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MHRA Adverse Incident Centre IT system developments

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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