Making ventilators in Egypt: tough, but not impossible
 
 
A patient suffering from coronavirus disease (COVID-19) wears a full-face Easybreath snorkelling mask given by sport chain Decathlon and turned into a ventilator for coronavirus treatment at the intensive care unit at Ambroise Pare clinic in Neuilly-sur-Seine near Paris, as the spread of the coronavirus disease continues in France, April 1, 2020. REUTERS/Benoit Tessier
 

More than 1.5 million people around the world have tested positive for the coronavirus. According to the World Health Organization, eight out of every 10 COVID-19 patients don’t need hospitalization. But one in six can experience breathing complications and develop lung failure. Ventilators are crucial to prevent death in such cases. In the absence of antiviral drugs, governments are scrambling to fill gaps in both current and projected needs for ventilators. 

The United Kingdom aims to produce 1,200 units in less than two weeks, with the National Health Service owning just 8,000 against a projected need of 30,000 machines. Hospitals in the US own about 160,000 machines and are working to add at least 40,000 more.

Automakers and other manufacturers are adjusting their production lines to make ventilators. Non-governmental initiatives are popping up worldwide to produce face masks and other medical supplies using 3-D printing technology, while other technical groups are designing prototypes of ventilators that can be easily replicated. 

Seven countries account for 70 percent of ventilators exports globally, according to two World Bank experts quoted by CNN. If one them stopped exporting, ventilator prices would rise by 10 percent. This hasn’t happened yet. India, Russia, the European Union and other countries have banned the export of facemasks and other personal protective equipment, but so far Italy, which has seen more than 18,000 COVID-19 patients die, is the only country banning exports of ventilators.

Egypt owns between 3,000 and 6,000 ventilators for its over 100 million people, according to researchers and government statements. And with the number of confirmed cases growing, attention has turned to sourcing more devices. 

 

Why do coronavirus patients need ventilators?

An oxygen saturation rate of at least 95 percent is considered healthy. If it falls below 90 percent, the patient should be put on oxygen, said Mahmoud Okasha, an intensive care unit physician in Qasr al-Aini Hospital. 

Blood oxygen levels can be raised with a number of ventilation methods, Okasha said. In case of a limited drop in oxygen concentration and mild difficulty in breathing, a mask connected to an oxygen tank can do the trick. This simple device is readily available in all hospitals, and could suffice in saving a large portion of COVID-19 patients if the virus hasn’t reproduced inside their lungs. But that won’t work for patients with advanced respiratory failure — they need mechanical ventilators.

The absence of artificial respiration for advanced cases means “suffocating to death,” Okasha said. He added that while most countries worldwide are facing a shortage in ventilators due to coronavirus, Egypt is in a particularly bad position. The total number of medical ventilators available in both public and private hospitals is already insufficient for the population’s needs under normal circumstances. Patients die while searching for intensive care unit beds with available ventilators.

“Given the shortage in ventilators, a surge in coronavirus infections means a catastrophic spike in fatalities,” he said.

 

Who owns the technology? 

Egypt has relied on buying ventilators from the US or Europe, but that has become difficult with the increase in global demand.

President Abdel Fattah al-Sisi ordered the prime minister and the industry minister to focus on manufacturing ventilators in the coming period, according to Hany Younes, an advisor to the prime minister. The Faculty of Engineering at Ain Shams University announced a design competition for ventilators that could be manufactured locally. The best three designs will be announced on April 24, and will be made available to manufacturers for free.

Medhat Nafae, the head of the state-owned Metallurgical Industries Holding Company, said his company will use Medtronic’s patent-free ventilator design to make a machine locally. All the holding company’s facilities are open for medical engineering professionals to use, he said. 

While Egypt lacks specialized ventilator manufacturers, Nafae told Mada Masr that automakers might be up for the task, because car assembly lines are somewhat similar to those of ventilators, he said, adding that his initiative aims to assemble the machines rather than making them from scratch. Tarek Arafat, an engineer who worked for 15 years on the design, development and manufacturing of ventilators in Canada concurs. 

