International Council for Commonality in Blood Banking Automation
ICCBBA
ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard for blood and transplant.
ID: 248042825272-17
Lobbying Activity
Response to Revision of the Union legislation on blood, tissues and cells
8 Sept 2022
ICCBBA (www.isbt128.org/about-iccbba) broadly welcomes the proposed framework for Blood, Tissues and Cells as an advance on the current directives. We wish to highlight the following:
A prerequisite for safety through biovigilance is an ability to effectively trace a product from the donation event to its transfusion or transplantation into another person. ICCBBA is concerned that the proposed legislation does not clearly emphasize the required biovigilance elements of a SoHO chain of custody from donation to therapeutic use. ICCBBA requests that the Commission reconsider the following 3 areas:
1. In 2010, the World Health Assembly Resolution WHA63.22 urged member states ‘to encourage the implementation of globally [our emphasis] consistent coding systems for human cells, tissues and organs … to facilitate national and international traceability of materials of human origin for transplantation” . ICCBBA proposes that Article 45(2)(a) be amended to read “...is unique globally” to minimise the possibility of duplication. This risk is illustrated by the 2013 case of a bone marrow transplant patient who received the wrong cells due to a mix-up of near-identical donor identifiers .
2. The framework proposes extensive provisions for vigilance and reporting of SAO under Articles 35, 36, 47 and 58 including measures to protect SoHO recipients and offspring of medically assisted reproduction from transmission of pathogens, toxins or genetic conditions. There should be a clear requirement to efficiently link the recipient to the donor of SoHO and not just the product so that anyone receiving a product from the same donation event can be quickly identified. The Global Registration Identifier for Donors developed by World Marrow Donor Association and ICCBBA is an example of how this problem could be addressed. The 2021 case of tuberculosis transmission in the US highlighted the need for full traceability of all SoHO, not just to individual lots but directly to the donor whereby implanted allograft bone material led to at least 8 deaths among recipients attributed to tuberculosis (3 deaths occurred after the outbreak was identified) with multiple opportunities for exposure of caregivers and others .
ICCBBA encourages the Commission to give full effect to Article 25(3) whereby SoHO entities that do not process and store SoHO but perform the human application of SoHO and can have significant influence on safety and quality should also require oversight. At minimum, those entities should be required to report on the disposition of each product and any arising SAO to the distributing establishment. This would help to close the traceability loop which is currently limited to the establishments and offer additional reassurances to EU patients.
Furthermore, vigilance is greatly facilitated when traceability measures use the same terminology and definitions to ensure accurate data collection and like-with-like comparisons. Standards such as ISBT 128 can support a truly effective rapid alert system as outlined in Article 36.
3. The proposal includes provision for the Commission to address sufficiency and supply issues and Commission Staff Working Document SWD (2022) 189 makes clear the significant movement of SoHO within the EU and to and from third countries. Product coding and identification standards like ISBT 128 support unambiguous identification of SoHO and are essential to facilitate more effective regional, national and international inventory management. Electronic systems supporting automated unique donation identifiers using clear and consistent product codes are critical to making inventory management feasible.
Our full feedback is attached.
Read full responseResponse to Revision of the Union legislation on blood, tissues and cells
14 Dec 2020
A revision of the BTC legislation is to be welcomed. In particular, a consistent approach to the unique identification of all products derived from a human donor is essential to ensure rapid and effective recall and follow-up.
Traceability is most challenging in situations where a single donation event generates multiple products that fall under different regulatory requirements regarding identification and labelling.
For these reasons, an internationally harmonized system of unique identification of the donation event that is carried forward onto every product derived from that donation, regardless of regulatory boundaries, is essential to support a level of traceability necessary to provide effective recall and lookback in order to protect patient safety.
The roadmap recognizes the challenges of ensuring traceability where cross-border exchange occurs. However, the essential need to transfer products across borders to provide life-saving interventions is global in scope and a global solution should be sought. Globally unique identification is the only way of eliminating the risk of duplication of identifiers.
The 2019 evaluation of the legislation on blood, tissues and cells recognized that legislative provisions for vigilance and traceability have helped to prevent harm to recipients. However, regarding the introduction of the Single European Code (SEC), the evaluation also recognized that “for stakeholders that were already complying with an international coding standard, a significant portion of establishments, this provision brought costs associated with IT upgrades and labelling changes that did not bring additional benefits over the existing systems leading to cost inefficiencies in the system.”
The introduction of the SEC has led to improvements in traceability in situations where local identification and labelling systems were previously used. Where established international systems are in place, these are more reliable for traceability purposes and should continue to be used as the primary systems for identification and traceability. Traceability depends upon accurate recording of identifiers at all stages from donation to clinical application. The use of standardized electronic delivery mechanisms (e.g. bar codes defined by unique identifier Issuing Agencies), and the use of checksum algorithms for situations where manual entry is unavoidable, are industry standard ways to minimise the risk of transcription errors. The SEC does not support these features and thus there is a heavy reliance on manual transcription of a long alphanumeric identifier without error detection tools. The risks of transcription errors are significant with a potential loss of traceability.
The adoption of a single, globally consistent, identification for BTC and other medical products of human origin is in the best interests of patient safety worldwide. We believe that the barriers to providing consistent unique identification across all product derived from a human donor should be identified as one of the problems to be tackled in the impact assessment to emphasize the importance of this topic given a) the lack of a standardized coding of starting material, intermediate products and processing details and b) the heterogeneity of coding systems for blood products in Europe that is not in the best interests of patient safety. We would also request that “Standards Development Organizations” be added to the list of stakeholders provided in section D of the document.
We hope that the revised legislation recognizes that such a system provides the optimal solution and allows the use of ISBT 128 for the identification and traceability of BTC without the need for an additional EU specific coding system. We would also encourage the EU to adopt a policy that moves towards the consistent use of ISBT 128 in all BTC establishments.
(expanded text of comment in attached file)
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