Digital Supplement: COVID-19 and Minimally Invasive Surgery

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COVID-19

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Understanding the basics PAGE 4

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The Hazards of Surgical Smoke - Beyond COVID-19 PAGE 8

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AirSeal System ®

0.01μm Filtration

Protect your patients, your staff, and yourself Biologic material is a known component of surgical smoke. The aerodynamic size of HIV viruses has been reported as 0.12 μm1; HPV has been reported as 0.055 μm2; and Hepatitis C has been reported as 0.06 μm3 in diameter.

Acronym

Name

Size

HAV

Hepatitis A Virus

0.02 μm4

HEV

Hepatitis E Virus

0.03 μm4

HBV

Hepatitis B Virus

0.04 μm4

HPV

Human Papiloma Virus

0.05 μm2

HCV

Hepatitis C Virus

0.06 μm3

COVID-19

Novel Coronavirus

0.06 – 0.14 μm6

HIV

Human Immunodeficiency Virus

0.12 μm1

BAC

Bacteria

0.30 μm5

Bacteria 0.30 μm HIV 0.12 μm COVID-19 0.06 – 0.14 μm

0.01 μm

HCV 0.06 μm

HAV HPV 0.05 μm

0.02 μm HEV 0.03 μm

HBV 0.04 μm

CONMED is pleased to offer two solutions that provide continuous active smoke evacuation and filtration for laparoscopic procedures. When used with the AirSeal® iFS, both the AirSeal® Tri-Lumen Tubing (ASM-EVAC1) and Bifurcated Smoke Evacuation Tubing (SEM-EVAC) offer continuous smoke evacuation through a 0.01 μm ULPA Filter.

ASM-EVAC1

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SEM-EVAC

Fisher, Bruce; Harvey, Richard P.; Champe, Pamela C. (2007). Lippincott’s Illustrated Reviews: Microbiology. Lippincott’s Illustrated Reviews. Hagerstown, MD: Lippincott Williams & Wilkins. p. 3. ISBN 978-0-7817-8215-9.

IARC Working Group on the Evaluation of Carcinogenic Risk to Humans. Human Papillomaviruses. Lyon (FR): International Agency for Research on Cancer; 2007. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 90.) 1, Human Papillomavirus (HPV) Infection. Available from: https://www.ncbi.nlm.nih.gov/books/NBK321770/ Hepatitis C virus--proteins, diagnosis, treatment and new approaches for vaccine development. Hossein Keyvani, Mehdi Fazlalipour, Seyed Hamid Reza Monavari, Hamid Reza Mollaie. Asian Pac J Cancer Prev. 2012; 13(12): 5931–5949.

Zuckerman AJ. Hepatitis Viruses. In: Baron S, editor. Medical Microbiology. 4th edition. Galveston (TX): University of Texas Medical Branch at Galveston; 1996. Chapter 70.

Size Limits of Very Small Microorganisms: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 1999. Bacteria, Their Smallest Representatives and Subcellular Structures, and the Purported Precambrian Fossil “Metallogenium”.

Cascella M, Rajnik M, Cuomo A, et al. Features, Evaluation and Treatment Coronavirus (COVID-19) [Updated 2020 Mar 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554776/ <https://www.ncbi.nlm.nih. gov/books/NBK554776/

CONMED makes no claims to the reduction in infection risk when using our products. ASM-EVAC1 and SEM-EVAC contain 0.01 μm ULPA filters; however, they are only effective in filtering the gas that is cycled through the system. Insufflation gases and surgical smoke that are not evacuated by the system cannot be filtered by the tube sets. At this time there is no product that can guarantee the 100% elimination for risk from aerosolization of biomaterials in laparoscopy.

