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 (FDA) as issuing agencies of UDI Systems. It was prepared for the American Association of Tissue Banks (AATB) under contract with Core Risks Ltd. LLC to produce a comparative matrix of these systems to facilitate membership discussion and decision-making regarding labeling of allograft (finished) tissue. The report contains the following sections: Introduction and Context Summary of Work Current Requirements o National AATB Standards for Tissue Banking State Laws Federal regulations o International Case for Action International Medical Device Regulator s Forum (IMDRF) Guidance Single European Code (SEC) Coding Standards Comparison o General Overview ISBT 128 GS1 HIBCC o Coding Standards Costs ISBT 128 GS1 HIBCC Data Structures/Technical Aspect of Labeling Standards o ICCBBA o GS1 o HIBCC Conclusions and Recommendations
Introduction and Context The UDI Systems Final Rule is new and applies specifically to device manufacturers, it is considered a solution to adequately address the importance of: Traceability of products (from origination to end use and back); Adequate identification of products through distribution and use; Identification of products involved in adverse events; The potential of a reduction in medical errors; and The capture of data on products. There are institutional members of the American Association of Tissue Banks (AATB) who are not only manufacturers of tissue allografts that fall under the FDA designation as an HCT/P (human cell, tissue, and cellular and tissue-based products), but who are also considered manufacturers of medical devices (that contain a human tissue component). Due to the UDI Systems Final Rule, a number of tissue establishments will be implementing a device identification solution over the next two years. Tissue processors in the United States currently employ their own coding systems to identify and track allografts within their possession/facility, however, very few use coding that can be interpreted and used by all distributors and end users. This practice was once the norm in the traceability and labeling of pharmaceutical products and medical devices but the FDA guided by the U.S. Congress - has developed coding and labeling policies over the past several years that would seem to suggest the possibility that conventional HCT/Ps could be held to similar expectations. AATB is considering its position on the topic. The development of new standards and implementation of global identifier solutions in the tissue-processing realm is complex. The reality is that the community as a whole has the opportunity to be proactive in the development of new policies and to be part of the greater discussion whether or not governmentally mandated requirements become a reality. The AATB Board of Governors is interested in providing the membership with an objective assessment of current industry tissue labeling capabilities and the associated potential risks. The information provided in this report provides the AATB a basis from which internal membership discussions and decision-making regarding tissue labeling systems can be facilitated. This document represents part of a multi-step approach designed to assist association members to systematically identify, assess and hopefully develop consensus relative to the best options regarding unique identification labeling of finished tissue grafts. 2
Summary of Work The information gathered for this report is based on interviews with leadership from each of the three standards organizations that AATB identified for the scope of this work (ICCBBA, GS1, HIBCC). Time was spent speaking with members of AATB as well as AATB leadership in the home office. On-line research of publications, regulations, work group products, and press rounded out the information that forms the basis for this report and the recommendations herein. A draft matrix of items to compare each coding system was developed and presented to AATB staff and to the Board of Governors at their Spring Meeting 2013 for input and consideration. After receiving input from the Board of Governors and AATB leadership, the Core Risks Ltd. project lead determined it was necessary to modify the matrix significantly to include only information that was directly related to the coding systems. The reason for this being that much of the content in the original draft of the matrix pertained to software solutions (e.g., reporting, necessary modules, operating systems, etc.). The variety and breadth of software available on the market and the various levels of software solutions that are already completely or partially implemented by AATB members makes it difficult to provide one price or even a range of prices to consider. The software decisions made by each organization will be key to implementation and their budgeting process when considering the full integration of a new labeling solution. The matrix format may be useful from a visual standpoint but the details of the comparisons are contained in this overview document. Current Requirements National AATB Standards for Tissue Banking Since the publication of the first edition of the Standards for Tissue Banking (Standards), there has been a requirement for accredited tissue banks to uniquely identify tissue donors and allografts for tracking purposes. In the 1984 edition, Standard B2.330 described that Each tissue and any components derived therefrom shall be assigned, in addition to generic designation, one unique tissue identification number which shall serve as a lot number to identify the material during all steps from collection through distribution and utilization. Today, this concept remains and requires use of a unique donor identification number and a unique tissue identification number to facilitate tracing of the tissue from the donor to the tissue s final disposition. The uniqueness of identification numbers is applicable when assigning numbers at each accredited tissue bank, but this concept has not been required to be unique on a broader scale across all 3
