The LifeVac is an easy-to-use device for clearing an airway. It’s FDA, MHRA, and UKCA accredited, and is single-patient only. It is not part of the Red Cross or Heart Association protocol. Despite its benefits, choking is a very dangerous medical emergency. If you or someone you know has choking, life vaportable suction can be a life saver.
LifeVac is a non-powered, non-invasive, single patient only airway clearance device
When a person is choking, time is of the essence. In fact, four to six minutes of oxygen starvation can result in irreversible brain damage. And if it takes longer than that, it can lead to death. Unfortunately, conventional treatment for choking often leaves a person in serious condition. LifeVac is designed to rescue a person within seconds. Its patented one-way valve prevents air from being forced upward and creates one-way suction, allowing the device to safely and quickly clear the airway from food or an object lodged in the windpipe.
The LifeVac is a portable, non-powered airway clearance device designed for use by a medical professional to assist in resuscitation of a choking victim. It has a one-way valve that prevents air from entering the victim when the user turns downward. This means that it provides minimal air suction, while still delivering powerful negative pressure to remove the obstruction. LifeVac is easy to use and requires no prescription for use. It also comes with a practice mask for resuscitation and requires no maintenance or prescription. The only maintenance it requires is the replacement of a mask every three years.
Since its launch, the LifeVac has won numerous awards and is now used in more than two thousand care homes in the UK. It is a world leader in the airway clearance device industry, and has received multiple accreditations and independent medical testing. LifeVac’s design is safe and effective for choking victims, and the product team has spent years studying and testing its effectiveness and safety. It is available to healthcare providers in over 2500 care homes in the UK and has saved countless lives.
It is FDA, MHRA, UKCA and CE accredited
Regulatory bodies for medical devices in the EU require the device to be MHRA, UKCA, and CE accredited. UKCA markings can be used until 30 June 2023. However, it will be mandatory to have a CE Mark for devices sold in the UK. EU market regulations apply to all medical devices sold in Great Britain. UK manufacturers must register with the MHRA to enter the market, and they must adhere to guidance issued by the MHRA.
UKCA and CE accreditations require the device to be regulated in the EU and MHRA, which is the competent authority for post-market surveillance. In the UK, UKCA marking is not recognized on the EU market. CE marking requires the device to meet all relevant EU legislation and be placed on the market prior to 1 January 2022. If a product fails to meet these requirements, it may not be accepted in the market.
EU-approved devices must be MHRA, UKCA, and CE accredited to be sold in the UK. UKCA and CE accreditation is mandatory for all medical devices placed on the UK market. To avoid being banned, the device must be FDA, MHRA, UKCA, or CE accredited. The device should carry the UK Responsible Person’s designation on the label. This number should also appear on the product’s label and instructions for use.
MHRA accreditation requires UK manufacturers to appoint a UK Responsible Person for the device. If the manufacturer is not based in the UK, it must appoint a UK Responsible Person or Authorised Representative. The UK Responsible Person will be responsible for registering the device with MHRA. A UK Responsible Person is a person that works on behalf of the UK manufacturer.
After a product is approved by these bodies, it must undergo post-market surveillance (PMS). Since it is a Class I medical device, LifeVac is subject to strict regulatory requirements. In order to meet these requirements, the manufacturer implemented a Post-Market Surveillance (PMS) process, which includes rigorous monitoring. LifeVac implements these measures to ensure a safe and effective product.
During the development of a product, FDA, UKCA, and MHRA regulations must be met. Life vaportable suction choking is FDA, MHRA, UKCA, and CE accredited. This accreditation is necessary to meet these standards and is a must for the safety of the product. There is no reason to wait and hope for the best!
It is not part of the Heart Association or Red Cross protocols
The device isn’t regulated by the FDA, the watchdog organization that oversees medical devices. And the American Red Cross doesn’t train its members to use it. The devices weren’t endorsed by a children’s hospital in Idaho either. As a result, they aren’t part of the Red Cross or Heart Association protocols. A Massachusetts internist and former president of the National Council Against Health Fraud, Dr. Robert Baratz, says these devices do not meet any of the two standards.
In 2010, the American Heart Association updated its choking rescue guidelines. It’s critical to read reports in scientific journals before using a choking suction device. The LifeVac, for instance, was able to dislodge simulated obstructions in a study. But since the device has only been available for a couple of years, there are no published reports showing that it works in real life. In one case, an elderly woman in Wales had a blockage in her throat, but the device was able to remove it, despite failing to remove it with standard treatments.