The ObserverChildren's health This article is more than 1 year oldWarning over use of anti-choking suction devices on children
This article is more than 1 year oldBritish medical charity says there is insufficient evidence on effectiveness or safety in family settings
- Update: in June 2023, the MHRA lifted previous restrictions on the marketing and use of the LifeVac device mentioned in this article [see footnote]
A leading medical charity has warned there is “insufficient evidence” for the use of £70 airways suction devices that are promoted online for saving children’s lives when they are choking.
The suction-based devices are already used in care homes across the country and there is a campaign for them to be more widely available, but emergency doctors are concerned that families may be misled by some of the promotional material. They say there is a lack of objective research demonstrating that they are effective and warn they may delay other life-saving treatment.
In its latest advice, Resuscitation Council UK, a charity that develops guidelines for health and care professionals, says the recommended treatment for choking includes back blows and abdominal thrusts. It acknowledges there are a number of suction-based airway clearance devices available in the UK, but says: “There is insufficient evidence on the safety or effectiveness of these devices for us to recommend their use, and we are concerned that the use of these devices could delay established treatments for choking.”
There are about 300 deaths a year in the UK from choking, with most of the deaths among elderly people. The suction devices were mainly developed in the US and their use is widely based on case reports rather than any clinical trials. They are intended for use when other efforts to remove a blockage in an airway have failed.
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].
LifeVac Europe, which is based in the UK and is one of the leading companies in this sector, promotes its device for saving children’s lives around the world. Its Facebook page and UK website last week included anecdotal evidence of toddlers’ lives being saved by a LifeVac, including a three-year-old who was choking on a chicken nugget.
The company is on a drive to convince regulators to relax the current restrictions in the UK, which it says do not apply in other countries. It denies the devices would delay other treatments because it says they are only intended to be used when all other efforts have failed and death is imminent.
The company said last week it did not market its devices for children. Its devices are available online from a number of distributors, but the company says it asks buyers to confirm they are healthcare professionals or have advanced life support training before purchase. It also pointed out that children’s masks for the device were not sold to UK buyers, and said that research in peer-reviewed medical publications had demonstrated the effectiveness of the device in real-life situations.
Dechoker UK does not promote its device in the UK for use on children. It said it considered more research was required on the efficacy of the devices, but pointed out there was also almost no clinical evidence on the effectiveness of back blows or abdominal thrusts for choking. It said it only sells its devices for use by care providers.
A review on the effectiveness of anti-choking suction devices published in the medical journal Resuscitation in February 2020 said there were “many weaknesses in the data” in the research examining the use of such devices and “few unbiased trials” that have tested their effectiveness.
The MHRA said LifeVac and Dechoker were registered with the agency and had agreed that the medical devices should not be used on children or marketed for that use. It said it was the responsibility of a manufacturer to ensure a device was marketed in line with its intended use.
A spokesperson said: “If a user or member of the public has any concerns regarding the compliance of a specific medical device available on the UK market, we would ask that they report this to the MHRA.”
Footnote added 26 October 2023. In June 2023, the MHRA informed LifeVac Europe that it had lifted restrictions on its anti-choking device, which had previously stipulated it should only be used by people with advanced life support training and not be marketed for use on children. The MHRA told the Observer that updated regulatory guidance regarding anti-choking devices would be published in due course.
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