“We wanted to provide the safest possible surgical environment for our patients — especially since our focus, cataract surgery patients, are generally elderly and among those at highest risk of mortality if infected.” – Dr. Joseph Ma, chief medical officer, Bionic-i™
In a state of emergency this spring, Canada’s hospitals took drastic measures to limit the spread of COVID-19 within their doors. Elective surgeries were suspended for weeks, adding to already lengthy waitlists.
Patients needing cataract surgery, for instance, are waiting up to 75 additional days, according to a recent study commissioned by the Canadian Medical Association (CMA) that quantified the backlogs resulting from the first wave of COVID-19 for six procedures.
Once surgical services resumed, hospitals faced pressure to recover from the backlogs along with a new challenge: the additional time required to sanitize operating rooms to ensure they are safe for each procedure.
“COVID-19 protocols have forced physicians, [other] health care workers, clinics and hospitals to function at a much lower efficiency than they usually would,” said Dr. Joseph Ma, an ophthalmic surgeon based out of Toronto, Ont.
He claims that these additional sanitizing procedures, which can take from 30 minutes to one hour, cause a delay that limits access to care — especially for those needing surgery or access to high-volume specialties.
“During our initial re-opening, we found that surgeons who normally see 30 to 40 patients might only see seven to 10,” he said. “It had an arresting effect on our surgical practice, and we needed to find a solution.”
The pursuit of efficiency
He searched the market for an existing product that could help but couldn’t find anything that could disinfect aerosols quickly enough and that met operating room standards.
“Unfortunately, they weren't optimized for the problem at hand,” said Dr. Ma. “The devices we were looking at were for surface sanitization, and although they were marketed as taking three minutes, that meant three minutes per limited surface area. When we added it all up with other procedures, it still meant around 50 minutes per room.”
Part of the current COVID-19 protocol for aerosol-generating procedures (AGP) includes 30 minutes to ventilate the room after each surgery, before cleaning staff can enter to disinfect surfaces.
Dr. Ma figured there must be a better way, so he and his team at Bionic-i™ got to work on a device to make this process more efficient. The outcome was the Lightshield™ Hyperflow™ Sterilization Robot.
Dr. Joseph Ma received a COVID-19 innovation grant from Joule for his work on the Bionic-i™ Lightshield™ Hyperflow™ Sterilization Robot. Learn more about the program and grant recipients
Lightshield™ Hyperflow™ Sterilization Robot prototype
How it works
The device has two modes that sanitize the air and surfaces in a room:
- Lightshield™ mode, where UVC technology sanitizes the air and surfaces the light can reach; and
- Hyperflow™ mode, where HEPA-based air-filtration technology heats, shears and filters contaminated air.
During a surgical procedure, staff can turn on the device’s Hyperflow™ mode to disinfect any aerosols generated while they’re working. It can run at all times to filter the air.
After a procedure, staff exit the room and turn on the Lightshield™ mode from a safe distance via their smartphone. The two technologies can then work in combination.
In a standard operating room, the incremental disinfection process takes three minutes.
The smartphone-enabled technology is subscription based and uses artificial intelligence and machine learning, allowing Bionic-i™ to continuously improve the software.
“We designed our device with aerosol-generating procedures (AGPs) in mind. While cataract surgery can generate aerosols, it was subsequently not categorized as an AGP. We believe our device may turn out to have an even more significant impact for procedures that are considered at even higher risk of aerosolizing virus — such as those that require intubation or that involve the oral or nasal passages.”
Ahead of the curve
From the beginning, Dr. Ma and his team focused on the potential for aerosolized transmission of COVID-19 and aimed to create a device to alleviate this risk.
“Emerging studies had us worried that with the use of ultrasound devices immersed in bodily fluids in our operating rooms, we could be artificially generating viral aerosols. Separate studies of aerosolized COVID-19 virus demonstrated that viable viral particles could be present for more than 16 hours, and we didn’t want to take any chances.”
This hypothesis about aerosol transmission has recently been confirmed by the World Health Organization, which stated that airborne transmission of the virus that causes COVID-19, SARS-CoV-2, can occur during medical procedures that generate aerosols.
A background in innovation
Dr. Joseph Ma began working in innovation 20 years ago, which led him to his current position as chief medical officer for Bionic-i™. Before the pandemic, he and his team were working on an implantable medical device to help people who are visually impaired.
According to Dr. Ma, their work in medical hardware gave them an upper hand in this new venture and the ability to pivot quickly.
“We happened to have already been in working relationships with the domain expertise required to bring such a solution to the market in an accelerated time frame, so we shifted our focus to make it happen.”
Dr. Ma and his team brought together experts from diverse fields including artificial intelligence, radiofrequency communication, integrated circuit design, autonomous navigation, optics, irradiation and electromechanical engineering to come up with this solution.
Dr. Joseph Ma holding up Bionic-i™’s cataract implant
Beyond the operating room
Throughout the process, Dr. Ma and his team were approached by interested parties beyond the operating room and clinical environments, which got them to expand their original scope.
To date, they have arranged to test the device for an international hospitality chain and a senior care centre group and to test it in a large retail group’s public spaces. Given its affordability, they predict that its rapid disinfection features could be used in many more public spaces including schools, long-term care homes, transit vehicles, workplaces and restaurants.
“Many of these industries could be facing costly renovations to improve airflow, which requires downtime,” he said. “We’re working on including additional safety features in our next model that would allow us to deploy our device in this environment at a much lower cost.”
He predicts the first industry to adopt their device in high volumes may be oral surgeons’ practices and dental clinics, where the risk of transmission is high. Bionic-i™ has already tested and deployed prototypes in these environments and expects to have beta devices ready for all clinical environments early in 2021.
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