Excerpt: "There is no confidence that this device should be used to transfer critical care patients within or between hospitals due to the unreliability of oxygen and ventilation delivery, lack of adequate safety alarms and continued need for fine titration of settings," it said, using a technical term relating to the fine-tuning of the devices.
Exclusive: "We believe that if used, significant patient harm, including death, is likely," British doctors said in a letter.
[Alexander Smith | April 30, 2020 | NBC News]
LONDON — Senior British doctors have warned that 250 ventilators the United Kingdom bought from China risk causing "significant patient harm, including death," if they are used in hospitals, according to a letter seen by NBC News.
The doctors said the machines had a problematic oxygen supply, could not be cleaned properly, had an unfamiliar design and a confusing instruction manual, and were built for use in ambulances, not hospitals.
The British case is not an isolated one, and it comes as a stark example of a procurement problem that has plagued many countries as the coronavirus has spread throughout the world.
Since March, many governments have been scrambling to buy more medical equipment — much of it from China — to make up for large gaps in their supplies. While much of this equipment has been vital in combating the pandemic, some has been faulty or unsuitable.
As in the United States, the government in Britain has been heavily criticized for its coronavirus response.
With more than 26,000 people dead, critics say the government has failed to provide protective equipment for health care workers and widespread testing.
On April 4, Cabinet ministers triumphantly announced that they had scored a much-needed win, buying 300 ventilators from China that were unloaded with some fanfare at a military base in England.
"I'd like to thank the Chinese government for their support in securing that capacity," Michael Gove, a senior member of Prime Minister Boris Johnson's government, said at a briefing that day.
But nine days later, a group of senior doctors and medical managers issued a grave warning about 250 ventilators that they had received, the Shangrila 510 model made by Beijing Aeonmed Co. Ltd., one of China's major ventilator manufacturers.
"We believe that if used, significant patient harm, including death, is likely," according to an April 13 letter seen by NBC News. "We look forward to the withdrawal and replacement of these ventilators with devices better able to provide intensive care ventilation for our patients."
The doctors said that the ventilator's oxygen supply was "variable and unreliable" and that its build quality was "basic." Its fabric case could not be cleaned properly — essential when fighting a highly infectious virus — and it arrived with a "non-E.U." oxygen connection hose.
As well as these serious concerns about the quality of the ventilators, they said part of the reason they were unsafe was because the devices were unfamiliar to British doctors and unsuitable for use in the current crisis.
Crucially, it was the wrong type of machine altogether: one that had been designed for use inside an ambulance rather than beside a hospital bed, according to the letter. Doctors said they had to jury-rig a makeshift stand for the device out of a hospital trolley.
The letter was written by a senior anesthesia and intensive care doctor, who was representing a group of clinicians and senior managers working in and around Birmingham, the U.K.'s second-largest city and one of the country's hardest hit areas.
The doctor who wrote the letter works at the Sandwell and West Birmingham NHS Trust, a regional division of the U.K.'s publicly funded National Health Service, and it was directly addressed to a senior NHS official.
The sender was not available for comment on what, if any, measures were taken to address the concerns raised.
It is not clear who in the British healthcare system directly saw the letter, but the Department of Health and Social Care, which oversees the NHS and the purchase of ventilators from abroad, said in an email to NBC News that it was aware of doctors' concerns and has raised them with the manufacturer.
The department declined to answer several detailed questions about the letter, including how many of these ventilators were bought in total, why that model was chosen, and whether front-line doctors were consulted beforehand. It said none of the ventilators is currently in use.
After repeated emails and phone calls, NBC News got through to the international sales manager for Beijing Aeonmed, who said "I don't know" when asked whether the company was aware of the concerns about its product before hanging up the phone.
The company has not responded to detailed questions about this model of ventilator, nor about where else in the world it has been exported.
A 'global battle of narratives'
Britain is far from alone in encountering problems after ordering lifesaving equipment made by Chinese companies.
In late March, the Netherlands was forced to recall 600,000 masks that it bought from China and distributed to its doctors after its health ministry foundthat they were not up to the required standard.
And earlier this month, the head of Finland's emergency medical supply agency resigned after a multimillion-euro shipment of masks from China was found not to be up to the standard needed by hospitals.
It's not just masks. The Spanish government said it had to withdraw and return a batch of 50,000 coronavirus testing kits that originated in China because they were only 30 percent accurate. The U.K. ordered 3.5 million Chinese testing kits but found none of them to be good enough for widespread use. The British government said it was seeking refunds from the suppliers.
Seemingly most of the equipment reported to be faulty has come from China, which has sought to portray itself as a country that has not only successfully dealt with its own outbreak but is now helping others tackle their crises by sending out tons of gear.
As the world's top manufacturing superpower, China makes much of the equipment essential in fighting the coronavirus.
Before the crisis began, it churned out 20 million medical masks every day — around half the world's total output — but by the end of February, it had already ramped up production to 116 million daily units, according to Chinese state media.
As of Saturday, 74 countries and six international organizations had signed 192 contracts for Chinese medical supplies totaling $1.41 billion, Li Xingqian, director of the Commerce Ministry's foreign trade department, said at a briefing Sunday.
Much of the equipment is received without complaint, but the manufacturing blitz has also led to increased reports of faulty orders and counterfeiting of established brands.
