BME-IDEA 2007 TNL
Classroom and Homework Exercises to Make the
Regulatory Process Real and Interesting
Biomedical Engineering-Innovation, Design, and Entrepreneurship Alliance 2007 Workshop
September 26, 2007
Los Angeles, CA
Terry N. Layton, Ph.D.
BME-IDEA 2007 TNL
Make the Regulatory Process Real and Interesting
Department of Bioengineering, University of Illinois, Chicago
1) GMP and Regulatory Requirements for Medical Devices
2) Product Development
3) Technology Assessment & the Start-Up of A Medical Device Company
4) Emerging Medical Technologies
5) Senior Design I & II
BME-IDEA 2007 TNL
Semester Assignments, Exercises & Oral Presentations
Medical Catheter Selection
Product Requirement Definition (PRD)
Catheter Complaint
Hazard Analysis (HA)
Defect/Complaint & Hazard/Harm
Catheter Modification
510(k) or Letter to File (LTF)
BME-IDEA 2007 TNL
Catheter PRDWho What Where When Why & How
• Who is using the catheter?• Who is it being used on?• What procedures?• What are the indications? contraindications?• What are the sizes or dimensions?• When is it used?• How is it sold?sterile, non sterile, 6’s, 10’s• What other devices is it used with or
compatible with?• What does it do?• What quality or manufacturing tests may be
important? Try to list 3• What standards exist? ASTM, ISO, ANSI
BME-IDEA 2007 TNL
Homework Assignment
• Define & Provide Example(s), if possible, with your catheter and consider for PRD– Accuracy– Actual Value– Deviation– Nominal– Range– Resolution
BME-IDEA 2007 TNL
Catheter ComplaintHazard/Risk/Solution
• Risk Analysis– Identify the hazard– What is the risk? Estimate risks– Where or when did it happen?
Company, Hospital, Doctor, Surgery• Risk Evaluation—determine/decide risk acceptability• What do I do about it?
CAPA (Corrective Action & Preventative Action)• Recall• Do more tests• Change specifications or label/instructions• Nothing but Monitor• Nothing
BME-IDEA 2007 TNL
Severity Level
Description
S1 Neglible; Little or no potential to injuryS2 Marginal; Potential to InjuryS3 Critical; Potential of death or serious injuryS4 Catastrophic; Multiple deaths or serious injury
Risk Level
Risk Acceptability
R1Broadly acceptable, no need to consider further risk reduction
R2Risk is unacceptable and should be reduced as low as reasonably pracricable (ALARP); both economic and technical practicability are balanced against risks/benefits
R3Same as R2 except risk is reduced even at considerable costs
R4 Unacceptable; risk MUST be reduced
Probability Descriptors
S1 Neglible
S2 Marginal
S3 Critical
S4 Catastropic
Frequent R3 R4 R4 R4Probable R2 R3 R4 R4Occasional R2 R2 R3 R4Remote R1 R2 R2 R3Improbable R1 R1 R2 R2Incredible R1 R1 R1 R1
2
3
1
BME-IDEA 2007 TNL
Catheter Modification• Submission
– 510(k) Decision Tree• Design
• Labeling
• Manufacturing Process
• Testing
– Letter to File(LTF)
• Documentation– Safety & Efficacy
– Tests & Measurements
DeLee tip
Color- size id
Single loopClear color
1-5 cm markings
14 Fr Suction Catheter
BME-IDEA 2007 TNL
BME-IDEA 2007 TNL
BME-IDEA 2007 TNL
Classroom and Homework Exercises to Make the
Regulatory Process Real and Interesting
Medical Catheter Selection (PRD)Catheter Complaint (HA)Catheter Modification 510(k) or Letter to File (LTF)
THANK YOU
Terry N. Layton, Ph.D.Visiting Professor,Department of BioengineeringUniversity of Illinois, [email protected]
Laytech, [email protected]