FDA Clears Teleflex ISO-Gard® Mask, Reducing Caregiver Exposure To Exhaled Hazardous Gases

In short

Critical care device company Teleflex Inc, has announced that its Anesthesia and Respiratory business unit has received FDA 510(k) clearance for its ISO-Gard® Mask with ClearAir™ Technology. The company says this novel product helps to reduce clinician exposure to hazardous waste anesthetic gases.


Teleflex estimates that anesthetic gases are used in 20 million surgeries in the US annually and up to 100 million globally. When patients are recovering in the Post Anesthesia Care Unit (PACU), they exhale these gases which are then released into the nurses’ breathing zone and work environment. The Occupational Safety and Health Administration (OSHA) warns of several potential health effects from WAG exposure, including nausea, dizziness, headaches, and fatigue.

The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG) within a nurse’s breathing zone to minimize the cumulative effect of low-level exposure to these hazardous gases in the PACU. The multi-purpose mask scavenges WAG while simultaneously delivering oxygen to the patient. The patent-pending ClearAir technology provides unidirectional flow of oxygen through the mask to assure maximum FiO2.

The PACU is currently a non-scavenged environment so other less-effective methods of waste gas removal are often relied upon, making it more difficult to control clinician exposure.

Physician comments

“I was surprised at the level of nitrous oxide and sevoflurane in the PACU from patient off-gassing from a recent study we conducted in a hospital in the Midwest,” said James D. McGlothlin, MPH, Ph.D., CPE.4 “Based on what I personally experienced during this study, I believe that waste anesthetic gases should be controlled in the PACU by a combination of engineering controls (i.e., scavenging systems), including regular maintenance of such equipment, and best practices by those who care for patients in the PACU.”

Company comments

“As the only available solution for ‘source control’ of WAG in the PACU, the ISO-Gard Mask with ClearAir Technology is a simple, safe, and effective solution to a pressing need,” said Cary Vance, President, Anesthesia and Respiratory Division. “By providing a means to reduce the amount of WAG within the breathing zone of the caregiver, hospitals can better comply with OSHA and NIOSH recommendations for workplace safety.”3,5

Source: Teleflex, Inc., Business Wire