP replacement system Recall tracking






• Implantable devices (>30 days)

• Devices intended to be used more than once and are sterilized before each use

• Stand-alone software

UDI Format There are very specific technical requirements for UDIs. FDA-accredited Issuing Agencies (IAs) are

required to issue UDIs that conform to the following ISO standards from which the UDI format is derived.

• ISO/IEC 646:1991 - Information technology -- ISO 7-bit coded character set for information

interchange.

• ISO/IEC 15459-2:2006(E) - Information technology -- Unique identifiers -- Part 2: Registration

procedures.

• ISO/IEC 15459-4:2008 - Information technology -- Unique identifiers -- Part 4: Individual items.

• ISO/IEC 15459-6:2007 - Information technology -- Unique identifiers -- Part 6: Unique identifier for

product groupings.

Technical Requirements A. Representation

UDI should appear in both human readable format (human readable version composed of a series of

numeric or alpha numeric characters) and in a format that can be read by an AIDC technology.

Automatic Identification and Data Capture (AIDC) technology: The most commonly used identification

data capture technology is Barcode and RFID.

Barcode has two forms: One dimensional (1D – linear stacked, linear concatenated) and Two

dimensional (2D – square data matrix) barcode.

1D Linear stacked barcode has the DI and PI barcodes on separate lines

1D Concatenated version joins the DI and PI together into one long barcode

2D Data matrix blends the DI and PI together into one image

Types of Barcodes Linear stacked Linear – Concatenated 2D Data Matrix

(00) 0 546465 431612345 4 (01) 0 546465 43 (16) 12345

(01) 2 56602198 097 5

(19) 4654316(20)1Q25






Examples of UDI

Figure 2: Illustrated Medical Device UDI label. This is for illustration purposes only.

B. UDI Elements

The final rule establishes requirements for the UDI that must appear on each label. Typically, UDI is

composed of two parts:

Unique Device Identifier (UDI) = Device Identifier (DI) + Production Identifier (PI)

Device Identifier: A mandatory, fixed portion of the UDI that identifies the specific version or model of a

device and the labeler of that device. Thus, the two key components are:

• Specific version or model of device

• Labeler

Production Identifier: A conditional, variable portion of the UDI that identifies one or more of the

following, when included on the label of the device:

• Lot or batch

• Serial number

• Expiry date (use by date)

• Date of manufacture

C. Standardized Date Format






Standardized formats for dates on medical device labels consistent with international practices will

eliminate confusion from date formats that might be interpreted in more than one way. Dates must

therefore be presented in a specified format that is consistent with international standards and

international practice. The format is: YYYY-MM-DD.

UDI Compliance Dates for Medical Devices

UDI Product Class Label/GUDID/Date

Format

Permanent UDI

Class III

Devices licensed under the

PHS Act

September 24, 2014 Class III Life Sustaining / Life

Supporting (LS/LS) devices must bear a

permanent UDI by September 24, 2015

All other Class III devices must bear a

permanent UDI by September 24, 2016

I/LS/LS (class II, class I &

unclassified)

September 24, 2015 September 24, 2015

Class II September 24, 2016 September 24, 2018

Class I or unclassified September 24, 2018 September 24, 2020






UDI Implementation – Process Approach Figure 3: Step-by-step implementation of UDI

Develop UDI product

assessment list

Prioritize products based on

medical device classification

Are Label

changes

major label

issues?

Provide UDI requirements

Initiate label changes for UDI

compliance

Initiate design changes on the

label

Provide product-specific Device

Identifier and Production Identifier

requirements

Design and develop label

changes

Approve UDI label changes

Update DHF and DMR

Implement UDI label

on devices

Submit device

information to GUDID

Identify UDI impacted products

YES

NO






UDI Compliance in Warehouse Operations Ensuring UDI compliance with warehouse operations is also important, as it increases customer

satisfaction, decreases financial risk, and satisfies regulatory compliance. With the requirements that

the UDI has placed on the organization, ensuring compliance with the factors at the warehouse is

significant:

Rework and re-label products:

• Warehouse’s FDA registration status to ensure it is listed as a re-packaging/re-labeling facility

• Specific processes and procedures for rework

• Maintain adequate inventory while rework is being done

• Ensure a clearly identifiable marker on the package to designate origin

• Establish a mechanism for identifying items that should/should not be re-labeled

Perform product dimensioning or information gathering:

• Requirement to dimension a product if no dimensions are found in the system, or to periodically re-

dimension inventory

• Verify information required for the GUDID from existing product labeling

• Ensure accuracy and consistency; consider using standardized forms or pictures to confirm the

information being sent to the manufacturer

Change barcode formats that affect scanners:

• Capital expenditures for new barcode scanners, image scanners, barcode printers and wireless

infrastructure

• Impact to warehouse workflows and processes, quality procedures, technical implementation, on-

going support, and operational headcount

• Synchronization of standards in the supply chain. e.g. GS1 format, HIBCC

• Impact due to change to a different barcode format, such as linear stacked or linear concatenated to

a 2D data matrix format

• New barcode scanners, printers and software have to be tested and validated

• Need of additional programming to existing scanners to parse, translate, and look up data from the

alternate format

Increase stock level:

• Ramp up production to ensure sufficient stores of inventory during the transition period

• Additional space in warehouses to manage inventory ramp up

Maintain multiple versions of the same product with different labels:

• Stock control challenges for warehouses due to labelling changes and impact on international

registrations






Impact on Distributors:

• Training for distributors – According to the FDA, distributors are required to know about UDI

implementation on medical devices

• Distributors should consider adding UDI as a product reference in their items master

• Compliance to the specific guidelines provided by FDA for the processing and relabeling of returns

GUDID Requirements The Global Unique Device Identification Database (GUDID) is a publicly searchable database

administered by the FDA that will serve as a reference catalogue for every device with an identifier.

