Market Overview

Ready or Not, Surgical Smoke Regulation Is Here


Ready or Not, Surgical Smoke Regulation Is Here

Acuderm provides the solution with its patented smoke evacuator products

PR Newswire

MIAMI, July 31, 2018 /PRNewswire/ -- After years of fighting, California will lead the way to improve surgical room air quality, setting a precedent for other states. Adding a small suction device to surgical suites could clear the air for patients and healthcare staff alike, but movement is slow and largely unsupported with regulatory agencies.

Medical device companies, like Acuderm, haven't waited on legislation. They anticipated a need and invented a solution. "Where there is smoke," said Charles R. Yeh, CEO, of Acuderm, Inc. "there are forward thinkers, like those of us at Acuderm, and we saw a need more than 20 years ago, when we developed our first smoke evacuator.

"Currently, there are thousands of facilities across the globe using Acuderm's patented, state-of-the-art capture, collection and filtration technology to remove harmful particles, viruses and toxic gases from the air and providing safer workplaces in the process," Yeh continued.

Two years ago, California Bill No. 402 passed the state senate, requiring to be in place no later than June 1, 2019. Parameters for the regulation include compliance with general room ventilation standards, but according to California's Legislative Counsel's Digest, use of universal protection measures will not satisfy requirements for surgical plume protection. Instead, the law will dictate use of plume scavenging systems that meet minimum standards. Just this month, Rhode Island followed suit, passing a Bill that mandates compliance by April 1, 2019.

Since 1996, OSHA (Occupational Safety and Health Administration) has recommended smoke evacuators within two inches of a surgical site to capture airborne contaminates. OSHA's etool kit for surgical suites states that…

  • "Exposure to high concentrations of smoke may cause ocular and upper respiratory tract irritation and create visual problems for the perioperative team
  • "Smoke may contain toxic gases that could have the potential for adverse health impacts, such as mutagenic and carcinogenic impacts"

Similarly, AORN (Association of periOperative Registered Nurses) and NIOSH (National Institute of Occupational Safety and Health) both recommend the same combination of precautions, general room ventilation and local exhaust ventilation (LEV) or a smoke evacuator at the surgical site. Unlike other evacuator manufacturers, Acuderm's patented TX™ nozzle collects the industry's largest field of surgical smoke.


For more than 35 years, medical professionals have relied upon Acuderm to provide superior value, while maintaining superior quality standards. Patents: FDA (USA), ISO 13485 (International) and CMDCAS (Canada) certified, UL2601 compliant and maintains a CE mark in Europe.

Media Contact:
Debbie Corson
954-523-1957 x151

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