FOI release
FOI MDSOs
Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.
Case reference FOI2024/00611
Received 10 October 2024
Published 5 November 2024
Request
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.
Response
see attached
Documents
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