How the MHRA investigates your report

1. How the MHRA investigatesyour report Medical Device Liaison Officer Conference 2nd November 2007

2. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Bindu Mistry

3. Adverse Incident Centre (AIC) • All reports come in to the Adverse Incident Centre. • This could be from the online reporting systems (user and manufacturer), e-mail, fax or post • All reports are logged onto the Adverse Incident Tracking System (AITS), which is a bespoke database available to all involved in the investigation of the incident • Reports assigned a unique reference number with the format- • Year / 0 Month / 0 Day of month / Inputter Number / Sequential Number 2007 / 011 / 002 / 401 / 001

4. Adverse Incident Centre (AIC) • The device involved determines which Unit will have responsibility for the incident • The incident is acknowledged and passed onto the relevant Risk Assessors within the unit • AIC flags any death or serious injuries and passes them • on to the relevant unit • AIC also send out and receive the questionnaires on incidents and pass them to the relevant Unit for consideration and action if necessary

5. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Ed Ball

6. Initial Risk Assessment Management • Process (iRAMP) • To assess what risk is associated with the reported incident • To allocate a level of investigation for DTS • This requires information on the actual or perceived hazard and the likelihood for occurrence • confirm details given on the report • obtain further information about the: • Device • User/patient • Usage of the device

7. Reported Incident High Risk / Profile Low Risk • Initial Risk Assessment Management • Process (iRAMP) Level of Investigation • URGENT IN DEPTH • IN DEPTH • STANDARD • INFORMATION

8. Initial Risk Assessment Management • Process (iRAMP)

9. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Jim Lefever

10. Incident investigation • To determine if the incident will happen again and, if so, determine what action is needed to prevent or mitigate any recurrence Why Investigate?

11. Incident investigation What is the device? • What do we know about it? • Is its CE mark appropriate? What happened? • What were its controls set to? • Did it give any alarms or warnings? • Was it being used correctly? • Are there instructions for use? • Are they adequate? • Were they being followed? • Was the user trained to use it?

12. Incident investigation Is there something wrong with the device? • Testing (by manufacturer) to establish if it meets its specification

13. Incident investigation If it does not meet its specification • Is the failure due to: • Manufacture? • QA? • Damage? • Design (including user instructions)?

14. Incident investigation If it does meet its specification or the design is suspected of resulting in the failure • Is its design appropriate? • Evidence of similar failures • Evidence of meeting the Essential Requirements • Evidence of compliance to standards • Any certification by a Notified Body • MHRA evaluation of design

15. Incident investigation If the failure is likely to recur then corrective action is required

16. Incident investigation Corrective action by the manufacturer • Design change • Manufacturing/QA change • Advice to users • Recall

17. Incident investigation Corrective action by MHRA • Issue a notice/publication • Medical Device Alert (MDA) • Dear Doctor letter • One Liner • Device Bulletin • Other • ERA involvement if there is a breach of the regulations

18. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Stephen Lee

19. PMDS input • Role of Principal Medical Device Specialist • Make a recommendation to MHRA Technical Management Group (TMG) • Present all the facts in a timely and intelligible way • Lead on consistency, quality and value

20. PMDS input • Safety Warning • What is the device? • What is the problem? • What are the clinical consequences to the patient and the severity of the hazard? • What are the mitigating factors? • How is the device used? • How is it intended to be used? • Numbers of devices • Manufacturer actions • FSCA - FSN, design changes • Reconciliation, targeting, timescales

21. PMDS input • Other considerations • Government/public/healthcare interest • Preventability • Regulatory actions • Other publications – generic or targeted Next Steps • Agree a recommendation for TMG consideration - perhaps with limited information • Lead drafting of Medical Device Alerts

22. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Susanne Ludgate

23. Clinical input The “so what” factor! • clinical risk • numbers involved • environment of use • politics/publicity

24. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Chaired by Philip Grohmann

25. Technical Management Group meeting • The TMG meets every Thursday afternoon • Adverse incidents flagged up for review during the initial risk assessment process are considered at this meeting • All Field Safety Notices issued by manufacturers are reviewed • The outcome of this review may be “No Further Communication” from the MHRA or the recommendation for a publication • Publication could be a Medical Device Alert, Targeted Letter or some other form of safety notice, such as a One-Liner, poster or leaflet

26. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Clive Bray

27. MDA production & distribution • Draft Medical Device Alert • Sent for external and internal consultation • Revised in light of comments received • Final draft signed off by Director DTS • Publication of Medical Device Alert • Sent to SABS team for distribution • Placed on MHRA web site at same time

28. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report Clive Bray

29. Closure of investigation • Outstanding actions completed • Closure letter sent to reporter of Adverse Incident • Adverse Incident record transferred to surveillance database

30. Adverse Incident Centre iRAMP Incident Investigation PMDS input TMG Meeting Clinical input MDA production & distribution Closure of investigation How the MHRA investigates your report