For more than 40 years, Harol has been providing non-invasive ventilation products to help hospital patients. The COVID-19 pandemic increased demand for its helmets dramatically, but the company still struggles to train clinicians about its products and to reach a global market.
“(W)e started 20 years ago, talking about using helmets. We know that it works,” said Massimo Callegher, co-owner and production manager at Harol based in Milan, Italy. “We started selling them for hyperbaric therapy, and then some ICU doctor had an idea to use it for ventilation.
Harol manufactures 4,000 helmets a year. But during the pandemic, it turned out 16,000 helmets from March through December 2020.
“At the beginning of 2020, we had just one machine to manufacture helmets. Now we have three,” Massimo Callegher said. “We started by making less than 50 pieces a day, and now we have a capacity of 150 a day.”
“We have completely changed our way of manufacturing the helmet, especially at the beginning of the pandemic, the numbers were dramatic,” he said.
Harol offers about 15 products, including face masks and helmets for non-invasive ventilation in various sizes and styles.
Confusion is common
Despite being the first distributor for the helmet interface, the company still finds some clinicians don’t understand its products or the best way to use them.
“With CPAP, when you deliver high flow and the helmet is completely enlarged, you have to make sure you’re providing appropriate CPAP therapy and giving enough airflow to the patient,” said Cristina Callegher, co-owner and sales director. “Sometimes, clinicians don’t understand what we mean - flow generator.”
Continuous positive airway pressure, or CPAP, is a type of positive airway pressure that is maintained during inspiration and expiration. Helmet CPAP ventilation uses high flow to achieve results without the use of a ventilator.
“They think CPAP is the ventilator mode,” Massimo Callegher added. “Dr. Foti says never connect a helmet to a ventilator in CPAP mode.” (Giuseppe Foti, MD, is director and associate professor at the Emergency Department, ASST Monza, San Gerardo Hospital, Italy, and a researcher in helmet ventilation.) Instead, the helmet becomes the CPAP. If you have a venturi system, you don’t need a machine, just the flow. But there’s a lot of confusion surrounding it.
Harol sells a flow generator that helps achieve CPAP therapy with high flow, Cristina Callegher said.
“Hospitals buy helmets but not the flow generator,” said Marco Bellati, a product specialist at Harol.
Harol’s helmets can be used with a venturi system or connected to medical air and oxygen to create a high flow for patients in respiratory distress. If oxygen is in short supply, the helmet could be used with a high-flow nasal cannula to achieve a higher oxygen concentration for the patient.
The bulk of the company’s helmets are sold in Italy where helmet ventilation is more common.
Italian hospitals didn’t have dedicated respiratory units like US hospitals. Instead, clinicians in various departments have learned how to administer the therapy. “They started 20 years ago, and now lots of the departments have two or three doctors and nurses dedicated to respiratory therapies,” Massimo Callegher said.
It is possible that helmet use will increase after the pandemic as people have time to study them and apply them in successful ways. The COVID pandemic is a stressful environment to work in, and implementing a new device is hard. Some clinicians ordered helmets but never used them because they didn’t know how to.
“We face the same problem here,” Massimo Callegher said, noting there’s confusion over a brand name or color change. “You are comfortable with one product. It works. So change is always stressful.”
Challenges to helmet use
Harol would like to branch out to a global marketplace, particularly the US, but it lacks US Food & Drug Administration, or FDA, approval for its helmets – a lengthy, expensive process for any company to undertake and almost impossible for a small company. Two helmets have been approved for emergency use in the US for COVID patients. Clinicians who wish to use helmets in the US are limited to only COVID patients, or doctors and hospitals can choose to use them “off label.”
“I really never understand why in the US” helmets for ventilation have not been approved, Massimo Callegher said. He recalled the former owner of Sea-Long, a US maker of hyperbaric helmets, tried many times to gain approval from the FDA.
Helmets face challenges in the US because they are new to many clinicians. Face masks faced the same issues. Doctors were used to intubating patients and were hesitant to use face masks. Over time, their use increased and became regular. As more clinicians use helmets and conduct studies with them, they will become more familiar and regularly used.
“We think that the doctor must believe in the product. It’s important,” Cristina Callegher said. “If they can’t trust (it), they give the sensation to the patient.
“Usually, patients change their opinion about the helmet when they sense the airflow directly,” she added. “Then, they understand that they can breathe better.”
“For us, the US will be an opportunity,” Massimo Callegher said. “The US is a big market for everything.” And helmets are a device that can limit the need for ICU care.
“This is the reason why we spread all over the departments in Italian (hospitals) because the cost of stay in the ICU is 10 times the one in a general ward,” Massimo Callegher said. “This is the reason why a lot of physicians try to introduce this type of device.”
But because of the pandemic, helmet makers were able to at least put their foot in the door. If US clinicians start to use helmets, everybody else will follow.
A face mask interface is about five times cheaper than a helmet, but the results aren’t the same. Helmet use can prevent intubation close to 90 percent of the time in COVID patients. And overall costs to treat the patient are lower with helmet interface, requiring fewer days in the hospital, fewer days in the ICU, and often eliminating the need for intubation and mechanical ventilation.
Harol’s helmet manufacturing
Harol’s helmets come in a range of sizes and include either an access port at the top or a zipper at the bottom. They can be used with underarm straps or a cushion pillow inside the helmet that helps seat it against the patient’s body.
Neck seals are made of polyurethane or silicone. The company doesn’t mold plastic, but it developed the components, which are made elsewhere and assembled onsite.
During the pandemic, it wasn’t easy to find people to work, Bellati said. He and Massimo helped assemble helmets every day.
“Most of the companies were closed because of the lockdown, but we worked 10 times more,” Massimo Callegher said. They had to train people and increase production. It wasn’t easy, he said, but they did it.
“I like to think (the) 20,000 pieces we manufactured last year saved 20,000 lives. Maybe not, but this is my thinking,” Massimo Callegher said.