BTSB's continued use of lethal Factor 9 scrutinised

The Tribunal has heard a lot to date about haphazard and ineffective product recalls by the Blood Transfusion Service Board

The Tribunal has heard a lot to date about haphazard and ineffective product recalls by the Blood Transfusion Service Board. Yesterday, however, it learnt of one that worked.

In October 1985, just after screening for HIV was introduced, a donor to the anti-D immunoglobulin programme tested positive for the virus.

Immediately, a team of doctors swung into action at Pelican House. Each was allocated a number of hospitals to contact personally and to check whether any potentially infected batches of anti-D were issued to them. All batches were returned, and no infections occurred.

Contrast that with the board's approach to another Pelican House-made product, Factor 9, the clotting agent used by haemophilia B or "Christmas disease" sufferers.

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In August 1985 haemophilia treaters expressed in the strongest terms possible the need to heat treat all such products immediately to guard against infection. But the board continued to issue the untreated product.

In January 1986 the Department of Health and the BTSB agreed all blood products made before the introduction of HIV screening should be withdrawn. But the notice did not reach all hospitals or haemophiliacs, some of whom continued to use the untreated Factor 9.

Finally, in June 1986, a formal recall notice was issued by the BTSB. But this did not work either, as at least one regional haemophilia treater, Prof Ernest Egan in Galway, only learnt of the recall through a third party in August 1986.

Seven people were infected with the product, five of whom died, and the board failed to trace 200 vials of the potentially-infectious material.

Why the BTSB handled the two cases so differently was one of the questions under scrutiny yesterday, the first day of evidence of Dr Terry Walsh, a consultant haemotologist who worked for the board in various positions from 1969 to 1995.

Initially, his main functions were the anti-D programme and the collection of blood supplies. However, on occasion, he was consulted on blood products for haemophiliacs.

Asked whether the anti-D scare would have "set off alarm bells" about Factor 9, Dr Walsh said he understood there was concern about the product and that it was under constant review. He stressed it was not his area of responsibility but that of Dr Jack O'Riordan, the national director.

Dr O'Riordan authorised the recall of anti-D and would have had to authorise any recall of Factor 9, said Dr Walsh.

All he could say about the issue was that he understood concerns existed over the safety of heat-treating the product, and this may have delayed its introduction.

The Factor 9 issue will be further examined next week, as will the question of professional responsibility.

Dr O'Riordan retired from the board in December 1985, and his departure, said Dr Walsh, created a "vacuum", and seemingly some confusion over roles.

Dr Vincent Barry, regional director for the BTSB in Cork, was appointed chief medical consultant but, on his own admission this week, his job "simply was not being done" as he was unable to combine the two roles.

Dr Walsh succeeded Dr Barry as chief medical consultant in January 1988, although from documentation he appeared to have taken over many of his duties earlier than that. The level of his involvement in product selection during the interim period will be teased out when Dr Walsh returns to stand next week.

What was clear from yesterday's evidence was that Dr Walsh was in an unenviable position during the period in terms of consultant support in the board. Three months after Dr O'Riordan retired, the only other Dublin-based consultant, Dr James Wilkinson, left.

Dr Walsh said it was difficult to describe the situation "without sounding self-pitying", but it took considerable effort just to keep the service ticking over.