Isolation pods: the rush to save lives
Isolation units flooded the market during the Covid-19 pandemic, with demand unusually high. How did that influence decisions around certification and safety? Clara Bullock spoke to air ambulance providers and isolation pod manufacturers about the situation
Isolation pods have been an integral part of air ambulance missions during Covid-19. Without them, the majority of air medical flights would not have been possible, meaning fewer lives would have been saved. However, due to the urgent nature of the situation, decisions around purchases were rushed and less informed than they usually would have been. What did that mean for air ambulance providers?
Isolation pods have been traditionally developed for military environments. The EpiShuttle, however, was developed in a civilian environment and, as a hard-shell device, is very well suited for international long-range transport of critically ill patients. The smaller, military-style pods are more suitable for short ranges and for patients with milder symptoms, and they are used on smaller aircraft (e.g. Learjet) and for shorter distances, thus providing more cost efficiency.
At the beginning of the pandemic, UK-based air medical provider Gama Aviation purchased xBio and Isovac Containment and Protection System Utilizing Life Support (CAPSULS). Neither portable Patient Isolation Unit (PIU) was designed specifically for aeromedical transportation, but in February/March 2020, options were limited, as was knowledge of Covid-19 and its transmissibility. Neither unit was ‘certified,’ but temporary use exemptions were granted by the UK Civil Aviation Authority (CAA), due to the nature of the pandemic.
Simon Forrington, Medical Director at Gama Aviation, told ITIJ: “Most portable isolation units have some issues with gaining a supplemental type certificate (STC). Many do not use aviation-grade materials or restraint systems. We are therefore presently working with a manufacturer to overcome these issues.”
Quality control by the manufacturer
However, Jorge Marchan, Operations Manager at isolation pod manufacturer Isovac Products, LLC, in Illinois, USA, said: “Every single patient isolation unit manufactured by Isovac Products must pass a strict quality control process, which includes a battery of tests, before they can be shipped to the buyer or the end user.
“The demand for isolation pods has increased dramatically worldwide. Covid, in general, is still prevalent and we can all agree, this is not the last pandemic the world will ever face. Covid showed how the world was ill-prepared to handle a pandemic. There are various entities that are now being proactive and are purchasing the Isovac CAPSULS in preparation for any future outbreaks or pandemics.”
Every single patient isolation unit manufactured by Isovac Products must pass a strict quality control process
There is currently less demand for Covid-19 transports than in 2020 and 2021, but preparation is key, and it is hard to predict which virus might hit next and how contagious this will be. Plus, isolation pods are not only useful for Covid-19, but equally for other contagious diseases like Ebola, tuberculosis etc.
Still, those who did not plan ahead often had long waiting times before receiving isolation units. Marchan said that while the current disruptions in the supply chain have caused delays in the manufacturing process, the company tried to keep an open line of communications with its vendors to avoid disruptions as much as possible.
Working together to handle the high demand
For nearly 30 years, Spectrum Aeromed in North Dakota, US, has designed and developed air ambulance medical interiors for hospital programmes, multi-mission charters, private operators, and military users around the world. “As an essential service provider, we’ve continued to be open during the Covid-19 pandemic,” the company said in a statement. “We work with a variety of isolation and containment units including AirBoss’ Iso-Pod and EpiGuard’s EpiShuttle. EpiShuttles are installed on our ITS decks, while other containment units can be installed on a stretcher. Our units can be quickly installed and removed within 30 minutes due to our adapter, which attaches to the existing seat rails of an aircraft.”
In August 2020, Spectrum Aeromed announced they became a distributor of Isovac Products’ CAPSULS PIUs. The partnership resulted from an increased demand of isolation units to offer a safe solution for air medical teams transporting infected patients amid the global pandemic. The companies have decided to combine their expertise in their respective fields, which allows users a one-stop shop for acquiring the best in mission-critical isolation and life support modules.
“The Covid-19 pandemic created new challenges for air ambulance operators, particularly relating to patient isolation. We met this challenge by integrating the company’s existing stretchers and transport decks with a variety of patient isolation solutions,” says Ricky Reno, Spectrum Aeromed VP Account Executive. “The collaboration of the two small businesses is vital as it gives customers confidence that they have the equipment they need to accomplish their mission of saving lives safely during this global pandemic.”
Shelf life and patient access can be concerns
Additionally, an isolation unit needs to be carefully selected so that it is suitable for the aircraft on which it is used. In the future, it is likely that each type of isolation unit will need an STC for a specific aircraft type and will not be considered as a ‘carry-on’ item by aviation authorities in the medium term. There are also concerns around patient access in an emergency, moving and handling issues, training an internal oxygen enrichment during use, potentially leading to
a fire hazard.
Each unit has a shelf-life defined by the manufacturer. This can range from a single-use device to upwards of 25 uses. An isolation unit needs to be fully disinfected after each use and materials can degrade with continuous cleaning and disinfection.
Eva Kluge, Chief Commercial Officer at Air Alliance Group, commented: “There is currently no global, unified certification system. It may be a very good idea to develop international standards for medical devices within an approved standardisation structure like the European Organisation for Civil Aviation Equipment (EUROCAE), equally recognised by the international aviation authorities like the European Union Aviation Safety Agency (EASA) and International Civil Aviation Organization (ICAO).”
While manufacturers are still trying to keep up with the high demand, Covid-19 cases across the world are slowly going down – so now might be a good time to take a closer look at standardizing isolation pod certification.
Isolation units can be a useful element in an aeromedical transportation provider’s toolkit. “However,” Gama Aviation’s Simon Forrington added, “I firmly believe that each unit does need certification/approval from aviation certification authorities. All staff then need to be fully trained and confident in their use, during simulation or cold-case scenarios. Each provider needs a robust set of procedures on when and how the units should be used and what to do in an emergency.
“Most portable isolation units have some issues with gaining an STC. Many do not use aviation-grade materials or restraint systems. We are therefore presently working with a manufacturer to overcome these issues.”