IP Requirement: Owens and Minor IP

Experience Requirement:

– Mechanical Design

– Rapid Prototyping

Project Background

Surgical smoke, produced by energy-based surgical instruments, contains harmful toxins, carcinogens, and viruses that can penetrate standard surgical masks and enter the respiratory systems of operating room (OR) personnel. Despite mounting evidence of its dangers, many healthcare facilities still lack comprehensive smoke evacuation protocols. As of 2023, 11 U.S. states have enacted laws mandating surgical smoke evacuation, with more considering similar legislation.

The Association of periOperative Registered Nurses (AORN) has been at the forefront of advocating for smoke-free ORs. However, challenges persist, including resistance from surgical staff, lack of awareness, equipment costs, and workflow disruptions. Successful implementation often hinges on leadership buy-in, hands-on product demonstrations, and inclusive decision-making processes.

Project Scope

This project challenges students to develop innovative, evidence-based solutions to improve surgical smoke evacuation practices in ORs. The scope includes:

• Investigating the health risks and legislative landscape surrounding surgical smoke.

• Identifying and analyzing barriers to compliance in various healthcare settings.

• Designing a solution—technological, or procedural—that addresses these barriers.

• Proposing a strategic solution for implementation, staff engagement, and sustainability.

Project Objectives

• Educate and Inform: Research and present the health hazards of surgical smoke and the rationale behind current and pending legislation.

• Identify Barriers: Analyze real-world challenges such as equipment costs, surgeon resistance, and workflow integration that hinder compliance.

• Design a Solution: Create a practical, scalable solution that could include:

• Smoke evacuation device prototypes or enhancements, alternative methods from existing solutions, cost effective and new forms of implementation that would improve efficiency, workflow and user safety.

• Engage Stakeholders: Develop strategies to gain buy-in from surgeons, nurses, and hospital administrators. This may include:

• Cost-benefit analyses

• Product demonstrations

• Testimonials or case studies from successful implementations.

• Measure Success: Propose metrics to evaluate the effectiveness of the solution, such as compliance rates, air quality improvements, or staff satisfaction.

• Specific:
  Students will identify at least three key barriers to surgical smoke evacuation and design a prototype to address these concerns.
• Measurable:
  The team will produce a functional prototype or detailed model and present it with supporting research and a stakeholder engagement plan.
• Achievable:
  Using available materials and design tools such as modeling, students will build a prototype within the project timeline and test it in a simulated OR scenario or through peer feedback.
• Relevant:
  The prototype must align with AORN guidelines and address compliance with at least one state or institutional policy.
• Time-bound:
  All research, prototyping, and presentation materials will be completed within the project timeline of the term.

Resource Examples (click on text): 

• Compliance Challenges in Implementing New Surgical Smoke Laws | AORN

• What’s New in Smoke Evacuation? | Outpatient Surgery Magazine

All project teams will provide a final report and presentation to the client at the end of the year. Please describe any other deliverables you are expecting for this project (design drawings, prototype, process document, etc.):

• Relevant component drawings, functional prototype with supporting V&V/performance data that meets desired criteria in design considerations & market and user requirements, and DHF (design documentation/project notebook to document iterations, material lists, user feedback, etc.)

Describe any specific skills, certifications, training, or clearances/background checks that will be required for students assigned to this project:

• Students should have analytical and prototyping skills.

Describe any resources that would made available to ensure the success of the project team (i.e. internal budget, capstone donation, equipment, codes/standards, prototyping facilities/materials, data, other documents) upload available documents on file tab:

• Students will be able to access the simulated Operating room