1. © Safeguarding public health MHRA Adverse Incident Centre IT system developments Roy Saunders November 2007

2. Roy Saunders © The advantages of reporting online Why our IT system developments are so important to us – and to you

3. November 2007 Roy Saunders © Adverse Incident User & Manufacturer Reports Risk Assessment Data input Investigation Action AITS Adverse Incident Tracking System Medical Device Alert for (Immediate) Action CA notification Other regulatory action incl. Safeguard action One-liners Device Bulletin Other advice e.g. wall posters Monitor and trend Education tools: manufacturers and users & manufacturer and user actions

4. November 2007 Roy Saunders © Adverse incident reports: Sources

5. November 2007 Roy Saunders © Do you personally (i.e. under your own name, and in your role as a Liaison Officer), submit medical device adverse incident reports to the MHRA? (select one option) A. Yes B. No Q1

6. November 2007 Roy Saunders © If you do submit reports yourself, do you use the MHRA’s online adverse incident reporting system? (select one option) A. Yes B. No – I didn’t know there was one C. No – I don’t have access to the internet D. No – I choose not to report online Q2

7. November 2007 Roy Saunders © Online reports 2006 - 68% of total user reports submitted online

8. November 2007 Roy Saunders © Advantages of online reporting - speedy - accurate - different forms for different devices - automatic acknowledgement & ref no. - paperless

9. November 2007 Roy Saunders © Advantages of online systems - improved communications

10. November 2007 Roy Saunders © - improved communications

11. November 2007 Roy Saunders © Advantages of online systems - improved communications “ cc” function in online form use of email

12. November 2007 Roy Saunders © We are increasingly using email as the means of communicating with incident reporters. Would you prefer to receive all communications from MHRA: (select one option) A. via email? B. by post? C. by fax? Q3

13. November 2007 Roy Saunders © Advantages of online systems - improved communications “ cc” function use of email - electronic links to other reporting systems - greater visibility of investigation progress

14. November 2007 Roy Saunders © If you (MDLOs) were able to log into a private, secure area where you could send reports directly to our incident database. What information about your ‘live’ incident reports would you like to be able to find out there? A. confirmation that report is on database? B. date and outcome of incident report risk assessment? C. dates of correspondence with device mfr? D. date device mfr’s response received? E. date and outcome of concluded incident investigation? Q4

15. November 2007 Roy Saunders © Next steps - consultation & feedback - IT project life-cycle scoping design & development testing & implementation But in the meantime…

16. © Safeguarding public health Roy Saunders November 2007 Report online www.mhra.gov.uk

17. © Safeguarding public health Roy Saunders November 2007 Any questions?