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

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

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

Page 2: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University 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

Page 3: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 4: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 5: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

QuickTime™ and a decompressor

are needed to see this picture.

Therapist: Same issue for MD, dosimetrist, etc UNC

Page 6: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

QuickTime™ and a decompressor

are needed to see this picture.

UNC

Billing guidelines; complex, distracting

Page 7: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 8: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 9: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 10: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

QuickTime™ and a decompressor

are needed to see this picture.

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.

Page 11: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

Alt + S + UDouble Click

on name

Page 12: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University 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

Page 13: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 14: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University 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

Page 15: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

Need for Training

Standardization

Usability

More More intuitive intuitive systemssystems

UNC

Page 16: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

Vendor Knowledge

Improve Usability

User Knowledge

User Training

UNC

Page 17: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

ProductUser

Feedback

FDA Approval

UNC

Modified Product

Clinical Use

Vendor Training

Improvements

Page 18: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

ProductUser

Feedback

FDA Approval

UNC

Modified Product

Software monitors its own use:

“Big Brother”

Clinical Use

Vendor Training

Focused Re-Training: automatic?

Improvements

Page 19: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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?

Page 20: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

The need for continuing The need for continuing education/trainingeducation/training

UNC

Page 21: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 22: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

UNCUNC

User Expectations

Habits/practice evolved in a paper-world

The power of paper!

Page 23: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

UNC

Picture = 1,000 words

Page 24: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

QuickTime™ and aTIFF (Uncompressed) decompressor

are needed to see this picture.

FEV1 1.3 LFEV1 1.3 L

Paper: easily edited, annotated, corrected, highlighted, emphasis

Page 25: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

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

Page 26: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University of North Carolina at Chapel Hill, NC

QuickTime™ and a decompressor

are needed to see this picture.

UNC

Miscommunication --> source of error, andCommunication is MORE challenging in electronic world

Page 27: FDA Public Meeting: Device Improvements and Reporting Lawrence B. Marks, M.D. University 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- User expectationPaper to Electronic Medical Record- User expectation

UNC


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