A UK scheme for reporting serious adverse events and reactions associated with ocular tissue transplantation.
Reporting and investigation of serious adverse events and reactions associated with tissue and cell transplantation is a fundamental aspect of ensuring adequate levels of safety and quality and is a requirement of the European Union Directives on tissues and cells. In the UK, a system for the reporting and analysis of events and reactions associated with ocular tissue transplantation is well established. It is operated by a network of individuals and organisations, each with clearly defined roles and responsibilities, following written procedures for reporting and investigation. Analysis of reports indicates that the most important adverse reactions associated with this type of tissue transplantation are endophthalmitis (0.58%) and primary graft failure (0.3%). This system allows the analysis of all types of events and reactions by the professionals involved so that trends can be identified and services improved. Tools to evaluate the severity and imputability of individual events or reactions, such as those developed by the EUSTITE project, can be utilised to facilitate the selection of those cases meeting the criteria for reporting to the Competent Authority. This vigilance model has been shown to be effective and could be applied in other fields of tissue or cell transplantation.
Kaye
Stephen
S
Ocular Tissue Advisory Group Audit Subgroup, Bristol, UK.
Baddon
Andrew
A
Jones
Mark
M
Armitage
W John
WJ
Fehily
Deirdre
D
Warwick
Ruth M
RM
D016039:Corneal Transplantation / Q000009:adverse effects*; D009877:Endophthalmitis / Q000209:etiology*; D006084:Graft Rejection / Q000209:etiology*; D006801:Humans; D019221:Mandatory Reporting; D012308:Risk Management / Q000331:legislation & jurisprudence* / Q000592:standards*; D006113:United Kingdom