Has lifevac been approved for use in australia?
Yes. LifeVac has been listed on the Australian Register of Therapeutic Goods (ARTG) for sale in Australia as a Class 1 Medical Device.
why do we need a device? aren't current first aid measures effective?
In Australia we do not manage choking in the same way as every other country in the world (that follow the recommendations of the International Liaison Committee of Resuscitation - ILCOR). Instead the recommendations in Australia utilise largely unproven techniques that have yet to show any documented success in relieving a severe airway obstruction in any person since their inception. Even using the best first aid measures in the world are not always sufficient to relieve an obstruction and a device such as the LifeVac can then be the difference between life and death. In fact first-aid measures are only effective in 50-70% of cases of complete obstruction. So far LifeVac has a record of 100%.
Is the lifeVAc a single use device?
The LifeVac is classified as a single use device, so as to avoid contamination. For carers, it can be used as a single patient device with appropriate cleaning. Don't worry, if you use your LifeVac in an emergency we will replace it free! The device is made of very durable materials and has an expected shelf life of over 5 years.
Does the lifevac expire?
No. The LifeVac device itself does not expire and will not need to be replaced unless used to save the life of a choking victim. The masks in your LifeVac kit should last 3 - 5 years. It is a good idea to check them annually and replace if/when necessary. The outer packaging of the masks should indicate either a date of manufacture or an expiration date - use these as a guide.
IN WHAT SETTINGS CAN LIFEVAC BE USED?
LifeVac can be used in any setting where choking management may be required, especially settings where the risk of a person choking is higher. These include child care, aged care and special needs facilities, and facilities for people with developmental disabilities. Around 8% of unexpected deaths in aged care facilities in Australia are caused by choking.
IS CHOKING A BIG PROBLEM?
Choking and suffocation accounts for approximately 11% of deaths in children under the age of 14 years, and the most common objects are lollies and coins. The second highest cause of death in aged care is choking - almost 8 per cent of premature deaths.
HAS ANYONE BEEN SAVED USING THE LIFEVAC DEVICE?
Yes, we are pleased to say that we have documented examples of hundreds of lives that have been saved using the LifeVac device despite the failure of first aid measures.
IS THERE ANY SPECIAL TRAINING REQUIRED TO USE THE DEVICE?
No. The LifeVac device comes with easy instructions and can be quickly mastered by anyone in an emergency. Hundreds of children have been saved by parents who have had no training.
what ages can the device be used on?
LifeVac is currently recommended for any person over 10kgs (or about 12 months). However, there is no evidence that use of the LifeVac on persons below 12 months/10kg causes any harm. Each unit comes with a variety of masks, to suit a full range of people. Kits can also be customised for special settings e.g. aged care, day care or schools
What makes lifevac anything more than a pump and a mask?
LifeVac is not just a pump and a mask. If you were to use just these two items connected together the result would be to drive obstructions down the airway of a victim. The real magic of the LifeVac design is the patented one-way valve assembly that is fixed between the pump and mask. This valve unit (that has been tested to ensure it is safe for humans) ensures that only a measured negative force is applied, to suck the obstruction out of the victim's airway.
The lifevac seems a bit expensive, is that because it is a medical device?
The main cost in the LifeVac unit is in manufacturing and importing the patent pending one-way valve assembly. These are only manufactured in the US and the UK (under license). To comply with Australian regulations, the device also has to have locally compliant instructions, labelling and packaging. Producing this material also adds to the cost of the device. The ideology of LifeVac is to save lives rather than seek large profits from the misfortune of others. This means that the LifeVac retail price is not inflated but represents costs and margins to ensure a sustainable business. The price of the device in Australia is equivalent to other countries where the device components have to be freighted across the world.
Has the Lifevac device been approved by the Australian resuscitation council (ARC)?
No, however this is because the ARC is not the regulatory body in Australia for medical devices. The ARC is a private, voluntary, non-government organisation that does not endorse any specific equipment for use in first aid in Australia. Therefore there exists no "approval" process at the ARC nor is it required in Australia for using the LifeVac device in first aid.
would using the lifevac in an emergency make me liable because it is outside my current first aid training?
