Overview
The North America Tissue Technical Advisory Group (NATTAG) was formed in 2006. Its members are from the US and Canada. This regional TAG operates under the direction and guidance of the International Tissue Technical Advisory Group (ITTAG).
The purpose of NATTAG is to:
• Develop a consensus on the detailed implementation of ISBT 128 in North America and maintain a North America consensus document for the use of ISBT 128 on tissues;
• Contribute towards the international standardization of tissue terminology and product naming;
• Provide advice and support to facilities introducing the ISBT 128 Standard in North America;
• Advise on the on-going development of the ISBT 128 standard to support new developments in tissue banking in North America;
• Prepare educational material and tools to support the implementation of ISBT 128 in North America; and
• Promote the adoption of the ISBT 128 Standard in tissue banking in North America.
Summary of Recent Activity
NATTAG finalized the IG-028 Use of ISBT 128 by North American Tissue Banks v1.4.0 document to highlight the two options for labeling tissues using ISBT 128. One option is the medical device option, which can accommodate both medical device tissues and tissues regulated as a biologic. The other option is the “traditional” method, which does not accommodate medical device tissues.
The VA (Veteran’s Affairs) now requires that their tissue suppliers label their products using ISBT 128 and there is also a requirement that the supplier be accredited. Tissues regulated as a biologic and tissues regulated as a medical device are also required to be labeled using ISBT 128 if supplied to the VA.
MTF (The Musculoskeletal Transplant Foundation) has implemented ISBT 128 across three business units: Orthopedic, Plastic and Reconstructive Surgery, and Wound Care. The types of tissues include bone, soft tissue, dermis, adipose, and amnion. They utilize ISBT 128 Data Structure 034 that allows a facility-defined product code to be specified along with the ISBT 128 standardized product description code. Their label contains an ISBT 128 2-D symbol and also a linear bar code containing an internal donor serial number.
Lifelink will be able to accommodate ISBT 128 for its customers that request it and will provide the corresponding ISBT 128 product description codes to their customers. They plan on utilizing ISBT 128 Data Structure 034 that allows a facility-defined product code to be specified along with the ISBT 128 standardized product description code.
The EBAA (Eye Bank Association of America) developed a tool to help their member eye banks and surgeons become familiar with ISBT 128 labeling requirements and the specific product description codes to use for the various types of keratoplasty.
Meeting Info
No face-to-face meetings are currently scheduled for NATTAG.
TAG Members
Chair
• Jelena Holovati
Representatives
• Albert Anouna – BioGenetics Corp.
• Rhubella Arata – One Legacy
• Beverly Bliss – American Association of Tissue Banks
• Esther Carbon – RTI Bilogics
• Jennifer DeMatteo – Eye Bank Association of America
• Robin Fowler – LifeLink Foundation, Inc.
• Mark Friedman – AxoGen, Inc.
• Mohamed Harunani – American Dental Association
• Becky Holman – DCI Donor Services Tissue Bank
Manager RA & QC
• Perrin Larton – Advanced Bioscience Resources
• Ken Lotherington – Canadian Blood Services
• Eric Nagel – Community Blood and Tissue Services
• Mike Poole – LifeNet Health
• Donna Ridder – Cryobiology, Inc.
• David Tinker – American Association of Tissue Banks (Alt.)
• Linda Tracy – Advanced Bioscience Research
• Elkin Vasquez – University of Miami Tissue Bank
Technical Experts
• Diane Wilson
Observers
• Geoff Browne
• Jeff Dragoo
• Sharon Joyner
• Andrew Keelor
• Brian Kirkpatrick
• John Kling
• Paul Lehner
• Heather Reddy
• Quynh Vantu
Liaisons
• Scott Brubaker – U.S. Food and Drug Administration / Center for Biologics Evaluation and Research
• Brychan Clark – U.S. Food and Drug Administration
• Barry Daniels – Global Medical Device Nomenclature
• Safa Karandish – U.S. Food and Drug Administration
• Mark Wasmuth – Global Medical Device Nomenclature
• Izabela Uhrynowska-Tyszkiewicz – ITTAG
ICCBBA Staff Liaison
• Mónica Freire