Directiva de codificación. Dr. Gregorio Garrido Jefe de Servicio Área Médica Organización Nacional de Trasplantes Madrid 19 de mayo de 2016

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1 Directiva de codificación Dr. Gregorio Garrido Jefe de Servicio Área Médica Organización Nacional de Trasplantes Madrid 19 de mayo de 2016

2 Aspectos legislativos

3 Aspectos legislativos

4 Aspectos legislativos

5 Directiva de codificación Key dates: Entry into force: 29/04/15 Transposition deadline: 29/10/16 Application from: 29/04/17

6 Directiva de codificación Borrador de modificación del RD- Ley 9/2014 en marcha!!! Key dates: Entry into force: 29/04/15 Transposition deadline: 29/10/16 Application from: 29/04/17

7 Aplicable a: Directiva de codificación Todas células y tejidos (incluidas importaciones) Excepciones: - distribución directa (PH) - urgencias - importación y distribución en el mismo ET - envío a otro banco para procesar (solo código donación) -tejidos almacenados a fecha 29/10/2016 si se liberan antes de 5 años 7

8 Directiva de codificación Estructura del código: Single European Code o Código Unico Europeo 8

9 Sistema europeo de codificación 1. The Tissue Establishment Compendium 2. The Product Compendium 3. A code translator application

10 1. The Tissue Establishment Compendium What is the Tissue Establishment Compendium? A register of all tissue establishments authorised by the Tissue and Cell Competent Authority(ies) of the Member State Activities for which each establishment is authorised(e.g. procurement, distribution import ) Tissue and cells types per activity

11 The Tissue Establishment Compendium: how it works Identifies TE using an ISO two character country prefix and a TE number. The latter has been assigned by the CA using a national identification code or, if not applicable (e.g: too long), by Eurocet128 e.g. TE Code for a TE in the Netherlands: NL Associated with this identifier is TE specific information

13 2. The Product Compendium What is the Product Compendium? List of all tissue and cell product codes that can be used in the SEC. It includes existing national and international coding system product descriptions and a list of EU Tissue and Cell product codes (EUTC) that must be used where a national or international system is not in use

14 Product Compendium: how it works (I) ISBT 128, Eurocode and the EUTC Code are the accepted coding systems and are identified in the SEC by a coding system identifier (A, B and E, respectively) UTC Code The Product Compendium maps all ISBT 128 and Eurocode tissue and cell codes to their corresponding EUTC Codes TEs can continue to use these existing coding systems as they are included in the product compendium If a product coding system is not currently in use, or the system in use is local only, a TE will be required, as a minimum, to use the corresponding EUTC Code

15 EUTC Codes: characteristics Very high level descriptions Approximately 90 terms in the list currently Examples CV, VALVE, AORTIC CV, VESSEL, ARTERY MS, BONE, FEMORAL MS, BONE, SHAPED GRAFT OCULAR, CORNEAL REPRODUCTIVE, OOCYTE PROGENITOR CELL, HEMATOPOIETIC, PERIPHERAL BLOOD

17 The Tools include: 1. The Tissue Establishment Compendium 2. The Product Compendium NL E A code translator application

18 The Translation Tool: characteristics Accessible on the EU web site Public access for lookup only Provides information on TE and product from the SEC 18

19 19

20 The Translation Tool: how it works (I) 20

21 The Translation Tool: how it works (II) 21

22 Creating a SEC» Situation 1: Existing labelling using acceptable coding system (ISBT 128 or Eurocode)» Situation 2: EUTC

23 » Situation 1: TE is in Netherlands and has been assigned TE number by the Eurocet 128 Consortium Product is ISBT 128 labelled: Product description code is S2092 Division code is A0 Expiry date is 31 Jul 2014 Donation Number: N

24 Directiva de codificación 24

25 Building the SEC:» Situation 1: SEC: NL028714N A00S20920A Two character ISO country code : NL Six character TE number: Unique Donation Number : N SEC: NL028714N A00S20920A Coding system identifier for ISBT 128: A ISBT 128 Product Description Code: 00S2092 Split number: 0A0 Expiry date (ISO format):

» Situation 2: ET en España (Centro Vasco de Transfusión) con código de banco numero 000091 por el Eurocet 128 Consortium El producto se codifica usando el

26 » Situation 2: ET en España (Centro Vasco de Transfusión) con código de banco numero por el Eurocet 128 Consortium El producto se codifica usando el código local: Donation number Bone ring Division number is 3 Expiry date is 31 Jul 2018 Bone ring maps to EUTC code MS,BONE,SHAPED GRAFT EUTC code 30

27 Directiva de codificación 27

28 Building the SEC:» Situation 2: SEC: ES E Two character ISO country code : ES Six character TE number: Unique Donation identification Number : SEC: ES E Coding system identifier for EUTC : E EUTC code: Split number : 003 Expiry date (ISO format) :

29 Provisions for TEs (I)» Application on the label: TEs that distribute tissue and cell products to other TEs or to endusers. If the TE provides to a second TE for further processing it should be labelled with the Donation Idendification Sequence At least in eye readable format. Preceded by the text SEC as a single line of characters with the Donation Identification Sequence and Product Identification Sequence separated by a gap, or as two successive lines respectively. In addition to SEC, other codes (local, national or international) may be also used, in accordance with the requirements of the national legislation.

30 Provisions for TEs (II)» Where the label size precludes the inclusion of SEC on the label: it can appear on accompanying documentation that is unambiguously attached to the product.» Tissues and cells imported from third countries should receive an SEC before distribution in EU except in the context of Direct Distribution. The importing TE is responsible for the application of the SEC on the label.

31 Provisions for TEs (III) Samples of the addition of the SEC on existing labels: Figure 1: Figure 2: Figure 3: Addition of the SEC to an ISBT 128 label (invented data) Addition of the SEC to a Eurocode label (invented data) Addition of the SEC to a local label

32 Gracias por vuestra atención 32

UDI Systems Comparison Report for Tissue Banks December 20, 2013

This UDI Systems Comparison Report for Tissue Banks provides AATB s membership with an overview of three specific labeling capabilities that will likely be approved by the Food and Drug Administration