On the Cutting Edge

James Paul Wallis highlights recent developments in the range of medical devices available to air rescue providers
Looking at the range of medical devices being marketed for use onboard medical helicopters and fixed-wing aircraft, there have a been a number of product announcements over recent months. The picture continues to change, with new products planned for launch in 2018. In this article, we’ll take a look at some of the advances being made with ventilators, monitors, defibrillators and infant transport systems.
Among ventilator innovations heading your way is the new Ventway Sparrow. Details of the new device, described by maker Inovytec of Israel as an ‘ultra portable turbine ventilator’, were revealed in December and it’s expected to go on sale in June. The name reflects the unit’s light weight and compact size, which the company says suits its intended use in emergency and transport medicine. A ‘Robust’ model aimed at military users weighs in at 1.15 kg (2½ lbs), while the standard version is just 1 kg (2lbs 3oz) – which Inovytec says compares to between 4 kg and 9 kg for the majority of turbine transport ventilators. Both have a footprint of approximately 165 mm (6½ inches) square and a height of 60 mm (less than 2½ inches). They can run on battery packs that give around four hours of ventilation, or external AC or DC power. Users can choose from volume control or pressure support ventilation modes, as well as synchronised intermittent-mandatory ventilation or continuous positive airway pressure (non-invasive) modes.
Mark Shahar, Chief Technology Officer for Inovytec, explained that the Sparrow is suited to patients weighing 5 kg (11 lbs) and above, and can work with a mask or endotracheal tube. He added: “The ventilator’s intended use is mainly for transport, but it can be also used for intra-hospital transport and helicopter medical evacuations.” Shahar also said that the Sparrow does not require any routine maintenance, other than filter replacement after each 300 hours of operation.
Inovytec CEO Udi Kantor added: “[The] Ventway Sparrow was developed for addressing the huge need for a highly portable, high-performance, turbine-driven ventilator. The complex Israeli environment generated the motivation to address this need. Our R&D team, which includes veterans of the ventilation industry, succeeded [in developing] the innovative Ventway Sparrow technology. I strongly believe that the Ventway Sparrow will have a significant impact on the transport and EMS ventilation sector, both civil and military.”
Another new ventilator coming out of Israel is the Ventoux from Flight Medical, maker of the existing Flight 60 ventilator. Due for launch later this year, the Ventoux features ‘adaptive ventilation modes’ that ‘learn and integrate patient responses in order to effectively adapt to their physiological and clinical conditions’, says Flight Medical. 
Two Ventoux models have been designed – a version with 12-inch screen suited for emergency room or acute care settings, and a more compact version with an eight-inch display that’s targeted at EMS and intra-hospital transport uses. The two models weigh 7 kg (15.4 lbs) and 6 kg (13.2 lbs) respectively, and can run on either batteries or external power.
The company asserts that the device is the only portable ventilator to feature an automated cuff pressure controller, such as the one offered with the Ventoux, as an advanced ventilator module. According to the firm, the automated, fully integrated cuff pressure controller ‘reduces clinical intervention by continuously monitoring and automatically adjusting cuffed tracheal and tracheostomy tube pressure during the entire ventilation period’. The company adds: “The automatic cuff pressure controller’s unique design helps prevent and control ventilator-associated pneumonia (VAP) and tracheal injuries whilst supporting and optimising mechanical ventilation therapy.”
Before the Ventoux and Sparrow announcements came the Oxylog VE300, which was announced in May. The latest model from Dräger of Germany, the Oxylog VE300 was released as a robust ventilator that is ‘straightforward and user-friendly’ with ‘intuitive operation’. The device is marketed as lightweight, sturdy and simple to operate, factors that make it ‘particularly apt for use outside of the hospital environment’. It was designed with ergonomics in mind, featuring a large handle above the centre of gravity for comfortable carrying, even with a gas cylinder loaded onboard.
Melanie Kamann, Dräger corporate spokeswoman, told AM&R: “The Oxylog VE300 was developed with the aim to support the customer in their daily work by reducing weight and by making the application easier (easy-to-handle) – e.g. a colour touch screen, intuitive user interface, quick start, low weight … Dräger has made it easier to handle for its customers by 30 per cent compared to the previous model.”
The battery provides up to nine hours of ventilation, says Dräger, while functions accessible from the 4.3-inch colour touch screen include volume control, pressure support and spontaneous breathing support modes. A CPR function allows ventilation of patients during resuscitation. Capnography comes via main-stream CO2 measurement. With its battery, the device weighs 3.3 kg (7.3 lbs). 
