BTSB recall notice failed to adhere to Department of Health's instructions

Fresh allegations that the Blood Transfusion Service Board ignored Department of Health safety instructions on blood products…

Fresh allegations that the Blood Transfusion Service Board ignored Department of Health safety instructions on blood products for haemophiliacs emerged at the tribunal yesterday.

A recall notice issued by the board on January 30th, 1986, failed to adhere to a Department request for all blood products issued prior to the introduction of HIV screening the previous October to be withdrawn.

In addition, the notice - written by Dr Terry Walsh, then consultant haemotologist to the board - appeared to contradict proposals agreed between the Department and board officials that only heat-treated factor 9, which was less likely to be infected with the AIDS virus, should be used by haemophilia B patients.

Dr Walsh, on his second day giving evidence, admitted the notice "might have been more positively worded". However, he stressed it reflected the instructions which he had been given.

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Primary responsibility for the area, he said, rested with the two medical officials within the board in a more senior position than him: Dr James Wilkinson and Dr Vincent Barry, chief medical consultant. It was Dr Barry who asked him to write the notice "in order to help him with his workload", said Dr Walsh.

The proposals agreed between the BTSB and the Department were recorded in a memo of a meeting between senior officials from the two bodies at Pelican House on January 21st, 1986.

The memo noted that some untreated factor 9 was still being issued and this should stop. Only heat-treated products should be used in future, it said, adding if Pelican House had insufficient stocks, heat-treated commercial factor 9 should be used.

But the recall notice, issued days later to hospitals which treated haemophiliacs, was much less emphatic. It merely stated "heat-treated commercial factor 9 is now available. It is hoped that heat-treated factor 9 prepared by the BTSB will shortly be available."

Asked whether the notice should have stipulated that untreated material should have been returned to Pelican House, Dr Walsh replied: "that was not the intention as I received my instructions at the time".

He said the notice was primarily aimed at giving "advice" to clinicians as the board could not "dictate" what they should or should not use.

Moreover, Dr Walsh said it was far from certain commercial factor 9, made from plasma sourced overseas, would be safer than untreated Irish products. Crucially, however, there appears to be no evidence of the board informing the Department of these concerns.

Similarly, no response from the board has been found to a letter from Mr P.W. Flanagan, secretary of the Department in January 1986, who said it was "imperative" all products, issued before the introduction of HIV screening, were withdrawn. This would have included all untreated factor 9.

The letter was dated January 25th but apparently did not reach the BTSB until January 31st, the day after recall notice was issued.

Dr Walsh agreed the recall notice ran counter to the Department's wishes but what the Department was looking for was "not a practical proposition".

Dr Walsh said a lead-in time would have been necessary for Pelican House to create factor 9 from screened donors or to source it from commercial outlets.

But again there is no evidence of the board informing the Department of this concern.

Dr Walsh noted, however, anyone could have come back after the notice was issued to say it did not reflect what was agreed between the board and Department but this did not happen.

In a further disclosure yesterday, it was learnt a treating doctor rather than the BTSB may have triggered the recall notice.

Prof Ernest Egan, a Galway-based regional haemophilia-treatment director, contacted Dr Walsh just days before the BTSB/ Department meeting to ask what plans Pelican House had to heat-treat factor 9.

Prof Egan had also suggested it would be timely for the board to issue some guidelines around the State on the use of products.

Prof Egan's concern seemed to have stemmed from his use on January 12th, 1986, of untreated factor 9 on a patient at Galway University Hospital. Records show 1,700 units of factor 9, batch 90753, was injected into the left knee of the patient. The batch was subsequently found to be infectious although the patient in question fortunately avoided contracting HIV.

Dr Walsh said the first time he learnt of a haemophilia B patient testing positive for HIV was in April 1986. Two months later, the BTSB issued a recall notice for untreated factor 9, although it appears not all hospitals received it.

Dr Walsh will be further questioned about the second notice, which he also wrote, today.