India’s babies first to use Kiwi device
Final quality and safety checks on Sir Ray Avery’s LifePod under way
Sir Ray Avery expects his LifePod baby incubators, for which $2 million has been raised from donors, will enter real-life hospital trials in about July — in India.
The update on the timing of the controversial project follows a Department of Internal Affairs review of the Sir Ray Avery Foundation, also called Medicine Mondiale, late last year after a complaint was made.
A letter from the department’s Charities Services section to the foundation, given to the Weekend Herald by Avery, says it is satisfied donations are being used properly.
But it also urges the foundation to consider “updating the public regarding the status of the LifePod incubators and managing their expectations as to when they will be most likely to be ready for delivery to Fiji”.
Avery told the Weekend Herald: “The commitment was made to have working incubators by February and that has happened. We are just ensuring they have world-class international sign-offs. For us, quality and safety are paramount and that will take as long as it takes. We estimated five months from February.
“We are not going to set a deadline for deployment in Fiji because the timeline is dependent on the European auditors and . . . quality and safety.”
Avery’s incubator, designed for sick or premature newborns by Medicine Mondiale, came under intense media scrutiny last year after a stoush involving former Prime Minister Helen Clark over a proposed fundraising concert at Eden Park.
A philanthropist and scientist, Avery wanted to stage a Live Aid-style concert on Waitangi Day this year to help raise $4m to make 2000 LifePods to distribute to hospitals in poor countries.
But Clark, a Mt Eden resident, and others objected to the concert plan. She claimed it was being used as a test case to hold more concerts at the park. The Eden Park Trust eventually
We are just ensuring they have world-class international sign-offs. For us, quality and safety are paramount and that will take as long as it takes.
Sir Ray Avery
withdrew its bid for council consent, citing the likely timeframe of court proceedings.
News website Newsroom ran a month-long investigation into the incubators.
The incubators, aimed at improving medical care in poor countries, are planned to be far cheaper than existing models used in hospitals. They are being made at a factory in Chennai, India. It has previously been reported that Fiji would be the first to receive them.
Avery said last week the first incubators would be trialled in India because of the stringent postmarketing requirements of medical authorities.
“In fairness to the hospitals in Fiji, these are best managed by larger teaching hospitals in Chennai, India.” Better support could be provided there, “in the case of unforeseen events”.
“No timelines or commitments to individual donors or hospitals have been made with respect to individual donors or donor recipients — hospitals in Fiji or elsewhere.”
The Chennai factory, Phoenix Medical Systems, demonstrated compliance in December with the International Organisation for Standardisation (ISO) standard for commercialscale, batch production of the LifePod.
Many developing countries would allow importation and sale on that basis, while some countries required additional certifications, such as the European CE mark, Avery said. Phoenix had approval to self-certify the LifePod with the CE mark, allowing international distribution from January this year.
But because of the intense scrutiny, Medicine Mondiale commissioned an independent CE mark audit from a British regulatory agency. This had added about five months to the process.
“During that time there is ongoing Lifepod life-cycle reliability testing in selected hospitals in Chennai and in the PMS [Phoenix] factory.
“It is important to note that the sale and distribution of infant incubators is arguably more stringently controlled than the sale of firearms.”
Avery said the foundation’s fundraising material had “always made it clear that we had to raise $2 million [to] build the LifePod incubator, and we have now delivered on this promise”.