FOI release

Freedom of Information request on how many faulty or otherwise not working PPE regulated by MHRA were received via the Yellow Card scheme in total by the MHRA from March 2020 to January 2022 (FOI 22/428)

Published 1 June 2022

FOI 22/428

23rd March 2022

PPE yellow card scheme complaints

Dear

Thank you for your information request, dated 8th February 2022 and further clarification received on 16th February, where you asked:

• How many faulty or otherwise not working PPE (i.e. medical/surgical face masks and medical gloves regulated by MHRA) were received via the Yellow Card scheme in total by the MHRA from March 2020 to January 2022.
• How many of these complaints initiated further action?
• How many of the complaints identified in response to Q1 were repeat complaints e.g. products that had received more than one complaint to the Yellow Card scheme
• A breakdown of the broad types of PPE that are identified as being complained about (as in Q1) and merited further investigation (as in Q2)

Please note that the MHRA does not regulate Personal Protective Equipment (PPE) which are intended to protect the wearer. The market surveillance authority for PPE is the Health and Safety Executive (HSE). Our response relates to products that are considered medical devices and are regulated by the MHRA.

We are pleased to provide you below with the information requested.

1. Between March 2020 to January 2022, the MHRA received 235 incident reports via the Yellow Card scheme relating to medical/surgical face masks and medical gloves (examination and surgeons).

2. Action by the manufacturer: When an incident report is received from a healthcare professional or members of the public via Yellow Card scheme it is logged onto our database and sent on to the manufacturer. The manufacturer must investigate and submit a formal report including any relevant corrective/preventative action for every incident which meets the legal reporting criteria. Where a final report has been submitted, 1 report resulted in preventative/corrective action by the manufacturer.

Action by MHRA: All reports are entered into our specialised database that allows us to process and analyse the reports rapidly to make them available for us to detect new safety issues. Every report therefore could be a potential safety issue or ‘signal’. Potential signals are evaluated and triaged to identify previously unidentified potential hazards and new information, including on recognised effects or safety issues.

A signal was identified and MHRA published Medical Device Alert MDA/2020/021/R.

1. As reporters are not required to complete all fields (for example ‘model’) in Yellow Card and there can be variability or absence in information, we cannot identify for certain, all devices where we have received more than one report. However, we have identified that 32 manufacturers had more than one report relating to one or more of the types of devices referred to in Q1.

2. The data relates to surgical/medical face masks, vinyl, latex, and nitrile medical gloves.

When considering this data, it is important to be aware of the following:

• A report does not necessarily mean it has been caused by the device, only that the reporter had a suspicion it may have been. The inclusion of a report on our adverse incident database could be due to unrelated user factors. The data provided, therefore, is not a summary of known or proven adverse events related to the device and must not be interpreted and used as such.
• We extracted the data on 11/03/2022. These numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
• It is not compulsory for healthcare professionals to report incidents directly to the MHRA via Yellow Card but we strongly encourage this, and it is frequently recommended within many professional standards.
• Adverse incident reports by members of the public are voluntary.
• Individuals may report an incident at any time after the event and people can make multiple reports at any time on the same issue. Where possible, multiple reports (Q3) for the same event are linked, however as reporters are not required to complete all fields, we cannot always be sure enough to link every duplicate.
• The principal purpose of the Yellow Card system is to improve the protection of public health and safety of patients and users. This is to be achieved by the evaluation of reported events and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such adverse events.

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

Yours sincerely,

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000