Question 1

Initial & future costings

Accepted Answer

• There is no initial outlay for your wall mounted kit, we have donated that via  our charity, The Oliver Steeper Foundation. The cost of the wall mounted kit is £84.95 plus VAT, and the cost of additional travel kits for school outings, residential stays and so forth are £62.95. Should you wish to order any additional travel kits for example, please goto www.lifevac.uk/shop/ (http://www.lifevac.uk/shop/)and when      making payment use the discount code ‘OF10’ this will give you 10% off your entire order, and LifeVac will donate 15% of the total sale back to our charity enabling us to fund more free devices.

• The only future costs: Due to material degradation, these masks will have a shelf life of 2 years from manufacture date. The expiry day will be printed either on the wall mounted box, or on the instruction manual in other kits. The device itself will not expire.

The current cost of replacement masks is £3.10p, plus VAT & postage which can be purchased directly from www.lifevac.uk.(http://www.lifevac.uk/)

For the above reasons, we strongly advise that you check the expiry dates of your masks regularly whilst undertaking your routine first aid equipment checks.

Question 2

As a childcare provider, do I need to inform my insurance?

Accepted Answer

This is a individual decision. We have spoken directly with many insurers and they are all happy for LifeVac devices to be used only when first aid has been attempted and failed, or cannot be performed.

Question 3

Why are the airway clearance devices/suction devices not mentioned in the Resuscitation Council Guidelines?

Accepted Answer

Anyone can use LifeVac®, we recommend to use LifeVac® when Resuscitation Council Guidelines (BLS protocol) fails. This is where LifeVac® has saved hundreds of lives, when standard BLS has failed or cannot be performed. Resuscitation Guidelines are reviewed every 5 years and created by a body called ILCOR (International Liaison Committee), this committee is made up from resuscitation council members from all over the world.

In the last review (2019/20) ILCOR stated “while we recognise they have saved lives, there is not enough evidence to encourage or discourage their use”. Since then LifeVac® has saved a further 400 lives and gained 6 more peer reviewed medical publications covering lives saved, comparison studies, ease of use, safety and effectiveness. We are certain non-invasive hand held suction devices will become part of the standard first aid choking protocol at some point in the future as LifeVac® is saving lives when BLS first aid fails. In addition, BLS protocol is only 70% effective when performed correctly in a perfect situation. You also have to remember these are “guidelines” not “laws”. LifeVac® is not a first aid device yet and does not claim to be a first aid device.

LifeVac® is a class 1 medical device, LifeVac® is registered and regulated by governing bodies such as the FDA, MHRA, TGA, CE and many more. These are the “governing/authoritative bodies” and governing bodies are who say what can and cannot be used in the public domain. Advisory bodies such as resuscitation councils look at things from a first aid perspective and do not have the authority to say what can or cannot be used outside of first aid/resuscitation guidelines.

Our long term goal is to have “non-invasive hand held suction devices” implemented into BLS first aid protocol. This will raise the current 70% effectiveness of choking protocol to as close to 100% effective as possible. This will also give people such as wheelchair users and people with physical disabilities an additional option when they cannot receive the abdominal thrusts or back blows.
Being a medical device, LifeVac® has full public liability insurance.

Question 4

Is LifeVac a first aid device?

Accepted Answer

LifeVac is not a first aid device, it is a medical device to be used when first aid fails or cannot be performed. Backed by multiple peer reviewed medical publications proving safety, effectiveness, lives saved, comparison studies and ease of use.

Question 5

Is LifeVac regulated?

Accepted Answer

LifeVac is regulated by the MHRA, FDA, TGA, HPFB, MOH, SAHPRA and many more medical device regulatory bodies. LifeVac is also CE registered.

Question 6

Can LifeVac be self-applied?

Accepted Answer

Yes, LifeVac® can self-applied and has also been used like this to save a life.

Question 7

How do I get training for LifeVac?

Accepted Answer

Option 1 – Refer to the enclosed training manual/videos within the LifeVac Kit
Every LifeVac® device comes with an easy to scan QR code. When scanned this takes every end user to free training videos. The video’s cover device overview, when and how to use a LifeVac® device in a choking emergency. The videos also explain how to use LifeVac® on someone that is laying down, sitting and standing. Roughly 70% of LifeVac® usages, the end user hasn’t received any LifeVac Training. They simply read the detailed instruction booklet and scan our QR code.
 
