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PROTECTING OPERATING ROOM PERSONNEL FROM SURGICAL SMOKE: DESIGN OF AN ERGONOMIC
ELECTROSURGERY SMOKE EVACUATOR
Jacqueline Soicher, Quan Guo Chao Jin, Navid Shirzad September 26th, 2014
Engineers in Scrubs (EiS) Program designed to foster innovaCon in medical technology by training biomedical engineers in clinical environments.
– Find the biomedical technology gaps in the medical field – Generate an innovaCve design that fulfills a true clinical need
ObjecCves
• User Centered Design Process • AdopCon of a device relies on its ability to integrate into the medical field
• Contextual Needs vs FuncConal Requirements • Case Study: Smoke EvacuaCon Device
User Centered Design Process
Phase I Needs Finding
Phase II Needs Screening
Phase III Concept GeneraCon
Phase IV Concept SelecCon
Phase I: Needs Finding
• Needs IdenCficaCon – ConsultaCon with Professionals – Clinical ObservaCon – Clinical Research
• ObservaCon – Understand and Characterize Need
• Needs Statement – SoluCon-‐Independent Key Points
QualitaCve research through clinical immersion to inform engineers and engage health professionals to co-‐create technologies.
• Discuss issues in vascular surgery • IdenCfy issues that can be solved by engineers • Do preliminary research to chose idea with most potenCal
Device Design: Needs IdenCficaCon ConsultaCon with Vascular Surgery (MedTech Cafe)
Device Design: Needs IdenCficaCon Clinical ObservaCon
Buffalo Filter's PlumePen® Surgical Plume Evacua8on Pencil
Device Design: Needs IdenCficaCon Current Smoke EvacuaCon Systems
A B
CONMED (A) and Echmann (B) Equipment Wand Mounted VSES
• Surgical Masks • Vacuum-‐based System • Wand Mounted System • Endoscopic Smoke EvacuaCon System
Surgical Smoke
• Toxic • Produced by Electrosurgery • Health Hazard
Current Technology
• Bulky External Vacuum • Add-‐on • Effects Dexterity
Technology Gap
• Contextual Needs • FuncConal Requirements • User Centered Design
A B
Device Design: Needs IdenCficaCon Technology Gap
Device Design: Needs IdenCficaCon Needs Statement
Device Design: Needs IdenCficaCon Needs Statement
User Centered Design Process
Phase I Needs Finding
Phase II Needs Screening
Phase III Concept GeneraCon
Phase IV Concept SelecCon
Phase II: Needs Screening
• Disease Fundamentals – Fundamental Knowledge – Clinical Relevance – Emerging Technologies
• Stakeholders Analysis • Market Analysis
AddiConal research to establish an unbiased understanding of the contextual needs and funcConal requirements.
Device Design: Needs IdenCficaCon Preliminary Research
Surgical Smoke: • 95% Evaporated Water • 5% CombusCon by-‐products and Cellular Debris – Benzene, phenols, nitriles and fady acids
– Acrylonitrile and carbon monoxide
– Airborne Virus (HIV, HepaCCs)
Preliminary Stakeholder Analysis
Affects people within close proximity to the electrosurgery. O.R. Personnel • Surgeon • Fellows & Residents • Scrub nurse • PaCent (in laparoscopic surgery)
Market Analysis
• Electrosurgical devices market $1.0 billion (2011, U.S.)
• Forecast 6.0% increase/year in value • UClizaCon of electrosurgery is increasing • Growing demand for new technologies
User Centered Design Process
Phase I Needs Finding
Phase II Needs Screening
Phase III Concept GeneraUon
Phase IV Concept SelecCon
Phase III: Concept GeneraCon
Once the needs are well-‐defined, it is Cme to use ideaCon and brainstorming to find new soluCons
Phase III: Concept GeneraCon
• Brainstorming – Open mind – MulCdisciplinary
• Concept Maps – Grouping Ideas – Discovering Gaps – Provide Guidance
Device Design: Concept GeneraCon Brainstorming
Device Design: Concept GeneraCon Concept Mapping: Physical Components Based
User Centered Design Process
Phase I Needs Finding
Phase II Needs Screening
Phase III Concept GeneraCon
Phase IV Concept SelecUon
Phase IV: Concept SelecCon
• Compare Concepts to Needs Requirements • Select / Test Concepts for Final Device
Summary
User Centered Design
NEEDS FINDING
NEEDS SCREENING
CONCEPT SELECTION
CONCEPT GENERATION
Conclusion Summary
• User Centered Design • First GeneraCon
Prototype
Thank you!
• Engineering-‐In-‐Scrubs (EiS) program
• Dr. Michael Van Der Loos • Dr. York Hsiang