Designsafe studies in Biomedical and Mechanical Engineering

By

Sebastien A. Daleyden

Vincent M. Goussen

Advisors:

Dr Paul King & Bruce Main

ICAM: Institut Catholique d’Arts et Metiers

• Advanced school of engineering in France• Last five years• Mechanical engineering• Exchange students for 5 months

Designsafe studies in Biomedical and Mechanical Engineering

• Project proposal

• About safety

• Completed work

• Current work

• Next steps

Project proposal

Safety through design, with the use of Designsafe

• Objective 1:– 1. Benchmarking study comparing Europe and the US in safety

– 2. Evaluating designsafe for its suitability to the European market,

– 3. Translation of designsafe to European language(s)

• Objective 2:– Helping students of BME 273 and ME 243 on safety issues

Importance of safety in design

Unintentional injuries• Every year 30 millions injuries occur due to manufactured

products.– 21 % Design defects– 25 % Inadequate guarding– 44 % Inadequate warning

• Cost of $399 billion a year only in the USA;• Fifth leading cause of death;• Due to interaction between machines and their

environment and the way people live and work

Engineers should more think about the safety of the users...

Sources: National safety council (NSC)

American Society of Safety Engineers (ASSE)

Importance of safety in design

The main reasons why we should more care about safety are:

Time Costs Competition International Influences Capturing knowledge Product liability

Hazard analysis: What is it?

Objectives:

Tool for engineers and safety practitioners to

• identify possible hazards,

• provide an evaluation of the risks,

• prompt alternative design solutions to mitigate or control the risks to an acceptable level.

Hazard analysis: What is it?

Hazard: Potentially dangerous condition, which is triggered by an event, called the cause of the hazard.

Risk: hazard that is associated with a severity and a probability of occurrence.

Hazard analysis: What is it?

Hazard analysis: Identify all possible hazards potentially created by a product, process or application.

Risk assessment: It is the next step after the collection of potential hazards. Risk in this context is the probability and severity of the hazard becoming reality.

European standard: EN 1050, Safety of machinery, Principles for risk assessment

A guidance for decisions during the design of machinery in order to comply with the essential safety and health requirements.

Hazard analysis: What is it?

D o cum e nt R esu lts

V e ri fy E ffec tiv e ne ss

R e d u ce R isks

D e riv e R isk R ating

A sse ss R isks

Id en ti fy H a zards

E s ta b lish A na lys is P aram ete rs

Catastrophic Critical Marginal Negligible

Frequent High High Serious Serious

Probable High High Serious Low

Occasional High Serious Low Low

Remote Serious Low Low Low

Improbable Serious Low Low Low

Severity Category

Probability Level

Hazard analysis flowchart

Example of risk matrix used

An useful engineers’ tool: Designsafe

dse has developed a fast, easy-to-use tool for engineers and safety professionals to incorporate safety through design by:

identifying hazards

prompting engineers to think about hazards which they otherwise might overlook

conducting a risk assessment for identified hazards

reducing risks in a structured method

preventing accidents and reducing liability

Answering to the EN 1050 requirements

An useful engineers’ tool: Designsafe

An useful engineers’ tool: Designsafe

Work completed

• Built a background on safety (hazard analysis & risk assessment, CE norms…)

• Learnt the use of Designsafe

• Prepared a course on hazard analysis and on Designsafe for the ME 243

• Assisted to all presentations of BME 273 class that require a DS analysis

• found the main safety websites and safety organizations, a list is available on

our homepage (Benchmarking). • Sent surveys to non US Designsafe demo downloader, and international safety

organizations.

• Meet Bruce Main in Ann Arbor, MI.

Current work

Benchmarking : • Settling designsafe as a reference (weaknesses, strong points)

• Criteria of analysis:Field of activity (medical, food, chemical, semi-conductor, robotic…), compliance, ease of use, cost, communication, languages, effectiveness ...

• Our sources:Internet, feedback of the surveys, study of competitors

Students projects:BME: pancreatic enzyme delivery device

Uterine Retraction DeviceBi-ventricular Assist DeviceCustomization of Teaching Resources

ME: Race car

Moonbuggy

Future work

• Keep on the benchmarking

• Recommendations on where to focus efforts for DS version 2

• DS French version

• Involving in students’ projects

• Preparation of TN Biomedical Engineering

conference

For more information….

Please visit our homepage :http://vubme.vuse.vanderbilt.edu/group34_99/

Thanks for your patience and understanding !