1. Sue Woodward Chair Patent Liaison Group RCS Eng 12 October 2011

2. What a patient wants to know about Medical Devices What is a Medical Device How safe are they What consent is needed What information is available What happens if things go wrong Cost vs Benefit

3. What is a Medical Device Medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, blood glucose monitoring/blood sugar meter, replacement joints, MRI scanners.

4. Patient assumptions Regulations are similar for devices as for drugs Uniform Transparent Clear processes exist for reporting and handling problems Devices are designed, manufactured and tested as fit for purpose (i.e. for clinical use)

5. Transparent straightforward ? Regulatory Bodies in Europe 74 separate notification bodies 25 countries 6 in the UK Ref. Heneghan C et al Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts

6. Device Recalls – January 06 – December10 field safety notices 1220 % 447 Medical device alerts Of which 44% serious adverse health consequences

7. Recall of devices - Highest risk category 25 % Cardiovascular 33% Musculoskeletal 88% assessed as a reasonable probability of causing serious adverse health consequences or death

8. Devices Registration Device Testing - Simulation - Patient Testing - Literature review Withdrawal in one country triggers independent assessment Required education and training is delivered

9. Informed Consent Surgical consent is given to a procedure and its risks. Where do devices fit into this? What information is given to patients on devices for a specific procedure? What information is given to patients to find further information and/or references? Off label use of devices – how is this evaluated or monitored.

10. When Things go Wrong Can they be corrected? Underlying damage How quickly can things be put right?

11. Device Cost vs Benefit Patients need devices to be chosen on the basis that:- The device is well tested The surgeon has received appropriate training Not individual choice of an investigator Not incentivised by a company Not just a cheaper brand

12. Conclusion- Patient Concerns Regulations are confusing Registration of new devices not transparent Patient consent - to what? How are problems rectified? Can they be? Training in the use of new technologies and devices Cost should not be the only influence