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False inspection records overseas forces NZ to use IV tubes from pandemic reserves

March 15, 2021

Medical equipment is having to be drawn from the National Pandemic Reserve after a product recall due to sterilisation concerns, the Ministry of Health says.

However, in a statement to 1 NEWS, a spokesperson from the Ministry also said some district health boards are likely to need to continue using the infusion pumps in some instances where other alternatives aren't immediately available.

After consultation with medical regulator Medsafe on Friday, Becton Dickinson - an American multinational medical technology company that manufactures and sells medical devices, instrument systems and reagents - initiated a recall relating to infusion tubing.

An infusion pump is a medical device used in clinical settings including hospitals, nursing homes and in the home to deliver nutrients or medications, such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers in a controlled way.

The company recall was initiated after being informed by a third party sterilisation company that it couldn't guarantee the quality of its work. 

"It doesn't mean the consumables are not sterile, but it does mean that the sterility of the consumables cannot be assured," the Ministry of Health said.

In a recall notice on Friday, Becton Dickinson said it was "due to an issue with a third-party sterilisation supplier falsifying inspection records".

"In the interests of patient safety and following engagement with regulators in Australia, New Zealand and internationally, the recall has been identified as a Class 1 recall requiring immediate attention," it said.

However, there has been no reports of harm to patients in New Zealand or overseas, with Becton Dickinson advising that no follow-up activities with patients who've used the products is required.

The Ministry of Health spokesperson said they were aware of more than 3000 pumps across New Zealand that use these consumables, which are mainly used in intensive care or emergency settings.

The consumables are proprietary to the pumps, meaning alternative products can't be used. 

"The Ministry, together with Medsafe, Pharmac, district health boards, suppliers, clinicians and technicians, has moved quickly to centralise supply management for pump consumables generally, to ensure services can be maintained nationally and alternative solutions identified and supported," they said.

"In addition to replacement pumps and consumables expected from Becton Dickinson, pumps have been drawn from the National Pandemic Reserve, and alternative pumps and consumables purchased. These are being allocated according to the type of product already in use by individual organisations and priority need."

The spokesperson said alternatives include other infusion pumps or other options including injecting medicines directly or using gravity fed drips.  

"The Ministry is aware that some DHBs are likely to need to continue using the pumps in some instances where other alternatives aren't immediately available," they added.

"Where other acceptable options aren't available, DHBs may decide to continue to use the infusion pumps where the risks on not using the pumps is higher."

In a statement to 1 NEWS, St John said affected batches of the equipment had been withdrawn on Friday after they were notified.

They added that some may have to be used.

"Our frontline ambulance officers and paramedics have alternative methods of medication administration, and clinical advice has been provided by our Clinical Director about continued use of the recalled product in extreme life-threatening situations, while an alternate supply is located," St John deputy clinical director Dr Craig Ellis said.

The Ministry of Health spokesperson said DHBs had been advised to consider risk and benefits for patients when doing so, including clinical advice on infection prevention and control.

"The Ministry of Health will be continuing to provide advice to DHBs and other providers on this issue.

"An expert clinical group is being formed to assist with formulating advice over coming weeks.

"New Zealand’s approach is in line with that taken by other comparable countries."

The Ministry of Health has advised anyone wanting more information to ring Healthline on 0800 611 116.

Send your news tips to Rebecca.Moore@tvnz.co.nz

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