VAN drivers employed by the Blood Transfusion Service Board (BTSB) were instructed to ask hospitals and clinics to return anti D stocks during the 1994 product recall, the former BTSB chief executive, Mr Ted Keyes, told the tribunal yesterday.
The recall programme, initiated on February 18th, 1994, failed to retrieve nine units of anti D which were used at six clinics in the next seven months.
Mr John Rogers SC, for the McCole family and Positive Action, said one unit was used at St Finbarr's Hospital, Cork, on February 18th and two units at the former Marian Nursing Home in Limerick, on March 17th and 27th.
On March 29th a unit was administered at a Clonmel hospital. On July 1st and July 4th two units were used at a Portlaoise hospital. And two units were used in Tralee on September 5th and 14th and one at a clinic in Loughlinstown on the 5th. Of the nine doses of antiD administered, eight have been traced and the women have tested negative for hepatitis C.
Mr Rogers said he would have assumed that the recall programme would have been an executive matter, where direction was required. Mr Keyes replied that the programme was directed by Dr Terry Walsh, the former medical director. He did not think there was any procedure in collecting the product, but he was not sure.
"He (Dr Walsh) did a lot of it on the phone himself. I remember him doing it," he said. He also agreed with Mr Paul Gallagher SC, for the BTSB, that Ms Cecily Cunningham, the BTSB principal biochemist, had phoned all hospitals and clinics after the letters were seat, instructing that the phials of anti D be returned.
Mr Keyes said no notes were kept of meetings with the Department from February 18th onwards because of their sensitive nature.
"Normally I would have had a secretary with me. The meetings were so sensitive that I felt we had to keep the information totally controlled. It would have caused chaos had we not released the information in a controlled way," he said.
He agreed with Mr James Nugent SC, for the tribunal, that it took two years to find another option to introducing a licensed viral inactivation procedure at the antiD manufacturing unit in Pelican House.
In January 1990 the BTSB received information from the New York Blood Bank about its solvent detergent method of inactivation. In August 1992 BTSB personnel visited a Canadian company's premises, whose product was imported in February 1994.
Mr Keyes said he believed it was "a genuine mistake" that the Department was misinformed about the licensing of that replacement product. Department personnel said they were told that the product had a licence from the Federal Drugs Administration (FDA) in the US and that the National Drugs Advisory Board had agreed to the importation. Neither was the case.
"I think that what had been said was approval from the FDA was imminent... We genuinely wanted to disclose everything that was there. We had nothing at that stage to hide. None of us were happy going down telling this horrible story," he said.