BTSB ignored instruction to recall supply of deadly plasma

The Blood Transfusion Service Board failed to withdraw an infectious blood-clotting agent from hospitals in January 1986 despite…

The Blood Transfusion Service Board failed to withdraw an infectious blood-clotting agent from hospitals in January 1986 despite an instruction from the Department of Health to do so, the tribunal heard yesterday.

Mr John Cann, a former chief technical officer with the BTSB, agreed with counsel for the tribunal, Mr Gerard Durcan SC, that a letter sent to hospitals was not in line with the Department's recommendation.

The letter said: "Heat-treated commercial factor 9 is now available. It is hoped that heat-treated factor 9 prepared by the BTSB will shortly be available" but it did not ask for non-heat-treated factor 9 or factor 9 made from plasma which had not been HIV tested to be returned to Pelican House.

The BTSB began screening blood donations for HIV and issuing heat-treated factor 9 in October 1985. After this date, however, it also continued to issue non-heat-treated factor 9 and no formal recall of the product took place until June 1986.

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The tribunal has heard that seven haemophiliacs in the State were infected with HIV between July 1985 and August 1986 from BTSB factor 9 which had not been heat-treated. Five of them have since died.

Mr Cann said a meeting took place between BTSB officials and Department of Health representatives on January 21st, 1986, at which Department officials strongly recommended that blood products made prior to the introduction of donor screening for HIV be withdrawn from hospitals. He said a meeting took place at Pelican House the next day and notes of the meeting made by him recorded the Department's recommendation and noted that some non-heat-treated factor 9 was still being issued by the BTSB.

Mr Cann's notes said: "Stop issue. Issue only heat-treated. Use commercial if necessary. What about stock already in hospitals? TW's (Dr Terry Walsh's) letter covers this."

The letter written by Dr Walsh, a consultant haematologist at Pelican House at that time, and sent to hospitals was opened to the tribunal. Questioned about it by Mr Durcan, Mr Cann agreed the letter did not recall non-heat-treated factor 9, referred to in his notes, or factor 9 made from plasma which had not been HIV tested, referred to by the Department.

Mr Cann had earlier told Mr Charles Meenan SC, counsel for Dr Terry Walsh, that the notice to hospitals was not meant to recall non-heat-treated factor 9. His final position on the issue was that the letter was meant to recall the infectious product.