China's quality control problem in leading coronavirus fight

Chinese workers sort masks at a factory in Nanjing in China's Jiangsu province. The factory switched from making surgical instruments and dental equipment to masks to meet increased demand during the COVID-19 pandemic.

By Alice SuBeijing Bureau Chief

April 10, 2020 10:18 AM PT

BEIJING — The COVID-19 pandemic has ignited a worldwide scramble for medical gear: masks, gowns, ventilators, testing kits, much of it made in China, which is attempting to recast its image as the source of the virus to the leader in the fight against it.

But that narrative is threatened by a major problem: quality control.

A growing list of foreign complaints about faulty medical gear and testing kits imported from China has upset Beijing’s designs. Within the last few weeks, scientists and health authorities in Spain, the Czech Republic, Slovakia, Turkey and Britain have complained of faulty antigen or antibody coronavirus tests purchased from Chinese companies — in some cases, costing these governments millions of dollars.

Georgia has canceled a contract with the Chinese company that sent flawed test kits to Spain, and Malaysia has opted to buy testing kits from South Korea instead of China because of the Chinese tests’ reported low accuracy rate.

Last week, the Netherlands asked to return 600,000 face masks purchased from China that had inadequate filters and fit incorrectly. On Tuesday, Finland tested a shipment of personal protective equipment, or PPE, from China and found the items unsuitable for hospital use. Australian border officials have also reportedly seized 800,000 faulty or counterfeit masks from China.

The problem is worse at home. On March 12, officials at a State Council news briefing announced that authorities had seized more than 80 million counterfeit or faulty masks and 370,000 defective or fake disinfectants and other anti-coronavirus products in the prior month alone.

In some cases, defective masks have been reported after buyers purchase them online as a donation to Wuhan and other cities, only for medical staff to discover they can’t use them. China is trying to rein in its subpar PPE manufacturers. Authorities have detained dozens of counterfeiters and threatened those producing poor quality medical products with life imprisonment.

Beijing has also tightened export standards in recent days, including quality checks at customs and requiring domestic certification as well as foreign licenses for medical products shipped abroad. Previously, exported medical products only had to have the certifications in receiving countries, such as the European Union’s CE certification, which could be easily counterfeited in China.

But the desperation of states, nations, hospitals and individuals competing worldwide, shelling out millions of dollars to get medical gear as people die by the thousands each day, has created a scammer’s paradise.

“It’s a complete mess,” said Dan Harris, a lawyer whose firm Harris Bricken has advised companies on sourcing from China for more than 15 years. He called the current situation “unprecedented,” especially as frenzied Chinese suppliers attempt to recoup losses after months of quarantine.

“A year ago, Chinese companies were fine. Now they’re desperate,” Harris said. “A lot of them know they’re going to be bankrupt in a week. A lot are going to be bankrupt already. So they’re selling bad product, fake product” — and the whole world is buying those products, regardless of how they’re made.

Many of those calling Harris’ firm for help are hospital purchasing managers who are under pressure from overwhelmed doctors asking, “Where the hell are the masks?” he said.

Then there are the middlemen, including experienced distributors and longtime sourcing agents who think it’s easy to shift into PPE. And a smattering of “crooks, who go to the hospital and say, ‘I can get you 5 million face masks’ … And they have no clue what they’re doing,” Harris said.

Many factories in China have pivoted into PPE manufacturing under government encouragement.

Meanwhile in China, many factories have pivoted into PPE manufacturing under government encouragement, even though they lack capacity and quality control.

“Everybody is jumping on this market and they have zero understanding of quality,” said Renaud Anjoran, a manufacturing supply chain auditor based in Hong Kong. “But these are high-risk items. If they don’t work, people might die.”

It’s common for Chinese suppliers to export a product under one licensed company’s name but to source their products from second, third or fourth factories, like a chain of Russian nesting dolls, with little to no traceability down the chain of supply.

“In China, nothing is really black and white,” Anjoran said. “You have manufacturers selling you stuff they don’t really manufacture. They’re making it somewhere else, but you don’t know where.”

