$100 Website Offer

Get your personal website + domain for just $100.

Limited Time Offer!

Claim Your Website Now

Complete Guide for Smoke Evacuators in the Operating Room

Health & Fitness
Posted on | by pritesh

1. Definition

What is a Smoke Evacuator (OR)?
A smoke evacuator, often referred to as a surgical smoke evacuation system, is a critical medical device designed to capture, filter, and eliminate the hazardous plume generated during surgical procedures that utilize heat-producing tools like electrosurgical units (ESUs), lasers, and ultrasonic scalpels. This plume, commonly called “surgical smoke,” is a byproduct of the thermal destruction of tissue and contains a mixture of toxic gases, vapors, and particulate matter. The primary function of a smoke evacuator is to protect the surgical team and patients from the harmful effects of inhaling this smoke, thereby ensuring a clearer surgical field and a safer operating room environment.

How it Works
The working principle of a smoke evacuator is based on a simple but effective three-stage process:

  1. Capture: A specialized suction tip (smoke evacuation pencil) or a capture device placed near the surgical site actively draws in the generated smoke at the source.
  2. Transport: The captured smoke is transported through flexible tubing connected to the main evacuation unit.
  3. Filtration & Evacuation: The smoke-laden air enters the unit, where it passes through a multi-stage filtration system. This system typically includes a pre-filter for large particles, a primary ultra-low penetration air (ULPA) or high-efficiency particulate air (HEPA) filter to remove microscopic particles and cellular debris, and an activated carbon filter to adsorb toxic gases and odors. The cleaned air is then safely released back into the OR or vented out.

Key Components

  • Main Console/Unit: Houses the vacuum pump, control electronics, and filtration system. It features controls for suction power and system status indicators.
  • Vacuum Pump: Creates the negative pressure (suction) required to pull smoke through the system.
  • Filtration System: The core of the device, usually consisting of:
    • Pre-filter: Captures larger particles, extending the life of the main filter.
    • Main Filter (ULPA/HEPA): Removes at least 99.999% of particulate matter down to 0.1-0.3 microns in size, including viruses, bacteria, and cellular material.
    • Activated Carbon Filter: Neutralizes volatile organic compounds (VOCs), toxic gases, and unpleasant odors.
  • Smoke Evacuation Pencil: A combination electrosurgical pencil and integrated suction tube that allows for simultaneous tissue dissection and smoke capture at the source.
  • Capture Accessories: Includes a variety of suction wands, in-line filters, and laparoscopic port adapters for different surgical applications.
  • Tubing: Connects the capture device to the main unit, designed to be kink-resistant.

2. Uses

Clinical Applications
Smoke evacuators are essential in any procedure that generates surgical plume:

  • General Surgery: Open and laparoscopic procedures using electrosurgery.
  • Dermatology & Plastic Surgery: Laser skin resurfacing, mole removal, and blepharoplasty.
  • Gynecology: Laparoscopic hysterectomies, LEEP (Loop Electrosurgical Excision Procedure), and cone biopsies.
  • Urology: Transurethral resection of the prostate (TURP) and bladder tumors.
  • Orthopedics: Procedures involving cauterization for hemostasis.
  • ENT & Head and Neck Surgery: Tonsillectomies, thyroidectomies, and laser procedures on the larynx.
  • Gastroenterology: Polypectomies and other endoscopic procedures using cautery.

Who Uses It

  • Surgeons: Primarily use the smoke evacuation pencil.
  • Scrub Nurses/Technicians: Manage the positioning of the suction wand, activate the system, and ensure it is functioning correctly.
  • Circulating Nurses: Are responsible for setting up the unit, replacing filters, and troubleshooting alarms.

Departments/Settings
Primarily used in Operating Rooms (ORs) and Ambulatory Surgery Centers (ASCs). They are also found in specialized procedure rooms in dermatology clinics, dental surgery suites, and veterinary operating rooms.

3. Technical Specs

Typical Specifications

  • Suction Flow Rate: 25 – 50 cubic feet per minute (CFM) is typical, with higher-end models offering adjustable flow.
  • Vacuum Pressure: 50 – 120 mmHg.
  • Noise Level: < 60 dBA is desirable to not disrupt communication.
  • Filter Efficiency: ULPA filter efficiency of 99.999% at 0.1 micron or HEPA 99.97% at 0.3 micron.
  • Alarms: Audible and visual alarms for low suction, filter saturation, and unit malfunctions.

