sshh--fdafda gs1 coding in the udi of medical device … · sshh--fdafda legal aff. content global...

SHSH--FDAFDA

LEGAL AFF.LEGAL AFF. GS1 Coding in The UDI of Medical Device GS1 Coding in The UDI of Medical Device

EnhancingEnhancing

the Tracebility of High Risk Medical Device the Tracebility of High Risk Medical Device

Pilot Project Pilot Project ImplementationImplementation in Shanghai Chinain Shanghai China

1

2008

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

2008-10-28

Pilot Project Pilot Project ImplementationImplementation in Shanghai Chinain Shanghai China

YAN, Liang

Legal /International Affairs FDA Shanghai

CHINA SFDA

28 Oct. 2008 Japan

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LEGAL AFF.LEGAL AFF.CONTENTCONTENTCONTENTCONTENTCONTENTCONTENTCONTENTCONTENT

� Global challenge in post market of medical device.

� The regulatory requirements for MD. supply chain control

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

2

� GS1 standard used in medical device tracing system

� The pilot project implement in China

SHSH--FDAFDA

LEGAL AFF.LEGAL AFF.

Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Big Challenge for MD Industry and Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)Competent Authority (CA)

�Device label description and records not meets the safety

requirements of supervision when in recall.

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2008

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

2008-10-28

�Tracing device in AE. often failure even US/EU international big

company in China market.

�Needs a scheme of Device UDI to promote tracebility for

medical device in post market vigilance system.

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UDI is Not RegulatedUDI is Not Regulated

�GHTF requires in principle a systematic traceability of

products as part of the manufacturers post market

surveillance activities.

�Manufacturers can chose what they want or what the

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

4

�Manufacturers can chose what they want or what the

different national markets need.

�Hospitals, distributors as well as the traders are using

their own barcode and classification system,

�The way of a systematic post market surveillance is not

regulated

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LEGAL AFF.LEGAL AFF. UDI UDI -- Unique Device IdentificationUnique Device Identification

Considration Unique on:

� Unique requirement must be considered on global scope

� Using distributors or hospital own coding is not meet safty

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

5

� Using distributors or hospital own coding is not meet safty

principle of Medical Devices Regulation.

� GS1 standard has been adopted in worldwide supply chain

environment which meets Unique requirement.

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2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

6



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Establish a Worldwide Vigilance SystemEstablish a Worldwide Vigilance System

Base on “Medical Device UDI” Base on “Medical Device UDI”

�When event really happened, where they are ?

�Using IT system to search the device UDI .

�High risk device is the firsr target to using UDI.

World Hospital / CA.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

7

Manufacturer

to trace a

deviceUDI Coding

M. NameGMDN Nomenclature

& codecodecodecode

GS1 standardGS1 standardGS1 standardGS1 standard

UMDN

World Hospital / CA.

Health Care others

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Establish Principals for System Base on RegulatoryEstablish Principals for System Base on Regulatory

Technology Support the Regulatory RequirementTechnology Support the Regulatory Requirement

(1) Basis of System(1) Basis of System

1. Adopt global uniform coding system to reduce

barrier: GS1

2. Minimum data set in the bar code and database of

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

8

device tracing system.

3. Separate two section in the tracing system,

– 1) Responded and controled by manufacturer for the data

not been used in sales chain and

– 2) Hospital for the data which has been used with patients.

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Establish Principals for System Base on RegulatoryEstablish Principals for System Base on RegulatoryTechnology Support the Regulatory RequirementTechnology Support the Regulatory Requirement

(2) (2) ResponsibilityResponsibility

1) Manufacturer take the fully responsibility for their own products released on the market.

2) Only manufacturer initiates the bar code on the label, distributor and hospital not been permitted to relabel or initiated a bar code.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

9

initiated a bar code.

3) Manufacturer should control the distributors which have been recognized to sale their product. Distributor should report the tracing information to manufacturer in sales chain on any time if it is need for.

4) Hospital should use the laser scanner to automatically readthe Device UDI data to reduce the mistake in the record.

5) Hospital opens the device information to the patient under the rule necessary.

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Establish Principals for System Base on RegulatoryEstablish Principals for System Base on Regulatory

Technology Support the Regulatory RequirementTechnology Support the Regulatory Requirement

(3) (3) Data Data EnvironmentEnvironment

1. Establish a public device Data PoolData PoolData PoolData Pool to support the

database maintenance in hospital.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

10

2. Establish a data Reporting Platformeporting Platformeporting Platformeporting Platform as a bridge link the

hospital and manufacturer and CA for tracing device used

on patient.