There are many ways medical product exporters could get away with counterfeited or substandard goods even with the certification requirements, Anjoran said: Certificates can be faked. Certificates can be real but altered to display another manufacturer’s name.

Certificates can be valid, with goods made at the factory, but the manufacturer may not be checking the quality of its raw materials — especially the filter material in masks, the most important factor in protecting medical workers from the coronavirus. Testing filter material can take up to two weeks and cost more than $2,000.

“You’ve got speed and greed,” Harris said. “It’s perfect for con artists.”

Many of the newly established mask factories also operate in unhygienic conditions, with no process to keep the air clean, Anjoran said, based on his own auditing visits.

“But this is not even on the radar of most buyers these days,” he said. “They’re like, ‘But did you see the masks were dirty? No? OK, who cares! It’s going to save lives. Don’t be picky.’”

Testing kits also require careful buying. The World Health Organization has listed only two COVID-19 diagnostic tests for emergency use, both nucleic acid tests that use a slower, swab-based method to detect viral RNA.

The faulty rapid test kits foreign governments bought from Chinese companies have all been antibody tests, which use blood samples to look for antibodies developed only a week or so into a person’s infection with the coronavirus, or antigen tests, which detect virus proteins.

But both kinds of testing are relatively new and not replacements for the nucleic acid tests — notably the antibody test, which is fast and can catch mild or asymptomatic cases in people who’ve already recovered from the coronavirus, but cannot determine whether a person currently has the coronavirus.

That’s why antibody tests should not be used for diagnosis, said Dale Fisher, chair of the WHO’s Global Outbreak Alert and Response Network.

“At the moment, we’ve just got the PCR as a gold standard,” he said, referring to the nucleic acid tests. “Antibody tests are really for research, to help us understand the transmission dynamics.”

Britain reportedly bought 3.5 million antibody tests from two Chinese companies, Guangzhou Wondfo Biotech Co. and Hangzhou AllTest Biotech Co. Only one of those, Wondfo, was on the Chinese National Medical Products Administration’s list of authorized test kits.

Chinese national guidelines also state that antibody tests should only be used as a supplement to nucleic acid tests, not for “screening in general population,” and that they should not be used as the sole basis to diagnose or exclude infections with SARS-CoV-2, as the new coronavirus is called.

The company that Spain bought faulty test kits from, Shenzhen Bioeasy Biotechnology Co., was also not on the list of nationally authorized suppliers. The Spanish government reportedly acquired the test kits through a middleman who produced documentation showing that Shenzhen Bioeasy had CE certification.

Chinese diplomats have tried to distance the government from the companies selling faulty medical products, while also asserting that due diligence is the buyer’s responsibility.

“We want to remind everyone to double-check the instructions for use to make sure what they purchase can serve their intended purposes and avoid making mistakes in a rush,” said Chinese Ministry of Foreign Affairs spokeswoman Hua Chunying at a recent news briefing.

China is worried about low-quality medical products damaging its image. On April 6, customs authorities announced they’d confiscated more than 11 million unregistered medical products within one week, including 9.94 million masks, 144,000 protective gowns, more than a million testing kits and 24,000 infrared thermometers.

Orders have meanwhile continued to roll in, with Germany beginning this week to ship millions of masks from China with the government’s help.

The governors of New York and Massachusetts have worked with the Chinese government and internet company Tencent to facilitate PPE deliveries.

The United States’ Project Airbridge, a public-private partnership led by President Trump’s advisor and son-in-law Jared Kushner, began chartering airlifted supplies from China this week.

But the coronavirus has exposed the world’s dependence on China and that country’s problems with quality control.

Whether this experience will lead to further “decoupling” after the pandemic, with more countries seeking to diversify supply chains away from China, will depend in part on how China’s regulators perform.

Special correspondent Meg Bernhard in Brussels and Nicole Liu and Gaochao Zhang in The Times’ Beijing bureau also contributed to this report.