Avery - Faulty masks will put lives at risk

Sir Ray Avery - Some face masks are `worse than useless.' Picture / File

Face masks that are not fit for purpose may be putting New Zealand medical staff, and their patients, at risk of death according to Sir Ray Avery.

China's medical device market regulators had in recent days seized more than 89 faulty million masks and 418,000 pieces of "questionable" personal protective equipment (PPE) in the fight against the coronavirus pandemic, he said, while more than 31.6 million faulty masks and 509,000 protective suits destined for export had been confiscated by port officials as of mid-April.

The Chinese government's intervention had followed a slew of complaints about faulty Covid-19 protective gear that had been exported worldwide.

Many countries, including Spain, India, the Netherlands, the Czech Republic, Canada and Turkey had been forced to recall hundreds of thousands of "shoddy" masks and pieces of protective gear imported from China.

Now, in the public's interest, Sir Ray was appealing to the government to disclose the names of the Chinese manufacturers to enable an independent external quality audit of the products.

"The lives of our frontline healthcare workers are at stake," he said.

All protective gear suppliers were required by New Zealand and Australian regulatory standards to provide the name of the manufacturer, the name of the local distributor, the batch number and regulatory compliance details on the product packaging. The United States' FDA and Australian TGA procurement process for PPE was to purchase products from regulatory-controlled, approved suppliers, the process for the approval of face masks including testing to ensure that 85 per cent of end users obtained a good fit during normal use.

Sir Ray said he had contacted five senior district health board managers, none of whom had any record of face mask testing conducted in their hospitals in living memory.

"A poor-fitting face mask is worse than useless to prevent Covid-19 infection," he added.

"Dutch health officials last month recalled more than half a million Chinese masks that had already been sent to hospitals after complaints that they did not close over the face properly, or had defective filters.

"There is a very real possibility that the masks that have been brought into New Zealand may not be fit for purpose.

"I have more than 30 years' experience in purchasing PPE and HEPA filters from China, and what we learnt is that the PPE CE mark and accreditation certificates are not worth the paper they are printed on. It is common for most Chinese PPE suppliers to export a product under one licensed company name but source their products from second, third or fourth party factories.

"Even with some of our most reliable Chinese suppliers, we have to reject some batches because they do not meet the required standards and are not fit for purpose. So we test every batch of product supplied from China, and right now it is more important than ever to do so."

In New Zealand there was no social distancing between healthcare workers and their patients, and the difference between life and death for both parties may come down to the quality of PPE used.

To date 130 front line healthcare workers were probable or confirmed Covid-19 cases. Fifty per cent of them were infected in the workplace, and there was a very real probability that some of Covid-19 deaths were due to infections caused by frontline healthcare workers infecting their patients due to not wearing the correct PPE or defective PPE.

"The auditor-general has been commissioned to conduct an independent inquiry into the procurement and distribution of PPE in New Zealand. This take about four weeks to complete, and by this time, as in Denmark, faulty PPE could be distributed to all our DHBs. The lives of our frontline healthcare workers are at stake," he said.

According to official figures, he added, China was producing more than 116 million masks per day, and had exported more than one billion masks so far this year.