Labelers must electronically submit information on each device to the GUDID.

Global Unique Device Identification Database (GUDID) Data = DI (not PI) + Device Attributes

The information to be submitted to the FDA is categorized into the GUDID elements below:

• Identification

• Regulation

• Packaging

• Characteristics

• Labeler

• Production

This includes,

• The device identifier

• The types of production identifiers

• The proprietary, trade or brand name

• The version or model number

• The size, if the device comes in more than one size

• The number of devices/packages

• Whether the device is sterile, non-sterile or requires sterilization

• If it contains latex

• The FDA 510(k) or PMA number or a statement that the device is exempt

• The FDA listing number (required, but not posted publically)

• The GMDN code (only if GMDN codes become freely available by the publication of the final rule)






GUDID Data Submission Methods Figure 4: The various data submission methods of GUDID

Medical Device

Manufactu

GUDID data collection for submission

(PLM, MDM, ERP/MES, RA,

labelling)

Manual Data Entry FDA GUDID Web Interface

Hosted Software

Outsourced Service

Internal Software

SPL

SPL

SPL

GUDID Data






HCL’s GUDID Data Submission Approach HCL has suggested the use of the Electronic Submissions Gateway (ESG) method, particularly as the

amount of data is large and it will help avoid data entry errors.

Software Details

Technology: .NET Framework

Language: C#

Tools: Microsoft Visual Studio 2010

Approach

• Data is validated

• XML files are generated based on SPL and HL7 standards

• XML files are validated against the schema given by the FDA

• Automation of uploading XML files into ESG

Benefits

• Avoids data entry errors

• Uploading effort is reduced by 70% with the automation framework

• Schema validation check reduces errors in the production environment

• Cost-effective

HCL’s GUDID Data Submission Approach

Figure 5: HCL’s data submission approach for GUDID

UDI Issuing Agencies An issuing agency is an FDA-accredited organization that operates a system for the assignment of UDIs

according to the final rule. The FDA has accredited the agencies listed below:

1. Firm Name: GS1

GUDID Data Collection for

(PLM, MDM, ERP/MES, RA,

Labelling)

GUDID Data Submission

GUDID Data

Medical Device Manufacturer






2. Firm Name: HIBCC

3. Firm Name: ICCBBA

General Exceptions There are a number of UDI exceptions that are typical for FDA device regulations such as custom devices,

investigational devices, class I GMP (Good Manufacturing Practice) exempt devices, veterinary devices,

export-only devices, devices used solely for research or teaching, combination products, shipping

container, individual single use devices, and devices held by the national stockpile.

Benefits of UDI Implementation

Figure 6: The advantages of UDI implementation in medical devices

Rapid identification of a device to obtain key attributes thataffect its safe and effective use

Reduces medical errors

Identifies problems with a particular device (recalls)

Allows rapid and accurate review and assessment of adverseevent reports

Standardizes the date format on all device labels

Enhances business processes – Improves supply chainprocesses, inventory management and enhance procurement

Improves device traceability, post-market surveillance, anddetection of counterfeit products

Simplifies the integration of device use information into datasystems (electronic patient records)

Allows more rapid and effective corrective actions






Conclusion

The implementation of UDI in medical devices improves patient safety and healthcare business

processes. This will fundamentally change and improve the way we all interact with medical devices.

When the UDI system is fully implemented, it can serve several important public health objectives.

HCL Technologies, as one of the medical device service providers in the world, supports the

implementation of the UDI system in the medical device manufacturing industry. HCL understands the

fundamental concepts and processes of the UDI system, and supports its global clients in implementing

it with great confidence.

References • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/def

ault.htm

• http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/Gl

obalUDIDatabaseGUDID/default.htm

• https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-

system

• www.gs1.org





http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm

https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system

https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system

http://www.gs1.org/


Authors Info Ragasudha Veerabathiran

Ragasudha has a Bachelor’s Degree in Biomedical Engineering. She has over 4 years of experience in the

Medical Devices domain as a Quality and Regulatory Affairs Engineer. She was also involved in getting CE

and UL marking for medical devices. She is experienced in creating and maintaining DHF (Design History

Files), TCF (Technical Construction Files), Dossiers for EU Submissions (CE & UL Mark) and FDA (510k)

submissions.

Mathiyazhagan Muthusamy

Mathiyazhagan has a Master’s Degree in Applied Chemistry and Chemical Engineering. He has over 27

years’ experience, of which 18 years were spent in the Medical Devices domain as Quality Head, R&D,

Quality Management Representative for US FDA-QSR, ISO 13485, MDD (CE Mark) and Certified Lead

Auditor for Quality Management Systems. He is currently working in an engagement for a large Medical

Devices OEM across quality, design control, and manufacturing and sustaining services areas.





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