MDA/2007/001 - Reporting Medical Device Adverse Incidents and Disseminating Medical Device Alerts

ACTION BY:

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

ACTION:
The following actions should be taken:

• establish, review and maintain local procedures and encourage staff and users to report adverse incidents involving medical devices in accordance with published MHRA guidance
• ensure a MDLO has been appointed to encourage and train staff and users to report adverse incidents (this role is often combined with the SABS Liaison Officer)
• advise MHRA of changes to MDLO contact details
• ensure local dissemination of Medical Device Alerts by the SABS Liaison Officer (LO)
• facilitate and encourage use of the MHRA’s online adverse incident reporting system
• 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

 >Page 2

 >Page 5