Introduction
The World Marrow Donor Association (WMDA) coordinates the assessment of reports on recipient and donor adverse events and reactions (SPEARs) which can lead to product quality issues or harm/risk to harm to donor and/or patient. WMDA member organisations and their affiliated organisations are expected to report to any reportable incidents in a timely manner. When necessary, WMDA may decide to issue communication to notify relevant stakeholders about a critical incident or situation reported that requires urgent attention. A distinction is made between rapid alerts and critical reports.
Rapid alerts are typically sent out when there is an immediate threat to patient or donor safety, or the integrity of medical procedures, such as a restriction imposed by the health authorities of a country in which the stem cell product is provided or transplanted or a donor death.
Rapid alert messages provide anonymised information about the incident and recommended actions. They aim to ensure that healthcare professionals and relevant authorities can respond promptly and effectively to mitigate any potential harm or adverse outcomes.
Communication on critical reports is created when a report does not fit the description of a rapid alert and no expedited communication is needed, but the incident is deemed important enough for key parties to be informed because of its potential impact on donation practices or the reparation of stem cell donation worldwide.
Rapid alerts
2020:
- S(P)EAR Rapid Alert: July 2020 - Timely Patient Verification and Extended Typing.
- S(P)EAR alert: May 2020 - Cryopreservation during COVID-19 pandemic (update 11 June 2020 in red)
2019:
- S(P)EAR Rapid Alert: Dec 2019 - Lost Product
- S(P)EAR Rapid Alert: April 2019 - A fatal event in an unrelated Bone Marrow donor
2013:
- S(P)EAR Rapid Alert: Nov 2013 - Wrong Donor Cells Transplanted
- S(P)EAR Rapid Alert: May 2013 - Cardiac arrest following double CBU infusion
2011:
SPEAR Communication
2024:
The SPEAR Committee received multiple reports of serious incidents involving product loss during transport. Read the recommendations by the SPEAR Committee here: PDC.1305.COMM.HPC Products Missing in Transport.pdf
2023:
The SPEAR Committee received various reports of subdural haemorrhage (SDH) in unrelated PBSC donors. The committee shares a summary of these events and some of the things that are worth considering regarding donor care. Read it here: PDC.1304.COMM.Subdural Haemorrhage.pdf
- The committee highlights the importance of person-to-person communication to prevent unnecessary donation due to late cancellation. Read it here: PDC.1303.COMM.Unnecessary Donations.pdf
- A donor tested negative for HIV but was found to be positive on the day of donation. Based on this case, the committee provides recommendations to help protect donor and patient safety. Read it here: PDC.1302.COMM.Near-Miss Donation From Donor With HIV.pdf
The SPEAR committee has received reports of adverse events related to mis-labelling. The committee has issued a statement stressing the importance of correct labelling. Read it here: PDC.1301.COMM.Labelling Errors.pdf
Reporting a rapid alert?
Rapid alert
If an adverse occurrence requires rapid dissemination to the international transplant community to ensure a timely, accurate and proportionate response, please contact the WMDA office directly by sending an e-mail at sear-spear@wmda.info and by phone on: +31 (0)88 505 7900.