Adverse events (SPEAR)

Every year, close to 30,000 volunteer donors are asked to donate blood stem cells to a patient they do not know. To ensure the continued viability of the global system using volunteer donors, donor health and safety are of critical importance. The WMDA collects Serious (Product) Events and Adverse Reactions –S(P)EARs– via an online reporting tool: SPEAR. The aim of the SPEAR system is to gain insight in the occurrence of serious events and adverse effects in relation to blood stem cell donation by volunteer donors and blood stem cell collection/processing from volunteer donors. Reporting for related donors is highly encouraged as well, and the reporting tool fully supports this already.

Get access to SPEAR

You can login to the SPEAR reporting tool here. Do not have access yet? Please send an email to Eefke van Eerden, our Pillar 3 representative, to request an account.

Learn more about SPEAR

To learn more about SPEAR reporting and the online reporting tool, we highly recommend you watch the Educational Webinar that was recorded in March 2020. In this video, Mirjam Fechter (WMDA’s medical advisor and member of the SPEAR committee) talks about what (not) to report, root cause analysis and how to assess the imputability, amongst other topics.

Rapid Alerts

WMDA sends out Rapid Alerts in case a (series of) Serious (Product) Events and Adverse Reactions must be brought to the attention of the public at once to avoid this type of incident for the future.

Find the Rapid Alerts that were sent out in the past below:

Useful documentation

External links