Internationally Standardized Nomenclature for Skin Products DRAFT

Transcription

1 Internationally Standardized Nomenclature for Skin Products DRAFT

2 SkinNomenclature 1 Introduction SkinNomenclature There is growing recognition of the need for a globally consistent nomenclature and a coding system to ensure unique identification of tissue grafts worldwide. This need has been recognized by the World Health Assembly in 2010 and Resolution WHA63 22 urges member states to encourage the implementation of globally consistent coding systems for human cells,tissues and organs as such in order to facilitate national and international traceability ofmaterials of human origin for transplantation. The European Tissue Technical Advisory Group (ETTAG) and the North American Tissue Technical Advisory Group (NATTAG) have been formed by ICCBBA to develop an international nomenclature for human tissue. The ETTAG, under the Chairmanship of first Dr. Deirdre Fehily and then Dr.Izabela Uhrynowska- Tyszkiewicz, has developed the nomenclature proposed in this document and NATTAG has reviewed and agreed the proposed terminology. The nomenclature presented is open for public comment and the advisory groups welcome constructive criticism. Following the consultation period, final adjustments will be made before formal publication. Background ISBT 128is a well established international coding system for blood, cell therapy, and tissue products. It provides a comprehensive and highly flexible system for describing products and assigning product codes. The foundation of this system is a nomenclature which is constructed by international consensus to ensure global consistency in use and understanding. New products are defined by combining pieces of information from the dictionary in a way that unambiguously describes the product. The ISBT 128 product description database is created using a rules-based system. It uses classes and attributes to describe products and then assigns each unique product a five-character product description code. Classes are broad descriptions of products. For skin,examples of classes are Skin, Full and Skin, Split. Attributes provide the means to uniquely define the product. Attributes are arranged in groups and within each attribute group there are a number of possible variables, only one of which can be selected. For example, Consent/Authorization is a group; For surgical use only is a variable within that group.where a product does not have a variable assigned for a particular group, the default variable for that group will apply. The full data structure for the product code is eight characters long (see Figure 1), with the first five characters comprising the product description code. The remaining three characters provide a means to uniquely identify multiple occurrences of a tissue product derived from the same donation event. Thus if two splitskin products are createdduring processing, they can be uniquely identified by using 001 and 002 in these three positions.

3 Skin Nomenclature 2 Figure 1 Product Code For more information, please see the following documents on the ICCBBA website: ISBT 128 Standard Technical Specification Standard inology for Blood, Cellular Therapy and Tissue Product Descriptions Implementation Guide: Use of Product Code Data Structure [003] Tissues

4 Skin Nomenclature 3 Proposed Nomenclature Classes Skin, Full Skin, Split Skin, Full with Hypodermis Dermis Full thickness skin (epidermis and whole dermis) Split thickness skin (epidermis and upper part of dermis) Full thickness skin with subcutaneous tissue (epidermis, dermis and hypodermis) Skin from which the epidermis and subcutaneous tissue have been removed leaving only the dermal layer. Attribute Groups Preservation technique and storage conditions Consent/authorization Processing Status Describes the preservation technique and/or the conditions under which the product will be stored Describes the consent/authorization obtained for use of the donation Indicates if a product is being held for further processing Pathogen reduction Meshed Donor-intended recipient relationship Processed to reduce cellular components Describes the method of sterilization or decontamination of the product Describes the degree to which the surface area of the skin has been increased by creating a net or web Describes the relationship between the donor and the intended recipient. Indicates whether or not the product has been decellularized

