Freedom of Information request (FOI 22/849)
Published 17 January 2024
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FOI 22/849
17th August 2022
Dear
Thank you for your FOI request dated 20th July 2022.
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.
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.
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.
Generally, the manufacturing process, excluding sterilisation, is a physical process that limits chemicals used in the manufacture of the final swab. We can confirm that the MHRA does not hold the information regarding EO levels and would suggest that you contact the notified body for this. The identifying number of the third party/ notified body can be found next to the CE/UKCA mark symbol on the packaging of the swab. This will help you identify the notified body to contact.
The notified body should also hold the information on whether the swab contains hydrogel or agarose gel.
Kind regards,
FOI Team
Safety & Surveillance Group