28 Dec It’s time for the surgical smoke evacuation industry to come out of the ether!
We all recognize that trace gases within the plume can be both carcinogenic and/or mutagenic1 but can their removal continue to be the primary reason for use of LEV’s in surgical suites? We also admit that the capture of nanoparticles that comprise 80% of the smoke2 can, after chronic inhalation, result in serious systemic illnesses3 and create a huge potential number of workman compensation claims for healthcare systems to manage. Now, however, there is an even greater reason to achieve “effective” smoke capture that needs focus and clarity as related to its potential effect on post-operative infection rates. Such infections, referred to as SSI’s or surgical site Infections, occur in 157,500 patients/year at an annual cost of $3-10 billion, not including the misery and potential for death (3%) that they cause.4 It is therefore important that evidence that supports a reduction in such infections be evaluated with an eye to answering the question, “Can effective bioaerosol capture be considered an adjunctive method of infection control?”
As a company, Nascent Surgical believes its technology helps to answer that question so I ask the reader to consider the following facts:
- In 2013, the University of Minnesota’s Particle Calibration Laboratory reported that our company’s miniSQUAIR® has a smoke capture efficiency of 98-99%.5
- ISO 16571, published in 2014, Section 4.3 stated that any plume evacuation system “…when used in accordance with the manufacturer’s instructions, the efficiency of plume removed (from the O.R.) shall be at least 90%. Evidence shall be provided by the manufacturer.”6 We now have a standard for what could be defined as “effective smoke capture efficiency.”
- An article published in the AORN Journal in 2015 described a bacteriology study that proved that clinical electrocautery can release viable bacteria into the plume.7 For the first time, the possible effect this might have on post-operative wound infection rates was discussed by the author.
- Dowe and others from the Hospital for Special Surgery in New York City, at the 18th annual ISASS conference, reported the presence of occult bacteria in tissue prior to use of electrocautery in spinal fusion.8
- At the same meeting, a poster presented by Drs. Kim and Schultz reported decreased post-operative infection rates in posterior spinal fusion cases when the miniSquair® bioaerosol capture device was used in conjunction with standard spinal surgical protocols.9
- The University of Massachusetts Medical School reported, in 2018, for the first time in a peer-reviewed journal, the results of effective smoke capture on posterior spinal fusion SSI rates using the miniSQUAIR®.10
- In 2019, spine surgeons at Stanford University Hospital reported the use of the miniSQUAIR® and the ESU “pencil;” both used for reduction of particulate counts in the area of open spinal wounds. The open cell foam device reduced particulate counts to a significantly greater degree when compared to the “pencil.”11 Particulates have often been equated with “contaminants” as occur in the area of open surgical wounds.12
- In 2020, a multicenter ENT study in which mechanical devices were used for nasal procedures, found that effective aerosol capture was possible, significantly so, when the miniSQUAIR® was used vs. an aspiration tube.13
- Just recently, a cooperative study from Stanford and Peking University Hospitals published in the journal, “Spine,” reported the presence of viable bacteria in aerosols following electrocautery of meat.14
From the above data, it is clear that bacteria are aerosolized following use of electrosurgery. Further, the data, both laboratory and clinical, show that bioaerosol capture systems can favorably affect surgical outcomes. It does appear that smoke (bioaerosol) capture is about to be designated as an adjunctive infection control device. As we approach an expansion of state-based mandates for plume removal in the O.R. and the reality of available high efficiency bioaerosol capture devices, the surgical team and health system administrators can now justify compliance by all physicians….let’s hope that they do!
- Dept. of Health Services (DHHS) National Institute for Occupational Safety and Health (NIOSH). Publication No. 96-128 (Hazard Control 11), March 2, 1998.
- Ball K. Compliance with smoke evacuation guidelines: implications for practices. AORN J. 2010; 92(2): 142-149.
- Buzea C, Pacheco II, Robbie K. Nanomaterials and nanoparticles: sources and toxicity. Biointerphases 2007; 2(4): MR17-MR71.
- Accessed 23Dec.2021 @ vdh.virginia.gov/epidemiology/surgicalsiteinfections/
- Olson B, Mgr., Particle Calibration Laboratory, Dept. of Mechanical Engineering, University of Minnesota. December 2, 2013.
- ISO 16571:2014. “Systems for Evacuation of Plume Generated by Medical Devices.” Published March 15, 2014, Publisher ISO, Geneva, Switzerland.
- Schultz L. Can efficient smoke evacuation limit aerosolization of bacteria? AORN J. 2015; 102(1): 7-14.
- Dowe C, Brecevich A, Callahan T, Lebl D, Commisa F, Abjornson C. The Prevalence of Occult Bacteria in Patients Undergoing Primary Spine Surgery. Abstract. 18th Annual ISASS meeting, April 11-13, 2018. Toronto, Canada, p.35.
- Kim S, Schultz L. Can Capture of Surgical Smoke Decrease Post-Operative Infection Rates (SSI)? Preliminary Report. Poster # 311. Presented at the 18th Annual ISASS meeting, April 11-13, 2018. Toronto, Canada.
- Krueger S, Disegna S, DiPaola C. The effect of a surgical smoke evacuation system on surgical site infections of the spine. Clin. Microbiol & Infect. Dis. 2018; 3(1): 1-5.
- Liu N, Filipp N, Wood KB. The Utility of Local Smoke Evacuation in Reducing Surgical Smoke Exposure to Spine Surgery; A Prospective Self-Controlled Study. 2020; Spine J. 20(2): 166-173.
- Landrin A, Bissery A, Kac G. Monitoring air sampling in operating theatres: can particle counting replace microbiological sampling? J. Hosp. Infect. 2005; 61(2): 27-29.
- Sharma D, Ye M, Campiti V, Rubel KE, Higgins TS, Wu AW,…Ting JY. Mitigation of Aerosols Generated During Rhinologic Surgery: A Pandemic-Era Cadaveric Simulation. Otolaryngol Head Neck Surg. 2021; 164(2): 433-442.
- Zhenqi Z, Ning L, Weiwei X, Haiying L, Wood, KB, Wang K. Bacteria in Surgical Smoke: A Self-Controlled Laboratory Study Using Porcine Spinal Tissues. 2021; Spine J. 46(23): E1230-E 1237.