KEY POINTS:
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 today.
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.
Green Party health spokeswoman Sue Kedgley said it was extremely concerning that contaminated product would continue to be used in the device.
"... patients needing urgent heart-lung bypass surgery are confronted with a terrible dilemma; whether to postpone surgery or take the small risk of experiencing severe allergic reactions to the contaminated Heparin ."
Ms Kedgley said while it was a relief that the contamination of Heparin, linked to more than 80 deaths in the United States, was discovered and the risks were being discussed openly it showed the danger of importing unchecked medicines and medical devices from China.
"Clearly we need more stringent safety checks on imported medicines and medical devices from China. Medsafe must develop a strategy to protect New Zealanders from contaminated and counterfeit medicines."
- NZPA
