Product was recalled only after doctor's intervention

A proper recall by the Blood Transfusion Service Board of products it manufactured could have prevented the infection with HIV…

A proper recall by the Blood Transfusion Service Board of products it manufactured could have prevented the infection with HIV of at least one haemophiliac, the tribunal heard yesterday.

After a meeting with the Department of Health in January 1986, where it was decided the BTSB should stop issuing nonheat-treated products (those that had not been virally inactivated), the board wrote to hospitals informing them of the decision.

The letter stated that the BTSB soon hoped to begin heat-treating its factor 9 blood product, used by patients with type B haemophilia, but did not ask that non-heat-treated products be returned to Pelican House.

It was only following a letter from Prof Ian Temperley, former director of the National Haemophilia Treatment Centre, in April 1986 in which he expressed concern that haemophilia B patients were testing HIV positive, that a formal recall took place.

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Counsel for the Irish Haemophilia Society, Mr John Trainor SC, suggested to Dr Emer Lawlor, deputy medical director of the Irish Blood Transfusion Service (formerly the BTSB), that it was extraordinary that no action was taken until patients became infected.

Dr Lawlor did not agree. She said the heat-treated factor 9 had come into use before April 1986, when the board learnt that haemophilia B patients were testing HIV positive. However, she said the non-heated products should have been formally recalled in January 1986. She believed the reason this was not done was more likely to have been due to a mistake than any other motive.

Mr Trainor put it to her that most if not all of the seven haemophilia B patients who tested HIV positive did so in early 1986 and a proper recall would have prevented this.

"There is one person who might have been spared if there was a recall in January 1986," Dr Lawlor said.

The tribunal was also told that the BTSB was not "very happy" when it was told by a doctor treating haemophiliacs in August 1985 that treaters would only accept heat-treated products.

A letter written in August 1985 by Dr Helena Daly, a locum for Prof Ian Temperley, who went on sabbatical for a number of months in mid-1985, detailed a meeting which took place between her and Dr Jack O'Riordan, former director of the BTSB, and Mr Sean Hanratty, former chief technical officer of the BTSB, on August 13th, 1985.

She wrote to Prof Temperley saying she had informed them it was now considered "unethical" to use any products for haemophiliacs except heat-treated ones and that they would want to change over completely in the near future to heat-treated products and stop using BTSB cryoprecipitate.

"They say freeze dried cryo can't be heat treated and so much cryo would be wasted. Obviously they weren't very happy as they have large stocks," she wrote.

Dr Lawlor accepted that Dr Daly's meeting with the BTSB was the catalyst for the commencement of heat-treatment. A decision was taken to heat-treat products at the BTSB the day after her meeting with BTSB officials.

Dr Lawlor said the board could have heat-treated its factor 9 earlier but was worried about making what appeared to be a safe product into an unsafe one. Extra heat could cause a thrombogenic effect in patients.

Counsel put it to her that the board did not heat-treat earlier because it was concerned about wasting stock. Dr Lawlor said this was a genuine problem but once it was satisfied heat-treatment was what clinicians wanted it was thrown out and there was no problem with this.