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Medical Devices New Technologies

Medical Devices New Technologies. Sue Woodward Chair Patent Liaison Group RCS Eng 12 October 2011. 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

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Medical Devices New Technologies

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  1. Medical DevicesNew Technologies 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

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