Absence of blood products safety `regrettable'

The Blood Transfusion Service Board had no policy or guidelines to ensure its products were as safe as possible, the tribunal…

The Blood Transfusion Service Board had no policy or guidelines to ensure its products were as safe as possible, the tribunal heard yesterday.

As a result, the recall of products made by the BTSB once safer ones became available was "haphazard" and "extraordinarily unsatisfactory" and its success depended on how proactive hospitals were, tribunal counsel Mr Gerard Durcan SC said.

Dr Terry Walsh, who was spending his second day in the witness box as a former chief medical consultant of the BTSB, agreed. He said it was regrettable that a policy did not exist.

New documents opened to the tribunal showed it was a letter from Prof Ernest Egan, a consultant haematologist treating haemophiliacs in Galway, that in the words of Mr Durcan "kickstarted" a recall of unsafe products at the end of January 1986. Prof Egan questioned whether Travenol's factor 9 was heat-treated to inactivate viruses such as HIV and asked when BTSB factor 9 would be heat-treated. He said it was timely for the BTSB to issue guidelines on the use of these products.

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The recall notice issued on January 30th, 1986, by Dr Walsh following receipt of Prof Egan's letter did not, however, request that non-heat-treated factor 9 clotting agents made by the BTSB be returned to Pelican House.

The tribunal has already heard that the non-heated product infected seven haemophiliacs in the State with HIV. One of these was a patient who continued to use non-heat-treated factor 9 at home up to February 20th, 1986.

It emerged yesterday that a letter received by the BTSB from the secretary of the Department of Health the day after the recall notice was issued stated it was "imperative" that "all" blood products issued to hospitals before the introduction of HIV testing of donors in October 1985 be withdrawn.

Dr Walsh said this would have been "impossible" at the time but there was no record of the BTSB replying to the Department's letter.

The correspondence from the Department followed a meeting between the BTSB and Department officials on January 21st, 1986, where it was noted that some non-heat-treated BTSB factor 9 was still being issued. The following decision was taken: "Stop issue. Issue only heat-treated; use commercial factor 9 if necessary. What about stock already in hospitals? T.W.'s (Terry Walsh's) letter covers this."

Counsel for the tribunal put it to Dr Walsh that his letter of January 30th, 1986, did not cover this. The letter stated that heat-treated commercial factor 9 was available and that BTSB heat-treated factor 9 would soon be available. It said non-heat-treated factor 8 should be returned to the manufacturer but did not say this should also be done in the case of BTSB factor 9.

Dr Walsh agreed that the letter might have been worded "more positively". He said it was not his decision not to withdraw non-heat-treated factor 9 and pointed out that there were two more senior doctors than him in the BTSB at the time.

The tribunal also heard that some non-heat-treated factor 9 sent to Our Lady of Lourdes Hospital, Drogheda, was returned for heat-treatment prior to the issuing of Dr Walsh's recall notice.