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MHRA Adverse Incident Centre IT system developments

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MHRA Adverse Incident Centre IT system developments. Roy Saunders November 2007. The advantages of reporting online Why our IT system developments are so important to us – and to you. User & Manufacturer Reports. Adverse Incident. Data input. Risk Assessment. AITS

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MHRA Adverse Incident Centre IT system developments

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  1. MHRA Adverse Incident CentreIT system developments Roy Saunders November 2007

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

  3. User & Manufacturer Reports Adverse Incident Data input Risk Assessment AITS Adverse Incident Tracking System Action Investigation • 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. Adverse incident reports: Sources

  5. Q1 • 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) • Yes • No

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

  7. Online reports 2006 - 68% of total user reports submitted online

  8. Advantages of online reporting • - speedy • - accurate • - different forms for different devices • - automatic acknowledgement & ref no. • - paperless

  9. Advantages of online systems - improved communications

  10. - improved communications

  11. Advantages of online systems • - improved communications • • “cc” function in online form • • use of email

  12. Q3 • 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) • via email? • by post? • by fax?

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

  14. Q4 • 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? • confirmation that report is on database? • date and outcome of incident report risk assessment? • dates of correspondence with device mfr? • date device mfr’s response received? • date and outcome of concluded incident investigation?

  15. Next steps • - consultation & feedback • - IT project life-cycle • • scoping • • design & development • • testing & implementation • But in the meantime…

  16. Report onlinewww.mhra.gov.uk • Roy Saunders November 2007

  17. Any questions? • Roy Saunders November 2007

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