3. Every manufacturer sitesitesitesite needs Own Manufacturer ID wn Manufacturer ID wn Manufacturer ID wn Manufacturer ID code on the device label.code on the device label.code on the device label.code on the device label.

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System Meet the Safe Medical Devices ActUS. 1990 (SMDA)

�Manufacturers must implement a tracking system for certain devices whose failure is likely to have serious health consequences for users. FDA issues letters to manufacturers who make and/or distribute devices subject to this requirement.

�After receiving notification, a manufacturer must write a

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

1134

�After receiving notification, a manufacturer must write a standard operating procedure detailing how its product can be tracked through distribution, including audit procedures, in the event that the device must be removed from distribution and/or use.

�Final distributors must also furnish the manufacturer with patient identification data and device information (lot number, batch number, and/or serial number) to ensure effective tracking of the device if necessary.

SHSH--FDAFDA


Central Data Pool

Man

ufa

cturer

Ho

spita

l Data

Supply Chain

Op

eratio

n

Ho

spita

l acco

un

ting

Implantable Device Information Flow

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

1213

Man

ufa

cturer

Ho

spita

l Data

FDA PV. Platform

Op

eratio

n T

hea

rtre

Ho

spita

l acco

un

ting

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2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

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SHSH--FDAFDA


Coding StandardCoding Standard

1. System adopts GS1 EAN-UCC128 standard for all imported

products and domestic products.

2. HIBC standard only permits for oversea manufacturer.

3. Manufacturer who has China business license should use

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

14

3. Manufacturer who has China business license should use

GS1 standard.

4. Two standards covers nearly 80% implantable device in

China market.

5. To permit Individual HIBC user to use EAN UCC 128 code on

second code (production code) in transition period.

6. System adopts GS1 EAN 13 code for not implantable device.

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Imformation in the Bar CodeImformation in the Bar Code

1. Two bar code combined printing on the product label. To be arranged as up and down position or in one line on the product label.

2. 5 basic information should be in the Bar Code.

3. Main code is product code for identify which product.:

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

15

3. Main code is product code for identify which product.:

Manufacturer + Product and Specification +Package size

1. Second code is production code. Include device’s time information, use it for trace product in Quality System of the manufacturer.

Expiration date / Manufacture date + Production lot/Serial number

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Different Possible Combination of Different Possible Combination of Two Code on the product label Two Code on the product label

Main and Secondary code are: HIBC；；；；

Main and Secondary code are: EAN-UCC128；；；；

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

16

Main and Secondary code are: EAN-UCC128；；；；

Main: EAN13＋＋＋＋ Secondary: EAN-UCC128；；；；

Main: HIBC Main: HIBC Main: HIBC Main: HIBC ＋＋＋＋ Secondary code EANSecondary code EANSecondary code EANSecondary code EAN----UCC128UCC128UCC128UCC128；；；；

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System accepts only System accepts only GS1GS1 and HIBC and HIBC

standards, others will be rejected in readstandards, others will be rejected in read

GS1

Scanner recognizing area

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

17

GS1

EAN-UCC 128

HIBC

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2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

18



SHSH--FDAFDA

LEGAL AFF.LEGAL AFF. Project Implementation Project Implementation

� To the end of 2005, starting this project after investigation,

which focus on implantable high risk device.

� At the middle of 2006, establishing a coding standard scheme

and solving special code reading technology.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

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and solving special code reading technology.

� On Nov.11 2006, SH-FDA worked together with SH-Hygiene

Bureau published documents to promote the project

implementing.

� At the end of 2007, more than 100 hospitals in Shanghai city

tracing back implantable device with the UDI.

SHSH--FDAFDA


Two Documents Put on Public For Using UDI Two Documents Put on Public For Using UDI

System to Trace Implantable DeviceSystem to Trace Implantable Device

MDR.DEPT.MDR.DEPT.

上海食药监局和卫生局联合发文规定上海食药监局和卫生局联合发文规定上海食药监局和卫生局联合发文规定上海食药监局和卫生局联合发文规定

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

20

2007

ESTABLISHING

MD. ADVERSE EVENT

TRACING BACK SYSTEM

BY UDI.I

SH-FDA-MDR.

2007-5-24 42

SHSH--FDAFDA


MDR.DEPT.MDR.DEPT.

