LifeVac - Choking Rescue Device Home Kit for Adult and Children First Aid Kit, Portable

Product Information

LifeVac is an innovative non-invasive airway clearance device that has been designed to enable suction used in ALS and ILS to the normal everyday person, to save lives in a choking emergency when choking BLS fails. The use of suction to help dislodge an FBAO has been around for many years in ALS and ILS protocol and used by paramedics around the world, so everyone already knows that suction works to help dislodge an FBAO.

How to use LifeVac when BLS choking protocol has failed on a casualty who is laying down, sitting, and standing. The following stage was to submit and agree a proposal with the MHRA to make the device available in the UK. The LifeVac Airway Clearance Device is designed with a patented one-way valve system that prevents air being forced through the mask when depressed. This creates one-way suction to safely and effectively remove the lodged food or object. 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.What many people do not know is that dysphagia in adults can also occur as a result of any of the following medical problems: stroke, head injury, brain tumour, HIV, lung cancer, Lupus, and many more. What is LifeVac and how does it work?

They are made of different and cheaper materials than a regulated LifeVac medical device. This means there is no evidence they will perform in hot or cold environments. For example if you leave one in your car in hot weather, it may melt. If you leave one in a cold car, the bellows may be too stiff to depress. LifeVac then went through durability testing to see if it could still be used in extreme hot and cold temperatures. Following this, the true tests came where the device was independently studied on adult and adolescent simulation manikins and a cadaver to see how effective LifeVac could be in dislodging an obstruction of the airway. A total of 49 out of 50 times in the independent cadaver study showed that LifeVac dislodged the simulated food bolus on the first application, and on the 50 th time the bolus was removed on the second application. These studies are available via The American Journal of Gastroenterology, The American College of Emergency Physicians and The American Journal of Emergency Medicine.LifeVac has dislodged full and partial airway obstructions in real life choking emergencies that have included: meat, garlic cloves, sandwiches, hard boiled sweets/candy, hotdogs, grapes, pretzels, coins, porridge, yoghurt, hard plastic, Velcro, bread, phlegm, sputum, leaves, and much more. Designed as a simpler alternative for providing immediate assistance to individuals in choking emergencies, this device is an essential investment for the following environments: Well there are MANY reasons as to why these Chinese counterfeit devices are dangerous, cheap and also illegal, here are just a few reasons: ensuring that medical devices placed on the UK market meet the essential requirements of the Medical Devices Regulations 2002 and, in relation to Northern Ireland, the general safety and performance requirements in Regulation (EU) 2017/745 and Regulation (EU) 2017/746;

In today’s day and age due to human rights and ethics, you cannot carry out clinical trials on humans with medical devices such as LifeVac” When one of these counterfeit devices are used and fails to remove an airway obstruction due to not creating enough suction, or breaking or it pushing the obstruction further down. The casualty will then sadly die, who will you report the incident to? You cannot report it to a regulatory body such as the FDA, MHRA, HPFB. TGA, MOH, SAHPRA or CE etc. As these dangerous counterfeit devices are not regulated or registered with any regulatory body. What insurance will pay for the damages caused? Many of these counterfeits are now using photocopies of LifeVac USA instruction sheets, which means there is no traceability and the first port of call when another counterfeit fails will be LifeVac LLC. LifeVac LLC and LifeVac Europe have full traceability of every manufactured device. The MHRA is the regulator and market surveillance authority for medical devices in the UK. This means that we safeguard patient safety by: LifeVac Wall-Mounted Kit: Supplied in a wall-mounted box ideal for care homes and areas with a high risk of chokingThe A3 laminated poster makes it easy to locate in an emergency. It also details how and when to use LifeVac to save a life. 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. But the use of airway clearance devices is not recommended by the UKRC, can I still use my LifeVac? The Medicines and Healthcare products Regulatory Agency ( MHRA) regulate medicines, medical devices and blood components for transfusion in the UK The two main brands of device, LifeVac and Dechoker, are registered in the UK as medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the companies that the devices should only be used by healthcare professionals or people with advanced life support training. It also says the devices should not be marketed for use on children [see footnote].

These are just a few examples of how you can tell if you have a genuine LifeVac device, that can actually save a loved ones life in a choking emergency. 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. The instruction booklet details how to use LifeVac and which coloured ring identifies the size of the mask.People that suffer from neurological diseases such as Parkinson's, MS, Cerebral Palsy, etc are at greater risk of choking due to difficulties swallowing (dysphagia). Having a LifeVac to hand for a healthcare professional to use can help to deal with choking patients in an easier fashion, and can be the difference between life and death. How Do I Know Which Mask to Use? The MHRA are an executive agency of the UK Government within the Department of Health and Social Care (DHSC)