The answer is yes, you can use your LifeVac and it is approved for use
From the beginning LifeVac Europe set out to put safety, effectiveness and ease of use at the forefront of everything we do.
This is why LifeVac are now marketing leaders, within the market that we created for airway clearance – anti choking devices. From the outset we created the benchmark for all airway clearance devices.
Being a medical device, we are governed by certain bodies who regulate what can and cannot be used around the world. LifeVac is registered with every relevant governing body within each country where LifeVac is sold. To name just a few, LifeVac is FDA, MHRA, UKCA and CE accredited.
In regards to medical devices in the UK the overriding responsibility lies with the Medicines and Healthcare products Regulatory Agency, the MHRA.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulate medicines, medical devices and blood components for transfusion in the UK
You will probably have heard the MHRA mentioned when discussing their role in ensuring COVID vaccinations are safe and authorising their use in the UK
The MHRA are an executive agency of the UK Government within the Department of Health and Social Care (DHSC)
One of their three principal responsibilities is ensuring the safety, quality and effectiveness of medical devices in the UK
In 2016 LifeVac completed and submitted a clinical evaluation to the MHRA as part of the UK MDR 2002 requirements.
This sets out both the rationale, clinical benefit over existing methods of treatment, and most of all – safety which LifeVac has already proven to many other governing authorities around the world.
The following stage was to submit and agree a proposal with the MHRA to make the device available in the UK.
Again this included the rationale for the sectors chosen, implementation of training, monitoring via a PMS and a framework for deployment.
Out of all the potential sectors agreed with the MHRA that LifeVac can be made available we have initially focused on the Adult Care Sector. With a significant number of choking deaths within the elderly cohort and an existing Adult Care framework this was deemed the most suitable.
But the use of airway clearance devices is not recommended by the UKRC, can I still use my LifeVac?
Again, the answer is yes you can. The UK Resuscitation Council (UKRC) do not regulate what can and cannot be used in the medical device industry and general public, that responsibility lies with the MHRA in the UK, not the UKRC. While the UKRC guidelines are their to follow for guidance, they are not law.
We are continually working hard to get “non-invasive airway clearance devices” into BLS Choking protocol, this is done through a body called ILCOR which are made up from different resuscitation council members from different countries around the world. ILCOR make all resuscitation guidelines for all resuscitation councils around the world to follow every 5 years.
At the end of 2020 when ILCOR reviewed all evidence available for airway clearance devices (only made available due to studies/publications carried out on LifeVac), they stated “While we recognise they save lives, there isn’t enough evidence to encourage or discourage their use” and “The financial gain would be to great for the evidence available“.
ILCOR’s decision to implement the use of non-invasive airway clearance devices would again, make things such as LifeVac mandatory within first aid around the the world.
We are working with relevant councils and bodies, continuously sharing information independently to achieve the above goal, this would ultimately save thousands of lives every year from choking to death when all current promoted methods within first fail. This would raise current 76% effectiveness of BLS Choking protocol to as close to 100% effective as possible.
LifeVac is a proven, safe and effective method to clear an obstruction in a choking emergency. LifeVac is a class 1 medical device regulated by bodies such as FDA, MHRA and CE. We have worked with 1000’s of care and nursing home providers across the UK, helping implement LifeVac from the beginning stages such as assisting with risk assessments, to training and deployment. LifeVac has full public liability insurance and follows stringent medical device guidelines while implementing GMP.
To learn more please visit Compliance and Regulations section on our website.
