Drawing a clear picture of infectious disease patient transport standards

Eva Kluge of UNICAIR, said: “We definitely believe that there can be a defined international standard for Covid-19 transportation and, as a multinational company, we already have some experience with this. This standard would be similar to international aeromedical accreditation like the European Aero-Medical Institute (EURAMI) or the Commission on Accreditation of Medical Transport Systems (CAMTS): there will always be local differences, but the point of a standard is rather to define the minimum shared standard and not the maximum.”

Dr Bettina Vadera of Kenya-based AMREF Flying Doctors agreed: “I would look at the use of patient isolation medical units (PIMUs) to transport patients with highly contagious diseases not differently from their use of other specialised medical equipment, like a transport incubator for neonates.” If there are agreed standards for neonatal transfers, then is the transfer of an infectious patient really any different?

She continued: “As an auditor of EURAMI, I am familiar with the standards for neonatal transports which looks, among other things, at the number of neonatal transports per year (a minimum of flights are needed per year to get endorsed for this specialization), the suitability of the equipment (different companies use different incubators), suitable aircraft configuration with the equipment safely secured (different operators use different aircraft types), specialized training of medical crew, standard operation procedures/protocols, etc.” Dr Vadera concluded: “I would think that in the same way, standards for the transport of highly infectious patients using a PIMU should be possible.”

Accreditation organizations

CAMTS and CAMTS Global devote an entire section in the accreditation standards to exposure control, disease prevention, and wellness policies. These standards require an Exposure Control Plan that is synchronous with US Centers for Disease Control and Prevention and World Health Organization guidelines, as well as work restrictions pertinent to personnel exposed to an infectious disease.

Eileen Frazer, Executive Director of CAMTS, told AirMed&Rescue: “In the past year, these policies have been updated by most medical transport services to address preventive measures, tracking, quarantining and illnesses for those who have been exposed along with isolation practices in the throes of the Covid-19 pandemic. Education programs have evolved to include proper donning and doffing procedures for ambulance operators, pilots, and crews.”

EURAMI sent out a missive to its members last year about the utilization of negative-pressure isolation pods for the transport of Covid-19 patients, which, essentially, urged an abundance of caution and said that members should use them ‘when available.

The organisation said: “There have been recent discussions around the necessity of a portable isolation unit to transport an actual/suspected Covid patient. Although there is an intuitive safety advantage of these isolation units, there is to date little information comparing their benefit to that of conventional PPE and routine infection control measures on the outcome of patients or incidence of infection for crew members. At the same time, in the midst of a pandemic threat that will not allow us time to adequately study these measures, it is important to insist on stringent infection control. Given the lack of definitive evidence, EURAMI encourages a conservative approach, utilizing negative pressure isolation units when available. This is likely to be of greatest benefit in aircraft that lack the HEPA filtration capability that is present in many commercial aircraft.”

Since then, EURAMI has been gathering data from its members and is learning more about the potential risks and benefits of transporting infectious disease patients in different ways. Once the data is analysed, it will be shared.

Certainly, the more data gathered by industry operators, the easier it will be to form judgements based on medical evidence about minimum standards and best practices when it comes to infectious patient transportation requirements, including whether or not asymptomatic patients with a positive Covid test should still be transported in a PIMU.

The practical problem of enforcement

The practicalities of introducing and enforcing a global standard for the air medical transportation of infectious disease patients, said Patrick Schomaker, former Director of Sales and Marketing at European Air Ambulance, are complex. While aviation regulations are clear and relatively easy to uphold, medical treatment protocols can differ widely in different jurisdictions, and even from doctor to doctor in the same hospital. So, standardizing the treatment of infectious disease patients might be nigh on impossible. What could be possible, though, is addressing the technical and operational side of transport.

Schomaker said: “What you could say, for instance, is that an operator must have certain measures in place for the transport of an infectious patient. You could specify a kind of air filtration device, specify the personal protective equipment a medical and non-medical crewmember has to wear, that the patient has to be in an isolation unit, and that the aircraft has to be disinfected after use.”

All positive moves, for sure, but when it comes down to specifics, how much more complex would it be? Would only certain isolation units be acceptable, for instance, or would the method of disinfection have to be agreed upon? How many times should air be filtered per hour in the isolation unit?

“Enforcement of standards in air medical transportation is always going to be tricky,” agreed Kluge It can be done though, as has been proved by the accreditation organizations, she added. The European Union Aviation Safety Agency (EASA) also enforces regulations, and standards in aviation, so could do it in theory. But the problem is that as far as EASA is concerned, the air ambulance market is so small as to be a mere drop in the ocean in terms of the wider aviation business.

The organization is more concerned with getting commercial travel going again, ensuring that airlines are operating safely, and being proactive in making customers safe onboard jet aircraft. A few hundred patients onboard private aircraft do not have the same power to push change.

