ISSUE IDENTIFIED IN BPL PLASMA PRODUCTS PRODUCTION
The Department of Health (DH) published a statement (below) 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.
On Wednesday 12 July, Ministers at the Department of Health were informed by the Medicines and Healthcare products Regulatory Agency (MHRA) about an issue identified during a routine inspection of Bio Products Laboratory (BPL). The MHRA provided confirmation on Monday of this week that, in light of all of the information currently available, their assessment is that no patients have been harmed and none put at additional risk of harm due to the issue.
BPL is responsible for the supply of a range of plasma products to the NHS and a range of other major health systems around the world. The company, in line with best practice, operates a three stage process to ensure the safety of its products:
Selection of healthy donors, with all donations tested and traceable to the donor.
Further safety tests of plasma in advance of the manufacturing process.
During the manufacturing process, all products specially treated to inactivate viruses.
The MHRA informed Ministers that their inspection identified a problem with the computer software, which controls the stage one process set out above Following the identification of the issue by the MHRA, a manual review was undertaken by the company to ensure that no inappropriate donations made it through this stage of the process due to the problems with the computer system. This manual review confirmed that no inappropriate samples had made it through to the next stage of the process, and a range of other risk mitigation steps were also implemented .
MHRA have continued to provide progress updates to Ministers regularly since notification on 12 July.
On Monday of this week the MHRA confirmed to Ministers their assessment that the problem had been addressed through interim measures to provide the necessary assurance while long-term solutions are being implemented. In the opinion of the MHRA, due to the three stage process outlined above, and in light of all of the information currently available, no patients have been harmed and none put at additional risk of harm due to the issue.
The MHRA is continuing to undertake all necessary regulatory activities in order to ensure patient safety, and will continue to keep Ministers informed of this work.
Although there is no evidence of risk to patients in this case, in the interest of transparency, I wanted to update the House to this situation as quickly as possible with the relevant information. In the unlikely event of any changes, I will update the House accordingly.
This statement has also been made in the House of Lords: HLWS71
Further updates will be made as soon as they are available