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©
Safeguarding public health
MHRA Adverse Incident Centre
IT system developments
Roy Saunders November 2007
November 2007Roy Saunders
©
The advantages of reporting online
Why our IT system developments are so important to us – and to you
November 2007Roy Saunders
©
Adverse Incident
User & Manufacturer Reports
Risk Assessment
Data input
Investigation ActionUrgent
IN-DEPTH
IN-DEPTH
STANDARD
INFORMATION, KNOWN & ECHO
AITSAdverse 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
November 2007Roy Saunders
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Adverse incident reports: Sources
0
10
20
30
40
50
60
2004 2005 2006
% r
epo
rts
NHS ManufacturersOther Government Bodies Overseas Reporting OrganisationsNon-Government Organisations Private Healthcare Organisations
November 2007Roy Saunders
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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. YesB. No
Q1
November 2007Roy Saunders
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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
November 2007Roy Saunders
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Online reports
Number of online reports from medical device users
0
1000
2000
3000
2001 2002 2003 2004 2005 2006 2007 est.
2006 - 68% of total user reports submitted online
November 2007Roy Saunders
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Advantages of online reporting
- speedy
- accurate
- different forms for different devices
- automatic acknowledgement & ref no.
- paperless
November 2007Roy Saunders
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Advantages of online systems
- improved communications
November 2007Roy Saunders
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- improved communications
November 2007Roy Saunders
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Advantages of online systems
- improved communications
• “cc” function in online form
• use of email
November 2007Roy Saunders
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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
November 2007Roy Saunders
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Advantages of online systems
- improved communications
• “cc” function
• use of email
- electronic links to other reporting systems
- greater visibility of investigation progress
November 2007Roy Saunders
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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
November 2007Roy Saunders
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Next steps- consultation & feedback
- IT project life-cycle
• scoping
• design & development
• testing & implementation
But in the meantime…
©
Safeguarding public health
Roy Saunders November 2007
Report online
www.mhra.gov.uk•
©
Safeguarding public health
Roy Saunders November 2007
Any questions?•
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