Option 2 – CPD Certified e-learning course
LifeVac Europe have created a CPD certified E-leaning training course which covers Choking prevention, How to identify different types of choking, What can cause a choking emergency, Case studies, Device overview, How and when to use LifeVac® in a choking emergency, Videos on the use of LifeVac® and a Competency Test where the end user will receive a certificate of training/competency. Enrol for free at www.lifevac.uk(http://www.lifevac.uk/)
 
Option 3 – Group online training via Teams/Zoom
LifeVac Europe offer free online training for staff members via Microsoft teams or zoom. Minimum of 5 and a maximum of 20 people per session and the end users will receive a certificate of training/competency.  Please contact Matt at www.lifevac.uk (http://www.lifevac.uk/)for bookings.
 
Option 4 –  Face to face regional centralised training - the only training that LifeVac Europe charge for. £320 + VAT
Face-to-face training can be carried out in any location throughout the UK to suit you. LifeVac Europe can train up to 15 people in each session and deliver 4 sessions throughout the day. LifeVac® training covers how LifeVac® works and how to use LifeVac® in an emergency situation when a casualty is sitting (in a wheelchair), standing or laying down and BLS has failed. Each person is shown how to easily identify the correct sized mask with their colour coded identifier and place them into the LifeVac® device. They then get to use a LifeVac® device on one of our choking Charlie manikin’s and dislodge the bolus inside Charlies airway. When the training session is complete and every trainee feels comfortable in the use of LifeVac® to save a life, each person receives a training certificate from LifeVac for your compliance records. Please contact Matt at www.lifevac.uk (http://www.lifevac.uk/)for bookings.

Question 8

Does LifeVac have medical evidence behind it as well as lives saved?

Accepted Answer

Yes, LifeVac® can proudly say it is the only airway clearance device or suction device with independent medical testing, peer-reviewed medical publications and medical abstracts covering safety, effectiveness, lives saved, comparison studies and ease of use. Click here to view these.(https://www.lifevac.uk/wp-content/uploads/2022/uploaded/lifevac-medical-folder-condensed.pdf)

Question 9

When you use LifeVac, can it push the obstruction further down?

Accepted Answer

No, LifeVac® has a patented one-way valve system, this means when applied no air can be forced through the interchangeable sized masks.

Question 10

Why is non-invasive safer than invasive, such as tube?

Accepted Answer

Being non-invasive, there is no risk of any tubes pushing the obstruction further back, pushing the tongue back in a panic situation, or tearing of the lingual frenulum which will cause bleeding and the tongue to become an additional obstruction. Also, there are no tubes that can become blocked which will render the equipment useless if only part of the obstruction has been removed.

Question 11

I am a training provider, can I add instruction on the LifeVac to my courses?

Accepted Answer

Yes. It is recommended to add LifeVac® to the training due to the ease of use and due to the potential consistency of use. The training should consider the availability and non-availability of LifeVac® devices. If the LifeVac® device is unavailable and not within reach, while it’s being retrieved from the first aid kit, it is required that the BLS protocol to be carried out promptly. Once available, LifeVac® can be used almost instantaneously once BLS protocol has failed. Training on LifeVac® is easy and “Train the Trainer” programs are available.

Question 12

What does the MHRA say about LifeVac?

Accepted Answer

Anti-choking devices
Anti-choking devices, also known as airway clearance devices, are intended for use in the management of choking incidents, by removing obstructions from the airways via manual suction after other approaches have failed. They first became available on the UK market from 2015.

These devices are classified under the Medical Devices Regulations 2002 and Regulation (EU) 2017/745 as class I devices. This means that the manufacturer is responsible for declaring that they conform to the regulatory requirements. The UKCA or CE mark is applied once the manufacturer is satisfied that the essential quality, safety and performance requirements of the regulations have been met.