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Our program can help every step of the way 9 Accredited Continuing Education Courses 9 Surgical Smoke Evacuation Article Library 9 Staff Competency Checklists 9 Clinical Needs Assessment 9 Equipment Audits 9 Proprietary Budgeting Tool Assistance 9 Product Gap Analysis 9 Smoke Evacuation Policy Development 9 Trial and Product Evaluation Support 9 Smoke-Free Posters 9 Compliance Monitors 9 Access to a Dedicated Team of Clinical Nurses

Visit myhealthyor.com or email ASCA@conmed.com for more information

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Understanding the Basics HEPA, ULPA and the Basics Behind Filtration iven the recent focus on evacuating and filtering surgical plume due to concerns of possible transmission of SARS-CoV-2, it is important to understand the basics behind some of the most common filtration standards. HEPA and ULPA are arguably two of the most common filter specifications being discussed today. Both specifications refer to the efficiency of the filter media’s ability to trap the particles that pass through them. To test filter efficiency, a liquid is aerosolized to a desired range of particle sizes which is then added to the air flowing at a certain flow rate across the filter media composed of microfibers. After a given period of testing, a test evaluates the number of particles that enter and exit the filter media. Filter efficiency is the ratio of the difference between the number particles that enter and exit the filter media to the number of particles that enter the filter media at a certain flow rate.

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HEPA stands for High Efficiency Particulate Air and is used to refer to a filter media that can trap 99.97% of particles that have the most penetrating particle size (MPPS) of 0.3 microns. ULPA stands for Ultra Low Particulate Air and is used to refer to a filter

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media that can trap 99.999% of particles that have the MPPS of 0.1 microns. While both HEPA and ULPA filter classifications specify a particle size of capture, this does not mean the filter is unable to filter particles smaller than that size. For both specifications, the defined size and efficiency are in regard to the MPPS. Aerosolized particles flowing through the filter media encounter three types of mechanisms: interception, collision and Brownian motion that are a function of particle size and air flow rate. Interception causes the particles to stick to the microfibers in the filter media when the flowing air carries the particles close enough to a microfiber to stick to it, collision happens due to the inertia of the particles particularly when the larger particles that are heavy to travel along the airstream they collide and stick to the microfibers and Brownian motion happens when the smaller particles get moved around in a zig-zag path and as a result the smaller particles stick to the microfibers. Balancing size and mass, there is an inflection point around which the microfibers in the HEPA and ULPA filters trap the smallest and the largest particles more effectively than the mid-size particles. This point of inflection or worst-case size that travels through the filter media is called as the MPPS. This happens to be 0.3 microns for the HEPA and 0.1 microns for the ULPA.

Filtration Basics: What Else You Need to Know • Filter Life: Another component of filter performance that is not to be overlooked is the usable service life of a given filter.

Overtime, the filter media collects the particulate it is designed to capture, and this eventually impacts the efficiency of the filter. When using filtering technologies in a clinical setting, it is important to understand the stated filter life of each system as the usage varies greatly from single use to several hours.

• Restricted Airflow: Airflow restriction is one the main reasons why an ULPA filter cannot be swapped in place of a HEPA filter. The key difference between HEPA and ULPA filter is the maximum airflow that it will allow to pass-through and the accompanying pressure drop. The ULPA filter in general is more restrictive in nature than the HEPA as it is denser. The denser media of the ULPA filter reduces airflow significantly for filters of the same dimensions.

• Capture vs. Filtration: Lastly, while it may seem obvious, filtration capabilities of a given system only apply to the gases or surgical plume that is captured. It is important that the evacuation system is placed appropriately relative to the source of plume generation. In open surgery, standards like the ISO 16571 standard provides guidance on capture and ISO 24953 provides guidance on filtration efficiencies for different types of filters. The standards advise that a system should capture 90% of plume created when placed within 2 inches of the source of plume. While no standards exist for laparoscopic surgical plume management, the potential for leakage or unfiltered suction devices should be considered. If the gas within a laparoscopic environment is not evacuated through a filtered pathway, it is not filtered, and precaution should be taken accordingly.

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Partnering with CONMED Rapid Change Management s with any change management initiative, implementing smoke evacuation policies and procedures can pose a unique set of challenges to providers. While healthcare facilities focus on managing the treatment of patients, triaging emergent procedures, and sourcing PPE, dedicating resources to focus on smoke evacuation policy and implementation may be challenging. To help overcome these barriers, CONMED has created the Clear The Air™ program to simplify the smokefree journey.

