1 / 16

Name MHRA Date 2007

CLINICAL INPUT TO ADVERSE INCIDENT INVESTIGATIONS DR SUSANNE LUDGATE Clinical Director Medicines and Healthcare products Regulatory Agency, UK. Name MHRA Date 2007. LIFE CYCLE…. obtain facts. establish root cause. VIGILANCE LIMITATIONS. failure of recognition non-promotion requirements

sachi
Download Presentation

Name MHRA Date 2007

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. CLINICAL INPUT TO ADVERSE INCIDENT INVESTIGATIONSDR SUSANNE LUDGATEClinical DirectorMedicines and Healthcare products Regulatory Agency, UK Name MHRA Date 2007

  2. LIFE CYCLE….. obtain facts establish root cause

  3. VIGILANCE LIMITATIONS • failure of recognition • non-promotion requirements • difficulties of professional communication • differences in aetiology • difficulties in interpretation • differences in EU/USA systems • failure to undertake trend analysis • failure to define corrective action trigger points

  4. LEARN ABOUT IT….. • vigilance (manufacturer reporting) • healthcare worker reporting • public reporting • committees, council meetings • other healthcare organisations

  5. OBTAIN FACTS….. communication!

  6. THE REAL FACTS….. • wrong device for circumstances • incompatible device combinations • failure to read instructions for use • inadequate training • re-use single use • modifications, adjustments • inadequate servicing, maintenance • inappropriate storage

  7. DEVICE, USER ..…..? Negative negative positive

  8. ESTABLISH ROOT CAUSE

  9. OUTPUTS, ADVICE • clinical perspective • clinical consequences • contents of advice • format of advice

  10. MESSAGE PROMOTION Royal Colleges professional bodies ADVICE paramedics dental, optical patient organisations government organisations eg NICE, NPSA, HPA

  11. IN CONCLUSION….. • if clinical facts are correct • if advice is clinically relevant • if message is clinically understandable • if targeting appropriate • if advice optimally promulgated • if aims of public health, public safety are fulfilled then …..yes you need your clinical team

  12. QUESTION Do you find the targeting lists supplied on the Medical Device Alerts helpful? (select one option) • Yes • No • Sometimes

  13. QUESTION Do you use the targeting lists on the Medical Device Alerts? (select one option) • Yes • No • Sometimes

  14. QUESTION Do you want targeting lists of some type? (select one option) • Yes • No

  15. QUESTION If you do use the targeting lists, could these be more clearly and helpful presented? (select one option) • Yes • No

  16. QUESTION If you do not use the targeting list, do you think that these are helpful to other staff? (select one option) • Yes • No

More Related