Life-saving blood-screening is faulty, warns Irish Medicines Board

A BLOOD-screening machine which can prevent serious complications, even death, is faulty, the Irish Medicines Board has warned

The Irish Blood Transfusion Service (IBTS) has been ordered by the IMB to carry out a risk-assessment of its Cork-based irradiator a machine which prevents a rare but sometimes fatal reaction in some patients who receive blood.

The IBTS has also been forced to suspend its re-routing programme at its Cork facility, where units of blood not used in one hospital are recalled and sent to another. According to the minutes of the Board's December meeting, an IMB inspection was critical of quality control at the St Finbarr's Hospital site. "QA [quality assurance) is not sufficiently aware of the urgency and extent of product recall," the minutes read.

A product is recalled when the IBTS is made aware that donated blood may have come from a donor with cold or flu or when a patient sample has the wrong hospital identification number, which means it would not be suitable for the patient for which it is issued.

The December minutes noted the IMB "had a major concern regarding the potential for inadvertent reissuing of recalled product." A spokesperson for the IBTS said the programme would be suspended until there was "greater clarity in recall procedures." This included determining if blood had been stored at the correct temperature and handled properly in the hospital from whence it had come.

A statement from the IBTS said yesterday the risk assessment in relation to the irradiator would be completed shortly.

The IMB inspection also reported problems with premises and equipment at the St Finbarr's site, according to a report in the Irish Medical News. Yesterday's statement from the IBTS confirmed the post of senior technical officer post has been vacant since August 2002, but is being filled on an acting basis. The quality officer post has been vacant since April 2003.

Competitions for both posts are ongoing and interviews will be held over the next number of weeks. The statement said the difficulty in filling the posts was due to "uncertainty regarding the development of the facilities.

"It is a very specialist market and we are competing with pharmaceutical companies who can offer more attractive packages than the public service," the statement said.

Cork staff of the IBTS have long argued for an improvement in facilities at the site. The IMB inspectors said the building was unsuitable for long-term use and was not Good Manufacturing Practice compliant.

The Board has approved the provision of additional temporary accommodation at St Finbarr's to the value of €2m. The Southern Health Board has approved the site on the campus of St Finbarr's for this accommodation. A spokesperson for the IBTS said: "We hope to be in a position to lodge a planning application in the next few weeks." Officials from the Department of Health will be meeting Department of Finance officials shortly to agree a capital programme for 2004.