tissue banks to avoid any duplication of numbering styles between tissue banks. Medical devices containing tissue are not specifically addressed. State Laws A few states, such as New York, Florida, California, and Maryland, have requirements for tissue banks to use a donor identification code and/or unique tissue number or require some additional aspect of tissue tracking. Some defer to following AATB s Standards. Medical devices containing tissue are not specifically addressed. Federal Regulations Since 2005, the FDA has required each HCT/P manufacturer to assign its own distinct identification code to each HCT/P and to label it with that code to enable the HCT/P to be tracked from the donor to the consignee or final disposition, and vice versa. 1271.290(c): Each HCT/P that is manufactured or processed must be assigned and labeled with a distinct identification code that relates the HCT/P to the donor and to all records pertaining to the HCT/P. 1271.290(b)(1): Processors/Manufacturers must have a tracking system in place that enables the HCT/P to be tracked from the donor to the receiving facility (consignee) OR final disposition and back to the donor. The full text can be found by visiting: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpar t=1271 Now, the UDI Systems Final Rule requires specific labeling for medical devices containing human tissue. On September 25, 2013, the AATB issued a News Release to alert membership to the publication by FDA of the Unique Device Identification (UDI) System final rule and provided notice of the availability of draft guidance for the Global Unique Device Identification Database (GUDID). Access all associated documents hyperlinked below: UDI System final rule (44 pages) GUDID draft guidance (59 pages) During November 2012, the AATB sent comments to FDA on the UDI System proposed rule, and in December to an amendment. Hart Health Strategies created two useful documents for the AATB membership: a 14-page summary of the UDI final rule; and a 7-page side-by-side comparison document that reveals FDA utilized comments we submitted. 4
International International Medical Device Regulatores Forum (IMDRF) Guidance The IMDRF issued a proposed draft, UDI System for Medical Devices Version 2.0 on April 10, 2013. Comments were collected until July 31, 2013. This regulators-only medical device harmonization group is made up the United States (FDA), Australia (Therapeutic Goods Administration-TGA), Brazil (National Health Surveillance Agency ANVISA), Canada (Health Canada), the European Union (EU), Japan (Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP). China recently became a full member and Mexico has been invited to participate as an official observer. The importance of the global aspect of the work group should not be overlooked. The April 10 guidance document provides nonbinding rules for use in the regulation of medical devices. This will likely serve as the basis for any country s guidance documents following a Final Rule. Perhaps most importantly, in the context of this report, the guidance refers to three UDI systems that were deemed acceptable for labeling use: The Global Standards One (GS1), Health Industry Business Communications Council (HIBCC) and the International Council for Commonality in Blood Banking Automation (ICCBBA). All three UDI labeling options meet the criteria of the UDI and manufacturers shall be permitted to choose which system to use. Each of these systems can meet the technology needs of labeling multiple and varied devices (and tissue products). GS1, HIBCC, and ICCBBA each have the responsibility for maintaining the global uniqueness of their coding systems. It is the IMDRF s strongly stated imperative that these coding systems be adopted and implemented, without national deviations or changes. It is also the IMDRF s position that a proliferation of coding systems should be discouraged. The IMDRF also believes that limitations relative to the number of accredited global organizations and available coding systems should be considered. This guidance document would point to the opportunity for organizations within the tissue processing community to adopt one of the three technologies without forcing all to adopt the same coding system. If there are standards developed, any of the three systems will serve the needs of the organizations implementing a new labeling system. Refer to http://www.imdrf.org/consultations/cons-udi.asp 5
