Do medical colleagues know who to report an adverse incident to? John Watkins Communications Division MHRA

1. Do medical colleagues know who to report an adverse incident to? John Watkins Communications Division MHRA

2. Research Research by Ipsos MORI in 2006: • General Public and Healthcare Professionals • Medicines and Medical Devices • Views on Risk, Regulation, Information sources, and how to report adverse reactions and adverse incidents

3. Coverage of research Healthcare Professionals: • GPs • Hospital Physicians • Pharmacists • Surgeons • Nurses Telephone interviews with 100 surgeons and 100 nurses

4. The question Who, or which organisation, if any, would you contact if you wished to report an adverse incident with a medical device or a piece of equipment? • no list of choices, no prompting • spontaneous replies • could give more than one answer – so percentages add to more than 100%.

5. The answers (1) Surgeons Nurses Would use an Adverse Incident Report Form Would use a Yellow Card Nurses Physicians

6. The answers (2) Would use an Adverse Incident Report Form MHRA MDA AI Report Form / MHRA / MDA (est) Central monitoring/ liaison officer in the Trust A technician Medical device / engineering / physics dept Fill in an incident report form Hospital risk team Specialist Support (estimate) Surgeons Nurses

7. The answers (3) Manufacturer A(nother) doctor/surgeon A(nother) nurse Another healthcare professional (est) Another Govt body (incl NPSA, DoH, NICE) Health Authority/Trust/Hospital or its mgmt/NHS Other (including professional bodies) Don’t know Miscellaneous (est) Surgeons Nurses

8. What’s the chances of a report to MHRA? AI Report Form / MHRA / MDA Likely to get to MHRA Specialist Support Might well get to MHRA Manufacturer Don’t know Another healthcare professional If they can be bothered Miscellaneous Very little chance of getting to us Surgeons Nurses

9. But can they be bothered? “Who, or which organisation, if any, would you contact if you wished to report an adverse incident with a medical device or a piece of equipment?” • I’m too busy • Everybody already knows about this • It’s not my job to report • etc Motivations – further research?

10. Do medical colleagues know who to report an adverse incident to? John Watkins Communications Division MHRA

11. QUESTION • This question is only for those of you who have • responsibilities within a hospital. • If you saw a report from a surgeon about an incident and • another report from a nurse, which do you think would give • the most useful account of what happened? • (select one option) • the surgeon’s • the nurse’s • there wouldn’t be much difference • don’t know

12. QUESTION • This question is only for those of you who have • responsibilities within primary care. • If you saw a report from a GP about an incident and • another report from a nurse, which do you think would give • the most useful account of what happened? • (select one option) • the GP’s • the nurse’s • there wouldn’t be much difference • don’t know

13. QUESTION • A medical colleague thinks an adverse incident ought to be reported. • They think they ought to report it to - the hospital, or hospital management, or to - the trust or the local health authority. How likely do you think it is that MHRA will get an adverse incident report about the problem? (select one option) • Very likely • Likely • Unlikely • Very unlikely • Don’t know

14. QUESTION • In your experience, are adverse incidents reported to the • manufacturer or supplier without informing MHRA? • (select one option) • Often • Sometimes • Never • Don’t know