Teleflex Receives FDA 510(k) Clearance for ISO-Gard Mask with ClearAir Technology


Teleflex Incorporated announces that its anesthesia and respiratory business unit received 510(k) clearance for the ISO-Gard® Mask with ClearAir Technology, the companys novel product that helps to reduce clinician exposure to hazardous waste anesthetic gases.

The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG) within a nurses breathing zone to minimize the cumulative effect of low-level exposure to these hazardous gases in the post-anesthesia care unit (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.

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 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 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.

 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, says James D. McGlothlin, MPH, PhD, CPE. 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.

The ISO-Gard Mask with ClearAir Technology is a featured addition to the Teleflex line of Hudson RCI® respiratory products.

Source: Teleflex Incorporated

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