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Source: MakeLemonade.nz

 By Sir Ray Avery

Auckland – China’s medical device market regulators have 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.

The Chinese government’s intervention followed a slew of complaints about faulty COVID-19 protective gear exported worldwide.

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

So, in the public’s interest, I’m appealing to on the government to disclose the names of the Chinese manufacturers supplying so we can arrange for an independent external quality audit of the products. The lives of our frontline healthcare workers are at stake.

All protective gear suppliers are required by New Zealand and Australian regulatory standards to provide the name of the manufacturer the name of the local distributor and the batch number and regulatory compliance details on the product packaging.

The United States FDA and Australian TGA procurement process for PPE is to purchase products from a regulatory controlled  approved suppliers and one of the key tests for approval of facemasks would include testing to ensure that 85 percent of end-users obtained a good fit during normal facemask use.

I have contacted five senior district health board managers and they have no record of any face mask testing conducted in their Hospitals in living memory.

A poor-fitting face mask is worse than useless to prevent COVID-19 infection. Dutch health officials last month recalled over half a million Chinese masks which 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 this is more important than ever to do so.

In New Zealand, there is 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 health care workers are probable or confirmed COVID-19 cases. Fifty per cent of them were infected in the workplace and there is a very real probability that some of the 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.

China is producing more than 116 million masks per day, according to official figures. It has exported more than one billion masks this year so far, commerce ministry official Li Xingqian has said.

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.

MIL OSI