Enforcement of standards in air medical transportation is always going to be tricky

EASA isn’t the only option for enforcement though; there are civil aviation authorities in every country, as well as the International Civil Aviation Organization. The key with all these organizations, according to Schomaker, is that they can take punitive action if an operator is found to be transporting patients with below-par levels of safety. Such action can include taking away a licence and grounding a fleet – which would certainly be a sufficient motivator to encourage companies to maintain a standard operating procedure with infectious patients.

Staff safety – an additional cost that is worth considering

As vaccine programmes gather pace in some nations, the issue of staff safety also comes to the fore. “Immunizations have always been addressed as appropriate to the service’s scope of practice,” said Frazer.

“The standards require clinical team members to have an annual physical exam or medical screening that includes immunization records. Tetanus immunization, measles, mumps, and rubella (MMR) immunizations are encouraged for those born after 1957. The Hepatitis B vaccine must be offered, and if the employee has not previously had the vaccination or does not have adequate titers and declines, the programme must have a signed declination form if the employee declines. The flu vaccine is required unless contraindicated per policy.”

Frazer believes that as Covid-19 vaccinations become more readily available, we will start to see this as a requirement by programme policy and as allowed by state and national regulations. In the US, under federal law, an employer may require a Covid-19 vaccination as a condition of continued employment or as a condition for an employee to return onsite. Employers with a mandatory Covid-19 vaccine policy must provide exceptions to their policies and/or other accommodations to employees with disabilities, sincerely held religious beliefs and, in some cases, employees who are pregnant. Under federal law, these accommodations do not need to be afforded to workers classified as independent contractors.”

What is an acceptable flight risk?

What one company views as an acceptable flight risk, others would run a million miles from. And the same is true when it comes to transporting an infectious patient. Would your company transport two Covid-positive patients in the same aircraft? Would you insist that a Covid-positive patient who was completely asymptomatic be transported inside an isolation unit?

The benefit of having a minimum global standard to which operators can adhere is that it would offer a guarantee of safety to the patient and crew – if those standards are upheld. Is there a danger, though, that by identifying a standard and agreeing to abide by it, a company is putting itself at an increased risk of liability if they were to break that rule?

Schomaker said: “Medical directors are responsible for placing that crew on that aircraft with that patient, and that equipment. If a protocol is broken, and someone on the crew is infected, is the company more liable because there has been a breach of an identifiable standard?”

Developing guidelines

The problem for the whole industry, said Kluge, is whose guidelines to follow. Air Alliance has bases in the UK and Germany and, as such, is only too aware of where health departments of countries can differ in their advice to operators transporting Covid patients. Important specific aspects noted by Kluge include missions with a patient that is on mechanical ventilation, where some health guidelines state it is acceptable to transport these patients without an isolation unit.

Another specific issue is which isolation units can be used for different routings, according to short- or long-haul flights. “A vital aspect of any guideline that is introduced,” emphasized Kluge, “is staff safety and the employer’s duty of care to keep staff protected from infection.”

Kluge also backs up Schomaker’s point about companies responding differently to risks presented, with assistance companies still putting out requests for quotes from multiple air ambulance companies, and they receive different figures back, as one company might insist on an isolation unit for an asymptomatic patient on a long-haul flight, while others would accept PPE as sufficient protection. Costs for each different mission profile would vary hugely.

Ultimately, the payers will have to pay for the service they are getting. “The assistance companies, generally, understand this,” said Kluge. “As long as the air medical operator communicates clearly with the assistance company about the risks, and how we are going to mitigate those risks through equipment, they will have a clear understanding of where an additional cost is coming from.”

“We are not looking for maximum standards,” she continued. “We are looking for minimum standard operating procedures that could realistically be introduced and adopted across the industry, and allow for peace of mind for patients and payers that everyone is adhering to a minimum safety standard.”

The cost of ensuring minimal risk

Air ambulance operators have invested huge sums of money in their aircraft, equipment, training and protocols over the course of 2020 and 2021, to ensure Covid-secure transports can take place with minimal risk to those onboard. And this has all come at a price.

Andy Lee, Director of Global Assistance and Aeromedical Evacuation for AMI Health stated: “Of course, the payers are going to have to pay, they can no longer expect operators to foot the bill for supplying all the extra equipment needed for infectious cases. Most operators have invested in isolation pods and personal protective equipment (PPE) as well as the time, effort, and equipment needed to keep the aircraft sterilized. This comes at a cost, but I’m sure insurers will not be afraid to raise their premiums to provide cover for Covid-19 and similar infectious diseases.”

He continued: “We as an industry should be trying to learn and develop our skills and services to deliver a stronger and more robust product to the clientele we serve. To do this we need to share and educate one another. We can no longer sit back and trust what has been, there needs to be a proactive approach that involves all the stakeholders, that provides the ultimate level of safety and treatment for the patient and of course, the crewmembers both in the air and on the ground, as everyone involved becomes at risk.”