Variants & Sizes

  • Standalone Units: Mobile carts that can be moved between ORs.
  • Wall-Mounted Units: Save floor space and are permanently installed.
  • Portable Systems: Smaller, lighter units designed for low-volume settings or office-based surgeries.
  • Integrated Systems: Built directly into the electrosurgical generator or OR table.

Materials & Features

  • Construction: Durable, medical-grade plastics and stainless steel for easy cleaning.
  • Features:
    • Auto-Start: Activates suction automatically when the ESU or laser is fired.
    • Quiet Operation: Advanced pump technology for minimal noise.
    • Digital Displays: For real-time monitoring of flow rate and filter life.
    • Dual-Filter Systems: Allow for staggered filter replacement, reducing cost.

Models

  • Buffalo Filter: Smoke Shark, PlumePen.
  • Stryker: Neptune 2 Smoke Evacuation System.
  • Medtronic: Emprint Smoke Management System.
  • Erbe: VIO Smoke Suction Unit.
  • CONMED: AirSafe 2 Smoke Evacuation System.

4. Benefits & Risks

Advantages

  • Protects Staff Health: Reduces exposure to carcinogenic and mutagenic compounds, minimizing risk of respiratory irritation and long-term health effects.
  • Improves Patient Safety: Reduces the risk of inhalation during awake procedures and potential implantation of viable cancerous cells in laparoscopic ports.
  • Enhanced Surgical Visibility: Removes obscuring smoke, allowing for a clearer view of the surgical site.
  • Regulatory & Professional Compliance: Helps healthcare facilities comply with OSHA, AORN, and other international guidelines recommending the evacuation of surgical smoke.
  • Reduces Unpleasant Odors: Improves the working environment for the OR team.

Limitations

  • Noise: Some models can be disruptive.
  • Cost: Initial investment and ongoing filter replacement costs can be significant.
  • Cumbersome: Additional tubing and equipment in the sterile field require careful management.
  • Incomplete Capture: If not positioned correctly, some smoke may escape.

Safety Concerns & Warnings

  • Filter Saturation: Using a filter beyond its capacity can lead to system failure and release of unfiltered smoke. Always heed filter life indicators.
  • Tubing Obstruction: Kinked or clogged tubing reduces efficiency and can damage the pump.
  • Electrical Safety: Must be used with proper grounding and in accordance with electrical safety standards.

Contraindications
There are no direct contraindications for the use of the device itself. The contraindication lies in not using it during procedures that generate surgical plume. The only scenario where its use might be paused is if the device is malfunctioning and releasing unfiltered air, in which case it should be taken out of service immediately.

5. Regulation

FDA Class
Class II medical device (special controls). It is typically regulated under product code OOK.

EU MDR Class
Class IIa or IIb, depending on the intended purpose and duration of use.

CDSCO Category
Class B or C medical device in India.

PMDA Notes
In Japan, it is classified as a “controlled medical device” and requires certification from a Registered Certified Body.

ISO/IEC Standards

  • ISO 80601-2-71: Particular requirements for the basic safety and essential performance of surgical smoke evacuation systems.
  • ISO 18562: Biocompatibility evaluation of breathing gas pathways.
  • ISO 13485: Quality management systems for medical devices.

6. Maintenance

Cleaning & Sterilization

  • The external surfaces of the main unit should be cleaned with a hospital-grade disinfectant wipe between procedures.
  • Reusable capture wands and pencils must be cleaned and sterilized according to the manufacturer’s IFU, typically using steam autoclaving.
  • Tubing is usually single-use and disposable.

Reprocessing
Strictly adhere to the manufacturer’s instructions for use (IFU) for reprocessing any reusable components. Never reprocess single-use-only items.

Calibration
Annual calibration and performance verification by a certified biomedical engineer are recommended to ensure accurate flow rates and alarm functionality.

Storage
Store in a clean, dry, and temperature-controlled environment. Protect from extreme temperatures and moisture. Ensure the unit is stored with the power off.