Single European Code (SEC) European Directive 2004/23/EC requires the European Commission to design a single European coding system to provide information on the main characteristics and properties of tissues and cells. The European Commission emphasized that the purpose of a Single European Code (SEC) is not to replace existing coding systems but to provide a common format to present information held in different coding systems throughout the European Union (EU). In 2011, the European Commission issued a service contract for the development of a compendium of tissue establishments and a compendium of tissue and cell products. Different coding systems can be represented within the SEC. The contract was awarded to Eurocet 128, a consortium whose members are the Italian National Transplant Centre (CNT), ICCBBA, and Artman Technologies. The Single European Code is an alphanumeric code that carries information on the tissue establishment in the European Union, the donation number, the product code, divisions and expiry date in a standard format. The SEC includes the following and should only be applied by a licensed/approved tissue establishment in the EU: Donation Identification A 2-character (alphabetic) ISO Country Identifier, a 6-character (alpha/numeric) TE Code, a 13-character (alpha/numeric) Unique Donation Number Product Identification A 1-character (alphabetic) Coding System Identifier, a 7-character ((alpha/numeric) Product Code, a 3-character (alpha/numeric) Split Number, and an 8-character (numeric) Expiry Date. It s unlikely to be a legal requirement to have the SEC on the label before 2017. References: http://ec.europa.eu/eahc/documents/health/conference_27-28_06_2013/sanco_i_siska_traceability_vigilance.pdf http://ec.europa.eu/eahc/documents/health/conference_27-28_06_2013/eurocet_28_- _European_Coding_System_for_Human_Tissues_and_Cells.pdf Case for Action The following areas should be considered in deciding an appropriate level of action: Regulatory Environment o There is a possibility that requirements similar to UDI will ultimately be developed for HCT/Ps 6
o Select members of AATB will be ramping up to meet UDI regulatory requirements because they also market medical devices or certain combination products. General Risk Areas o Patient Safety o Public Trust/Public Perception o Protection Against Counterfeiting o Enhancement of Traceability o Serious Adverse Reaction Reporting Capabilities o Serious Adverse Reaction Notification o International Distribution o Supply Chain Management and Capabilities Coding Standards Comparison General Overview ISBT 128 The ISBT 128 coding standard is the proprietary property of ICCBBA (formerly the International Council for Commonality in Blood Banking Automation). ICCBBA is an international non-governmental organization (NGO) that manages, develops and licenses ISBT 128; the international information standard for the terminology, coding and labeling of medical products of human origin. ICCBBA has a working group that is tasked with developing definitions and standards for labeling of HCT/Ps. This working group, the North America Tissue Technical Advisory Group (NATTAG), is currently working on naming and defining recovery products. Interviews with leadership at ICCBBA point to continued interest in pursuing a standards-based solution to traceability and labeling. GS1 GS1 is an international not-for-profit association with member organizations in over 100 countries. GS1 designs and implements global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world. GS1 is used in a variety of sectors including healthcare, transportation and logistics, aeronautics, defense, chemicals, high tech, and the retail supply chain. Interviews with GS1 North America staff indicate that currently they do not have an interest in taking on the development of standards and definitions for human tissue products. GS1 focuses on the identification of products through the supply chain it is 7
industry driven. GS1 and their Healthcare Leadership Team work to meet needs of their members. Human tissue labeling has not been on their radar because their members have not brought it up as a priority As GS1 has a strong relationship with ICCBBA and recognizes their work in the blood products and other healthcare realms, the view of the GS1 leadership is to allow ICCBA to take the leadership role in coordinating the development of standards and definitions for human tissue products. HIBCC Health Industry Business Communications Council (HIBCC) is the primary standardsetting and educational organization for bar coding in the world of healthcare. HIBCC is an American National Standards Institute (ANSI) accredited organization, with a primary function of facilitating electronic communications by developing appropriate standards for information exchange among all health care trading partners. HIBCC, as a standard setting organization, is available to organize a work group to develop standards. The leadership of HIBCC is available for the administrative and project management support that is necessary to finalize definitions and standards. The Executive Director is available to provide a presentation on how they would work with AATB to move toward standards development. Coding Standards Costs ISBT 128 INITIAL FEE: There is an initial $200 registration fee for the labeling institution, which includes the allocation of the first Facility Identification Number (FIN). ANNUAL FEES: Annual fees are determined by the number of final labeled products produced in the previous year. Tissue facilities with up to 1,000 in annual final labeled products = $206 Tissue facilities 1,000-5,000 in annual final labeled products = $310 Tissue facilities in excess of 5,000 annual final labeled products = $310 + $0.11 per additional labeled product. Refer to http://www.iccbba.org/registration-licensing/isbt-128-fees GS1 INITIAL FEE: The initial license fee is determined by how many barcodes the company needs currently (one barcode for each product and for each product variation) PLUS how many 8
