Freedom of Information request on safety of lateral flow tests (FOI 21/797)
Published 29 December 2021
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26h July 2021
FOI 21/797
Dear
Thank you for your information request, dated 10/07/2021, where you asked for all information pertaining to the safety assessment of Lateral Flow Devices, in particular all which contain data related to ethylene oxide.
I am pleased to provide you with the information requested, see below.
Ethylene oxide (EO) is a gas that is commonly used to sterilise many different types of medical devices, including swabs used in test kits
The sterilisation process consists of a number of highly controlled and monitored stages, including removing ethylene oxide after treating the swabs. The amount of residual EO that is allowed on medical devices is set by the international standard ISO 10993-7:2008.
As part of the sterilisation process the manufacturer must confirm, and document, that the residual EO level on a medical device is below the specified allowable limit before the device is packaged ready for use. The whole process is overseen by an independent, third-party organisation (notified body or UK approved body) before a CE or UKCA mark can be placed on the medical device. The identifying number of the-third party can be found next to the CE/UKCA mark symbol on the packaging of the swab.
The amount of residual ethylene oxide that is allowed on any medical device, including test swabs, has been set according to the time that the device (swab) is in contact with the person. This contact time is divided into 3 categories: limited, prolonged, and permanent duration. The swabs used in lateral flow test kits fall into the category of limited contact time.
These allowable limits were selected to ensure that any residual levels present on the medical device after sterilisation pose a minimal risk of causing cancer to the person using the device.
In the highly unlikely event that a swab does contain a residual amount above the allowable limit, the risk to the user is still considered to be very low. This is because, to be on the safe side, the limits of residue were deliberately set to be much lower than the limit thought to be a risk of causing cancer.
Following many enquiries on this topic, we added information to our page on Gov.uk to include information about the use of ethylene oxide in swabs for lateral flow tests.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre