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Medical Device/Equipment Alerts (MDEAs)

New guidance for providers

Currently RQIA distributes MDAs and MDEAs to regulated establishments as part of general 'mail shots' periodically by post and by e-mail. However, from 1 April 2010 all registered persons and managers should ensure that a suitably competent member of staff is nominated to:

Visit/log on to the NIAIC website at suitable frequencies and access MDAs and MDEAs. These are published on an ongoing basis. It is recommended that the website is accessed at least weekly.

  • Keep a log of all visits to the website

  • Print off all alerts which relate to equipment held or used at the premises

  • Ensure that appropriate action is initiated or taken as outlined on the alerts and retain records of such action

  • Report any adverse incidents involving medical devices or equipment to NIAIC using the form provided on the website and retain a copy of same

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