No. In fact most states have "Good Samaritan" (or equivalent) legislation that protects individuals acting in good faith in an emergency e.g. NSW
"A good Samaritan does not incur any personal civil liability in respect of any act or omission done or made by the good Samaritan in an emergency when assisting a person who is apparently injured or at risk of being injured."
A ‘“good Samaritan” is a person who, in good faith and without expectation of payment or other reward, comes to the assistance of a person who is apparently injured or at risk of being injured’.
To be a good Samaritan the person has be
1) acting in good faith;
2) without expectation of payment or other reward
3) to assist a person who is
4) apparently injured or at risk of being injured.
Nothing in that list says anything about ‘acting within one’s qualifications’ and that is for obvious reasons. The Act is intended to encourage people, including those without any qualifications, to help when help is needed.
Applying that reasoning to the good Samaritan provisions requires that the rescuer is acting ‘not maliciously or to achieve an ulterior purpose’ so they’re acting to assist the injured person, not to steal their wallet or do them harm and it’s a genuine attempt not to harm the person, i.e. to do the right thing. So a person who is confident in the use of oxygen and who genuinely believes that oxygen is warranted in the best interest and to avert harm to the patient is acting in good faith when they administer that oxygen; or use the person’s Epi-pen or help them with their Ventolin; or do CPR or use an automatic defibrillator, or use the LifeVac when first aid has failed. The person who says ‘I always wanted to do a tracheostomy using a Swiss army knife and a pen (as in M*A*S*H Season 5 Episode 8, ‘Mulcahy’s War’) and now I can because I can’t be sued’ is not acting in good faith.
The LifeVac is designed to be used without specific training and after first aid attempts have failed. We believe that using the LifeVac therefore does not constitute a rescuer "exceeding their training" i.e. constituting negligence or reckless behaviour under law; regardless as to whether specific LifeVac training was included in their first aid training.
"A good Samaritan does not incur any personal civil liability in respect of any act or omission done or made by the good Samaritan in an emergency when assisting a person who is apparently injured or at risk of being injured."
A ‘“good Samaritan” is a person who, in good faith and without expectation of payment or other reward, comes to the assistance of a person who is apparently injured or at risk of being injured’.
To be a good Samaritan the person has be
1) acting in good faith;
2) without expectation of payment or other reward
3) to assist a person who is
4) apparently injured or at risk of being injured.
Nothing in that list says anything about ‘acting within one’s qualifications’ and that is for obvious reasons. The Act is intended to encourage people, including those without any qualifications, to help when help is needed.
Applying that reasoning to the good Samaritan provisions requires that the rescuer is acting ‘not maliciously or to achieve an ulterior purpose’ so they’re acting to assist the injured person, not to steal their wallet or do them harm and it’s a genuine attempt not to harm the person, i.e. to do the right thing. So a person who is confident in the use of oxygen and who genuinely believes that oxygen is warranted in the best interest and to avert harm to the patient is acting in good faith when they administer that oxygen; or use the person’s Epi-pen or help them with their Ventolin; or do CPR or use an automatic defibrillator, or use the LifeVac when first aid has failed. The person who says ‘I always wanted to do a tracheostomy using a Swiss army knife and a pen (as in M*A*S*H Season 5 Episode 8, ‘Mulcahy’s War’) and now I can because I can’t be sued’ is not acting in good faith.
The LifeVac is designed to be used without specific training and after first aid attempts have failed. We believe that using the LifeVac therefore does not constitute a rescuer "exceeding their training" i.e. constituting negligence or reckless behaviour under law; regardless as to whether specific LifeVac training was included in their first aid training.
Can lifevac be purchased as part of the National disability insurance scheme (NDIS)?
We offer our life-saving anti-choking device for people under the NDIS scheme who are at risk of choking due to a physical and/or neurological condition.
Choice & Control
The NDIS provides lifetime funding support for people with a permanent and significant disability. It is a new way of providing individual support. It is designed to give choice and control over the supports needed to achieve an individual’s life goals and aspirations.
Who is eligible?
The NDIS is progressively being rolled out throughout Australia and will provide complete national coverage.
How are products and aids funded under the NDIS?
If your choking risk is due to your disability, your LifeVac device should be supplied through your NDIS plan, so you need to ensure you include them in your plan.
