logistics project coding quality assessment of medical devices · nuno loureiro logistics project...
TRANSCRIPT
Nuno Loureiro
Logistics Project
CODING QUALITY ASSESSMENT OF MEDICAL
DEVICES
22 October 2015
© GS1 2015 2
Framework
Description of logistics
Project Methodology
Conclusions
Next steps
© GS1 2015
Framework
3
Problem CHLN (North Lisbon Hospital Centre)
Need to frame the different Capture solutions and existing information processing to address
different forms of identification of products used by each supplier.
GS1 proposal
Assess the level of GS1 identification and marking in selected medical devices.
Promote the continued use of the GS1 System among all supply chain partners.
Implement the use of GS1 Standards using GTIN, Data Validity and Lot.
Ambition CHLN / GS1
Optimize the flow and processing of the data from the identification of DM based on GS1 global
standards.
© GS1 2015
Framework - Long term goals
4
CHLN
Adoption of a "global language" in order toreduce costs, stocks, time and waste.
Meet coding requirements within the QMSaudits.
Ensure increased traceability and safety.
Alignment and timing and physical flow of information along the supply chain.
Raise the level of service provided to clients.
© GS1 2015
Framework – Short term goals
5
CHLN
Infer the use of GS1 Standards in marking Medical Devices which arrive at the CHLN warehouse.
Awareness among suppliers to the added value of using the GS1 System.
Assess the relevance of recommended GS1 coding with suppliers, in order to achieve our medium to long-term goals.
Start active involvement of suppliers.
© GS1 2015 6
Framework
Description of logistics
Project Methodology
Conclusions
Next steps
© GS1 2015
Description of logistics
7
North Lisbon Hospital Centre since March 1, 2008
University established as part of the Portuguese National Health Service;
Plays integrated functions of providing health care, pre training, post - graduate
and continuing to constitute an essential unit within the Portuguese health system;
Innovation and research center
Has integrated goals of a health unit of the public system, with a view to ensuring
equality and universality of access, effective and efficient assistance and the
promotion of quality and excellence, to the satisfaction of patients and
professionals;
In addition to the support it provides to the people of this area of direct influence,
CHLN ensures differentiated referencing in multiple clinical areas at regional
and national level and in Portuguese-speaking countries;
© GS1 2015
Description of logistics
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29.531 surgeries
701.056 consultations
6.312 employees
43.130 out patients
1.183 beds
about €400 Mn budget
Dimension
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Logistics Service
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Description of logistics
Employees38
Hospitals2
Central warehouse1
Stock keeping Unit2.200
Units Handled 201378.000.000
SKU approved daily250
Supply Locations280
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Logistics Service - route
New Warehouse
Newdistribution
channel
Newreplacement
method
IntroductionHardware and
Software
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Logistics Service - route
11
Medical Action Service Central warehouse
Material flow
Flow of information
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Framework
Description of logistics
Project Methodology
Conclusions
Next steps
© GS1 2015
Project Methodology
13
Information checking
F
Phase I
Analysis and Data
Processing
Presentation and
Results Validation
Approach to Suppliers Implementation of
recommendations
Phase III Phase IV Phase V
• Conductingplanning meetings
• Choice of products for analysis (CHLN)
• Survey of information on codes of selected productss
• Technicalverification ofbarcodes
• Structuring of data for analysis
• Processing and data analysis
• Preparation of technical reports for each product
• Developing remedial proposals of non-conformities
• Meeting to validate the study results with GS1
• Defining the approach strategy to suppliers
• Performing 2 clearing sessions for presentation of the study results and awareness of the benefits of using GS1 Standards System
• Realization of a practical workshop to clarify the essential details for a flawless coding
• Promotion and monitoring of suppliers in the correction of non-conformities
Phase II
© GS1 2015
Project Methodology
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Sample
21 Suppliers (participants)
48 boxes Transport
40 Consumer Units
96 Barcodes
Choose Sample
40 items chosen for their high turnover
Articles with high impact on warehouse operations
(Reception, Picking and Warehouse)
Articles with and without barcodes
Referência do Fornecedor Referência do Fornecedor
Lote Lote
Nº de Série Nº de Série
Tipo de Código de Barras Tipo de Código de Barras
Info em Código Barras Info em Código Barras
EHL em Código Barras EHL em Código Barras
Data de Validade Data de Validade
Data de Produção Data de Produção
Quantidade Quantidade
Referência do Fornecedor Referência do Fornecedor
Lote Lote
Nº de Série Nº de Série
Tipo de Código Barras Tipo de Código Barras
Info em Código Barras Info em Código Barras
EHL em Código Barras EHL em Código Barras
Data de Validade Data de Validade
Data de Produção Data de Produção
Observações
Imagem do Produto
Observações
Imagem do Produto Imagem da Etiqueta
Código Barras LoteCódigo CHLN
Unid
ade
de C
onsu
mo
Fornecedor
NIF
Código Barras Referência
Código Barras Lote
Código CHLN
Unid
ade
Logí
stica
Imagem da Etiqueta
Unid
ade
Logí
stica
Observações
Imagem do Produto
Fornecedor
NIFCódigo Barras Referência
Unid
ade
de C
onsu
mo
Imagem do Produto
Observações
Information checking
Phase I
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Project Methodology
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Data analysis was structured by
categorizing the problems / errors
encountered in coding the products
analyzed using a simple visual symbols,
in accordance with the following table.
