The Department of Health (DH) published a statement this morning regarding an issue identified during a routine inspection of Bio Products Laboratory (BPL) and their production of plasma derived blood products.
The statement says that there was a problem with the computer software which controls the process of selecting, testing and tracing healthy donors.
While the statement says that ‘there is no evidence of risk to patients’ and ‘that the problem has been addressed’ The Haemophilia Society are very concerned by this development and are seeking further information from the DH and the Medicines and Healthcare products Regulatory Agency (MHRA).
We want to urgently understand how the fault occurred, the risks identified and the actions that are being taken to rectify it.
We also expressed our deep reservations that the review to ensure no patients were put at risk was undertaken by BPL rather than an independent inspector.
We want to better understand the timeline that lead to today’s notification, when did the fault first occur, how long did it take to be identified and why did over a week pass between identification of the problem and the informing of patients and clinicians.
We have asked what the next steps are, when will the next inspection take place to ensure long-term solutions have been implemented and how will this be monitored in future. We will share any further information with members.