Up to 467 patients who received a British blood product which carried a potential risk of infection with CJD will be contacted and counselled, the Minister for Health, Mr Cowen, told the Dail.
The figure has risen by almost 200 from the initial figure of 268 because the Department discovered that hospitals could treat more than one patient with each vial of the product Amerscan Pulmonate II, depending on the circumstances of each patient.
Defending the approach he took in relation to the scare about the blood product, Mr Cowen said that if he stood indicted for anything it was for taking the most cautious approach possible. He stressed his approach was "proper, prudent, appropriate an d sensitive". There were serious ethical issues which had to be considered before a decision was made to remove the product and inform affected patients.
He pointed out that in the US the advice to the Food and Drugs Administration was that "given the level of risk, this product should not be withdrawn from use". The Minister said the amount involved in each case was half a drop of blood divided by 20,000, and there was no evidence to say it could be passed by blood.
Opposition deputies criticised Mr Cowen for the delay in informing patients so that they first heard about it on RTE television news. The Fine Gael health spokesman, Mr Alan Shatter, said it was "scandalous" and the Department should have acted sooner to inform people.
It was very unfortunate that it came into the public domain before the people affected were contacted, the Minister said, but he was not in a position to act until he was fully advised by the CJD committee. The Opposition did not take account of the ethical questions involved, he said.
Outlining what happened, Mr Cowen said the Irish Medicines Board was informed by the UK Medicines Control Agency about the product on November 18th and the following day all nine hospitals involved withdrew the product.
The Department became aware of the need for a recall on November 26th. The Department's assessment of the situation indicated that its handling raised "complex medical, scientific and ethical issues" and decided to seek the advice of the CJD advisory group which met on December 4th. "The group concluded that the risk involved was unquantifiable but likely to be very low."
The following week, further consideration was given to the ethical issue "having regard to the extremely low risk, the lack of a diagnostic test for new variant CJD, the lack of any treatment and the unknown incubation period of the disease".
Last Friday it was agreed patients should be informed of the facts and appropriate mechanisms should be put in place as soon as possible to give effect to this.
He said eight of the nine hospitals had identified all their patients and the ninth had almost completed the task. A clinical information pack was being prepared for each hospital. The hospital consultants would meet each patient individually and brief them fully on their own circumstances. Counselling would be arranged according to each patient's needs and wishes.
Ms Roisin Shortall, Labour's health spokeswoman, said a number of people had phoned the Department during the past two days and were told they would be better off contacting the hospital.
Mr Cowen said he apologised to anybody who received that response and he had told the secretary general of the Department yesterday afternoon that medical staff should be involved in dealing with such inquiries.
Mr Cowen rejected suggestions he had taken an approach inconsistent with his actions two weeks ago over the risks involved with beef on the bone. He said he had been entirely consistent and the beef on the bone issue was a matter of general public health, while the CJD risk applied to a specific number of people and required specific medical and ethical consideration.
Ms Liz McManus (DL, Wicklow) said the Department did not seem to have learned any lessons from previous blood scandals. She asked when he was going to inform all the people who had taken lung tests that did not involve this blood product who need to be reassured. "The hospitals have no problem in finding these patients in order to send them their bills," she said.
Mr Cowen said that when the hospitals have informed all the patients, the Department will issue a statement so that all others who underwent lung tests not including the Amerscan Pulmonate II would be reassured.