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Serious Product Events and Adverse Reactions - SPEAR
WMDA has set up a central global reporting system to report Serious (Product) Events and Adverse Reactions – S(P)EARs – to the WMDA. To access the reporting system, you login with your email address and password. If you do not have a password, contact the WMDA office.
Aim
- To gain insight in the occurrence of serious events and adverse effects in relation to blood stem cell donation by unrelated donors and blood stem cell collection/processing from unrelated donors.
Purpose
To collect and analyse information on recipient and donor serious adverse events (SAE) and reactions which affect donors and/or products from all WMDA stem cell donor registries and cord blood banks.
To follow a rapid alert system for disseminating information on SAE/R to all members of the international community in contact with allogeneic donors and patients.
Important note on Rapid Alerts
The SPEAR Committee reviews all reported incidents once a week. If you have a rapid alert that needs to be shared with the community quickly, we urge you to submit it via the online reporting tool and to immediately send an e-mail to sear-spear@wmda.info or call us on: +31 88 505 7900.
In case of recall or big risks for future donations or transfusions a report can be submitted as a rapid alert. This includes, but is not limited to:
- any prohibition or restriction imposed by the competent authority/health authorities of any country in which the stem cell product is provided or transplanted;
- donor death;