The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 5th edition of the Guide to the quality and safety of tissues and cells for human application. The updated guide provides a comprehensive overview of the most recent advances in the field, as well as technical guidance on ensuring the quality and safety of human tissues and cells applied to patients. It is intended for healthcare professionals involved in all stages of the relevant activities, from identifying potential donors to the clinical application in patients and their follow-up.
Petra Doerr, EDQM Director, stated on this occasion, “This extensively revised edition takes into account the latest medical and scientific knowledge, data and techniques. It will further the objective of supporting professionals in improving the safety of tissues and cells and the efficiency of their clinical application. We thank the experts involved for their unfailing dedication and tireless work, all during the trying COVID-19 pandemic.” She also highlighted the initiative of complementing the guide with an innovative online tool, the EDQM Microbiological Risk of Contamination Assessment tool (MiRCA). “This tool will help users – in particular tissue establishments, fertility clinics and health authorities – assess aseptic processes during the procurement and processing of tissues and cells, with significant benefits for public health in Europe and beyond.”
New content includes a section with guidance on assessing risks of deceased tissue donors with an antecedent or tumour diagnosis, new algorithms for the interpretation of infectious markers (HIV, HCV, HBV) and guidance on testing for bacterial endotoxins, bioburden testing and validating decontamination with antibiotics.
For more information, read the press release “EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals”.