Data Platform of FDAData Platform of FDA

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base

Fin

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Sell From Maf.

Sell from

Distributor.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

212007-02-07 50

2007

ESTABLISHING

MD. ADVERSE EVENT

TRACING BACK SYSTEM

BY UID.

SH-FDA-MDR.

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Dis. Urgent Sell

Maf. Urgent Sell

Maintenance Data

By Maf.

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First User: Chang Hai Hospital First User: Chang Hai Hospital

2006 Shanghai China2006 Shanghai China

MDR.DEPT.MDR.DEPT.

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

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2007

ESTABLISHING

MD. ADVERSE EVENT

TRACING BACK SYSTEM

BY UDI.I

SH-FDA-MDR.

2007-5-24 79

SHSH--FDAFDA


14 Basic imformation of one device 14 Basic imformation of one device

in database in database

links with product links with product Bar CodeBar Code

1. Name of Manufacturer *

2. Maker / contract maf.

3. Manufacture Site.

8. Lot/batch/serial number *

9. Quantity *

10. No. of Re. Certification

2008-10-28

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GS1 MEETING

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3. Manufacture Site.

4. Name of Device *

5. Device Specification

6. Device Expiration Date *

7. Device Release Date

11. Issue Date of Certificationg

12. Expiration Date of

Certification

13. Contact Person

14. Final Distributor

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3 Data Sources Supporting 3 Data Sources Supporting A Device Form A Device Form

for Patient Keepingfor Patient Keeping

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MDR.DEPT.MDR.DEPT. Used Device Form of PatientUsed Device Form of Patient

Hospital Purchase HIS

Read Lot / Batch / Series NO. In

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2007-11-22浙江浙江浙江浙江SH-FDA

TRAINING

POST-MARKET

AE. VIGILANCE

MONITOR AND

INSPECTION

IN

ZHE JIANG &

JIANG SU

2007-11-08

2007-11-22

155

Purchase

DatabaseHIS / Series NO. In

Secondary Code

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Structure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information SystemStructure of Hospital Information System

HIS

Patient

Record Sys.

Finance

System

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Purchase

System

Report

Platform

Tracking

System

port

Port of

Pay Money

Port

第25页共87页

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DM

H ( On FDA Platform) －－－－M－－－－D ＝＝＝＝0

Maf. And Distributor collecting data from FDA PlatformFDA check the balance result of data on the supervision platform

2008-10-28

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H

F D AF D AF D AF D A

Hospital report data

ManufacturerCollects data

and report

SHSH--FDAFDA


高值器械招标高值器械招标高值器械招标高值器械招标高值器械招标高值器械招标高值器械招标高值器械招标//追溯系统图追溯系统图追溯系统图追溯系统图追溯系统图追溯系统图追溯系统图追溯系统图 1/21/2

数据数据数据数据

企业企业企业企业医院医院医院医院

药监药监药监药监

生产企业

生产企业

生产企业

生产企业

医院原始数据

医院原始数据

医院原始数据

医院原始数据

医院招标数据库




卫生招标数据卫生招标数据卫生招标数据卫生招标数据

器械数据池器械数据池器械数据池器械数据池 1

2招标数据招标数据招标数据招标数据

设定和过滤设定和过滤设定和过滤设定和过滤

销售在途报告销售在途报告销售在途报告销售在途报告

预先检查

BID & BID & BID & BID & TRACINGTRACINGTRACINGTRACING

2008-10-28

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生产企业

生产企业

生产企业

生产企业

医院原始数据

医院原始数据

医院原始数据

医院原始数据

卫生招标监管平台卫生招标监管平台卫生招标监管平台卫生招标监管平台

销售链销售链销售链销售链

医院手术室

医院手术室

医院手术室

医院手术室

医院财务

医院财务

医院财务

医院财务





1 2

药监追溯监管平台药监追溯监管平台药监追溯监管平台药监追溯监管平台 1

2

直销进医院直销进医院直销进医院直销进医院

病人清单使用报告

预先检查

SHSH--FDAFDA


Thank YouThank You

2008-10-28

REPORT OF MD UDI

IMPLEMENTATION

IN SHANGHAI CHINA

GS1 MEETING

TOKYO JAPAN.

2828

REGULATION SIMPLYEST OPENREGULATION SIMPLYEST OPENREGULATION SIMPLYEST OPENREGULATION SIMPLYEST OPEN