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, Chicagotnl@uic.edu

Laytech, Incwww.laytechinc.comTlayton71@aol.com