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FDA Public Meeting: Device Improvements and Reporting

FDA Public Meeting: Device Improvements and Reporting

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FDA Public Meeting: Device Improvements and Reporting

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  1. FDA Public Meeting:Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

  2. Summary Thank you: There is a problem Utility Devices/Processes : Must Consider Context Incorporate QA/monitoring tools into devices -sometimes Human factors engineering UNC

  3. UNC

  4. Acknowledge context: competing demands/concerns/distractions Documentation-Legal/Billing Log in/out repeat Dueling EMRs Residents/Nurse-Documentation Distractions UNC

  5. Therapist: Same issue for MD, dosimetrist, etc UNC

  6. Billing guidelines; complex, distracting UNC

  7. QA Initiatives and Deviation Rates (36/28,523) Overall Deviation Rate (23/24,937) (25/31,019) (29/23,764) Deviation Rate % Standardized physicist pre-RT chart check (11/32,136) Pre-RT verbal timeout: 2 therapists Color-coded field marks Pre-RT Timeout: 1 therapist Pre-RT physicians port-film review Dosimetry calculation time-outs Pre-RT Checklist QA measures appear effective UNC

  8. QA Initiatives and Deviation Rates (36/28,523) Overall Deviation Rate (23/24,937) (25/31,019) (29/23,764) Deviation Rate % Standardized physicist pre-RT chart check (11/32,136) Pre-RT verbal timeout: 2 therapists Color-coded field marks Pre-RT Timeout: 1 therapist Pre-RT physicians port-film review Dosimetry calculation time-outs Pre-RT Checklist QA: External to Product!! UNC

  9. Specifics 1. Incorporate QA measures into systems; where reasonable e.g. checklists, time-outs, patient ID 2. Standardization (e.g. display screens), connectivity expert committees to determine 3. Reporting “near misses” Culture change Rules on what to report: ambiguous Reporting tools within existing products (as option) Facilitate reporting !! Make it easy to report. 4. Human Factors considerations UNC

  10. UNC

  11. Alt + S + U Double Click on name

  12. Summary Thank you: There is a problem Utility Devices/Processes : Must Consider Context Incorporate QA/monitoring tools into devices -sometimes Human factors engineering UNC

  13. FDA Public Meeting:User Training Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

  14. Summary Vendors --> good user training Challenge: Why is so much training needed? usability suboptimal lack of standardization Training usability Pace of software evolutionary Rapid FDA-review? Limited items Continuing education Paper to Electronic Medical Record-User expectation UNC

  15. More intuitive systems Need for Training Standardization Usability UNC

  16. User Training Vendor Knowledge User Knowledge Improve Usability UNC

  17. Vendor Training FDA Approval User Feedback Clinical Use Product Modified Product Improvements UNC

  18. Vendor Training FDA Approval User Feedback Clinical Use Product Software monitors its own use: “Big Brother” Focused Re-Training: automatic? Modified Product Improvements UNC

  19. Vendor Training FDA Approval User Feedback Clinical Use Product “Fast FDA Review” Software monitors its own use: “Big Brother” Focused Re-Training: automatic? Modified Product Improvements More Evolutionary Cycles --> Better Product UNC

  20. The need for continuing education/training UNC

  21. Deviation increase: Need for continued training/reinforcement Low Tech 0.16 Deviation Rate % High Tech 0.10 0.09 0.06 0.11 Learning Curve 3 Low Tech 1 High Tech 4 High Tech 1 Low Tech 4 High Tech Years UNC Low Tech = No MLC High Tech = MLC

  22. UNC User Expectations Habits/practice evolved in a paper-world The power of paper!

  23. Picture = 1,000 words UNC

  24. Paper: easily edited, annotated, corrected, highlighted, emphasis FEV1 1.3 L

  25. UNC Patient is a 56 year old man with a T5 N0 left breast cancer. He initially presented with a rapidly enlarging mass….. Electronic record is NOT easily edited- Errors readily propagate

  26. Miscommunication --> source of error, and Communication is MORE challenging in electronic world UNC

  27. Summary Vendors --> good user training Challenge: Why is so much training needed? usability suboptimal lack of standardization Training usability Pace of software evolutionary Rapid FDA-review? Limited items Continuing education Paper to Electronic Medical Record- User expectation UNC