MDA/2008/001 - All medical devices

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Action by:

• Chief Executives of NHS Trusts, including Primary Care Trusts (England)
• Safety Alert Broadcast System (SABS) and Medical Device Liaison Officers in NHS Trusts, including Primary Care Trusts (England)
• Directors and Medical Device Liaison Officers of Social Services Departments (England)
• Headquarters of Commission for Social Care Inspection
• Headquarters of Healthcare Commission
• Directors (local and regional services) of the Health Protection Agency.

Action:

• Ensure that comprehensive and effective systems are in place for the reporting of medical device related adverse incidents to the MHRA, and that these systems are regularly reviewed and maintained.
• Encourage staff and medical device users to report adverse incidents in accordance with published MHRA guidance, and to use MHRA’s online adverse incident reporting system.
• Ensure that a Medical Device Liaison Officer (MDLO) has been appointed to train staff and users to report adverse incidents (this role is often combined with the SABS Liaison Officer), and to advise MHRA of any changes to MDLO contact details.
• Ensure that Medical Device Alerts are disseminated locally by the SABS Liaison Officer
• Register on the MHRA website to receive e-mail notification of new publications or ensure that the website is checked regularly for updates and further information.

Distributed to:

 * via CE Bulletin

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Contacts:
Details of MHRA contacts for reporting adverse incidents.

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