Sunday, April 5, 2020

China's coronavirus supplies are being rejected — how do we ensure quality in a pandemic?

China's coronavirus supplies are being rejected — how do we ensure quality in a pandemic?

Posted Fri at 11:59am
China's had a rough few months.

Key points:

  • China has been rapidly scaling up its medical equipment manufacturing base
  • Most medical product regulation varies by country, at varying enforcement levels
  • Australia's only mask manufacturer says faulty products risk introducing more pathogens
As the emerging superpower entered 2020, a coronavirus outbreak in the industrial hub of Wuhan swept the nation, then the world, which crippled the global economy in turn.
By March, things began to slowly turn around, as China's drastic lockdown measures appear to have slowed the country's infection rates.
This has placed China in a position to supply sorely needed medical products as coronavirus has shuttered production capacity elsewhere.
Chinese state media Xinhua reported in early March that China was producing 116 million masks daily, about 12 times as many as a month prior, according to official data.
But China's efforts to help haven't gone smoothly, as several countries have reported faults with Chinese-made supplies.
This began with Spain's recall of about 58,000 inaccurate rapid COVID-19 test kits late last week, and Turkey also casting aside a number of sample test kits that were faulty.
This was then followed last Saturday by a Dutch recall of some 600,000 face masks that didn't provide an airtight seal.
Australia also found fault with Chinese products, with Border Force officials telling the ABC on Wednesday that it seized $800,000 worth of faulty face masks and personal protective equipment (PPE) in recent weeks.
So, in a time of supply scarcity during a global pandemic, how do countries ensure the medical supplies they import actually work?

How did faulty equipment get to Europe?

China's Shenzhen Bioeasy Biotechnology was identified as the manufacturer of Spain's faulty test kits, which local health authorities said had an accuracy rate of about 30 per cent.
While China's been on a diplomatic mission to send vast amounts of medical aid around the world, including to Spain and Italy, these kits were not part of the aid efforts.
Spanish health authorities said they bought Bioeasy's kits as they had European Union standard certification, which is known by its French acronym, CE.
In a statement via WeChat, Bioeasy stated its coronavirus-related products, which include the rapid test kits supplied to Spain, received a CE certificate on March 12.
However, CE certification is mostly self-declared by manufacturers, as it is their responsibility to choose between self-certification or whether to seek an EU-approved independent verifier.
In Australia, Bioeasy's products are not listed on the Register of Therapeutic Goods (ARTG), nor has the company been granted an official vendor licence from China's National Administration of Medical Products, according to a tweet from the Spanish Embassy in China.
In response, Bioeasy said its crown series was not sold in China and was "only used for scientific purposes".
Bioeasy manager Zhu Hai denied the company's test kits had a low accuracy rate in a statement to the South China Morning Post, adding that a "more detailed explanation would be given via official Chinese Government channels".
When asked to comment on the quality concerns on Monday, China's Ministry of Foreign Affairs spokeswoman Hua Chunying said "some masks" ordered by the Dutch "were not suitable for medical staff in intensive care units".
The Chinese Commerce Ministry followed up on Wednesday with a statement compelling all medical product exporters to provide extra documentation showing their products met the standards of its export destination, and were officially registered in China.
Bioeasy initially declined an interview with the ABC, but later shared a test validation report from researchers at Chile's Desarollo University, showing its Fluorescence Antigen rapid test attained 96.1 per cent diagnostic accuracy.
"The results show that this antigen test is a very good quality test kit," the company told the ABC in an email.
The ABC was unable to independently verify the data shared.

Are there universal standards for PPE or test kits?

Technically, there is a global mask standard from the International Standards Organisation (ISO), which outlines the test used to assess a mask's resistance to blood and bodily fluids (including that of small liquid droplets).
However, ISO has stated the test does not "address the performance of the medical face mask's design, construction, interfaces or other factors which may affect the overall protection offered by the medical face mask and its operation".
To determine whether a product is safe to use, health professionals are obligated to look at regulations in their country or at a supranational level for blocs such as the EU.
For example, the Australian Register of Therapeutic Goods has a database of approved medical items for distribution, and that database is updated by the regulatory body Therapeutic Goods Administration (TGA).
On its website, the TGA has specified an exemption for the "importation, manufacture and supply" of COVID-19 test kits to accredited pathology laboratories even if they haven't undergone TGA assessment, and it has also published a list of tests it has approved.
A TGA spokesperson told the ABC via email the body "encourages" all Australians searching for equipment to look at "medical devices included in the ARTG".
"Manufacturers of medical devices must be able to provide evidence that demonstrates they have used appropriate design, development and production systems to the manufacture of their medical device," the spokesperson said
The World Heath Organisation has also published a list of recommendations for PPE usage amid COVID-19.
Ian Burgess, chief executive of the Medical Technology Association of Australia, told the ABC that Australian medical product manufacturers were "in a position of strength" to respond to COVID-19.
"Medical technology companies see the COVID-19 response as a national duty and have been working around the clock together to fight this unprecedented virus," Mr Burgess said.

What happens if faulty equipment gets past regulators?

The more faulty equipment that gets past regulatory nets, the higher the risk there is of infection with COVID-19 if someone uses a faulty product.
Health workers, and those most vulnerable to severe cases of COVID-19, are the people who depend on masks and test kits the most.
In Spain, about 14 per cent of those infected with COVID-19 are frontline health workers, with many desperate for more equipment.
Until now, the US Centres for Disease Control and Prevention, like the World Health Organisation, has advised that healthy people do not need to wear a mask.
This is to ensure that medical-grade masks such as N95 are available for those who need them the most, such as health workers in the US, which has become the world's latest coronavirus epicentre.
New Yorkers have recently been told to wear face coverings outside of the home, while the White House is considering implementing that rule across the US.
Steve Csiszar, chief executive at Med-Con — Australia's only manufacturer of medical face masks — told the ABC it was critical for people to find masks that meet official standards, otherwise there would be "a false sense of security".
Prior to the pandemic, Med-Con's masks made up 5 per cent of Australia's domestic supply, but the military has since been drafted to ramp up production.
Mr Csiszar said Australia had lost considerable homegrown manufacturing capacity to countries with cheap labour, which has consequences if medical manufacturers cost-cut further.
"Quite frankly, I'd be very dubious about any low-cost manufacturer having their products tested to standard," he said.
"You may as well just have a handkerchief or a piece of toilet paper over your face — it's useless."
He said that because masks use synthetic materials, masks not to standard also run the risk of introducing other pathogens that may be travelling with the raw materials, or the product.
"Faulty masks are a two-fold thing: they don't work, but they could also cause more damage by introducing third-party problems that weren't there before."
The ABC has contacted the researchers cited by Bioeasy for comment.

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