Blood service not told about problems with testing device

The Irish Blood Transfusion Service (IBTS) says it was not told about previous problems with a testing device blamed for providing inaccurate results to blood donors.

Hundreds of women who donated blood to the service in the past 18 months may have been anaemic when they gave blood or become anaemic after the device missed women with an iron deficiency.

The IBTS has questioned whether the device, made by German company MBR Optical Systems, was properly validated before being used to test 180,000 Irish blood samples since last year.

It only became aware of a problem with the device, which measures haemoglobin levels, when it was contacted by a donor who had been diagnosed by her doctor as severely anaemic. The woman had donated a unit of blood a week earlier.

"That set alarms bells ringing. It's a 'never event' and we were very distressed by it," said IBTS medical and scientific director Dr William Murphy.

When the service contacted MBR, it said a similar event had occurred in Germany. “We should have known that. There should have been an alert . . . but they hadn’t told us.”

On Tuesday an MBR representative said, while issues regularly arise with products, there was “nothing of any substance” in relation to the device. He said the company was working “shoulder-to-shoulder” with the IBTS to resolve any issues.

Rethink standards

Dr Murphy questioned whether the machine had been properly evaluated and said regulators and companies needed to rethink the standards required before new testing equipment is released into the market. As things stand, companies needed to perform only 2,000 tests to show how a device performs and this “clearly isn’t enough”.

The IBTS has suspended taking blood donations from women who gave blood in the last 18 months, until it has checked a blood sample from each donor.

Since last week, more than 30 women with anaemia were identified, whose condition was not picked up by the new device.

Dr Murphy said donors had responded positively to this week’s announcement, with donations up 10 per cent on Tuesday, but blood supplies would likely be under pressure in the immediate future.

IBTS said it will pay for concerned donors, who feel “under the weather”, to see a GP and have their haemoglobin levels tested.

The cost of the issues caused by the inaccurate readings is expected to run into six figures. The IBTS said it was working constructively with MBR to resolve the issues but legal advice is also being taken, it is understood.

The device uses a white light to measure redness of blood in the finger. Dr Murphy said it helped to speed up donor clinics, reduced staff costs and did not incur costs of disposal averaging €1 a donor.