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Ethylene Oxide and covid 19 test swabs

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Dear Medicines and Healthcare products Regulatory Agency,

It is known that over exposure to ethylene oxide carries the risk of certain cancers..

I would like to know if a risk assessment has ever been undertaken to establish the possible medical health harms of the mass use of covid 19 test swabs that have been sterilized using ethylene oxide??

I would like to know if a risk assessment has ever been undertaken to establish the possible medical health harms of over exposure to ethylene oxide and the mass testing of covid 19??

Yours faithfully,

Kristina

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 21/393

Dear Kristina,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 12 April 2021.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

FOI 21/393

 

Dear Kristina

 

Thank you for your email of 10 April 2021 with your concerns on the use of
ethylene oxide to sterilise swabs used in testing for Covid-19.

 

Please be reassured that the swabs are safe to use.

 

Ethylene oxide 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 has been set (by the
international standard ISO 10993-7:2008) according to contact time of the
medical device with the person. Contact time is divided into 3 categories:
limited, prolonged, and permanent duration.

 

The swabs used in lateral flow test kits fall under the category of
limited contact time. These limits are not further divided by body weight
and therefore the limits set are also applicable for children.

 

These allowable limits were selected to ensure that any residual levels
present on the medical device after sterilisation pose minimal risk.

 

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, 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. Therefore, the manufacturer’s original calculations that these
swabs are in the ‘limited’ contact category are still valid for the
current testing regime.

 

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.

 

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 organisations
before a CE/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.

 

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The Information Commissioner can be contacted online:
[2]https://ico.org.uk/make-a-complaint/offi...

 

Yours sincerely

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

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