7. Procurement Guide

How to Select the Device

  • Procedure Volume: High-volume centers need robust units with high CFM and large filter capacity.
  • Type of Surgery: Laparoscopic cases may require specific port adapters; laser surgeries need high odor control.
  • Ease of Use: Look for intuitive controls, auto-start features, and easy filter change systems.
  • Noise Level: Consider the impact on OR communication.

Quality Factors

  • Suction Performance: Consistent and powerful suction even under load.
  • Filter Efficiency: ULPA is superior to HEPA for capturing ultrafine particles.
  • Durability & Serviceability: Build quality and availability of service contracts.
  • Alarm System: Comprehensive and unambiguous alarms.

Certifications
Look for CE Marking (for Europe), FDA 510(k) Clearance (for USA), and compliance with relevant ISO standards.

Compatibility
Ensure compatibility with your existing electrosurgical generators (for auto-start function) and the availability of appropriate laparoscopic and open surgery accessories.

Typical Pricing Range

  • Portable Systems: $2,000 – $5,000 USD
  • Standard Standalone Units: $5,000 – $12,000 USD
  • Integrated/High-End Systems: $12,000 – $20,000+ USD
  • Consumables (Filters, Tubing, Pencils): Ongoing cost of $50 – $300 per procedure, depending on use.

8. Top 10 Manufacturers (Worldwide)

  1. Stryker (USA): A global leader in medical technology. Notable for the Neptune Waste Management System, which integrates fluid and smoke evacuation.
  2. Medtronic (Ireland): Offers the Emprint Smoke Management System, known for its integration with their Valleylab energy platform.
  3. CONMED (USA): Provides the AirSafe 2 system, recognized for its efficient filtration and user-friendly design.
  4. Buffalo Filter (USA): A specialist in surgical smoke evacuation, famous for the Smoke Shark and a wide range of proprietary capture devices like the PlumePen.
  5. Erbe Elektromedizin (Germany): A renowned manufacturer of electrosurgical equipment, offering integrated smoke evacuation in their VIO and APC systems.
  6. Bowa Medical (Germany): Known for high-quality electrosurgical and smoke evacuation products, particularly strong in the European market.
  7. Symmetry Surgical (USA): Manufactures the Filtered Smoke Evacuation system, focusing on cost-effective solutions.
  8. IC Medical, Inc. (USA): A pioneer in the field, offering a range of smoke evacuators for various surgical disciplines.
  9. Megadyne (USA, part of Ethicon/Johnson & Johnson): Known for its electrosurgical pencils and accessories, with compatible smoke evacuation options.
  10. CooperSurgical (USA): Provides smoke evacuators targeted at the women’s health market, particularly for LEEP procedures.

9. Top 10 Exporting Countries (Latest Year)

(Note: Based on recent trade data trends for HS Code 901890 – “Instruments and appliances used in medical, surgical, dental or veterinary sciences”)

  1. United States: Dominates with high-value, technologically advanced systems from leading manufacturers.
  2. Germany: A hub of precision medical engineering, with strong exports from companies like Erbe and Bowa.
  3. Ireland: A major export location for Medtronic’s devices.
  4. China: A growing exporter of both low-cost and mid-tier medical devices.
  5. Mexico: A key manufacturing and export base for the North American market.
  6. Japan: Exports high-quality devices from its robust domestic medical technology sector.
  7. Netherlands: Serves as a major European distribution and export hub.
  8. Switzerland: Home to precision engineering firms that contribute to the medical device supply chain.
  9. United Kingdom: Exports niche and specialized medical devices.
  10. France: Has a stable of established medical device companies contributing to exports.

10. Market Trends

Current Global Trends

  • Rising Regulatory Pressure: Mandatory smoke evacuation laws are being passed in several US states and are under discussion in the EU, driving adoption.
  • Growing Awareness: Increased knowledge of the health hazards among surgical staff is creating a bottom-up demand for these systems.
  • Minimally Invasive Surgery (MIS) Boom: The growth in laparoscopic surgery, which generates concentrated smoke in a closed cavity, is a significant driver.

New Technologies

  • Smart Integration: Connectivity with OR integration systems for data logging and compliance monitoring.
  • Advanced Filtration: Development of more efficient, longer-lasting, and eco-friendly filters.
  • Miniaturization: Smaller, quieter, and more powerful pumps for portable units.

