Certain air ambulances now routinely carry blood and blood products, enabling transfusions to be administered on scene. This may be the difference between life and death, and is an innovation made possible by temperature-control technologies. Air ambulances can also carry organs swiftly around the globe for transplantation, delivering them directly to the hospital. “Expeditious transportation is critical for organ transplantation; for every hour an organ is outside of the human body, surgical success rates decrease materially,” said Nate Alexander, Director of Rotorcraft at BLADE, providers of end-to-end organ transportation.
In addition to crucial equipment, specific standards must be met and regulations considered. “Environmental conditions for medical devices used in air ambulances are different from those expected in a normal hospital environment,” said Ernst-Ulrik Haxthausen, Senior Product Manager at °MEQU, which has developed a portable blood warmer. “This refers to temperature and humidity, vibration and shock caused by movement of the air ambulances, variable atmospheric pressures and electromagnetic disturbances between air ambulances and the medical device. What differentiates a blood warmer used in a helicopter – or any other aircraft – to one on the ground is that a blood warmer in a HEMS environment must live up to specific standards.”
Surmounting implementation challenges
“We have had blood products at some bases for a long time, where they are co-located at a hospital, and could obtain and exchange blood daily,” said Kelly Miller, VP of Clinical Services, Air Methods – the air medical transport service. “In 2013, we started making a strong push to expand our blood program to more remote community bases.” But it wasn’t easy. “The biggest challenge was the limited exposure the blood distributors had with providing prehospital blood. We had to instill confidence that our quality control measures would work,” he said. “Once we put a program in place that was acceptable to blood distributors, and also the hospitals receiving the short-dated products, the next challenge was state regulatory bodies. The number of state EMS systems, with regulations built around carrying prehospital blood, were very few. In several places, we’d assist the state in writing the regulations as we expanded. For the most part, the blood program was met with open arms and a ‘tell us how we can help you get this done’ attitude.”
Robert Smith, Chair, SERV Wessex, said that the charity started supplying HEMS blood in March 2014. “As Hampshire and Isle of Wight Air Ambulance (HIOWAA) was only the second air ambulance to consider carrying blood on the aircraft, we were really setting the framework for other AAs and Blood Bike groups to follow.” He shared the key obstacles. “The first was to obtain special Crēdo boxes, validated to safely keep the products within the aircraft and during the road transfer to the base. We worked with HIOWAA and Southampton General Blood Transfusion Lab to come up with a workable service,” he said.
If plasma was also carried and administered, this could be given to everyone
“After a few years, it was discovered that although giving blood at the scene was life-saving, it wasn’t suitable for all. However, if plasma was also carried and administered, this could be given to everyone. HIOWAA now carries two boxes: one with two units of O neg and two units of plasma, while the other box has two units of O pos and two plasma.”
BLADE launched its MediMobility Organ Transplant program in August 2019, with NYU Langone offering rotor and fixedwing solutions for organ transplant. “We invested significantly in our operational and tech platform to launch this program. We have since become the largest dedicated air transporter of human organs in the US, but we never stop learning and constantly make improvements as we scale,” said Alexander. “Transplant is a 24/7 business, requiring pilot and dispatch coverage at all hours. Ground staff and drivers must be able to dispatch at a rapid pace, even at 03:00 hrs. Aircraft resources, under such short timeframes, can be extremely challenging, so BLADE quickly utilized its scale to secure additional dedicated planes and helicopters.”
He added: “We worked with the Federal Aviation Administration (FAA) to help our operators obtain a Helicopter Air Ambulance (HAA) certification to service flights for both doctors and human organs. This requires additional specifications, pilot training and added equipment in the cockpit for improved landing capabilities.”
Transplant is a 24/7 business, requiring pilot and dispatch coverage at all hours
Storage and transport complexities
Sophisticated refrigeration equipment is required for blood and organs, to ensure they remain at the correct temperature. “Storage of blood at remote locations and on missions, that can last for multiple hours in all climates, is difficult,” said Miller. “When looking for equipment, we referenced the blood distributors we worked with for the on-site equipment such as refrigerators multiple calibrated monitoring systems, and quality assurance programs,” he added. “For mobile equipment, we assessed what the military was using. They, like us, are exposed to all climates. The equipment on transports is not your standard lunch cooler. We have coolers that are validated to maintain the exact range needed for blood products up to 72 hours in the field. At base or on the transport, we monitor the blood with calibrated thermometers, set to alarm around strict parameters.”
Miller said on-site storage is key to a prehospital blood program, which includes:
- A refrigerator with multiple temperature monitoring devices, capable of sustaining the correct temperatures for the duration of your mission
- The capability for blood to be monitored at all times and the team quickly alerted if any issues arise with the temperature
- A strong quality assurance program to monitor policy compliance
- A mobile in-line warming device, to not induce hypothermia in a patient.
