ANAESTHES IA


Advancing regional anaesthesia Cambridge-based medical device development company, Medovate, was founded in 2017 to support the development and commercialisation of pioneering medical technologies created within the NHS. Spun out of the NHS three years ago, the company collaborates with innovators working on the frontline of healthcare delivery who have spotted a gap in their specific area of care. These clinicians are kept involved throughout the whole development process of the device right through to its commercialisation. Medovate’s current pipeline of novel medical technologies is focused on anaesthesia, airway management, critical care and surgery. During the development of Safira, the company worked closely with consultant anaesthetists Dr. Peter Young, Dr. Emad Fawzy, Dr. Joseph Carter, and Dr. John Gibson from the Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust. As an NHS innovation envisioned by a frontline clinical team, the device was developed to be intuitive to use, be easily integrated into current practice and promote improved safety during injection of regional anaesthesia. The key driving force was to reduce the potential for nerve injury by using built-in safety mechanisms to mitigate this risk. Safira also has the potential to realise additional time and cost saving benefits as revealed by health economic modelling. As Dr. Young explains: “Any new innovation should be convenient for normal workflow while improving care for patients at an acceptable cost. Safira has been designed to put control in the hands of the operator, while improving workflow and offering patients the protection against this mechanism of nerve injury.” There are two main advantages for the use of Safira for anaesthetists, Dr. Joseph Carter explains – and two areas where it addresses current unmet clinical needs: “The current system of trying to make sure that nerve injections are not occurring at high pressures is flawed for two reasons: firstly, by asking an operator what the feel of the injection is and asking if it is difficult to inject – at this point that pressure has already been applied to the system and therefore to the distal end and the needle tip, which may be in a nervous structure. Secondly, we know from clinical studies that humans are not good at sensing when pressures are too high, or when pressures change through injections. “There are key advantages for the use of Safira. First, by giving control of the injection back to the anaesthetist this allows for improved precision of the injection of small doses of anaesthetic, and will facilitate hydro-dissection; second, the pressure limiting feature in the system means that the


MARCH 2021


Designed using a clinician-led approach, Safira incorporates a built-in safety feature to promote safer injection during regional anaesthesia procedures by automatically stopping injection above 20psi, thereby helping to reduce the risk of nerve damage.


individual anaesthetist can be certain that they are doing all that they can to try and reduce the risk of a permanent nerve injury.”


Reducing the risk of nerve injury While complications such as transient or serious nerve damage resulting from regional anaesthesia procedures are relatively rare, when they do occur, they can have significant implications for patients, leading to severe pain or permanent paralysis of the area involved, research shows.4


Meanwhile,


transient nerve damage, though less severe, can involve additional costs from requiring follow-up appointments and potentially further tests. There is also the potential for negligence cases to be raised in more extreme cases. Studies have shown that injection of regional anaesthesia at pressures above 20psi can result in transient or serious nerve damage (transient nerve damage in up to 8% of cases5


in up to 1% of cases3


and serious nerve damage ). Moreover, injection


‘feel’ is highly subjective and varies between individuals. Studies consistently show 40%- 70% injections occur above 20psi, with a significant portion above 30psi.6 Safira is built to help reduce these risks. Designed using a clinician-led approach, it incorporates a built-in safety feature to promote safer injection during regional anaesthesia procedures by automatically stopping injection above 20psi, thereby helping to reduce the risk of nerve damage. The device will also have a positive impact on the confidence of anaesthetists. Safira uses a foot pedal operator which allows the anaesthetist to control the syringe to either aspirate or inject the local anaesthesia, thus eliminating the need for an assistant. By turning the regional anaesthesia process into a one-person process, the anaesthetist can be confident that they have full control of the procedure and the built-in safety mechanism reassures them that they are not injecting at too high a pressure. “The main reasons to consider for switching to use Safira for regional anaesthetics are control and safety,” Dr. Carter adds. “In terms of control, the ability to precisely deliver small doses of local anaesthetic is very desirable in the process of a regional block. “From a safety perspective the fact that the injection pressure is limited to a


level below which the risk of permanent nerve injury is reduced is a very desirable feature for both patients and anaesthetists performing the block. The use of Safira will change the process of a block for most clinicians in so far as it will allow them to perform the block process themselves.” Further, with its integrated safety solution to help limit the injection pressure threshold, Safira can effectively help to reduce the chance of accidental nerve damage in patients, omitting follow-up procedures and additionally potentially reducing the risk of litigation. Perhaps as importantly, the device also brings economic savings. Research shows that Safira could save up to five minutes per procedure and limits the costs associated with extra operators.1


This means that


procedures can be performed faster, saving valuable theatre time. At a time when health systems across the world are experiencing huge strains and critical care remains under pressure, every inch of efficiency that can be procured is welcome news. Eliminating the need for an assistant, Safira also creates an additional safety net to address the challenges of COVID-19.


“In the current COVID environment the fact that there is a reduction in exposure between the operator and their assistants, and also between the patient and clinical staff, means that from a social distancing perspective, this is a step forward in clinical practice,” Dr. Carter explains.


Latest guidance


COVID-19 has brought additional challenges to health systems globally, posing new threats to both patients and healthcare workers. In March of last year – as the UK went into its first lockdown – the European and American Societies of Regional Anaesthesia produced joint recommendations stating that regional anaesthesia should be preferred over general anaesthesia whenever possible, and practice recommendations for regional anaesthesia during the pandemic have since been published.7


This guidance was issued on the basis that general anaesthesia (GA) with airway intervention leads to aerosol generation, thus exposing healthcare teams to the risks


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