|Several countries have recalled China-made test kits and masks due to quality concern (Photo: CNSphoto)|
Accordingly, Spain, Dutch, Australia took turn to recall tens or hundreds of thousands of test kits, face masks imported from China.
How did faulty equipment get to Europe?
According to ABC net, 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 percent.
While China's been on a diplomatic mission to send vast amounts of medical aid around the world, including 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 license from China's National Administration of Medical Products, according to a tweet from the Spanish Embassy in China.
|All products that are sold in Europe market must carry the CE certification (Photo: Wikimedia Commons)|
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 ABC in an email.
The ABC was unable to independently verify the date shared.
|N95 face mask is highly sought after by consumers across the world (Photo: ABC News)|
Are there universal standards for PPE or test kits?
To determine whether a product is safe to use, health professionals 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".
|Globally, people have scoured stores online and in person to purchase face masks amid the pandemic.(Photo: Reuters)|
What happens if faulty equipment gets past regulators?
Health workers, and those most vulnerable to severe cases of COVID-19, are the people who depend on masks and test kits the most.
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, ABC net reported.
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