Freedom of Information request about the safety of ethylene oxide (EO) and its use to sterilize the swabs used in lateral flow tests (FOI-21-294)
Published 28 May 2021
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Thank you for your enquiry of 25 March 2021 relating to the safety of ethylene oxide (EO) and its use to sterilize the swabs used in lateral flow tests. Please see our replies below.
Can you please confirm whether the swabs used in the LFTs are sterilised with ethylene oxide?
The swabs used in the lateral flow test kits can be sterilised using either ethylene oxide or radiation. The method used to sterilise a swab will be displayed on the packaging. The symbol is a rectangular box with the word ‘STERILE’ followed by either ‘EO’ (sterilised using ethylene oxide) or ‘R’ (sterilised using radiation).
Information as to what, if any, independent tests have been carried out to check for any residues of ethylene oxide on a random sample of swabs
The manufacturer is responsible for testing the amount of ethylene oxide left on the device after sterilisation to ensure that the residue left is below the allowable limit. The allowable limit of residual EO is set by the international standard ISO 10993-7:2008.
The sterilisation process, including residual testing, is documented by the manufacturer. This documentation is reviewed by an independent third-party body called an ‘Approved Body’ (in Europe these are called ‘Notified Bodies’), before the manufacturer is allowed to manufacture swabs for the UK market. Testing on random samples of swabs by the approved body once market approval has been given is unusual. However, the ‘Approved body’ carries out periodic audits of the manufacturer’s process to ensure continued compliance.
Each approved body has a unique identifying number that appears next to the CE (or UKCA) mark symbol on the packaging of the swab. An internet search using this number with the words ‘notified body’ should give the name and contacts for the Notified or Approved body. The MHRA audits these Approved Bodies to make sure they are fulfilling their obligations. European Notified Bodies are audited by their relevant Competent Authority.
Information as to what, if any, assessments have been conducted to ensure that the invasive use of these swabs for children is safe?
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 and the type of contact that the swab has with the person. The contact time is divided into 3 categories: limited, prolonged, and permanent duration. The contact type is divided into two categories: surface contacting and implant. The swabs used in lateral flow test kits fall into the category of limited contact time and contacting the inner surface of the nose and the throat (surface contacting device).
These allowable limits were carefully selected by the International Standard Organisation (ISO) to ensure that any residues on the medical device after sterilisation pose a minimal risk of causing cancer to the person using the device. The limits set by this organisation apply to adults and children.
The average time of contact for a single test (around 20 seconds) and the current testing regime (twice a week), means that each person is exposed to any residue on the swab for around 40 seconds per week.
Calculating from the allowed residues, even with this increased use of the swabs, the contact time still falls within the ‘limited contact’ level originally set by the manufacturer.
A person would need to be tested twice a week for over 40 years for the total contact time to be in a higher contact category.
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.
What LFTs that children and adults are being advised to use are sterilised with ethylene oxide?
The MHRA does not hold this information.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.
The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU