Freedom of Information request on the health impacts of wearing face coverings for a prolonged period of time (FOI 21-567)
Published 13 August 2021
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15th June 2021 FOI 21/567
Dear
Thank you for your email dated 24th May where you asked:
“I would like to know if a health impact risk assessment has ever been undertaken regarding the potential medical, physical and psychological harms of a person, both adult and/or child wearing a face mask/face covering of any kind for a prolonged amount of time??
“I would like to know if a health impact risk assessment has ever been undertaken regarding the potential medical, physical and psychological harms of a person, both adult and/or child wearing a face mask/face covering of any kind for ANY length of time??”
Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator of medical devices, medicines, and blood components for transfusion.
Face coverings intended for use by the public are not medical devices and are not regulated by MHRA. Neither are respiratory protective equipment such as FFP3s.Therefore, our response relates only to medical face masks described below and in relation to ‘risk assessments’. For ‘Health Impact’ assessments as described by a Department of Health and Social Care (DHSC) framework, please contact DHSC and / or Public Health England
Medical (surgical) face masks are medical devices mainly intended for health care staff to wear to protect patients during surgical procedures and in other medical settings. These are sometimes called ‘Type II or Type IIR’. Masks intended to be worn by patients and other persons to reduce the spread of germs are sometimes called ‘Type I’. Those on the market in the UK will have a CE, CE UKNI or UKCA mark, to show they are fit for their stated intended purpose and meet the relevant requirements of the medical device legislation. MHRA is the UK regulator of these types of masks.
Before placing a mark on the device, manufacturers must undertake a risk evaluation to identify any risks which may be associated with a medical device and remove or reduce them as far as possible. These risks must be acceptable when weighed against the benefits to the patients or users. Also, clinical, safety and performance data are needed by a manufacturer to show they meet the legislation.
Once on the market, medical device manufacturers must monitor the safety of their devices. This involves continual assessment of the benefits-risks associated with use of their products for as long as it is in use.
Manufacturers should inform the MHRA if there are any problems. If there are any concerns relating to any medical device, the MHRA will take timely and appropriate action, which includes publicly communicating safety messages when necessary.
If you have any concerns about a particular medical face mask, MHRA encourage reporting by everyone; public, patients and users through our Yellow Card Scheme.
If you have a query about the information provided, please reply to this email.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review.
Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
Please remember to quote the reference number above in any future communications. Please note, due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
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 at:
Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU