One Liners issue 66 - April 2009

What is the role of the MDLO?
The primary role of the Medical Device Liaison Officer is to encourage reporting of adverse incidents, to provide feedback as required to the reporter regarding ongoing investigations, and to ensure dissemination of Medical Device Alerts to the appropriate target audiences.

• This role is vital in the protection of public health.

What to Report - and how
Any adverse incident involving a medical device or its instructions for use should be reported to MHRA especially if it led to, or could have led to, death or serious injury. Please follow your local reporting procedures and ensure that your trust MDLO is informed.

• Please use the online form to report these promptly to the MHRA, www.mhra.gov.uk You can use the online system to copy your report to your MDLO or other colleagues. Reporting enquiries should be directed to the Adverse Incident Centre hotline: 020 7084 3080, fax: 020 7084 3109 or e-mail aic@mhra.gsi.gov.uk

What to do next
As soon as an adverse incident has occurred, or was avoided in a near miss, consider whether the device needs to be taken out of use for examination.

• Please ensure, where possible, that all faulty equipment is quarantined, including disposable items. Phone MHRA Adverse Incident Centre for further instructions and inform your MDLO of the action you have taken.

Who is your local MDLO?

• Dear MDLO,
  Please paste your local Information/photograph over this space.
  Suggested information is:
  Name
  Job Title
  E-mail
  Telephone number
  Link to trust policies

Medical Devices Alerts
The information, recommendations or advice contained in Medical Device Alerts (MDAs) is important.

• If an MDA applies to you, or medical devices in your area, your timely response is crucial.

Sharing Information
If you report an incident through your MDLO ensure that they have your contact details so that they can keep you informed of the progress and outcomes of an incident investigation.

• MHRA can only send information to the original reporter.

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