Demand Drivers

  1. Patient and Staff Safety Awareness
  2. Stringent Government Regulations and Guidelines
  3. Increasing Volume of Surgical Procedures Globally
  4. Technological Advancements in Surgery (e.g., robotics)

Future Insights
The market is expected to see sustained growth. The future lies in fully integrated OR systems where smoke evacuation is a seamless, automatic function of the energy device and room management system. “Smart” evacuators that track filter life, usage, and air quality in real-time will become the standard.

11. Training

Required Competency
Users must be able to:

  • Correctly set up and connect all components.
  • Understand and respond to all system alarms.
  • Perform a pre-use check for leaks and suction power.
  • Safely change filters and dispose of used components.
  • Position the capture device for optimal smoke retrieval.

Common User Errors

  • Failure to Activate: Forgetting to turn the system on or place it in “auto” mode.
  • Poor Positioning: Placing the suction tip too far from the source of the smoke.
  • Ignoring Alarms: Overriding or ignoring filter change or low suction alarms.
  • Using Incompatible Accessories: Using non-sterile or non-approved tubing and wands.

Best-Practice Tips

  • Position the suction tip within 2 inches of the surgical site where smoke is generated.
  • Activate the evacuator before activating the energy device to capture the initial plume.
  • Perform routine maintenance as per the schedule to prevent unexpected downtime.
  • Educate the entire surgical team on the importance and proper use of the system.

12. FAQs

1. Is surgical smoke really that dangerous?
Yes. Studies have shown it contains toxic chemicals like benzene, formaldehyde, and hydrogen cyanide, viable viruses (including HPV), bacteria, and cancerous cells. Chronic exposure is linked to respiratory illnesses.

2. Can’t we just use the standard room suction or overhead suction?
No. Standard wall suction is not powerful enough, lacks the necessary filtration (it puts the hazardous material directly into the hospital’s plumbing system), and will quickly clog and be damaged.

3. How often do the filters need to be changed?
It depends on usage. Most modern units have a filter life indicator. Always change the filter when the alarm activates or as specified in the IFU after a certain number of hours of use. Never use a saturated filter.

4. Are smoke evacuators noisy?
Older models were, but newer technologies have significantly reduced noise levels to below 60 dBA, making them much less disruptive.

5. Is smoke evacuation required by law?
It is becoming increasingly mandated. Several U.S. states have passed laws requiring smoke evacuation in operating rooms. Globally, professional organizations like AORN strongly recommend it as a standard of care.

6. Can I use a laser plume filter on a standard suction canister?
This is a common but often inadequate practice. While the filter captures some particulates, it does not provide the high flow rate needed for effective capture, nor does it remove dangerous gases and odors like a full smoke evacuator.

7. What is the difference between ULPA and HEPA filters?
ULPA (Ultra-Low Penetration Air) filters are more efficient than HEPA (High-Efficiency Particulate Air) filters. ULPA filters capture 99.999% of particles down to 0.1 microns, while HEPA captures 99.97% of particles down to 0.3 microns.

8. Who is responsible for managing the smoke evacuator during surgery?
It’s a team effort. The surgeon uses the pencil, the scrub nurse manages the wand, and the circulator manages the unit itself. However, ultimate responsibility for a safe working environment lies with the entire surgical team and the healthcare facility.

13. Conclusion

The smoke evacuator has evolved from a niche accessory to an indispensable piece of operating room safety equipment. As evidence of the severe health risks posed by surgical plume continues to mount and regulations become more stringent, its adoption will become universal. Investing in a high-quality smoke evacuation system, coupled with comprehensive staff training, is no longer optional but a fundamental responsibility. It is a critical step toward ensuring the long-term health and safety of the surgical team, improving patient outcomes, and upholding the highest standards of modern surgical care.

14. References

  • Alp, E., et al. (2016). “Surgical smoke and infection control.” Journal of Hospital Infection.
  • Association of periOperative Registered Nurses (AORN). (2022). “Guidelines for Perioperative Practice.” AORN.
  • ISO 80601-2-71:2020. “Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of surgical smoke evacuation systems.”
  • Occupational Safety and Health Administration (OSHA). “Surgical Smoke.” OSHA Safety and Health Topics.
  • Ulmer, B. C. (2008). “The hazards of surgical smoke.” AORN Journal.
  • Food and Drug Administration (FDA). “Product Classification: Surgical Smoke Evacuator.” FDA.gov.