© safeguarding public health mhra adverse incident centre it system developments roy saunders...

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Safeguarding public health

MHRA Adverse Incident Centre

IT system developments

Roy Saunders November 2007

November 2007Roy Saunders

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The advantages of reporting online

Why our IT system developments are so important to us – and to you


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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


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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


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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


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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


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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


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Advantages of online reporting

- speedy

- accurate

- different forms for different devices

- automatic acknowledgement & ref no.

- paperless


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Advantages of online systems

- improved communications


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• “cc” function in online form

• use of email


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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


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• “cc” function

• use of email

- electronic links to other reporting systems

- greater visibility of investigation progress


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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


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Next steps- consultation & feedback

- IT project life-cycle

• scoping

• design & development

• testing & implementation

But in the meantime…

© safeguarding public health mhra adverse incident centre it system developments roy saunders...

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