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. Author Deviation Rates Per treatment day Per treatment course Marks 2007 Marks 2007 0.1% French, 2006 French, 2006 0.3% Huang, 2005 Huang, 2005 2.0% Yeung, 2005 Yeung, 2005 4.7% Patton, 2003 Patton, 2003 0.2%3.3% Fraass, 1998 Fraass, 1998 0.4%1.2% Macklis, 1998 Macklis, 1998 3.1% UNC

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

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

6. UNC Billing guidelines; complex, distracting

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

8. Deviation Rate % QA: External to Product!! (29/23,764) (23/24,937) (36/28,523) (25/31,019) (11/32,136) Pre-RT Checklist Pre-RT verbal timeout: 2 therapists Pre-RT Timeout: 1 therapist Pre-RT physicians port-film review Color-coded field marks Standardized physicist pre-RT chart check Dosimetry calculation time-outs Overall Deviation Rate QA Initiatives and Deviation Rates 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. Facilitate reporting !! Make it easy to report. 4. Human Factors considerations 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. Need for Training Standardization Usability More intuitive systems UNC

16. Vendor Knowledge Improve Usability User Knowledge User Training UNC

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

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

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

20. The need for continuing education/training UNC

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

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

23. UNC Picture = 1,000 words

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

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

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