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«Making things clear around Surgical smoke Surgery without smoke Foreword Following the introduction of laser surgery in the mid 1980s, education and ...»

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• Sterile with double peel pouch packaging for presentation to the surgical field

• Ready-to-use: no assembly required

• Easy to connect to the trocar with no leakage at the connection

• Long lasting performance even when challenged with elevated levels of moisture in effluent gas from the pneumoperitoneum.

In addition to the above, connecting the filter to the central vacuum system will ensure a complete elimination of the hazards of surgical smoke, without risking contamination of the system itself.

Administrative Controls In addition to the equipment required for evacuating smoke, hospital policies and education and training programs for the health care professionals are of utmost importance to ensure that steps are actively taken to protect the personnel and the patients against surgical smoke[15].

Surgical Smoke:

An Increasing Concern Worldwide Back in the nineties, the USA and Northern Europe expressed an increasing concern about the hazardous effect of smoke caused by electrosurgery and laser surgery on the health of OR workers and patients. Nursing associations and national authorities have since developed recommendations to improve the working environment in that regard, though with widely varying results.

England The Control of Substances Hazardous to Health Regulations (COSHH - 2002) require that exposure to substances hazardous to health are adequately controlled to prevent occurrence of ill-health.

In a device bulletin from 2008, the MHRA (Medicines and Healthcare products Regulatory Agency) recommends that smoke evacuation systems are used during laser surgery. In addition it is specified that masks and OR evacuation systems are not suitable for protection from surgical smoke.

France In addition to a section of the Labor Code regarding evacuation of smoke from the workplace (R. 232-5-7), there are recommendations of the C. CLIN Paris-Nord and the French Society of Hospital Hygiene (SF2H) dating from 2000 and 2004, relating to the use of medical devices (scalpels, lasers) equipped with smoke evacuation, and the use of filters for exsufflation of the pneumoperitoneum during laparoscopic procedures.

Denmark In Denmark, the European directive concerning the minimum safety and health requirements for the workplace (89/654/EEC) is implemented as a regulation with specific provisions concerning the elimination of polluted air from any working place. Recirculation of filtered air is furthermore forbidden; a dispensation request addressed to the government regarding recirculation of filtered air during surgical procedures was even dismissed in 2002.

Canada In January 2009, a new standard was issued covering any type of smoke emitting surgery, requiring the use of a smoke evacuator (CSA 7305.13-09). The new regulation states that facility safety officers shall ensure that plume removal requirements are established, implemented, monitored for compliance, reviewed, and revised periodically.

USA There is no regulation requiring the elimination of surgical smoke in the USA. However the concern about the posed hazard is on the rise, under the effort of the AORN (American Association of Registered Operating Room Nurses). The most important official document is the Hazard Controls No. 11 issued by NIOSH (National Institute for Occupational Safety and Health), recommending evacuation and filtration of surgical smoke[13].

Australia The Australian College of Operating Room Nurses (ACORN) represents professional nurses across Australia. The organisation practice guidelines recommend the prevention of patients’ and healthcare personnel’s exposure to surgical smoke, by means of appropriate equipment and procedures.

Evacuation of Surgical Smoke:

An Area of Expertise for SafeAir SafeAir is dedicated to making the working environment safe for all present in the operating room, without impairing the effectiveness of the surgical procedure.

The product range includes devices that match the various requirements of electrosurgical


Smoke evacuation pencils The SafeAir Smoke Pencil products are singleuse electrosurgery pencils with fully integrated smoke aspiration and liquid suction functions. A slim design and no additional cable that can disturb the surgical act make this product the perfect pencil for safe electrosurgery.

Smoke evacuation units Combined with the SafeAir Smoke Pencil products, SafeAir smoke evacuation units form a very effective solution for evacuation of electrosurgical smoke. Synchronised to the pencil, the unit provides a silent, powerful aspiration flow and effective filtration of particles and odours.

Notes Notes Notes References 1. “Surgical Smoke, a concern for infection control practitioners”, Girolamo A. Ortolano, PhD, Joseph S. Cervia, MD, MBA, and Francis P. Canonica, PhD, Managing Infection Control, Auguct 2009, pages 48-54 2. ”The potential alveolar hazard of carbon dioxide laser-induced smoke”, Kunachak S, Sobhon P. J Med Assoc Thai. 1998, Apr;81(4):278-82.

