Much of the work relating to identification of adverse occurrences has been carried out through professional associations. For example, the World Marrow Donor Association (WMDA) is an organization, which fosters international collaboration to facilitate the exchange of high quality haematopoietic stem cells for clinical transplantation worldwide and to promote the interests of donors. Its Clinical Working Group not only produces guidelines, recommendations and standards involving clinical aspects related to the donation of bone marrow and peripheral blood stem cells (PBSC) but also maintains the adverse events registry, S(P)EAR - the central reporting system for adverse events in unrelated donors. S(P)EAR is in fact comprised of two registries (Table 2):
In the field of Cornea transplantation, the Eye Bank Association of America (EBAA) initiated an adverse reaction reporting system in 1990 and in 2004 the Online Adverse Reaction Reporting System (OARRS). With respect to eye bank adverse reaction reporting, the EBAA Medical Advisory Board requires that recipients be tracked and that they seek a 3 – 12 month follow-up. Reporting, which is part of the accreditation process, was redesigned in 2004 for online submission.
In the field of Tissue Banking, the American Association of Tissue Banks (AATB) has produced a Guidance Document that aims to educate end users/clinicians by providing them with direction on how to: define proper recognition of suspected allograft-caused adverse outcomes (reactions and graft failures); describe reporting responsibilities (communication); detail expectations of cooperation during investigation through closure; and promote the non-punitive concept. The document also gives tissue banks advice on how to; ensure compliance with their communication responsibilities; define their expectations for investigation protocols and timelines; develop outcome terms and definitions in coordination with EUSTITE; and list and describe international implications. Completion of the guidance document took into consideration being given a focus on V&S for tissue allograft types that pose the most risk. The document was disseminated to all stakeholders in order to optimize recognition, reporting and investigation.
In the field of blood, the ISBT working party on haemovigilance, in collaboration with the International Haemovigilance Network (IHN) (previously the European Haemovigilance Network), has pursued the development of definitions for non-infectious transfusion reactions and complications of blood donation since 2004. See chapter 14. Current definitions for blood donation complications (2014) and for non-infectious transfusion reactions (2011) are available on the websites of the IHN and ISBT. In addition, definitions (tools) are available for classifying severity of adverse reactions and their imputability, i.e. the likelihood with which they can be ascribed to the transfusion. These are aligned with the imputability levels and severity criteria, which are current in clinical trials as well as (international) guidelines and legislation, also in the domain of tissue, cell and organ vigilance. Some groups, including the European Commission, in drafting guidance for the mandatory reporting of serious adverse reactions and serious adverse events associated with transfusion of blood or blood components, refer to these definitions
(13).
