Planned maintenance of Medical Devices - NHS Guidance ?

classic Classic list List threaded Threaded
8 messages Options
Reply | Threaded
Open this post in threaded view
|

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
www.healthtec.co.uk
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

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
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

fraser gilmour
In reply to this post by Chris Pearson
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
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

Chris Pearson
In reply to this post by Garry
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
www.healthtec.co.uk
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

Roger Moore
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

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
www.healthtec.co.uk
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

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/
Kind regards

Roger

ART Chair
Reply | Threaded
Open this post in threaded view
|

Re: Planned maintenance of Medical Devices - NHS Guidance ?

Chris Pearson
Thanks Roger.
www.healthtec.co.uk