The Chinese government has been quick to address the concerns, vowing to "crack down on counterfeit and shoddy products" and "mete out punishment with zero tolerance" to any company found to be exporting substandard equipment, a Foreign Ministry spokesman, Zhao Lijian, said at a briefing April 15.
Meanwhile, the Commerce Ministry announced this month that it had revoked the export licenses of two companies, warning that faulty exports "seriously damaged the country's image." Spokesman Gao Feng also suggested that some complaints from other countries were the result of "differences in production standards" or European doctors being "not familiar enough with how to use the products, and even making mistakes."
Many outside the country are wary of what they see as China's attempts to capitalize on the crisis, boosting its power by casting itself as the world's benevolent savior. Critics say the narrative ignores the allegation that some Chinese officials covered up aspects of the crisis in its early stages, as well as more recent claims that they suppressed death and infection data — which the Beijing government vehemently denies.
One of those doubters is Josep Borrell, the European Union's foreign policy chief, who warned last month of a "global battle of narratives" with China.
"China is aggressively pushing the message that … it is a responsible and reliable partner," Borrell said in a statement, calling it a "struggle for influence through spinning and the politics of generosity."
He warned that other countries risked being stigmatized in the PR war. In the early days of the crisis, several European nations squabbled with their neighbors and accused them of withholding vital medical exports. And the U.S. has faced claims that it outbid allies for equipment and redirected orders its way.
'Solid as a rock'
Like many other countries, the U.K. was scrambling to make up the shortfall in its ventilator capacity by the middle of March.
Health Secretary Matt Hancock warned that Britain would need to increase its number of the machines from 10,000 to 18,000 to stop the NHS from being overwhelmed.
Although some doctors have recently moved away from relying so heavily on ventilators, warning that they could harm certain patients, for much of the crisis the machines have been seen as vital in coping with the projected surge in intensive care cases.
There are many different types — ranging in complexity and price, with top models costing upward of $50,000. They work by pushing oxygen into the lungs of patients who cannot breathe for themselves, and they are used to treat the most serious COVID-19 patients.
On April 4, the British government announced a major step toward that goal after 300 ventilators from China arrived at MoD Donnington, a military base in England.
However, less than two weeks later came the letter from senior doctors and managers at the Sandwell and West Birmingham NHS Trust.
In a five-page document seen by NBC News, they detail a litany of concerns with the Shangrila model by Beijing AeonMed, which was established in 2001 and says it has branches in Germany, Mexico, Indonesia and India.
According to listings on Made-in-China.com, which connects global buyers with Chinese manufacturers, the ventilator is a relatively cheap machine, costing $1,500 to $3,000.
AeonMed describes it as a "solid as a rock ... emergency transport ventilator" that was the first device in China to get a "CE marking" — meaning it would have passed the E.U.'s health and safety requirements. It says the device was the sole emergency ventilator used at the 2008 Summer Olympic Games in Beijing.
Li Kai, assistant to the chairman of Beijing Aeonmed Co Ltd, told China’s state-run Global Times newspaper that all of its products go through inspections before being imported overseas. "Our plants are working around the clock to increase production capacity as we have received orders from several countries," he said.
But because of the ventilators' problems, the British doctors said, they would be usable only with careful and time-consuming supervision by senior specialists. They warned that its unreliable and unfamiliar settings were "highly likely to cause serious harm" when used by the army of nonspecialist doctors and nurses who have been conscripted into ICUs to fight the virus.
The unfamiliarity was compounded by an "inadequate" instruction booklet, according to the doctors, who said they could not find a U.K. distributor for support, spare parts and servicing.
"There is no confidence that this device should be used to transfer critical care patients within or between hospitals due to the unreliability of oxygen and ventilation delivery, lack of adequate safety alarms and continued need for fine titration of settings," it said, using a technical term relating to the fine-tuning of the devices.
'The public wanted headlines'
The NHS department that sent the letter declined to comment, instead directing NBC News to the Department of Health and Social Care.
But Dr. Ron Daniels, a senior ICU doctor in another NHS region covering Birmingham, said his team was sent a small number of the same model and shared some of the same concerns. He believes the hasty purchase was the result of the U.K. government's seeking a quick public relations win.
"The public wanted headlines and the public wanted good news, so the government chose to supply ventilators that were not really fit for purpose just to grab some headlines — I don't think that's an unreasonable angle," said Daniels, who is also the founder and executive director of the Sepsis Trust, a British charity.
He said that he did not have as much experience using the ventilator and that it was possible it could be used on less serious patients or in other circumstances.
The Department of Health and Social Care did not respond to detailed questions about the procurement process for the Shangrila 510: how and why it was purchased, whether front-line doctors were consulted beforehand and whether it had passed the relevant safety and regulatory checks.
Instead, the department said in an emailed statement: "We are leading a coordinated effort to rapidly increase ventilator capacity and ensure these vital pieces of equipment are delivered to the frontline. Patient safety is our absolute priority and new orders are all dependent on machines passing robust regulatory tests to ensure they are up to standard."
It said that none of the machines in question were currently being used and that all NHS hospitals had spare capacity and the option to use other models if needed.
Alexander Smith reported from London, and Eric Baculinao and Leou Chen reported from Beijing.
Read the original article here.