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Through this program, CONMED helps facilities navigate a proprietary step-by-step process to help achieve their “smoke-free” goals and incorporate smoke evacuation into their daily practice. The goal of the Clear the Air ™ program is to partner with facilities to understand their goals, identify practices to reduce exposure to surgiSPONSORED BY CONMED

cal smoke, and implement solutions in a seamless manner that does not disrupt the rhythm of surgery.

Educating Staff – Establishing the Why Educating staff members on the hazards and risks associated with exposure to surgical smoke plume can set the table for successful adoption of a smoke evacuation policy. CONMED provides accredited continuing education courses to support this effort, in addition to a surgical smoke evacuation article library.

Scoping the Initiative Identify types of procedures performed, what energy sources are used, and what smoke evacuation equipment is already in place to help evacuate smoke is critical step in the smokefree process. CONMED provides tools to help assess a facility’s smoke evacuation needs, performs on-site audits, and has developed a proprietary budgeting tool to help facilities asses the scope and cost of implementing smoke evacuation.

Smoke Evacuation Policy Development Implementing a smoke evacuation policy is critical to ensure adoption and compliance. CONMED has a team of clinical nurses on staff, as well as a team of key opinion leaders in the nursing community to support policy development.

Product Evaluation and Implementation Support A smooth implementation of smoke evacuation products requires coordination and focus. CONMED provides on-site support to ensure the staff can focus on the patient and clinical outcomes

Monitoring Policy Compliance Implementation is an important first step, but compliance with a policy is crucial to ensure smoke evacuation becomes the standard of care.

CONMED provides tools such as competency checklists and concurrent monitoring tools to help anchor smoke evacuation into the culture of the facility.

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COVID-19 and Minimally Invasive Surgery

By James Porter, MD he COVID-19 pandemic has had a profound impact on healthcare around the globe.

Healthcare workers on the front lines are directly exposed to patients afflicted with this disease and are at a significantly higher risk of contracting COVID-19 as the virus has demonstrated that it is highly contagious.

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One important consequence of the pandemic has been the decrease in surgical procedures with most elective surgeries being postponed. The reduction in surgical volume has impacted most hospitals systems, with

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some regional variation, and is based on concerns around patient exposure, availability of ICU beds and ventilators, and the risk of overwhelming the healthcare system. Despite these concerns, surgery has continued for patients in need of emergent treatment and, more recently, previous surgical restrictions have eased in some situations especially in patients needing surgery for the treatment of cancer.

A major concern during surgery on COVID-19 positive patients is the potential aerosolization of SARSCoV-2 in surgical plume when energybased technologies are used to dissect, cut, and coagulate surgical tissues.

While there is currently no definitive evidence that active SARS-CoV-2 can be aerosolized, previous studies have demonstrated that other viruses have been found in surgical plume. Based on this theoretical risk, some surgeons raised concern about the relative concentration of surgical plume generated during minimally invasive surgical (MIS) procedures as compared to open surgery and some went as far as to recommend against performing MIS procedures during the COVID-19 pandemic. Because the vast majority of abdominal MIS is performed with the assistance of CO2 insufflation, concerns about the pressurized release of abdominal gas during various points SPONSORED BY CONMED

A major concern during surgery on COVID-19 positive patients is the potential aerosolization of SARS-CoV-2 in surgical plume when energy-based technologies are used to dissect, cut, and coagulate surgical tissues.

in a procedure have come to the forefront of the discussion. Out of caution, many surgical societies and other entities have published statements, guidelines, and/or recommendations to surgical teams in an effort to address the concerns about the potential release of aerosolized SARS-CoV-2 during MIS. Below is an example of such guidance from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES): 1. Every effort should be made to limit exposure of the health care team to CO2 insufflation plume during MIS procedures.

2. During the procedure, all ports should remain closed and surgeons should avoid venting of CO2 during the procedure.

3. CO2 insufflation should be filtered through an filtration system to control release of surgical plume.

4. If movement of the insufflating port is required, the port should be closed prior to disconnecting the tubing and the new port should be closed until the insufflator tubing is connected. The insufflator should be “on” before the new port valve is opened to prevent gas from backflowing into the insufflator.

