M.H.R.A. Liaison Officer Mr. Andrew Leverton

1. Medical Devices – reporting adverse incidents and disseminating safety warnings M.H.R.A. Liaison Officer Mr. Andrew Leverton

2. Medicines and Healthcare Products Regulatory Agency Procedures for action to be taken for Medical Device Alerts and Notices from other Organisations

3. Types of Notice • Device alert • Immediate Action • Action • Information • Update • Device Bulletins • NHS Estates Notices • N.P.S.A. Notices • Manufacturers Alerts

4. Drivers for the Change "A complete record of hazard and safety notices issued by the Medical Devices Agency is maintained; notices are distributed to the appropriate people in the organisation; and recommendations contained in thenotices are implemented." Controls Assurance Criterion 25

5. Criterion 25 Examples of verification • Library/catalogue of notices • Distribution records • Reports demonstrating implementation of recommendations

6. MDA SN 2003 (01) Organisations should: …establish control procedures to record action taken following the receipt of Medical Device Alerts indicating to whom they have been sent. Medical Devices - reporting adverse incidents and disseminating safety warnings

7. The process • Notices to be issued within 24 working hours of receipt by the the Trust • Lead Officer for each notice to be identified • Short-term action report • Longer-term action report • Establishment of the MDA sub-group • Six-monthly report to the Clinical Governance sub-committee

8. Acknowledgment Notice • Copy of notice is attached • Identifies lead officer • Gives action point list • Provides return slip • Provides full distribution list • Allows MHRA liaison officer comments • Individually identified and dated

9. Lead Officers' Actions • Return acknowledgement slip to MHRA Liaison Officer • Immediate action - within 24 hours • Action - within 7 working days • (or as directed) • Preliminary report within three weeks • Comprehensive report within three months

10. 3 Week Report • Was the notice applicable or relevant to the Trust- Recognising S.L.A’s • Details of immediate action taken to minimise risk • Details of action yet to be taken • Other relevant information • Signed and dated

11. 3 Month Report • Immediate action taken to reduce risk • Details of any training needs identified • Details of any changes in policies or procedures • Details of any residual risk to which the Trust is still exposed • Details of any remaining action needed to be taken and who is responsible for ensuring that this is completed. • Signed and Dated

12. Action by Key Staff • Disseminate to appropriate personnel • Return acknowledgement slip indicating who else the notice has been sent to • Liase with the Lead Officer on action proposed or taken

13. Managing the process • Approved policy • Good knowledge of the organisation • Support of clinical governance and risk management forums • Clerical support

14. Purpose Designed Database • Flexible and Adaptable • Designed for our specific requirements • Reduces many time consuming processes • Provides statistical information • Allows for continuing development

19. MDA Sub-group • Reviews reports provided by the Lead Officers • Ensures that appropriate information regarding prevention of risk in relation to Medical Devices is disseminated throughout the Trust • Provide a written report to the Clinical Governance sub-committee on a six-monthly basis.

20. Contact Details M.H.R.A Liaison Officer – Andrew Leverton Telephone DRI ext 3025 (Voicemail) Page via DRI Switchboard E-mail andrew.leverton@dbh.nhs.uk Fax 01302 738308 Deputy – Michael Sheldrake ext 3558

21. The aim? Pro-active action, not post-incident reaction!

22. MDA/2003/016

23. Thank you