Medical Device Management: Avoiding the problems Towards integrated reporting and learning from adverse incidents

1. Medical Device Management:Avoiding the problemsTowards integrated reporting and learning from adverse incidents Medical Device Liaison Officer Conference 2006 Name Tony Sant, Group Manager, MHRA Date 7 Nov 2006

2. Outline • Towards integrated reporting • Recent trends in adverse incident reporting • MHRA/NPSA focus group findings • Route map for development • Questions • Towards integrated learning • FSN statistics • Our expectations vs reality • Questions

3. Reporting: Fatality and Serious Injury: 2001-2006*

4. Question to delegates at the MHRA Liaison Officer Conference 2005 Q As a minimum, where should you send adverse incidents reports involving failure of a medical device to? (Select one option) • MHRA • NPSA • Your Local Risk Management system (LRMS) • MHRA and NPSA • MHRA and your LRMS

5. Select one option only Results at Conference

6. Data Comparison Exercise between NRLS and AITS • MHRA identified some Teaching/Acute Trusts, a PCT and an Ambulance Trust that had good track records of reporting incidents • NPSA provided anonymised data for these Trusts to MHRA for comparison • Incident numbers and details were reviewed

7. Reporting comparison: NPSA NRLS vs MHRA AITS incident reports

8. Areas of Concern to MHRA • Reducing adverse incident numbers reported to MHRA • Growing reporting to NPSA’s National Reporting and Learning System (NRLS) • Overall there are more device related incidents reported to the NRLS than to MHRA – and in the sample there was little commonality • Some reporters send incidents only to their Local Risk Management Systems (LRMS) and not MHRAEvidence: 12% of delegates to the MDLO conference felt LRMS reporting was sufficient. • Only 10% of sampled incidents on the LRMS contained sufficient information to allow MHRA to progress the incident immediately with the manufacturer e.g. no device details

9. “ Wherever possible incidents should only be reported once and, as trusts move to electronic reporting, the Department should explore the possibility of recommending a single entry point”

10. MHRA/NPSA Focus Group – 8 May 2006 • How can medical device reporting in the future be arranged to address these concerns: • Several groups comprising medical device liaison officers,NPSA patient safety managers, risk managers and MHRA staff • Joint MHRA/NPSA background paper outlined several options for progressing towards a single reporting route • All groups recommended the same option

11. MHRA/NPSA Focus Group Main Findings - 1 • MHRA should work with all Local Risk Management System (LRMS) providers to: • Develop a single mechanism for two way communication between MHRA and LRMS systems for adverse incident reporting • Add extra data fields for a full medical device reporting dataset • Incorporate triggers to highlight the need to report immediately to MHRA • Incorporate a medical device adverse event nomenclature (ISO TS 19218) • Incorporate high level General Medical Device Nomenclature (GMDN) terms • incorporate patient focussed device related SNOMED-CT terms • incorporate an outcome nomenclature

12. MHRA/NPSA Focus Group Main Findings - 2 • MHRA should pilot the proposals, working with some representative Trusts, NPSA and other stakeholders to develop reporting guidance • MHRA should develop these proposals in consultation with Connecting for Health and their dictionary of medicines and devices project (dm&d) • Major hurdles recognised: • funding • Agreement with numerous LRMS provides • Training in a new reporting route

13. MHRA/NPSA Focus Group Main Findings - 3 Adverse event LRMS data NRLS data IR 1 form Proposed new reporting route with mandatory and additional LRMS fields and two way electronic communication between MHRA and Trust MHRA User or NPSA Eform medical device report i.e. (on-line systems), fax, email, paper copy MHRA user reporting data

14. Conclusion and progress • MHRA Devices management believe these are sensible proposals • BUT they are also challenging • We will be asking you what you think about them What have we done with the proposals so far: • discussed them with Connecting for Health representatives • begun to consider whether they make sense for medicines • looked at the finances and begun outlining the proposals with our developers • If the response from this conference is positive we will begin to engage with LRMS provides

15. Could use a general question Q Does your Trust use an electronic Local Risk Management system (LRMS) ? • Yes • No • Not sure

16. Probably better to get a better picture from our audience with this question rather than the previous – agree? Q What LRMS system is used in your Trust ? • Datix • Ulysses • Vantage • CAMS • PRISM • Savant • Chimera • Other system • None used • Not sure

17. A question on how much internal electronic reporting is used, suspect not much Q What type of internal reporting form is used within your trust? • Electronic form • Paper form • No form is used • Not sure

18. Are we proceeding along the right lines? Q Do you agree that MHRA should work with LRMS providers to develop an LRMS reporting route to MHRA ? • Yes • No • Not sure

19. Are we proceeding along the right lines? Q Do you think two way electronic communication on reported incidents via this route would be helpful and improve joint learning ? • Yes • No • Not sure

20. Medical Device Management:Avoiding the problemsTowards integrated reporting and learning from adverse incidents Medical Device Liaison Officer Conference 2006 Name Tony Sant, Group Manager, MHRA Date 7 Nov 2006

21. FSN proposals at last year’s conference • At last years conference we shared our plans for putting Field Safety Notices on our website with you • We also asked you how we should publicise them……here is what you said!

22. Select one option only

23. Field Safety Notices on the MHRA wbsite • On 28 July 2006 our FSN facilities were launched • We now have over 660 email subscribers • 31 of these are known to be MDLOs • 134 of these are known to be SABS officers • 498 are company representatives etc..

26. Reactions and feedback so far • Good number of subscribers • 271 NHS subscribers • 277 company subscribers • 30 support organisation • Don’t know which emails are for new FSNs and which are for updates • We now add update at the end of the title • We now only send an email alert when we publish additional guidance, not to inform about MHRA taking no additional action or the action by the manufacturer being complete • Place a note of the date of the last status change • Response from clinical groups has been positive

27. MHRA actions on Medical Device FSCA/Recalls Manufacturers or their authorised EU representatives are obliged to inform MHRA of all medical device recalls (FSCAs) occurring within the EU and EFTA countries • MHRA assess the manufacturer’s FSN and their ability to contact their customers • If we are satisfied with these we monitor the action of the manufacturer • If we are not satisfied MHRA will issue a Medical Device Alert or a targeted letter or other publication

28. Best use of the service by Trusts • Subscribe to email alerting • Once you receive notification check whether your Trust have received the FSN • Take action requested by manufacturer if you have received it • Take action on any additional MHRA advice • Use the FSNs for learning concerning proper use and possible problems Note: MHRA assess and monitors manufacturer actions therefore Trusts do not need to treat FSNs like Medical Device Alerts

29. Integrated learning Question: Would taking MHRA proposed best practice advice be ? • A practical way of reduced burden from FSNs • Not be a practical way to reduce burden within my trust • Unlikely to change current practice of checking whether all FSNs are relevant to my Trust • Don’t know/not sure

30. Integrated learning Question: When should MHRA send the FSN email alert ? • only when the FSN is first placed on the website • when the FSN is first placed on the website and if we issue new/additional advice • when the FSN is first placed on the website and whenever we change a status box

31. Integrated learning Question: Do you find the fourth box – completion of manufacturer action of any value ? • Always • Frequently • Occasionally • Never

32. Integrated learning Question: What two additional things could MHRA do to improve the MHRA FSN website facilities? (generated at the meeting, but likely to contain) • Add FSN reference numbers • Tell us which hospitals are affected where known • Scrap the system entirely • Nothing its perfect

33. Safeguarding public health • Thanks for listening