I have an approved NDIS plan so can I use NDIS funding to buy from LifeVac Australia?
Yes. LifeVac can supply its anti-choking device for personal care and safety on a national basis.
What if my NDIS plan is managed by NDIA?
We will supply your LifeVac and seek payment from your budget from the National Disability Insurance Agency (NDIA).
What if my NDIS plan is self-managed?
Place your order and pay online via credit card. You will then have to arrange reimbursement from the NDIA.
What if my NDIS plan is managed by a registered Plan Management Provider?
Your Support Coordinator can order and pay online and then they will seek reimbursement directly from the NDIA.
Choice & Control
The NDIS provides lifetime funding support for people with a permanent and significant disability. It is a new way of providing individual support. It is designed to give choice and control over the supports needed to achieve an individual’s life goals and aspirations.
Who is eligible?
The NDIS is progressively being rolled out throughout Australia and will provide complete national coverage.
How are products and aids funded under the NDIS?
If your choking risk is due to your disability, your LifeVac device should be supplied through your NDIS plan, so you need to ensure you include them in your plan.
I have an approved NDIS plan so can I use NDIS funding to buy from LifeVac Australia?
Yes. LifeVac can supply its anti-choking device for personal care and safety on a national basis.
What if my NDIS plan is managed by NDIA?
We will supply your LifeVac and seek payment from your budget from the National Disability Insurance Agency (NDIA).
What if my NDIS plan is self-managed?
Place your order and pay online via credit card. You will then have to arrange reimbursement from the NDIA.
What if my NDIS plan is managed by a registered Plan Management Provider?
Your Support Coordinator can order and pay online and then they will seek reimbursement directly from the NDIA.
Can i use the lifevac on myself?
Yes. For people living alone LifeVac is the ideal device when first aid measures have failed or cannot be applied effectively.
Is the lifevac saFe?
Yes. Neither LifeVac nor any regulatory body in the world has ever received a report of the device causing any harm. The device has been safely used by untrained people on people ranging from 3 weeks old to 95 years of age, with no regurgitation and no injury. This has been confirmed by medical examinations post episode.
I HAVE READ ON THE INTERNET ABOUT CONCERNS WITH LIFEVAC?
The LifeVac has been tested and proven to save lives. On our site you can see it recommended by real health professionals. There are those who find it hard to believe that a simple device can be so effective and safe and so LifeVac has been misrepresented or misunderstood by individuals who have made unsubstantiated claims online, or expressed opinions that are not supported by facts or clinical evidence. Unfortunately, this is the world we live in, where anyone's blogged opinion is immediately accepted as fact. LifeVac has a 100% success rate of removing upper airway obstructions following the failure of first aid measures, and has already saved hundreds of lives. All of our saves are documented and the device is subject to regulation in all countries in which it is used. LifeVac is also the subject of a worldwide, multi-institutional research project.
I HAVE HEARD OF A 'SIMILAR' DEVICE CALLED THE DECHOKER?
The LifeVac is a unique device and any similarity is only used to undermine the reputation of the LifeVac.
The Dechoker has never undergone TGA post-market review or clinical review for safety and efficacy.
The Dechoker was rejected by the peak international resuscitation body (ILCOR) as having too much inherent risk due to insertion of the device into the mouth.
The Dechoker and Abdominal Thrusts (formerly Heimlich Manoeuvre, and the best evidenced first aid measure in the world) were compared with LifeVac in an independent published study that found that the outcomes from the Dechoker were barely better than first aid (76% vs 71%) whilst the LifeVac efficacy started at 97% and rose to 100% by the third pump.
The Dechoker has never undergone TGA post-market review or clinical review for safety and efficacy.
The Dechoker was rejected by the peak international resuscitation body (ILCOR) as having too much inherent risk due to insertion of the device into the mouth.
The Dechoker and Abdominal Thrusts (formerly Heimlich Manoeuvre, and the best evidenced first aid measure in the world) were compared with LifeVac in an independent published study that found that the outcomes from the Dechoker were barely better than first aid (76% vs 71%) whilst the LifeVac efficacy started at 97% and rose to 100% by the third pump.
WHERE CAN I FIND MORE INFORMATION ABOUT LIFEVAC?