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On 26.03.2024, under ref. FOI 24/201, MHRA released the list of organisations with an MDSO contact recorded on MHRA's database. At that time, there were 305 MDSO contacts recorded on the MHRA database. According to this list, none of the private NHS Wheelchair Service subcontractors, providing NHS community services and providing reused medical devices had an MDSO with contact recorded on MHRA's database (e.g. A J Mobility Ltd. [aka AJM Healthcare], Opcare Ltd, etc were not on MHRA’s database). By stark contrast, according to this list all of the NHS Trusts and NHS Hospitals providing NHS Community Wheelchair Service had an MDSO in place. FYI, the MHRA FOI response and the said list are public and are visible on the WhatDoTheyKnow platform. According to NHS England, one of the enduring standards from past alerts that remains valid is: “Identify a medical device safety officer (MDSO) and ensure contact details are kept up to date with the MHRA’s CAS team.” Inexplicably, on 06.03.2024, AJM Healthcare misleadingly claimed: “AJM already has a MDSO and a has fully complied with the MHRA process.”, when in fact AJM were not following the MHRA and NHS England guidances and alerts about updating MHRA regarding an MDSO. Apparently, since this date, several private NHS WCS subcontractors have contacted MHRA to provide the contact details of their MDSO. I would like to receive an updated list of organisations with an MDSO contact recorded on MHRA's database. I also would like to receive the number and details of any meetings/forums/conference calls/events of the Medical Devices Safety Officer network, taking place in 2023. How long does it take for MHRA to add a new MDSO on the MHRA database, after the MHRA CAS team receives notification of an appointment? Do MHRA registered MDSOs file MHRA Yellow Card reports via the same channel that is available to the general public? What support or information does MHRA provide to MDSOs to help them to improve safe and effective use and management of medical devices? What initiatives and/or collaborative work has MHRA undertaken to encourage private subcontractors, providing NHS community services, to appoint and notify MHRA about MDSOs - thereby ensuring equal standards and effective risk management compared to NHS Trusts who all systematically appoint MDSOs and rapidly notify MHRA of the appointment? Does MHRA intend to put a reminder in the next version of the Managing Medical Devices guidance about the importance of appointing an MDSO and notifying MHRA of their contact details? Comment: it might be helpful if MHRA published in the above guidance the up-to-date email address of the MHRA CAS team where notification of appointment of an MDSO should be sent, together with a link to the MDSO Contact Form (Appendix F, p22/25), as was published in the 2014 directive. I would greatly appreciate a response in PDF format on the WhatDoTheyKnow website.
Published: 5 November 2024
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I am writing to request information under the Freedom of Information Act 2000 regarding the use of the ChemoCare software system in the prescription and administration of chemotherapy drugs. Specifically, I am seeking information related to adverse incidents reported through the Yellow Card Scheme. 1. Total number of adverse incidents. The total number of adverse incidents involving the ChemoCare system reported through the Yellow Card Scheme over the past five years. This should include any issues related to errors in prescription, administration, or software functionality. 2. Summary of adverse incident themes including issues relating to ChemoCare 3. Details of any regulatory actions, safety alerts, or warnings issued by the MHRA regarding ChemoCare, particularly those related to incidents reported through the Yellow Card Scheme.
Published: 5 November 2024
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Can you please advise how many customer emails/letters have been received per annum since the Finasteride drugs launch for male pattern baldness. If possible, please include emails/letters from medical professionals and detail them separately.
Published: 5 November 2024
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Can you please advise the total number of complaints received and of those how many were upheld regarding Finasteride
Published: 5 November 2024
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1. For each of the last ten calendar years, 2014 to 2023 inclusive please state (i) how many reports you received relating to adverse reaction relating to breast implants, and (ii) how many suspected adverse reactions these reports were connected with? 2. For the 2023 calendar year could you please state the number of Adverse Reactions reported relating to breast implants used in breast enlargement surgery. 3. For the 2023 calendar year's Adverse Reactions to breast implants used in breast enlargement surgery please could you give me a complete breakdown of the side effects that the reporter has claimed. Note. If it is possible to isolate reports that relate to cosmetic surgery rather than reconstructive surgery following a different medical procedure then please provide separate answers for both types of surgical implant. Also I would be grateful if the response could be supplied on the same basis as that which was supplied to me in a similar request for 2013 data [Ref: FOI 14/378]
Published: 5 November 2024
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Could you please advise how much funding the MHRA received per annum over the last decade from Big Pharma and also confirm what proportion of the total annual budget this equated to per annum.
Published: 5 November 2024
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I would like to request a copy of all inspection reports and Post Inspection Letters from 30 Sep 2022 to 30 Sep 2024 held by the MHRA for: Mawdsley-Brooks & Company Ltd.
Published: 5 November 2024
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As per Freedom of Information Act, I request details of the three batch numbers that appear most often in the Adverse Drug Reaction (ADR) reports, including those with a fatal outcome, reported to the Yellow Card scheme in association with the COVID-19 Pfizer/BioNTech Vaccine, COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Moderna and GSK/Sanofi VidPrevtyn Beta vaccine, including separate aggregated tables for patient age and patient sex, for all the three batches combined, for each of the four COVID-19 vaccines requested, up to the date of this email which is 19/9/2024
Published: 29 October 2024
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Can you please confirm if Medicines and Healthcare products Regulatory Agency, have utilised Crown Commercial Services RM6277 Framework for the hire of either: * Contingent Labour * Agency Workers * Contractors If the answer is yes, can you please confirm how you engage with suppliers on the RM6277 Framework? Ie at Line Manger Discretion or if this process is managed by a particular department? Can you also confirm the following: * The name and/or Job Title of the person or team who is responsible the use of the RM6277 Framework on behalf of Medicines and Healthcare products Regulatory Agency * Contact email address of the person or team who is responsible the use of the Framework on behalf of Medicines and Healthcare products Regulatory Agency
Published: 29 October 2024
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Under the freedom of information please can you answer the following: 1 Has the Sars Cov2 virus ever been able to be passed on in clinical tests via infected blood transfer to anybody uninfected 2 Has the virus ever been able to be scientifically proven to be able to be passed on from one person infected with Sars cov2 then injected into another person 3 Have any tests using bodily fluids of any kind which have proven that sars cov2 can be injected into another person to cause a sars Cov2 infection If none of these modes of transmission can be proven then how scientifically can it be proven sars cov2 is transmissible?
Published: 29 October 2024