In 2017, the MHRA investigated concerns about the evidence to support the quality, safety and performance of these devices, engaging with two manufacturers, LifeVac Europe Ltd and Dechoker LLC, which had first introduced these devices to the UK market. This was specifically in light of the use of these devices falling outside the established Basic Life Support protocols and resuscitation guidelines in the UK, produced by the Resuscitation Council UK. These protocols recommend the application of back slaps and abdominal thrusts when managing a choking incident. You can read the recommended resuscitation guidance on the UK Resuscitation Council’s website.(https://www.resus.org.uk/) The anti-choking devices manufactured by LifeVac and Dechoker are intended for use only after these established Basic Life Support protocols have been attempted and failed.

Because these devices are intended to be used as part of a response to choking incidents, the MHRA recognised that it was not possible to conduct clinical investigations to gather pre-market clinical data to demonstrate the quality, safety and performance of these devices.

Due to the lack of supportive clinical evidence demonstrating the quality, safety and performance of the anti-choking devices, in August 2017 both LifeVac and Dechoker adopted voluntary restrictions on the use of their devices in the UK. These restrictions limited use of the devices to healthcare professionals trained in advanced life support. They also meant that the devices could be used only for patients in moulded wheelchairs; or where emergency services were unable to respond. The restrictions were intended to facilitate close monitoring of the use of these devices, with the aim of further developing and improving the clinical data and scientific literature available in relation to airway clearance devices.

Since these devices were first marketed in the UK, the MHRA has not received any reports of adverse incidents attributed to these devices.

In 2022, the MHRA undertook a review of the restrictions in place for these anti-choking devices, which considered multiple factors including: the progress made by the manufacturers since the restrictions were adopted; developments in the clinical data and literature surrounding these devices; usage and adverse incident data; regulation on other markets; the remit of MHRA’s regulatory role; and assessing whether the restrictions in place were proportionate to the risk. The MHRA review culminated in a proposed action plan, discussed and approved by the Devices Expert Advisory Committee, to lift the restrictions in place on these devices, once specified actions were completed.

As of June 2023, the voluntary restrictions on the LifeVac anti-choking device have been lifted, meaning that this device may again be made available for purchase on the wider UK market. This brings the regulation of these devices in line with other countries, including the United States, Australia and the EU, where they have always been available to buy and use. The MHRA is continuing to work with the remaining manufacturer Dechoker LLC towards the lifting of restrictions on their device, and we will update this guidance in due course.

The MHRA continues to recommend that users follow the established Basic Life Support protocols in the UK when managing a choking incident. We have worked with both LifeVac and Dechoker manufacturers to ensure that their device instructions clearly explain its intended purpose and set out the established protocols to follow first so that users are able to make informed decisions about using these devices.

Patient safety remains our utmost priority. We continue to monitor the use of airway clearance devices in the UK and will take proportionate action to address any potential risks that are identified. To support this, we request that users report any adverse incidents experienced when using these devices to the legal manufacturer as well as to the MHRA via our Yellow Card scheme.(https://yellowcard.mhra.gov.uk/)

Counterfeit and non-compliant anti-choking devices

The MHRA is aware of numerous unbranded anti-choking devices being sold online via marketplaces (such as Amazon and eBay) which do not comply with the requirements of the Medical Devices Regulations 2002 or Regulation (EU) 2017/745 in relation to Northern Ireland. These devices appear similar or identical in design to legitimately UKCA or CE marked anti-choking devices such as LifeVac or Dechoker and, in some cases, may claim to be these brands. However, they are not the genuine product, and do not include appropriate instructions. They may pose a serious risk if used to address choking incidents due to inadequate instructions, quality and design.

The MHRA is working with online marketplaces to remove them from sale, and we advise users to exercise caution when purchasing these devices online. Ensure that you purchase only from reputable sellers and confirm that the device’s manufacturer is registered with the MHRA via our public access database.(https://pard.mhra.gov.uk/) We have published advice on buying medical devices online (https://www.gov.uk/guidance/medical-devices-information-for-users-and-patients#buying-medical-devices-for-personal-use)for users and the public.

1743

5574

LifeVac FAQs

Questions and answers on the LifeVac device. Please also visit www.lifevac.uk for manufacturer guidance and technical specification information.