Data can be exported, including patient data and screen shots. Dräger explained: “The ventilation data can be transferred using the USB or Bluetooth interface and can thus be documented when the patient is transferred to the hospital team providing the further treatment.” 
Dräger followed up on the release of the Oxylog VE300 with the launch of the ClassicStar Plus disposable mask in July. The non-invasive ventilation mask has a silicone sealing lip instead of the usual mask cushion. The lip is anatomically shaped, and the position of the mask can be individually adjusted using the forehead support. The ClassicStar Plus is available in four sizes.
For invasive ventilation, the patient is intubated, with an endotracheal tube being passed through the mouth and down into the wind pipe. The key, of course, is to ensure that you’re accessing the trachea (windpipe), which leads to the lungs, not the oesophagus, which leads to the stomach. There are existing methods to help medics identify correct placement, such as video laryngoscopes, but Guide In Medical is about to launch a new device that takes a novel approach – illuminating the trachea from the outside. The product comprises a self-adhesive patch that attaches to the front of the patient’s neck and shines light of a tailored wavelength into the skin. The blinking light is powerful enough to reach the trachea, while the oesophagus remains dark, making it easier to see where to aim the endotracheal tube. As the Israeli firm says, the Guide In unit is capable of ‘transforming ordinary video intubation devices into guided devices’. The Guide In device is semi-disposable, in that each one can be used for five intubations. The company gives the estimated retail price as around US$40.
In late 2017, Acta Anaesthesiologica Scandinavica, the official publication of the Scandinavian Society of Anaesthesiology and Intensive Care Medicine, published an article (Kristensen MS, Fried E, Biro P. , Infrared Red Intubation System (IRRIS) guided flexible videoscope assisted difficult airway management) in which the authors said: “The blinking nature of the light from the [device] helped to distinguish it from the reflections in the mucosa that inevitably arise when the mucosa is hit by the light from the flexible scope itself.” They added: “The addition of the IRRIS technique to intubation with flexible videoscopes may be a tool that will make intubation of the most difficult airways easier and may be of special help to the clinician who only rarely uses flexible videoscopes for tracheal intubation.”
Ariel Shrem, CEO of Guide In Medical, told AM&R that the device will soon be launched onto the market: “We [have] obtained marketing approvals in Europe, Canada and Israel. In addition, we are [working with] the [US Food and Drug Administration] and are about to get the marketing approval in the US.”
Turning to monitors and defibrillators, a recent addition to the market was the Tempus ALS, which was launched at the Emergency Services Show in September 2017. The system comprises a separate – but paired – defibrillator and monitor, each with a large colour display. The concept for separating out the two units, explains UK-based manufacturer RDT, is that while a defibrillator is a must-have to take on a mission, it’s only actually used in a small percentage of callouts. Therefore, the Tempus ALS has a dual-screen capability that allows the monitor and defibrillator to perform all functions independently, but also to automatically pair up when they are together. “This helps the user to focus solely on the critical information at hand and to better recognise and manage a deteriorating patient,” says RDT. 
Both the vital signs monitor and the defibrillator are meant to be small enough to fit in a medic’s grab bag or even motorcycle panniers. They weigh in at 3.2 kg (7 lbs) and 2 kg (under 4.5 lbs) respectively. RDT’s promotional material highlights the weight, saying: “Imagine not having to carry an 8-to-15 kg monitor to the scene.”
Among the functions offered are automatic defibrillation, cardioversion, fixed and demand pacing, CPR feedback and STEMI transmission. All patient data can be streamed in real time, meaning information can be shared through secure communications with, for example, colleagues in the emergency department, helping to increase situational awareness, make better transport decisions and potentially improve treatment at the scene, avoiding unnecessary transfers. The monitor boasts 3G, Wi-Fi and Bluetooth connectivity – 4G is expected in 2018. The modular system can be upgraded with additional capabilities as required, says RDT, such as point-of-injury ultrasound or video laryngoscopy.