Infectious passenger handling in air ambulance operations

EUROCAE Working Group 123 has been formed to develop standards for the safe and effective handling of infectious patients during air medical transportation.

EUROCAE is a non-profit organization, created in 1963 as The European Organization for Civil Aviation Equipment, and is an internationally recognized Standard Developing Organization (SDO) known for its high quality, safety-critical standards. The initial focus was the development of standards for aircraft equipment/systems, but now its portfolio includes any aviation-related equipment, system, services or process aspects. To date, over 4,500 experts from association members contribute to the production of EUROCAE Documents (EDs).

Covid patient transportation

The Covid-19 pandemic has changed society and the economy on an unprecedented scale. Commercial aviation was and still is, severely affected. At the same time, the pandemic has resulted in high demand for air medical transport of seriously ill patients, both domestically and on international missions.

In early 2021, the EUROCAE secretariat was contacted by an air ambulance organization as the aeromedical industry found it was lacking a set of common and cohesive guidelines for the safe handling and transportation of infectious passengers. The movement of patients with highly infectious diseases (HID) between hospitals in air ambulance aircraft is a technical, logistical, and medical challenge, with significant risks to the safety of the patient, the crew and the public.

It is likely that other pandemics will impact the aviation industry in the future

Of course, the main reason for this request was related to the Covid-19 pandemic; however, it is likely that other pandemics will impact the aviation industry in the future, never mind other infection risks during regular ambulance operations. Air ambulance providers are a niche set of operators in the world of aviation, and therefore are not being recognized sufficiently in ongoing standardization activities neither in the medical nor aviation domains. Therefore, a framework of guidelines is considered to be a means by which to foster crisis response and help combat the impact of infectious diseases in the future.

Actions taken to remedy the lack of clarity for air medical operations

Following the process for new activity at EUROCAE, this initiative was first discussed at the Technical Advisory Committee (TAC) level, where a group of technical experts assessed the rationale and expected outcomes.

In November 2021, the creation of a specific Working Group (WG) was agreed upon by the Council – the EUROCAE governing body representing our members. To avoid any duplication with existing work or documentation, the scope of this new WG-123 was limited to air ambulance operations only, with a mandate ‘to develop guidelines for aeromedical passenger handling and transport in respect to Covid-19 and other infectious diseases.

WG-123 was requested to produce, following our approved development process, a document that would specify the expected international framework and include all measures related to risk prevention, management of incidents, training, and tracking with regard to infectious passenger handling. This ED is expected to be ready in about one year for the Open Consultation phase, where the content is submitted to the review of all experts, within and even outside EUROCAE.

The kick-off meeting of this new activity took place virtually on 10 February 2022, with around 20 participants from around the globe.

A global perspective on a global problem

Experts with a wide range of expertise and origin joined the initial meeting, and newcomers are always welcome to improve the quality of the work. At the moment, 14 organizations representing diverse affected sectors are registered in the Group, including air ambulances, medical teams, medical equipment makers, aircraft manufacturers, research and development and airspace regulatory authorities. The participants come from 10 nations, and while most are European, we are also pleased to welcome input from professionals in Australia, China, Korea and the US. The participation of representatives from the United Nations and from the military medical community is also to be noted and serves as an indication of the strong interest we have seen in our work from the global community.

The aim of the first meeting was to establish a common understanding of the task and adopt a methodology for the coming months. Following an introduction of the various organizations in the audience, the leadership team was elected, with Dr Alex Veldmann and Dr Walter Klimscha, both from UNICAIR, as WG Co-Chairs and Dr Cai Glushak, from EURAMI, as WG Secretary.

Since February, several meetings have been organized to progress the document, firstly agreeing on a table of contents, then integrating inputs provided by the different contributors. The guidance document is expected to include:

• Considerations about the notion of isolation of patients with HIDs
• Guidance regarding isolation in aeromedical transport, through PPE
• A risk-benefit analysis for the crew and the patient
• Recommendations for, and special considerations of, the patient, the aircraft cabin, and medical equipment.

Of course, a preliminary chapter on the purpose and scope of the WG will be included, and a concluding chapter will complement the document, according to the EUROCAE template.

From the beginning, all meetings were organized virtually to optimize the agenda of the different experts, as most of them are frequently involved in the provision of emergency medical services on the ground and in the air. The next meeting is planned to be virtual on 26 September and will see a first draft document made available for review by all members.

We expect that by the end of the year, as the document matures, an in-person meeting will allow direct contact with all WG members and will facilitate the progression of the project, as was the norm in the pre-Covid years for a standardization activity.

Article first published on https://www.airmedandrescue.com/latest/long-read/drawing-clear-picture-infectious-disease-patient-transport-standards