Analysis and Data Processing
Phase II
Categorization of data Situations encountered in analyzing
Coding smoothly or removable correction Coding flawless
Small inaccuracies in coding Coding flawless but the UDI guidelines suggest that
the expiration date and lot should be coded
Significant errors without coding, but the date
must not contain the day when it is not specific
Symbology used is not GS1
The date should be coded before the lot to be a
fixed field
Failure or error in coding Use AL (02) without the AL (00)
Article without any coding
Unable to capture the barcode
The date is not correctly inserted
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Project Methodology
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Presentation and Results Validation
Phase III
Logistics units Consumer Units
48
60
9
40
36
16
Analyzed units
With barcodes
Unitswithout
barcodes
88
96
TOTAL
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Project Methodology
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Presentation and Results Validation
Phase III
Symbology GS1
Logistics units
Consumer Units
40 3 7
9 8 11
49 11 18TOTAL
GS1-128 GS1 DataMatrix EAN 13 HIBCC Code-39 Code-128 DataMatrix
2
0
7 0
5 2
0
27
2
7 2
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Project Methodology
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Presentation and Results Validation
Phase III
72% of the analyzed units are coded (81% and 60% Logistics Units Consumer Units)
81% the analyzed bar codes are GS1
! 18% of barcodes GS1 analyzed comply
X 28% the analyzed units are not encoded
X 19% the analyzed barcode are not GS1
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Project Methodology
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Cx Ext Cx Int UC Cx Ext Cx Int UC
3M Portugal
Albino Dias de Andrade, Lda
Alves & CA, Lda
B.Braun Medical, Lda
Biotorax
Covidien Portugal, Lda
Edwards Life Sciences (EXTRA)
Eugénio Pereira, Lda
HR - Produtos Químicos, Lda
Intersurgical Portugal
Johnson & Johnson, Lda
Medinfar - Sorológico
Medtronic Portugal
Molnlycke Health Care
Overpharma
Paul Hartman
PMH - Produtos Médico Hospitalares
Sarstedt - Tecnologia de Laboratório
Smith & Nephew, Lda
Smiths Medical
Vygon
Produto I Produto II
Approach to Suppliers
Phase IV
Failure or error in coding
Small inaccuracies in coding
Coding smoothly or removable correction
Subtitle:
Phase V
Implementation of
recommendations
© GS1 2015 20
Framework
Description of logistics
Project Methodology
Conclusions
Next steps
© GS1 2015
Conclusions
21
Assess relevance of recommended GS1 coding with our suppliers, in order to achieve our objectives for the medium - long term.
Realize whether to develop further awareness-raising among suppliers.
Start active involvement of suppliers.
© GS1 2015
Conclusions
22
Hospitals need to reduce the costs of their activities, but they can not jeopardize the quality of care provided to their users, and that global standards (GS1) can help achieve these two objectives ... at the same time!
Benefits Supply Chain(Efficiency and Cost Reduction)
Benefits to the user(Traceability and Safety)
Reduction of inventory levels Recall process easier
Reduction of obsolete stocks Electronic records in the output / more rapid and effective user
Facilitated recall process and faster Combat counterfeiting
Improved order management process
Reduction of medical errorsCalculation cost for more accurate patient
© GS1 2015 23
Framework
Description of logistics
Project Methodology
Conclusions
Next steps
© GS1 2015
Next steps
24
Sending letters of recommendation for the use of the GS1 system, by the CHLN.
Continue to monitor suppliers, monitoring the degree of correction carried out by them.
Development Edition II of the Logistics Project GS1 - CHLN, selecting and engaging a new batch of
suppliers for the project.
Widely publicize the project in order to raise awareness throughout the CHLN supply chain.
Included in these steps is the CHLN initiated, internal logistics
project. This involves the management of information about
medical devices arriving in the CHLN and uses fully automatic
capture mechanisms.
