Suspect dialysis filter use suspended

Croatian hospitals have stopped using the equipment

Medical equipment manufacturer Baxter International says it is suspending the European distribution of filters used during dialysis treatment after 21 kidney patients died in a single week in Croatia.

Company spokeswoman Patricia O'Hayer told the BBC that it was a precautionary measure to allay patients' anxiety pending a full investigation, but stressed they were sure of the safety of their product.

We believe in the safety of the dialysers, but we believe that patient safety has to be paramount

Baxter spokeswoman

All the victims were found to have used the US-made equipment, fibrous filters known as dialysers.

The Croatian Government has launched an inquiry, and Health Minister Ana Stavljenic-Rukavina said they were in touch with the authorities in Spain where 10 kidney patients died in August.

Ms O'Hayer said the cases were very different to those in Spain, where an independent investigation cleared the firm of responsibility.

Rigorous tests of the Baxter equipment had shown no link with the Spanish deaths, Ms O'Hayer said.

Ms Stavljenic-Rukavina said their initial inquiries showed that the dialysis filters were the common denominator among the victims.

Patient safety

Baxter says there is no evidence of a connection, pointing out that the machines used, dialysers, are only one part of the treatment process.

But Ms O'Hayer said: "Given the high level of patient concern here in Croatia, we have decided to suspend the distribution of the A series dialysers, just strictly as a precautionary measure.

"We believe in the safety of the dialysers, but we believe that patient safety has to be paramount."

Ms Stavljenic-Rukavina offered to resign after being criticised for the speed at which all hospitals were alerted to the dangers.

The first deaths in Croatia happened last Monday, but the authorities only alerted all of the country's hospitals to the dangers on Friday. Most of the victims died on Friday and Saturday.

Ms Stavljenic-Rukavina said no new deaths had been reported after the dialysers had been replaced and that clinics using other dialysers had not reported any problems.

In an average week in Croatian hospitals, between three and six kidney patients die.