Since the outbreak of COVID-19, Medtronic continues to coordinate with our customers, employees and relevant public health authorities to better understand any emerging issues and ensure that appropriate guidelines and best practices are being followed. Our priority is the safety and wellbeing of our employees, our customers, the patients who rely on our products and the resilience of our shared communities.
Societies from across the world, including the Society of American Gastrointestinal Endoscopic Surgeons (SAGES)([FOOTNOTE=SAGES recommendations regarding surgical response to COVID-19 crisis. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Website. https://www.sages.org/recommendations-surgical-response-covid-19/ . Accessed March 27, 2020],[ANCHOR=],[LINK=]), the American College of Surgeons (ACS)([FOOTNOTE=Frequently Asked Questions. American College of Surgeons (ACS) Website. https://www.facs.org/covid-19/faqs. Accessed March 27, 2020],[ANCHOR=],[LINK=]) and Intercollegiate General Surgery([FOOTNOTE=Intercollegiate General Surgery Guidance on COVID-19. Association of Upper Gastrointestinal Surgeons (AUGIS) Website. https://www.augis.org/wp-content/uploads/2020/03/intercollegiate-surg-guidance-COVID-19-infographic2.pdf. Accessed March 27, 2020],[ANCHOR=],[LINK=]) (UK) have published recommendations on how to operate in the Surgical Theatre with COVID-19 infected patients. These societies are recommending that healthcare providers use smoke evacuation devices in open and laparoscopic procedures in addition to ensuring that proper Personal Protective Equipment (PPE) is used.
Open and Laparoscopic: The RapidVac™ smoke evacuator (SE3690/SE3695) is equipped with ultra-low particulate air (ULPA) filtration technology. It is used in combination with an ULPA filter (SEA3700) and handheld smoke removal pencils/tubing.
Laparoscopic: The Valleylab™ laparoscopic smoke evacuation system (SEL7000A) with in-line ULPA filtration is a standalone device that connects directly to suction and effectively and efficiently removes surgical smoke from laparoscopic procedures.¹
In all surgical procedures, including those involving a patient with suspected or confirmed COVID-19, Medtronic recommends the continued use of these products in accordance with its labeling. The viability of virus particles once captured in Medtronic ULPA filters is unknown; therefore, filter disposal techniques should always assume contamination and hospital staff should follow hospital safe disposal protocols.
For the RapidVac™ smoke evacuator the design of this device prevents airflow in the incorrect direction (equipment to patient) and therefore reduces the risk of cross-contamination. As a result, the filter may be used until it has reached the end of its life as indicated on the device, at which point it should be replaced.
For the Valleylab™ laparoscopic smoke evacuation system, this device is single patient use and should be discarded after each procedure or replaced after 4 hours of continuous use.
For the RapidVac™ smoke evacuator after passing through the four stage ULPA system, filtered air is returned to the room.
For the Valleylab™ laparoscopic smoke evacuation system this system is connected to suction, and filtered air is not returned into the operating room.
The Sonicision™ device, like other ultrasonic dissection devices, produces surgical plume (mist) caused by the mechanical oscillation of the active blade against tissue. LigaSure™ devices produce steam caused by the heating of molecules between the jaws of the instrument.
In laparoscopic surgery, this plume/steam can be removed through laparoscopic smoke evacuation either with the Valleylab™ laparoscopic smoke evacuation system or the RapidVac™ smoke evacuator with smoke lap tubing.
In open surgery, this plume/steam can be removed using the RapidVac™ smoke evacuator and RapidVac™ smoke tubing by holding this tubing near the surgical site.
No, and for that reason, proper Personal Protective Equipment (PPE) techniques should always be employed even when using surgical smoke evacuation.
Open Surgery: Smoke evacuation pencils and open smoke tubing only filter particulate that is captured by the device, meaning that some particulate will dissipate into the operating room even though the vast majority is captured and filtered.
Laparoscopic Surgery: While smoke capture in laparoscopic surgery is more efficient due to the closed nature of the system, some leakage will still occur. For example, trocars may leak CO2 and particulate into the operating room during instrument exchanges or trocar insertion/removal/venting.