barcodes the company will need over the next few years AND on Annual Gross Revenue. To see the bar code fee estimator please visit: http://www.gs1us.org/getstarted/i-need-a-gs1-company-prefix (bar code fee estimator on right hand side). ANNUAL FEES: There is also an annual fee, which is calculated based on Annual Gross Revenue and the number of bar codes needed. The same bar code estimator calculator can be used to determine the annual fee (see link above). Example: # of barcodes needed = 700 Annual Gross Revenue = $35 million -$50 million INITIAL FEE= $11,700 Annual RENEWAL FEE = $500 HIBCC INITIAL FEE: There is a one-time registration fee to obtain the primary Labeler Identification Code (LIN). The fee for primary licensing is computed on the principle of is based on annual Gross Sales of private labeled packaged products to the health care industry. The calculation includes: sales of all divisions and sales to other manufacturers but not intracompany sales. Please see the application for detailed information by visiting, http://www.hibcc.org/wp-content/uploads/2012/09/lic-application.pdf. There are no recurring fees on an annual basis or per label for the HIBCC labeling standard. 9
Data Structures/Technical Aspect of Labeling Standards Each of the three accepted coding standards discussed in this document are globally accepted for medical devices. The UDI is required to have two parts: a Device Identifier (UDI-DI) and a Product Identifier (UDI-PI). The UDI-DI (GS1, ISBT, HIBC-LIC) should be globally unique. The UDI-PI may include items such as a serial number, lot/batch number, manufacturing and/or expiration date. The technical ability for these coding standards to include that level of depth means that any of the three can be used to meet traceability needs. The UDI carrier is composed of the Automatic Identification and Data Capture (AIDC) and the Human Readable Interpretation (HRI), and will appear on the label of each product. In the guidance document, UDI System for Medical Devices, published by the International Medical Device Regulators Forum, it is specifically stated that no particular AIDC methods should be required by a regulatory authority. The specific labeling data structures of each coding standard are extremely specific and can be can be found on the organization websites. ICCBBA is the only organization with tissue specific standards developed. ICCBBA Tissue Technical Specifications can be found at this link: http://www.iccbba.org/tech-library/iccbba-documents/tissues-documents GS1 GS1 Architecture and Integrity: http://www.gs1.org/gsmp/process/arch_group Barcodes and ID Key Standards: http://www.gs1.org/gsmp/kc/barcodes HIBCC Health Care Industry Bar Code Standards http://www.hibcc.org/udi-labeling-standards/ http://www.hibcc.org/udi-labeling-standards/barcode-upn-standards/ 10
Conclusions and Recommendations The data included within the matrix and in this report is based upon interviews, research and fact finding collected by a neutral party. As the project progressed, it was clear that the technical specifications of the labeling solutions are perhaps the least relevant piece of a complex puzzle. While the revised matrix provides valuable information regarding specific coding solutions that are available, it should be noted that it does not address many other factors that a business will have to consider when developing a budget, choosing or amending software, and implementing a labeling solution. Reporting capabilities, timelines for implementation, specific costs, hardware, staff time and other important considerations will need to be taken in to account by each business entity of they choose to move forward with a globally unique identification labeling solution. Recommendations for AATB: AATB membership should consider moving forward with a more robust assessment that addresses the membership's highest-level strategy, objectives, and plans regarding labeling and traceability. This will ensure that the industry perspective is clear and that work toward consensus can be achieved in a way that will address various member interests. STRATEGY: Membership should develop a strategic position related to: o Continuing planning for possible implementation or inclusion in the accreditation program now or; o Determine that the Association will not address the inclusion of unique identification standards at this time and will readdress at some later point or; o Determine that the membership will only implement if required to do so by regulation. OBJECTIVES: Articulate a set of objectives against which the Association and its members can act over time to maintain a proactive stance and a consistent way of addressing new developments and requirements. PLANS: Based on strategy and objectives, develop high-level steps, and associated timelines, as a guide against which to measure progress toward final goals. KEY ACTIONS: o Perform an in-depth assessment of the tissue labeling issue and associated risks and provide members of AATB with a report of the findings that can be used by AATB leadership to facilitate the development of a proactive plan of action. This would consist of supply chain, end user, 11
member organization and other stakeholder interviews and polling. It would result in a gap assessment and a clear, detailed report of actual and perceived risks that exist. o Defining individual categories and stratification of the AATB membership to ensure that standards are appropriate for each type of member organization. Assuming the goals and objectives determined by AATB members include moving toward unique identification of tissue products, the development/finalization/definition of baseline standards will be required. If implementation is to be conducted, begin to develop standards and unique identification, it will be imperative to include the supply chain and end user in the development of overall industry solutions. 12