Freedom of Information request on PCR testing kits and ethylene oxide (FOI 22/052)
Published 31 May 2022
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FOI 22/052
8th February 2022
Dear
Thank you for your information request, dated 10 January where you asked for:
“Please will you indicate what safety checks, if any, you have performed on PCR test swabs used in the U.K. I am referring not only to those tests supplied by the NHS, but also to the private tests approved by the government for foreign travel, many of which, are made in China and are pushed very high up into the nasal cavity.
As you will be aware, there are claims that these items contain ethylene oxide. Have you investigated this claim? If so, has ethylene oxide or any other potentially harmful substance been found to be present? Please clarify the steps you have taken to protect the public from harm.
In the event that no safety checks have been performed, please state your duties with regard to ensuring the safety of the public with regard to these swabs.”
MHRA is responsible for regulating medical devices and medicines in the UK and the aim of the MHRA Devices Division is to take all reasonable steps to protect the public’s health and safeguard the interests of patients, public and users by ensuring that manufacturers of medical devices and equipment comply with the relevant regulations to show they meet appropriate standards of safety, quality and performance as long as they are in use. MHRA does not undertake performance testing of CE marked devices.
Manufacturers of all medical devices are required to gather data on the safety and performance of their devices after they have placed them on the market for use and are required to report adverse incidents meeting certain criteria that they are made aware of involving their device, taking corrective action when necessary.
All collection swabs used to test for Covid-19 are regulated as medical devices and must meet the regulatory requirements of the UK Medical Devices Regulations 2002. For a medical device to be safe to use, it must have a valid CE, UKNI or UKCA mark. These marks are a declaration by the manufacturer that the test meets the required standards of safety and performance. If it is sterile it becomes a Class Is medical device and should undergo a Notified Body /UK Approved Body (independent 3rd party) assessment of the aspects of manufacture relating to the sterility of the device before a CEUKNI, UKCA mark can be placed on the medical device.
With regards to your request for information on Ethylene oxide (EO), most of the swabs used in the Covid-19 test kits can be sterilised using either ethylene oxide gas or by irradiation. 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 identifying number of the third party can be found next to the CE/UKCA mark symbol on the packaging of the swab.
MHRA has published further information following concerns about the use of ethylene oxide in sterilising test swabs here:
The MHRA encourages the reporting of adverse incidents with a medicine or medical device using the Yellow Card Scheme which can be accessed via the following link:
MHRA looks for similar reports in our database and checks information from other sources (such as scientific papers or information from regulators in other countries) to identify if there is a pattern of problems with the device or the way it is used (a ‘signal’). When there is an identified signal, the MHRA can provide safety guidance to health and social care organisations and to patients and the public.
I hope the information provided has been helpful to you.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Experience Centre