Dáil Éireann debate -
Thursday, 8 Feb 1996

Vol. 461 No. 3

Written Answers. - Blood Products Recall.

Noel Treacy

Question:

18 Mr. N. Treacy asked the Minister for Health the schedule of events surrounding the recent recall of blood products from hospitals supplied by the Blood Transfusion Service Board; and the findings of the investigation into the alert. [2702/96]

Minister for Health (Mr. Noonan,

Limerick East): The Blood Transfusion Service Board (BTSB) informed my Department on Friday, 12 January 1996 that they had received a report of the development of serratia marcescens septicaemia in a patient in a Dublin hospital which it was considered may have been associated with a possible fault in a blood bag. At that time, the BTSB was engaged in an audit of blood bags and handling procedures for blood bags currently in use and supplied by NPBI, a CE accredited manufacturer of blood bags. In view of this, and in an effort to allay public anxiety, the BTSB took the following urgent measures:—

(i) The Medical Director at the BTSB instructed all hospital blood bank heads by fax, on 12 January, to quarantine all blood, platelets and plasma which had been collected into NPBI bags. BTSB staff at the same time contracted relevant hospital personnel to advise of the instructions and follow up action.

(ii) The Medical Director advised that if products contained in NPBI packs has been transfused close observation of the patient was warranted.

(iii) Urgent arrangements were put in place to restore stock supplies. In order to assist in the replenishment of stocks special donor clinics were arranged for Saturday 13 January and Sunday 14 January in Dublin and Cork. In addition, the North London Blood Transfusion Centre and the Scottish Blood Transfusion Service were contacted in order to secure additional supplies. Additional supplies of blood were also subsequently obtained from Holland. All imported blood met the relevant European Union, World Health Organisation and European Pharmacopoeia standards of safety which encompass donor selection, testing and processing.

(iv) A decision was taken on an interim basis to suspend using NPBI at donor clinics; arrangements were put in place as a matter of urgency to import bags from Baxter, a UK blood bag manufacturer.

(v) Arrangements were put in place to commence an immediate investigation to determine, if possible, the source of the serratia marcescens which infected the patient.

(vii) The Irish Medicines Board and the Dutch Inspectorate were informed of the situation and of the investigation.

An extensive and thorough investigation followed which included members of the BTSB staff, members of the company NPBI, the Irish Medicines Board and the Department of Microbiology in St. James's Hospital. Physical inspection of all quarantined bags in Pelican House and all hospital blood banks was undertaken by BTSB laboratory staff. Independent environmental monitoring was undertaken in the BTSB including the monitoring of the blood transport system. Environmental monitoring of St. James's blood bank and the Meath Hospital Dublin where the blood transfusion took place was undertaken by the Department of Microbiology in St. James's Hospital. Likewise, results of detailed environmental monitoring undertaken routinely in the NPBI plant in Holland were reviewed.

On 31 January, the results of the investigation were examined and no evidence was found of any breakdown in the manufacturing procedures of NPBI or of bacterial contamination of the blood bags in question. Likewise, environmental monitoring of the BTSB, the blood transport system, St. James's Hospital blood bank and the Meath Hospital revealed no evidence of contamination with the relevant bacteria. BTSB processing equipment and transport passed all the relevant tests and there was no evidence of any defect in the product supplied by the BTSB. BTSB and the Irish Medicines Board are satisfied that NPBI bags meet all European standards. In view of the above findings, it was decided to reintroduce NPBI bags for routine use in the BTSB. All aspects of blood supply will, of course, continue to be monitored very closely.

I would like to take this opportunity to commend all those involved at the BTSB and the Irish Medicines Board who worked continuously throughout the investigation. I would also like to extend particular thanks to those donors who responded so generously to the need for additional donations.