Blood bank says tracking system is safe despite warning

THE blood bank moved yesterday to reassure the public that its blood tracking system is safe, despite an international warning that its newly installed computer network might be defective.

A statement issued by the Irish Blood Transfusion Service (IBTS) yesterday said the Irish Medicines' Board had inspected a validation of their computer system and found it to be satisfactory.

When the blood bank launched the French-manufactured Progesa computer system earlier this year it said it would allow better tractability of blood from the time of donation to use by hospitals.

The system would also reduce the potential for human error in releasing products not fully tested.

The US regulatory authority the Food and Drug Administration (FDA) has sent a letter to system manufacturer Mac-Systems warning that an inspection had found that the system was faulty and did not conform with good manufacturing practice.

The IBTS installed the system with effect from March in Cork and from May in Dublin.

When the IBTS learned about the FDA letter they wrote to Mac-Systems seeking a copy of the letter and the authority's report. The blood bank also expressed their concerns about the report's findings.

To date, the bank has not received all of the documentation requested and has notified Mac-Systems that they would be auditing them before the end of October.

At the blood bank tests are performed using automated equipment and tracked by a unique barcode number assigned to each donation.

The results are then transmitted to the mainframe computer where all the details and test results are collated.

The system is used to handle around 200,000 blood donations from Irish people each year that are screened for HIV, hepatitis and other blood-borne infections.

The FDA said investigations had found that the same computer system used by the blood bank is adulterated and is angry that the manufacturers has failed all blood banks around the world until a user encounters the problem.

The makers of the equipment have been accused of not properly investigating errors in the system that include the loss of data on labelled blood bags and mistakes in relation to names and dates.

The manufacturer was accused of failing to supply available corrective software to firms.