5. All pneumoperitonuem should be safely evacuated from the abdomen using a filtration device before closure, trocar removal, specimen extraction or conversion to open surgery.

6. During desufflation, all escaping SPONSORED BY CONMED

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CO2 gas and smoke should be captured with an filtration system and desufflation mode should be used on your insufflator if available.

If the insufflator being used does not have a desufflation feature, be sure to close the valve on the working port that is being used for insufflation before the flow of CO2 on the insufflator is turned off (even if there is an in-line filter in the tubing).

The patient should be flat and the least dependent port should be utilized for desufflation.

Specimens should be removed once all the CO2 gas and smoke is evacuated.

Surgical drains should be utilized only if absolutely necessary.

Suture closure devices that allow for leakage of insufflation should be avoided. The fascia should be closed after desufflation.

Hand-assisted surgery can lead to significant leakage of insufflated CO2 and smoke from ports and should be avoided. If used to remove larger specimens and protect the wound, it can be placed after desufflation. The specimen can then be removed and the closure performed.

Other methods of filtration have been suggested as an effective means of protection from SARS-CoV-2 transmission in surgery. These include N95 masks, Powered Air Purifying Respirators (PAPRs), and filters that are used intraoperatively to remove smoke and other particulates. Particulate filters

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are available from numerous manufactures and their filtration efficiencies vary from High-Efficiency Particulate Air (HEPA) filters, which have a minimum 99.97% efficiency rating for removing particles greater than or equal to 0.3 microns in diameter, to UltraLow Particulate Air (ULPA) filters, which can remove from a minimum of 99.999% of airborne particles with a minimum particle penetration size of 0.1 microns. As the SARS-CoV-2 virus is believed to have a diameter between 0.06 and .14 microns, most institutions have opted to implement ULPA filtration in an effort to mitigate viral transmission concerns. However, it should be stated that no filtration device should be viewed as 100% effective as pressurized gas can escape in numerous ways during MIS including but not limited to instrument insertion/withdrawal from trocars, specimen removal, desufflation, and cavity overpressurization. Guidance, like that provided by SAGES, may help to reduce unnecessary exposure of health care personnel to surgical plume and aerosolized particulates that are created during surgical procedures.

While there is ongoing research to determine whether the SARS-CoV-2 virus is aerosolizable in surgical plume, nothing definitive has yet been proven.

Therefore, it is best to proceed with caution and take necessary measures to protect surgical staff from possible exposure.

It is better to be safe than sorry – or sick.

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The Hazards of Surgical Smoke Beyond COVID-19 he COVID-19 pandemic has created numerous challenges for healthcare facilities as providers work to prioritize the surgical treatment of patients with the need to mitigate transmission risks to healthcare workers. One potential concern during surgery is the transmission of COVID-19 via aerosolization of viral particles. While data on COVID-19 aerosolization is limited, the transmission of biologic and viral material through surgical smoke generated from electrosurgery devices, lasers, and ultrasonic scalpels has been documented in the literature. Whole, intact virions have been isolated from smoke created by laser tissue ablation, and the virions ability to cause infection has been documented1. Researchers have identified HIV DNA2 and intact strands of HPV DNA3,4,5 in laser smoke. Another study found the presence of infectious viral genes, infectious viruses, and viable cells in surgical smoke6.

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The exposure risks associated with surgical smoke are not limited to aerosolization of viral particles. Surgical smoke also contains toxic gases and vapors which can be hazardous to the perioperative team, as well as to patients. Research has shown that surgical smoke contains 40 carcinogenic chemicals7. In fact, one study found the average amount of smoke generated during a day of surgery equated to the smoke produced from smoking 27 to 30 cigarettes8. Surgical smoke has also been shown to contain ultrafine particles ranging in size from 0.05 microns to larger than 25 microns9. The mean particle size found in surgical smoke is 0.22 microns, meaning these particles may enter the bronchioles and alveoli of the respiratory system10. A study by Kay Ball found that perioperative nurses

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experience 2x the incidence of some respiratory problems compared to the general population11.

