Australia & NZ

NZ:Contaminated blood thinner used in medical device


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25/05/2008 - A medical device used in heart-lung bypass surgery in New Zealand was coated in a contaminated product and has been quarantined, the Ministry of Health revealed on Friday.

However it will still be used in cases where the risks are outweighed by benefits to the patient.

Contaminated supplies of heparin, a blood thinner used in dialysis and other treatments, from China, was recalled internationally after deaths and allergic reactions.

The injectable version of the contaminated product was not used in New Zealand.

However, the Health Ministry medicines and medical devices regulatory arm, Medsafe, identified six devices in New Zealand which use heparin and involved contact with patients. Testing found one product that is coated with contaminated heparin. It was the Trillium Affinity NT Hollow Fibre Oxygenator and is used in heart-lung bypass surgery. The coating is used to prevent blood
clotting on the equipment during surgery.

The manufacturer, Medtronic, last week told clinicians to quarantine the device until uncontaminated product was available -- possibly as long as three months away.

Medsafe spokesman Dr Stewart Jessamine said if the risks of using the machine were outweighed by the benefits it would still be used.

He said there was a "very small risk" of allergic-type reactions. Laboratory testing while in use found there was no contaminant released.

Dr Jessamine said even if contaminant was released by the device there would not be enough to cause harm.

"Clinicians and staff involved in using any medical device containing heparin have already been informed about the issue of potential contamination, this means that the equipment will be used with appropriate precautions," Dr Jessamine said.

Any side effects would be reported.

An expert advisory committee endorsed the Health Ministry's managing of the risk.

Health Minister David Cunliffe said he was satisfied with Medsafe's approach.

"Expert advice is that clinicians should use uncontaminated products where possible, Replacement supplies of this device are not expected for at least two months and DHBs are taking steps to obtain an alternative to the affected devices," he said.

Source: AAP NewsWire

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