Smith said that SERV Wessex offers a continuous service to HIOWAA to resupply the blood and plasma carried in the air ambulance and critical care cars. He provided a unique insight into how this happens: “We purchased a special hard, weather-protected Peli Case that could carry two boxes of blood, easily placed on the back of our motorcycles. A couple of years ago, we moved to four-wheel vehicles for the Air Ambulance resupply, giving us more flexibility in adverse weather. We also provide a service to repatriate the medical crew back to Thruxton, if they have to stay with patients transferred by land ambulance and separated from the aircraft.”
Seamless all-in-one organ transport
There are a few ways that BLADE helps improve the transplant transportation process, easing the strain on surgeons and reducing time in transit, according to Alexander. “BLADE’s vast accessible fleet of dedicated rotorcraft, jets and turboprops offers unparalleled time savings, no matter the mission type. Our scale and operator relationships give hospitals unmatched trip flexibility, with favourable cancellation terms given the volatility in operating room timing,” he said. “BLADE’s rotorcraft solutions team will secure permission to land at any hospital helipad and can depart directly from NYC versus an area airport. This eliminates the need for ambulance transport and unknown traffic delays for ground transport.” He added: “For missions out of direct helicopter range, BLADE seamlessly harmonises helicopter/jet and ambulance connections. Helicopters land and depart jet-side, transforming a one- to two-hour drive into a five-minute flight, drastically reducing the time the organ spends between operating rooms.
Helicopters land and depart jet-side, transforming a one- to two-hour drive into a five-minute flight, drastically reducing the time the organ spends between operating rooms
Our multi-modal platform allows us to offer lights and sirens for ground transport in an all-in-one ecosystem for seamless hospital-to-jet-to-hospital recovery.” In terms of equipment for organ transportation, Alexander said insulation and temperature-controlled packaging – including adequate ice or refrigeration – protect the organs during transport: “A rigid container is often used. Recently, companies like Paragonix and Transmedics are adopting new methods. These devices optimize the useful life of the organ by either pumping blood through it (Transmedics) or optimizing the cooling process (Paragonix).” In terms of certification for air ambulances, on the aircraft side, helicopters are required by the FAA to have an HAA certification to carry human organs and doctors. This requires certain equipment to be installed on each helicopter, additional training for pilots, and regulations on air operators.
We spoke with Peli BioThermal, which supplies the Crēdo ProMed product. “Our Crēdo reusable parcel product range was devised back in the early 2000s, initially following a call from the US Army to devise a product to keep blood and plasma products at the correct temperature when being used by medics in battlefield conditions,” the Peli BioThermal said. “The product selected was Golden Hour™, the winner of the US Army’s Greatest Invention Award in 2003. The technology was quite new at the time and featured PCM (Phase Change Material), encased in a Thermal Insulation Chamber (TIC) as the coolant, plus Vacuum Insulation Panel (VIP). Using these products together gave reliable, consistent, high-performing temperature control that customers could trust and rely upon. From this, a whole range of reusable products were designed for clinical pharmaceutical, clinical trials and commercial pharmaceutical uses.”
Within a 48-hour period there is little variation in temperature, which essentially makes it possible for blood to be used and protected outside of a controlled, hospital environment
Peli BioThermal reported that thorough testing to industry standards was central to the success of this range. “In this case, to ISTA 7D. This testing procedure covers the thermal performance of packaged products, evaluating the effect of external temperature exposure. The standard can be used for the development of temperature-controlled transport packages against normally encountered conditions, such as heat or cold.”
Beyond this, Peli BioThermal also said that air ambulance customers carry out their own validation programs: “Products are lab tested to their own standards and protocols to give additional reassurance that within a 48-hour period there is little variation in temperature, which essentially makes it possible for blood to be used and protected outside of a controlled, hospital environment.”
Haxthausen confirmed that for the °MEQU blood warmer, EN 13718-1 (Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances) was the most important standard. “It defines a medical device designated as portable to be able to be carried inside and outside the aircraft, by one person. From the start of the development of the °MEQU blood warmer, portability has been key, and the focus has therefore always been on making the system as small and lightweight as possible, yet still live up to the stringent needs of both civilian and military users,” he said. “A specific standard requirement is: manufacturers of the aircraft installation, and of the medical devices intended for transport and use within air ambulances, shall provide recommendations for the proper attachment of the medical device. It has therefore been important that both the battery and the warmer are able to be fixed properly. This is done by using the adhesive on the back of the warmer to ensure that it does not move around and potentially compromise the IV/IO access, and the battery can be securely mounted by the supplied carabiner. Also, the medical device shall be IPX3 rated. The complete °MEQU system (both the battery and the warmer) has an IP rating of 54.”
If blood onboard services can be introduced to more air ambulance services, the impact on patient care will continue to grow
Gravely ill and injured patients in need of emergency blood transfusions are benefiting from the ability of air ambulance helicopters to carry blood and blood products, while international organ transport is facilitated and expedited by helicopter air ambulances. Ultimately, this means lives saved, and if blood onboard services can be introduced to more air ambulance services, the impact on patient care will continue to grow.