FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North...
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Transcript of FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North...
FDA Public Meeting:FDA Public Meeting:Device Improvements and ReportingDevice Improvements and Reporting
Lawrence B. Marks, M.D.Lawrence B. Marks, M.D.
University of North Carolina at Chapel Hill, NCUniversity of North Carolina at Chapel Hill, NC
SummarySummaryThank you: There is a problemThank you: There is a problemUtility Devices/Processes : Utility Devices/Processes : Must Consider Must Consider
ContextContextIncorporate QA/monitoring tools into Incorporate QA/monitoring tools into
devices devices -sometimes-sometimes
Human factors engineeringHuman factors engineering
UNC
AuthorAuthor Deviation RatesDeviation RatesPer treatment Per treatment dayday Per treatment Per treatment coursecourse
Marks 2007Marks 2007 0.1%0.1%
French, 2006 French, 2006 0.3%0.3%
Huang, 2005Huang, 2005 2.0%2.0%
Yeung, 2005Yeung, 2005 4.7%4.7%
Patton, 2003Patton, 2003 0.2%0.2% 3.3%3.3%
Fraass, 1998Fraass, 1998 0.4%0.4% 1.2%1.2%
Macklis, 1998Macklis, 1998 3.1%3.1%
UNC
Acknowledge context: competing demands/concerns/distractionsAcknowledge context: competing demands/concerns/distractions
UNC
Residents/Nurse-Documentation
Dueling EMRs Documentation-Legal/Billing
Distractions
Log in/out repeat
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Therapist: Same issue for MD, dosimetrist, etc UNC
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Billing guidelines; complex, distracting
0.13
0.08
0.03
0.09
0.12
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
2003 2004 2005 2006 2007
Dev
iati
on R
ate
%
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
0.13
0.08
0.03
0.09
0.12
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
2003 2004 2005 2006 2007
Dev
iati
on R
ate
%
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
SpecificsSpecifics1. Incorporate QA measures 1. Incorporate QA measures into systemsinto systems; where ; where
reasonable reasonable e.g. checklists, time-outs, patient IDe.g. checklists, time-outs, patient ID
2. 2. StandardizationStandardization (e.g. display screens), (e.g. display screens), connectivityconnectivityexpert committees to determineexpert committees to determine
3. Reporting “near misses”3. Reporting “near misses”Culture changeCulture changeRules on what to report: ambiguousRules on what to report: ambiguousReporting tools Reporting tools withinwithin existing products (as existing products (as
option)option) Facilitate reportingFacilitate reporting !! Make it easy to report. !! Make it easy to report.
4. Human Factors considerations4. Human Factors considerations
UNC
QuickTime™ and a decompressor
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UNC
QuickTime™ and a decompressor
are needed to see this picture.QuickTime™ and a decompressor
are needed to see this picture.
QuickTime™ and a decompressor
are needed to see this picture.
Alt + S + UDouble Click
on name
SummarySummaryThank you: There is a problemThank you: There is a problemUtility Devices/Processes : Utility Devices/Processes : Must Consider Must Consider
ContextContextIncorporate QA/monitoring tools into Incorporate QA/monitoring tools into
devices devices -sometimes-sometimes
Human factors engineeringHuman factors engineering
UNC
FDA Public Meeting:FDA Public Meeting:User TrainingUser Training
Lawrence B. Marks, M.D.Lawrence B. Marks, M.D.
University of North Carolina at Chapel Hill, NCUniversity of North Carolina at Chapel Hill, NC
SummarySummaryVendors --> good user trainingVendors --> good user trainingChallenge: Why is so much training needed?Challenge: Why is so much training needed?
usability suboptimalusability suboptimallack of standardizationlack of standardization
Training usabilityTraining usabilityPace of software evolutionaryPace of software evolutionary
Rapid FDA-review? Limited itemsRapid FDA-review? Limited itemsContinuing educationContinuing educationPaper to Electronic Medical Record-Paper to Electronic Medical Record-User expectationUser expectation
UNC
Need for Training
Standardization
Usability
More More intuitive intuitive systemssystems
UNC
Vendor Knowledge
Improve Usability
User Knowledge
User Training
UNC
ProductUser
Feedback
FDA Approval
UNC
Modified Product
Clinical Use
Vendor Training
Improvements
ProductUser
Feedback
FDA Approval
UNC
Modified Product
Software monitors its own use:
“Big Brother”
Clinical Use
Vendor Training
Focused Re-Training: automatic?
Improvements
ProductUser
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?
The need for continuing The need for continuing education/trainingeducation/training
UNC
Devi
ati
on
Rate
%
High Tech = MLC
3 Low Tech1 High Tech
Low Tech = No MLC
Years
High Tech
Low Tech
4 High Tech1 Low Tech4 High Tech
0.16
0.11
0.09 0.100.06
Deviation increase: Need for continued Deviation increase: Need for continued training/reinforcementtraining/reinforcement
UNC
Learning CurveLearning Curve
UNCUNC
User Expectations
Habits/practice evolved in a paper-world
The power of paper!
UNC
Picture = 1,000 words
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FEV1 1.3 LFEV1 1.3 L
Paper: easily edited, annotated, corrected, highlighted, emphasis
UNCUNC
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
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Miscommunication --> source of error, andCommunication is MORE challenging in electronic world
SummarySummaryVendors --> good user trainingVendors --> good user trainingChallenge: Why is so much training needed?Challenge: Why is so much training needed?
usability suboptimalusability suboptimallack of standardizationlack of standardization
Training usabilityTraining usabilityPace of software evolutionaryPace of software evolutionary
Rapid FDA-review? Limited itemsRapid FDA-review? Limited itemsContinuing educationContinuing educationPaper to Electronic Medical Record- User expectationPaper to Electronic Medical Record- User expectation
UNC