The Tempus ALS has already been adopted by services such as the Essex & Herts Air Ambulance, Kent Surrey & Sussex Air Ambulance Trust (KSAAT), and by the Emergency Medical Retrieval and Transfer Service in Wales (EMRTS Wales). Professor Richard Lyon, Associate Medical Director at KSSAAT, commented: “Measuring, recording and transmitting physiological data accurately is crucial, not only for life-saving pre-hospital care, but also for audit, research and clinical development ... the Tempus design allows it to be carried easily within our response pack, yet it is versatile enough to transmit data directly from scene, ambulance or even helicopter in-flight. The data handling capacity of the Tempus is first-class, as it seamlessly interfaces with our patient record system, improving clinical care and powering research and development.”
In-flight infant
The Baby Pod 20 hit the scene in July, coming as the follow-up from Advanced Healthcare Technology (AHT) to its Baby Pod II Infant Transport Device. According to the UK-based maker, the spur behind the creation of the original Baby Pod was a need for a safe solution for inter-hospital transport of neonates who don’t require a full transport incubator. AHT said the design of the latest evolution of the concept incorporates over a decade of user feedback. Advances in material technologies have made it possible to cut weight while making the new unit stronger and safer than the model it has replaced. The outer shell is a lighter, thinner carbon fibre-reinforced plastic design, making it easier to handle. A new, clear lid affords better visibility and access to the patient, even within the restricted space of an aircraft cabin – the front section slides open to give access to the head and upper body, and the whole lid folds over the rear of the pod to expose the whole patient. The opening mechanism was designed with aircraft use in mind, says the manufacturer: “Due to the nature of the Baby Pod being used increasingly for air transport, the limitations of the original Baby Pod II lid opening mechanism became increasingly apparent, its outwardly opening lid sections not being convenient when operating in a tight space being a key challenge to overcome when designing a new evolution of the product.”
AHT also introduced a new strapping system from Ponsa, whose high-tensile webbing and metal buckles mean the Baby Pod 20 will stay attached to a transport stretcher when subjected to forces up to 9 kN (2,000 lbf). A further update is an improved vacuum mattress: “The infant positioning strapping [passes] directly through the mattress outer foil to better secure the mattress around the patient, making the most snug cocoon possible.”
Another innovation is a CO2 evacuation system that was taken from AHT’s Evac Pod model. Users can attach a medical air supply to an inlet on the front of unit, which then, ‘using low-pressure and jet flow and mixing principles’, draws any carbon dioxide layered at the base of the unit out of an exit valve on the underside of the shell. This, says AHT, in turn draws clean ambient air into the patient compartment via the patient access port in the viewing lid.
More than new products
Of course, the changing state of the transport medical device market is not just defined by new and recently released models, but also by updates to existing designs and take-up of existing devices by new customers.
For example, while not a new model, the MEDUMAT Standard2 ventilator is being upgraded, gaining a Bluetooth connectivity option from the end of January 2018. Users with the option will be able to transmit data via Bluetooth, in order to support digital documentation, says maker Weinmann of Germany. The fact that data can be transferred quickly and easily at the end of a mission means that the team can be rapidly restored to operational readiness, says the firm.
Existing devices are also gaining ground with major new sales – one example is the purchase of automatic chest-compression devices by Poland’s state-funded air rescue service Lotnicze Pogotowie Ratunkowe (LPR) in December. Following a tender process, LPR selected the Easy Pulse made by Swiss manufacturer Schiller. Poland saw its first rescue using a chest compression device in February 2017, said Schiller, in a mission involving a hypothermic man on Pilsko mountain. Less than year later, LPR is adopting the devices for use on its helicopters at 21 bases across Poland. The device straps around the chest of a patient to assist with CPR by automatically delivering chest compressions, leaving the treating medical personnel free to focus on other aspects of care.
Continuous development
No doubt the range of devices produced by both major and emerging manufacturers will continue to grow. If the current trends are increased connectivity and reduced weight, it will be interesting to see how that will continue to be applied to the range of equipment used onboard air ambulance helicopters and planes over the coming year.
Regarding connectivity, there are factors to consider outside of the hardware. Let’s give a last word to Rebecca Boughey, RDT Marketing Director: “The adoption of new technologies in prehospital care is fundamental to enable improvements in patient outcomes, whilst supporting the delivery of operational and clinical improvements. Innovation will need to address the real challenge of capturing and sharing data easily so that often disjointed healthcare delivery can be integrated to give better care yet make efficiencies and address pressures on resource utilisation. All of this will have to be achieved against a backdrop where cybersecurity and data protection will be going above and beyond current standards to truly prioritise the rights of patients.”