The Blood Transfusion Service Board (BTSB) began heat-treating clotting agents on a trial basis 10 months before it issued the products for patients, it emerged at the tribunal yesterday.
The blood bank began heat-treating samples of factor 9 clotting agent in December 1984, but did not issue heat-treated product to patients until October 1985.
Ms Cecily Cunningham, a former biochemist with the board, said that even when the BTSB began issuing heat-treated product, it supplied only St James's Hospital, Dublin, where the National Haemophilia Treatment Centre was located. Other hospitals were meant to continue using non-heat-treated product until the effects of the heated product on patients at St James's could be gauged, she said.
Ms Cunningham said she believed haemophiliacs at St James's were to be given both heat-treated and non-heat-treated products during these "clinical trials". In January 1986 a decision was taken to heat-treat factor 9 for all patients.
The tribunal has already heard evidence from Prof Ian Temperley, former director of the National Haemophilia Treatment Centre, that he was only prepared to accept heat-treated product after November 1985. Prof Temperley had written to the BTSB in December 1984 asking them to heat-treat products but Ms Cunningham said she was unaware of this.
Ms Cunningham said one of the batches she took a sample from to heat-treat was numbered 90753. The heat-treatment had no ill-effect on the sample but the batch from which it came was issued to hospitals without being heat-treated. It was one of two batches which infected seven haemophiliacs in the State with HIV.
The heat-treatment trials done in December 1984 were deemed unsatisfactory as the heat caused some of the product to be destroyed, and the BTSB was worried this might cause a reaction in recipients, Ms Cunningham said.
From December 1984 Ms Cunningham was in regular contact with the Oxford Plasma Fractionation laboratory to see what heat-treatment they used, and their view was that the heat-treatment of factor 9 could cause thrombosis. She said they were as worried about this as about AIDS. She added that the BTSB depended on such overseas research.
Ms Cunningham added that there was a "fervent hope" in the BTSB at the time that its manufacturing process for factor 9, which included washing, freezing and thawing, would have killed any viruses it contained.
In August 1985, she was told by Mr Sean Hanratty a decision had been made to begin heat-treating immediately. A new incubator was placed in her laboratory and she was surprised how straightforward the procedure was.
She said the first batch was heated at 68-70 degrees for 72 hours and she was ordered by Mr Hanratty to heat-treat the next batches at 60 degrees for 20 hours. The tribunal has heard this was not an effective heat-treat to eliminate hepatitis C.
Ms Cunningham said a decision was taken in July 1986 to heat-treat factor 9 to 60 degrees for 72 hours after one of the BTSB's technical staff learnt from a Paris conference that this was the minimum standard required.