MHRA Issues Urgent Public DSI (Device Safety Information) For General Public & Healthcare Professionals
The UK regulator for medicines, healthcare products, and medical devices (MHRA), have issued an urgent public Device Safety Information alert. This DSI is on the use/purchase of illegal dangerous Chinese unregulated anti choking devices/airway clearance devices.
Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is a counterfeit. You can find images within this public safety alert here
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not comply with device regulations and could cause harm.
It is estimated that over 10,000 counterfeit or unbranded anti-choking devices, also known as airway clearance devices, choking rescue devices or emergency first aid devices, have been purchased by the public within the last two years based on listings found across online marketplaces like Amazon and eBay, and drop-shipping websites.
These counterfeit/unbranded devices can either look like LifeVac or come in different colours such as:
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant. – MHRA
Dr Alison Cave, MHRA Chief Safety Officer, said:
Patient safety is our top priority. Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK’s regulatory requirements.
These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents.
The MHRA is working with online marketplaces to remove unbranded and counterfeit anti-choking devices from sale. Do not use the device if you suspect it is counterfeit. Please submit a Yellow Card report if you have previously used a counterfeit or unbranded device and it failed to work, including details of where you bought the product.
The majority of counterfeit or unbranded anti-choking devices are manufactured or shipped from China, appear in a similar or identical design to the LifeVac anti-choking device and, in some cases, claim to be the genuine brand.
None of the anti-choking devices registered with the MHRA are manufactured in China. Any products shipped from China should be treated with caution and disposed.
- The legal manufacturer, LifeVac Europe, can verify the legitimacy of a purchased product against their records of authorised distributors and product serial numbers.
Read the full DSI and the urgent public safety announcement please click here and here.
