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Ethicon Supports Sages Guidelines for Surgery Amid Covid-19 Pandemic as Parts Of Country Begin to Resume Elective Surgery
As hospitals and surgeons around the country begin to resume elective surgeries postponed due to the COVID-19 pandemic, Ethicon*, part of the Johnson & Johnson Medical Device Companies**, and one of the world’s leading manufacturers of surgical devices, announced its continued support of guidelines from the Society for American Gastrointestinal and Endoscopic Surgeons (SAGES), which recommends the use of personal protective equipment (PPE) and smoke evacuation in the operating room during laparoscopic and open surgery.
Currently, there is no data on the transmission of SARS-COV-2 in surgical smoke during surgery.1 However, there is no indication or proof that SARS-COV-2 is not transmissible through surgical smoke.1 In fact, there is no conclusive evidence to indicate that use of electrosurgical or ultrasonic devices during surgery increases the risk of infectious disease transmission via surgical smoke.2 SAGES and AORN1 are providing recommendations to ensure the perioperative team takes measures to protect themselves from any potential unknown risk.1,3 Ethicon recommends the use of smoke evacuation to minimize the potential risk to surgical teams from potentially hazardous substances including cellular material, blood fragments, bacteria, viruses, toxic gases, vapors and chemical compounds4.
Each year, in America, approximately 500,000 OR personnel are exposed to surgical smoke5, with this number estimated to be double worldwide6. Surgical smoke can cause acute and chronic health effects ranging from eye, nose and throat irritation to emphysema, asthma and chronic bronchitis. 4,7
“We stand with the surgical and healthcare community during this unprecedented and challenging time,” said Raymond Fryrear, MD, VP & Integrated Leader, PreClinical, Clinical and Medical Affairs, Johnson & Johnson. “The safety and protection of hospital personnel and patients has always been our top priority. Our goal is that every hospital has access to smoke evacuation and energy products in an effort to make procedures safer for surgeons, nurses and the entire OR team.”
In early April, Ethicon released a letter to customers explaining its support of the SAGES surgical guidelines and describing the theoretical risk of COVID-19 transmission through surgical smoke. The company noted that COVID-19 particles range from 60-140 nanometers (nm) in diameter and generally disperse in the form of much larger water droplets. Smoke evacuators that use an ULPA filter, such as Ethicon’s MEGADYNE Smoke Evacuators, capture and filter at least 99.999954% of particulates and microorganisms sized 120nm. ULPA filter efficiency improves with particles both smaller and larger than the listed size rating (rating range of 100-200nm). 8
In addition to SAGES, smoke evacuation in the OR is recommended by industry associations including the Association of periOperative Registered Nurses (AORN),1 and the National Institute for Occupational Safety and Health (NIOSH).6
* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.
** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
1 AORN - COVID-19 FAQs [https://www.aorn.org/guidelines/aorn-support/covid19-faqs] Accessed 4/30/2020
2 Morris SN, et al. Understanding the "Scope" of the Problem: Why Laparoscopy is Considered Safe During the COVID-19 Pandemic. J Minim Invasive Gynecol. 2020 Apr 2. [Epub ahead of print]
3 SAGES Resources for Smoke & Gas Evacuation During Open, Laparoscopic, and Endoscopic Procedures [https://www.aorn.org/guidelines/aorn-support/covid19-faqs]. Accessed 4/30/2020.
4 Okoshi K, et al. Health risks associated with exposure to surgical smoke for surgeons and operation room personnel. Surg Today. 2015 Aug;45(8):957-65. Epub 2014 Nov 25.
5 OSHA – Laser Hazards [https://www.osha.gov/SLTC/laserhazards/]. Accessed 05/08/2020.
6 Memon AG, Naeem Z, Zaman A, Zahid F (2016) Occupational health related concerns among surgeons. Int J Health Sci 10 (2): 279-291.
7 CDC - NIOSH Study Finds Healthcare Workers' Exposure to Surgical Smoke Still Common [https://www.cdc.gov/niosh/updates/upd-11-03-15.html] Accessed: April 30, 2020
8 ISO – High efficiency filters and filter media for removing particles from air. Part 1: Classification, performance, testing and marking. ISO 29463-1. Second edition, 2017-09
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