Planned maintenance of Medical Devices - NHS Guidance ?

[Chris Pearson]

Hi all,
Could anyone point me in the direction of any NHS Guidance notes on the mandatory requirements for annual maintenance of all medical devices please ?
Thanks,
Chris

[Garry]

Hi Chris,

Fairly sure annual is not actually stated anywhere.  Maintenance frequency would be based on manufacturer advice.  Even the usual annual electrical safety test is interpreted from the wording 'regular electrical testing'

https://www.gov.uk/government/publications/managing-medical-devices

[fraser gilmour]

agree with Garry. I'm not aware of any guidance that states a mandatory annual schedule, only to follow manufacturers recommendations and implement periodic testing based on risk

[Chris Pearson]

Thanks Garry,yes quite correctly I should have really said in line with manufacturers recomendations.
The problem I have with the MHRA document is that it is only "guidance" rather than mandatory/compulsory so somebody could choose not to unfortunately.
BR
Chris

[Roger Moore]

Hi Chris

Have you checked section 8 of this document?

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982127/Managing_medical_devices.pdf

[Chris Pearson]

Thanks for highlighting that section Roger that really helps for this and another pressing issue with another customer in relation to competancy and qualifications.
BR
Chris

[Roger Moore]

Hi Chris

This is also another useful document to refer to; https://www.ipem.ac.uk/resources/books/report-95-risk-management-and-its-application-to-medical-device-management/

[Chris Pearson]

Thanks Roger.