In light of the evidence of the potential risk factors of exposure to surgical smoke, a number of nursing and surgical societies have provided guidance to healthcare facilities to evacuate and filter surgical smoke to ensure the safety of patients and healthcare providers. The Association of Perioperative Nurses recommends “the evacuation of all surgical smoke as it contains hazardous chemicals, ultrafine particles, viruses, bacteria, and cancer cells.”12 Similarly, the Society of American Gastrointestinal and Endoscopic Surgeons suggests suing a “smoke evacuation devices with a suction and filtration system” in addition to proper room filtration, ventilation, and appropriate PPE13. The AmeriSPONSORED BY CONMED

can College of Surgeons and the American Association of Gynecologic Laparoscopists provide similar guidance, stating “Use a smoke evacuator when electrocautery is used.”14 With strong guidance from these societies, more and more healthcare facilities are working to rapidly implement smoke evacuation policies into their daily practice.

References

7. Pierce J., Lacey S., Lippert J., Lopez R., Franke J. “Laser-generated air contaminants from medical laser applications: a stage o-of-the-science review of exposure characterization, health effects, and control. J Occup Environ Hyg. 2011; 8(7): 447-66.

8. Hill, D.S. et. al., (2012). Surgical Smoke- A health hazard in the operating theatre. A study to quantify exposure and a survey of smoke extractor systems in UK plastic surgery units. Journal of Plastic, Reconstructive, and Aesthetic Surgery. doi:10.1016/j.bjps.2012.02.012.

1. Matchette LS, Vegella TJ, Faaland RW (1993) Viable bacteriophage

9. Mowbray N, Ansell J, Warren N, Wall P, Torkington J (2013) Is surgical

in CO2 laser plume: aerodynamic size distribution. Lasers Surg Med 13:

smoke harmful to theater staff? A systematic review. Surg Endosc 27 (9):

18–22

3100-3107.

2. Baggish M, Poiesz B, Joret D, Williamson P, Rebai A (1991) Presence of

10. Taravella MJ, Viega J, Luiszer F, Drexler J, Blackburn P et al. (2001)

human immunodeficiency virus DNA in laser smoke. Lasers Surg Med 11:

Respirable particles in the excimer laser plume. J Cataract Refract Surg

197–203

27 (4): 604-607

3. Garden JM, O’Banion K, Shelnutz L, et al. (1988) Papillomavirus is

11. Ball, K., (2010) Compliance With Surgical Smoke Evacuation Guide-

the vapor of carbon dioxide laser-treated verrucae. J Am Med Assoc 8:

lines: Implications for Practice. AORN Journal. https://doi.org/10.1016/j.

1199–2029

aorn.2010.06.002

4. Ferenczy A, Bergeron C, Richart RM(1990) Carbon dioxide laser energy

12. AORN (2020) COVID FAQs; https://www.aorn.org/guidelines/aorn-

disperses human papillomavirus deoxyribonucleic acid onto treatment

support/covid19-faqs

fields. Am J Obstet Gynecol 163: 1271–1274

13. SAGES (2020) RESOURCES FOR SMOKE & GAS EVACUATION DUR-

5. Kashima HK, Kessis T, Mounts P, Shah K (1991) Polymerase chain reaction

ING OPEN, LAPAROSCOPIC, AND ENDOSCOPIC PROCEDURES; https://

identification of human papillomavirus DNA in CO2 laser plume from recur-

www.sages.org/resources-smoke-gas-evacuation-during-open-laparo-

rent respiratory papillomatosis. Otalaryngol. Head Neck Surg 104: 191–195

scopic-endoscopic-procedures/

6. Burns PA, Jack A, Neilson F, Haddow S, Balmain A (1991) Transformation

14. ACS (2020) COVID-19: Considerations for Optimum Surgeon Protec-

of mouse skin endothelial cells in vivo by direct application of plasmid DNA

tion Before, During, and After Operation; https://www.facs.org/covid-19/

encoding the human T24 H-ras oncogene. Oncogene 6: 1973–1978

clinical-guidance/surgeon-protection

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