But problems will arise from the different sizes of components, he said. In other words, the length of one car component might be nine inches, while its ventilator counterpart could be half an inch. And having the industrial infrastructure in place isn’t sufficient, according to Arafat. Making a ventilator requires specialized software, electric circuits to measure vital signs and control the machine, and supporting industries.

In Canada, too, some technology isn’t readily available. Arafat said his company had had to send machines to the United States to drill ultra-fine holes in one ventilator model the company was manufacturing.

Nafae hopes two of the holding company’s subsidiaries specializing in car parts, NASCO and AYAMCO, will have the necessary technology to make ventilators, even if they require some upgrades or adjustments. Nafae said he has already started researching suppliers of the parts that could be needed to repurpose the facilities in the two subsidiaries.

Three other privately owned medical equipment makers have set their sights on making ventilators in the last few weeks, said Khaled Ghoneim, an official at the Federation of Egyptian Industries, although he declined to name the three companies in question.

“We’re looking at assembling the machines here, but all the components will be imported from China, South Korea and Taiwan,” he said, adding that such components are in high demand globally.

Skilled workers will be needed for any production or assembly. Nafae says he is in contact with two research groups at Alexandria University and Zewail University who have already designed prototypes. He’s now coordinating between the two groups and creating a work space for them in the holding company’s factories. 

 

Who regulates?

Arafat said it took his company 6 months to go through the tests required by the US’s Food and Drug Administration to get certification and start manufacturing ventilators. 

Complicated bureaucracy aside, such tests are absolutely necessary, according Sherif Ezzat, head of the medical equipment chapter at the Federation of Egyptian Industries. 

Ventilators are serious medical tools and a 1 percent mistake in specifications could endanger lives, he said. “The problem is time. We need eight to twelve months to produce a tested and approved machine.”

For Arafat, this is the main hurdle. “It’s not about getting certified, it’s about ensuring that the ventilator doesn’t risk people’s lives,” he said. “If the machine is made of 50 components, each one has to be tested individually to know what would happen if it breaks down for any reason.”

Last year, Egypt created two medical supervisory agencies to oversee medical supplies. The Egyptian Drug Authority (EDA) is in charge of regulating medical supplies and equipment. The Unified Medical Procurement Authority is in charge of buying all the government’s medical needs. Together, the two new bodies are responsible for setting the specifications and tests needed to approve a locally made ventilator.

But the agencies’ modus operandi remains ambiguous, according to Ezzat. “So far, we don’t know what supervisory mechanisms the EDA will utilize,” he said.

Ghoneim added that EDA standards for ventilators haven’t yet been finalized. 

Nafae aims for the holding company to start producing in a month’s time, provided that the research groups prepare a prototype in a week and regulatory approvals are obtained within another week.

Ezzat, however, is less optimistic. Importing components is “difficult because we’ve never dealt with their suppliers before,” he said, adding that component suppliers are under immense pressure due to the spike in demand all over the world.

 

Alternatives

Arafat sees a possibility of sourcing cheaper ventilators.

“Disposable ventilators are single-use devices that cost $100,” he said, adding that he’s not sure if Egypt can afford them. Xerox confirmed that it is partnering with an American medical manufacturer to scale up production of a disposable ventilator called Go2Vent to fill the gap in US hospitals. Go2Vent is already approved by the US Food and Drug Administration and is used by emergency medics and first responders.

Another course of action is to bring international firms that are already producing ventilators to set up shop in Egypt, Ezzat said. This could be a faster solution than using local manufacturers, but is also hard to implement: there are few ventilator makers worldwide, and they are now facing immense demand.

Egypt could try to import ventilators from South Korea or China. But Chinese producers are already stretched, with 1,700 devices exported in March, the South China Morning Post reported. Manufacturers have about 20,000 outstanding orders, with more coming every day, the article stated.

The Chinese manufacturers are facing difficulties procuring components for ventilators, especially those produced in the EU and the US. Additionally, the pandemic is disrupting supply chains and shipping, complicating matters for countries, like Egypt, that are just beginning the manufacturing process. 

It’s “tough,” Ezzat said. “But it’s not impossible.”

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Mostafa Mohie 
Sara Seif Eddin 
 

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