5 Skin Nomenclature 4 Attribute Variables Preservation Technique and Storage Conditions Default: NS No information is provided about preservation technique or storage conditions Frozen Stored frozen, but not meeting the definition of cryopreservation. Cryopreserved Preserved with the use of non-specified cryoprotectant and stored at very low temperatures in the frozen or vitrified state in order to maintain cellular viability and/or preserve tissue matrix structure. Cryopreserved - DMSO Cryopreserved - Glycerol Freeze dried Refrigerated Glycerolized Preserved with the use of DMSO and stored at very low temperatures in the frozen or vitrified state in order to maintain cellular viability and/or preserve tissue matrix structure.dmso is usually in the range 5-10%. A more specific concentration may be stated in text on the label or in the accompanying documentation. Preserved with the use of low concentration glycerol and stored at very low temperatures in the frozen or vitrified state in order to maintain cellular viability and/or preserve tissue matrix structure.glycerol usually in the range of 5-10%. A more specific concentration may be stated in text on the label or in the accompanying documentation. (Lyophilized) Preserved in a dried state achieved by freezing followed by sublimation of water under vacuum to very low residual moisture contents. Stored at the room temperature. Refrigerated between 1 and 10 C; national requirements may narrow this range Preserved by immersion in high concentration glycerol and stored in the liquid state (refrigerated or room temperature)'

6 Skin Nomenclature 5 Consent/Authorization Group Default: Consent/authorization information not provided Consent/authorization information NS For surgical use only Consent has only been given for surgical use. For surgical or research For surgical or educational use For surgical, research or educational use For research use only For research or educational use For educational use only Consent has been given for either surgical or research use but not for educational use. Consent has been givenfor either surgical or educational use but not for research use. Consent has been given for surgical, research, or educational use. Consent has only been given for research use. Consent has been given for either research or educational use but not for surgical use. Consent has only been given for educational use. Processing Status Group Default: Not defined For further processing No information is provided as to the processing status of the product The product produced as an intermediate stage. Not suitable for use without further processing

7 Skin Nomenclature 6 Pathogen Reduction Group Default: Not specified Radiation sterilization ETO Peracetic acid Antibiotics Combined process No information about pathogen reduction is provided Exposed to ionizing radiation in accordance with a validated sterilization process Exposed to ethylene oxide gas in accordance with a validated sterilization process Exposed to peracetic acid in accordance with a validated sterilization process Treated with antibiotics as a decontamination step Multiple methods of sterilization or decontamination used. Further details available in accompanying documentation. Meshed Group Default: Not specified Not meshed Meshed 1:1 Meshed 1:1.5 Meshed 1:2 Meshed 1:3 No information about whether the skin has been meshed is provided. The skin has not been meshed The skin has been through a mesher to facilitate stretching Surface area of the skin is increased by creating a net or web to an expansion ratio of 1:1.5. Surface area of the skin is increased by creating a net or web to an expansion ratio of 1:2. Surface area of the skin is increased by creating a net or web to an expansion ratio of 1:3.

8 Skin Nomenclature 7 Donor-Intended Recipient Relationship Group Default: Not specified Autologous Allogeneic No information about relationship between donor and intended recipient is provided Donor and intended recipient are the same individual Donor and intended recipient are different individuals. Processed to Reduce Cellular Components Group Default: NS Cell reduction process: Yes Cell reduction process: No No information is provided regarding a process to reduce cellular components Product has undergone a processing step to reduce cellular components. Details may be provided in accompanying documentation Product has not undergone a processing step to reduce cellular components.

9 Skin Nomenclature 8 Consultation This document is being made publically available on the ICCBBA web site, and relevant professional bodies have been notified and asked to bring this to the attention of their stakeholders. The advisory group welcomes comments on these proposals. Feedback should be submitted to by May 16, The advisory group will review all comments prior to finalizing the nomenclature.

10 Skin Nomenclature 9 European Tissue Technical Advisory Group Participants Deirdre Fehily [Former Chair] Izabela Uhrynowska- Tyszkiewicz [Current Chair] John Muircroft [Secretary] Kyle Bennet Anne Cathrine Bollerup Catarina Bolotinha Scott Brubaker Doris Datlinger Bernhard Fattinger George Galea Jørgen Georgsen Luca Gianaroli Ramadan Jashari Dorte Kinggaard Holm Teemu Laakso Stella Larsson Aurora Navarro Rita Piteira Stefan Poniatowski Ruth Warwick Jannine Westby Diane Wilson