3. “Surgical smoke and infection control” - Alp E, Biji D, Bleichrodt RP, Hansson A, Voss A. - J Hosp Infect. 2006; 62:1-5 4. “Analysis of Surgical Smoke Produced by Various Energy-Based Instruments and Effect on Laparoscopic Visibility” - Kyle J.

Weld, MD, Stephen Dryer, Caroline D. Ames, Kuk Cho, Chris Hogan, Myonghwa Lee, Pratim Biswas, and Jaime Landman, MD

- Journal of Endourology, March 2007, Volume 21, Number 3, pages 347-351 5. “The visualisation of surgical smoke produced by energy delivery devices: significance and effectiveness of evacuation systems.” - Tjeerd de Boorder, Rudolf Verdaasdonk, John Klaessens - Proc. of SPIE Vol. 6440, 2007, 6440R 6. “Chemical Composition of Smoke Produced by High-frequency Electrosurgery” - O. S. Al Sahaf, I. Vega-Carrascal, F. O.

Cunningham, J. P. McGrath & F. J. Bloomfield - Irish Journal of Medical Science, 2007 7. “Surgical smoke-a review of the literature” - Barrett WL, Garber SM - Business Briefing: Global Surgery. 2004; 1-7 8. “Peritonectomy with high voltage electrocautery generates higher levels of ultrafine smoke particles”, S.N. Andreasson, H. Anundi, B. Sahlberg, C.-G. Ericsson, R. Walinder, G. Enlund, L. Pahlman, H. Mahteme - European Journal of Surgical Oncology (EJSO), 2008 9. “The Hazards of Surgical Smoke”, Brenda C. Ulmer, AORN Journal, April 2008, Vol. 87, No 4 - Pages 721-738 10. “Randomized clinical trial of suction versus standard clearance of the diathermy plume”, S. H. Pillinger, L. Delbridge and D. R. Lewis, British Journal of Surgery 2003; 90: 1068–1071 11. “AORN Position Statement - Statement on Surgical Smoke and Bio-Aerosols”, approved by House of Delegates, Anaheim, CA. April 2008 12. “IFPN Guideline on Smoke Plume”, IFPN, 2009

13. Hazard control 11 (HC11) - NIOSH - Publication no. 96-128 - September 1996 14. “Laryngeal papillomatosis with human papillomavirus DNA contracted by a laser surgeon”, P. Hallmo and O. Naess, Eur Arch Otorhinolaryngol, 1991; 248: 425-427 15. “Surgical smoke evacuation guidelines - compliance among perioperative nurses”, PhD dissertation, Kay A. Ball, March 2009, Richmond Virginia (197 p.) 16. “Human immunodeficiency virus-1 (HIV-1) in the vapors of surgical power instruments.”, Johnson GK, Robinson WS., Journal of medical virology, 1991; 33: 47-50 17. “Current attitudes and practices towards diathermy smoke”, John Spearman, George Tsavellas, Paul Nichols, Annal Royal Coll Surg Engl 2007; 89: 162–165 18. “Operating room nursing and lung cancer risk in a cohort of female registered nurses”, Margaret A Gates, Diane Feskanich, Frank E Speizer, Susan E Hankinson, Scand J Work Environ Health 2007; 33(2):140–147 19. “Human Papillomavirus DNA in LEEP Plume”, Anil K. Sood, Zahra Bahrani-Mostafavi, Jay Stoerker and I. Keith Stone, Infect Dis in Obstet and Gynecol. 1994; 2(4): 167–170.

20. “Surgical Smoke”, J. Fan, F. Chan and K. Chu, Asian Journal of Surgery, 2009; Volume 32, Issue 4, Pages 253-257 21. “Mutagenicity of Smoke Condensates Induced by CO2 - Laser Irradiation and Electrocauterization”, Toshifumi Tomita, Shigenobu Mihashi, Kazuto Nagata, Setsuo Ueda, Masakazu Fujiki, Minoru Hirano, and Tomio Hirohata, Mutation Research, 1981, 89, 145-149

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