MDA/2009/001 - All medical devices

Action by:

• Chief Executives of NHS Trusts, including Primary Care Trusts (England)
• Central Alerting System (CAS) 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.
• Directors of Children’s Services of OFSTED
• Chief Executives of NHS Boards in Scotland

Action:

• Ensure that this and all subsequent Medical Device Alerts are disseminated locally by the CAS Liaison Officer to all those on the distribution list.
• 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.
• Ensure that local reporting and risk management systems do not filter out medical device related adverse incident reports that should be sent directly to the MHRA Adverse Incident Centre.
• Encourage staff and medical device users to report adverse incidents direct to the MHRA in accordance with published MHRA guidance, and to use the 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 and to advise the MHRA of any changes to MDLO contact details (the role is often combined with the Central Alerting System (CAS) Liaison Officer).

Distributed to:
The MHRA has sent this MDA to:

• NHS trusts in England (Chief Executives)
• Commission for Social Care Inspection (CSCI) (Headquarters)
• Healthcare Commission (CHAI) (Headquarters)
• Health Protection Agency (HPA) (Directors)
• NHS Boards in Scotland (Chief Executives)
• OFSTED (Directors of Children’s Services)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

 * via CE Bulletin