California-based Amron International finds success in modified oxygen hood design for NIV
Updated: Jul 22, 2020
5/14/2020 Chicago Over the last 42 years, California-based Amron International has focused its attention on commercial diving, hyperbaric and military equipment. They had no way of knowing that one of their products would be used to help fight a worldwide pandemic. Fast forward to March 2020 and that is right where the medical division at Amron has found themselves.
In a recent interview with Aurika Savickaite, co-founder of www.HelmetBasedVentilation.com, Amron’s Vice President of Engineering and Manufacturing, Scott Ritchie, shared the company’s history with helmet ventilation and how it has adapted the design of its oxygen treatment hood to meet the increased demand from hospitals caused by the COVID crisis.
A 34-year veteran with Amron International, Ritchie has focused much of his career on product design and development. He also oversees the manufacturing division, quality, and safety at the company.
In the late nineties, the company had developed a hood to be used in clinical decompression chambers, which provides treatment for diseases such as multiple sclerosis, cerebral palsy, serious infections, and wounds that will not heal due to gangrene, diabetes and radiation injuries.
“It was actually a fun product to design and it became a very successful product for Amron, Ritchie said”.
In the beginning, getting customer input was important, so the company sent out a survey to its clients, including medical personnel, to see what features they would like to see incorporated into the design.
“I gathered all the information and then came up with the design,” Ritchie said. “There were many requirements that doctors wanted to see incorporated into the product.”
That included the ability to allow the patient to lay down – which required the design to feature an offset neck opening, back towards the rear of the helmet, and not have the hood lift over their head. A two-part design provides a means of securing the neck ring with a neck seal on the patient, allowing full access to the patient to make adjustments as needed, including control of the gas supply. It also allows for the temporary removal of the hood without disturbing the patient, connections, or gas supply.
Entering 2020 and with COVID-19, the helmets found a new application.
“We went into (what) I would call “hyper-speed mode” considering the new requirements and redesigning certain aspects of the hood to make it more compatible for CPAP, NIVA and other types of treatments hospitals need,” Ritchie said.
Because helmet ventilators require higher internal pressures, Amron incorporated a unique locking system that eliminates the need for locking clips. This locking system also acts as a built-in pressure release feature at 40-plus cm of water.
Straps and strap retainers were added to help secure the hood system to the patient due to elevated pressures.
Ritchie had ideas for the current design back in the late nineties, but at that time, the design was cost-prohibitive and certain FDA-approved materials available today, were not available at that time.
Another feature of the Amron hood is the solid one-piece neck ring design, which Ritchie refers to as the “heart of the design.” The neck seal is removable and easily attaches to the neck ring. The neck ring is made from an autoclavable medical-grade plastic, which can meet the various cleaning processes at different hospitals. The one-piece design helps eliminate contamination and can be soaked in a germicidal disinfectant, and unlike two- or three-piece designs, it can dry quickly.
The ring itself is the main base, which includes a patented front placement of the couplers. The supply of oxygen comes over the patient’s face providing a fresh breath, eliminating fogging and helps to keep the viewing window clear. The rounded shape helps scrub out the CO2. Much study went into the coupler placement design to make sure the lower flow rates – especially for younger patients – were perfect. Attention also was given to address the various flow-rate noise levels, to avoid the ear area and to aid oxygen circulation.
“We found that many patients using other products would overheat, where they just never felt like they were receiving fresh oxygen,” he said. “That’s why we felt the circulation going from front to back, up and over and back is a better concept because it does cool, it gives them fresh oxygen and you’re getting that fresh breath”.
“And it reduces the CO2 levels, as well,” Ritchie said. “So that was a key part of that ring design.”
Ritchie believes that physicians should monitor and measure the CO2 flows for the unique, individual needs of the patient, he said. Monitoring CO2 levels can be the best tool to determine success, along with proper flow rates.
The hood is easy for the attendant to place over the patient’s head. The hood’s viewing window is made of optical quality vinyl and not only provides comfort for the patient, allowing them to watch TV or read but is also a safety aspect. Due to the inherent thickness of the hood window material, the patient is able to breathe, even if the hood is pushed against the user’s face.
A multi-access port allows for multiple uses for both the patient and the physician, from testing CO2 levels to providing liquids, to suctioning the patient, if needed.
“That’s one of the features that everybody is looking for in the medical field,” Savickaite said. “It’s patient comfort and definitely it helps the staff to take care of the patient.”
The silicone neck seal is unique as the base is thicker for increased durability and provides a good seal, yet is thinner around the neck, allowing for improved patient comfort. The silicone neck seal is a patented product and the overall hood was patented in 1998. The hood has been FDA approved since 2001, and has had to undergo testing at Amron, in hospitals, and at the US government. A variety of toxicology tests also had to be passed to achieve marketing approval. Amron has also implemented a robust ISO 9001:2015 quality management system that actively promotes customer feedback into its processes in order to continually improve its products as well as customer satisfaction.
“That’s what we’re all about; we’re constantly improving all of our products. It’s been a great journey for the product,” said Ritchie.
The medical manufacturing division is one of the three market-segment divisions at Amron International, in addition to the military and commercial diving divisions. While the commercial diving industry is slow right now, due primarily to plummeting oil prices and the economic impacts of COVID-19, the last several weeks have been extremely busy for the medical division.
“We were in the hyper-speed mode to develop our new hood for COVID-19, but we continue to sell the hyperbaric hood,” he said.
COVID-19 has not only garnered international interest in the hoods but also in the United States.
“Even in the US, I can see where hospitals are starting to slowly incorporate this product and our hope is to try and get the hood introduced into clinical studies for use in hospitals, and to also promote education because I do feel the hood is very beneficial versus intubating a patient and putting them on ventilators, which they’ve found isn’t always the best solution.
“With hoods, we’re using PEEP valves with elevated pressures, which is found to be a significant help for some COVID patients,” he said.
Savickaite was pleased to hear of the US interest.
“We still have a big learning curve,” she said. “I’m so glad that you are also listening to your customers so well and making all these changes to the design, which are beneficial for patient treatment.”
Ritchie is excited and passionate about Amron’s participation in the fight against COVID-19. “At Amron, we would like to see this type of therapy become more widely utilized by hospitals in order to accommodate differing levels of pulmonary and respiratory treatments as well as COVID-19 – we find it extremely fulfilling to help doctors save lives, and because of that, I would like to help spread the word.”
Ritchie would like to see all unite to get through the COVID-19 era.
“I hope that doctors, clinicians, and related communities will try and create a unified group,” he said, acknowledging that it’s been a challenge. “As a whole, I think everyone can all agree these types of therapies are beneficial for patients”.
“The goal is to save lives and help people,” he said. “We have to keep the common goal in mind, in moving forward, always.”
“When the physicians and the patients see the benefits of the helmet-based ventilation, this is when it’s going to be more widely accepted,” she said. “I truly believe we both have the ultimate goal of patient safety in mind – to make sure the patient is safe, that the patient gets better, and that clinicians learn and study more about non-invasive ventilation via the helmet.” Savickaite acknowledged Ritchie and Amron’s dedication to the helmet-based ventilation effort.
“It’s a good goal to have, and I believe we are all are on the same page here,’ she said. Now we just need more helmet champions – and one of them is you and your company.”
A video review of this helmet.