Faulty prostate cancer testing kits at Connolly and Mayo hospitals withdrawn

Mayo General Hospital is reviewing the results of almost 13,000 tests for prostate cancer after it emerged the model of kits used on patients was faulty and resulting in artificially high readings.

News that such a high number of tests are being reviewed comes after Connolly Hospital in Blanchardstown, Dublin, said it had withdrawn the kits after they were found to be faulty.

The kits, manufactured by Siemens, are used to measure PSA, a protein made by the prostate gland and which, when raised, may indicate the presence of prostate cancer.

They were used at Blanchardstown hospital between February 2013 and June 2013 and in Mayo General between July 2012 and June 2013. They indicated levels of protein up to 23 per cent higher than reliable working kits.

A total of 12,866 tests were carried out in Mayo General in the period and in a statement the hospital said its review would determine how many results were elevated as a result of the faulty equipment.

“This incident, which is outside the control of Mayo General Hospital, is considered to be of low clinical risk in relation to long-term negative outcomes for patients,” the statement said.

In Blanchardstown, some 2,186 patients were tested during the period and of these, 162 received a result which may have indicated a need for further investigation.

In a statement, the HSE said it was reviewing the results of these 162 patients in Blanchardstown to determine if further actions were necessary.

It said it was in contact with GPs to track patient outcomes. Similar steps were being taken in Mayo with a view to offering doctors re-tests for any patients.

PSA tests at Connolly Hospital are currently being sent to Beaumont Hospital for analysis where the Siemens kits are not in use. A spokesman for the HSE was unable to say when analysis of PSA tests would resume at Connolly Hospital.

Mayo General Hospital said an alternative method of testing had been in place since July when the issue with the Siemens kit emerged.

A statement from the hospital added that since late June, a notice for doctors had been attached to all PSA test results from the new method, informing them a new test was being used and alerting them to the elevated levels in the now discontinued Siemens testing kit.