The novel Coronavirus, COVID-19 is described as round or oval in shape, with a diameter within the range of 60-140nm and widely distributed in humans and other mammals.([FOOTNOTE=Wu J, Liu J, Zhao X, et al. Clinical characteristics of imported cases of COVID-19 in Jiangsu Province: A multicenter descriptive study. Clinical Infectious Diseases. 2020;ciaa199. https://doi.org/10.1093/cid/ciaa199],[ANCHOR=],[LINK=]),([FOOTNOTE=Shereen M, Khan S, Kazmi A, Bashir N, Siddique, R. COVID-19 infection: Origin, transmission, and characteristics of human coronaviruses. Journal of Advanced Research. https://doi.org/10.1016/j.jare.2020.03.005. 2020],[ANCHOR=],[LINK=]) Infected patients are presenting with varied symptoms across several organ systems, suggesting the virus is present in tissue outside of the respiratory system.([FOOTNOTE=Li Y-C, Bai W-Z, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020;1–4. https://doi.org/10.1002/jmv.25728],[ANCHOR=],[LINK=]),([FOOTNOTE= Rothan H, Siddappa B. The epidemiology and pathogenesis of coronavirus disease (COVID-19) Outbreak. Journal of Autoimmunity. https://doi.org/10.1016/j.jaut.2020.102433. 2020],[ANCHOR=],[LINK=])
The information related to this virus changes daily as more data is being collected, analyzed and reported. Regions highly impacted by this virus are sharing surgical recommendations, which include managing exposure to droplets, bodily fluids, surgical smoke and aerosols.([FOOTNOTE=Zheng M, Boni L, Fingerhut A. Minimally invasive surgery and the novel coronavirus outbreak: lessons learned in China and Italy, Annals of Surgery. 2020],[ANCHOR=],[LINK=])
Currently, there is no research or data on the transmission of the COVID-19 virus via surgical smoke([FOOTNOTE=COVID-19 FAQs. Association of Operative Registered Nurses (AORN) Website. https://www.aorn.org/guidelines/aorn-support/covid19-faqs. Accessed March 27,2020],[ANCHOR=],[LINK=]); however, other viruses are known to transmit through surgical smoke.([FOOTNOTE=Rioux M, Garland A, Webster D, Reardon E. HPV positive tonsillar cancer in two laser surgeons: case reports. J OtolaryngolHead Neck Surg. 2013;42:54],[ANCHOR=],[LINK=])
Medtronic has not conducted direct testing to evaluate the interaction of COVID-19 and surgical smoke evacuation products, and our clinical experts are not aware of external publications on this subject.
Medtronic smoke evacuation products utilize ULPA filtration, which is the standard in surgical particle filtration. Filters are rated to capture a wide range of particle sizes but typically have a stated particle size rating. The ULPA filter efficiency rating of 99.9995% is based on a 0.12μm particle size, but this is not a minimum size. ULPA filters can capture smaller and larger particles.([FOOTNOTE=Based on engineering report #RE0025744, Particle capture performance of ULPA filters vs. particle size],[ANCHOR=],[LINK=])
Despite this potential, there is no definitive evidence at this time to conclude that Medtronic smoke evacuation products are effective to prevent the transmission of the COVID-19 virus.
If the clinician determines it appropriate to use a Medtronic smoke evacuation product or any other Medtronic product during a surgical procedure involving a patient with suspected or confirmed COVID-19, Medtronic recommends they be used in accordance with their respective labeling.
The viability of virus particles once captured in Medtronic ULPA filters is unknown; therefore, proper filter disposal techniques should always assume contamination and hospital staff should follow hospital safe disposal protocols. While surgical smoke evacuation cannot capture smoke particles with 100% efficiency, this technology represents an effective tool in reducing exposure to the known hazards of surgical smoke and aerosols.([FOOTNOTE=AORN Guidelines for Perioperative Practice ed. 2017 Reference Collection WY 49A849 2017-03-27 14:25:16],[ANCHOR=],[LINK=])
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