LIMERICK, Pa.--(BUSINESS WIRE)--Apr. 11, 2013--
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical
devices for critical care and surgery, has announced that its Anesthesia
and Respiratory business unit received 510(k) clearance1 for
the ISO-Gard® Mask with ClearAir™ Technology, the Company’s
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 nurse’s 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.2
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.2
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.3 “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.”
“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
The ISO-Gard Mask with ClearAir Technology is a featured addition to the
Teleflex line of Hudson RCI® respiratory products. “This
unique device exemplifies Teleflex’s commitment to provide solutions
that enhance provider safety,” said Vance. Learn more at iso-gardmask.com.
About Teleflex Incorporated
Teleflex is a leading global provider of specialty medical devices for a
range of procedures in critical care and surgery. Our mission is to
provide solutions that enable healthcare providers to improve outcomes
and enhance patient and provider safety. Headquartered in Limerick, PA,
Teleflex employs approximately 11,600 people worldwide and serves
healthcare providers in more than 140 countries. Additional information
about Teleflex can be obtained from the company’s website at teleflex.com.
About Dr. James D. McGlothlin
JAMES D. McGLOTHLIN is an Associate Professor of Health Sciences in the
College of Health and Human Sciences at Purdue University. Dr.
McGlothlin’s research specializes in ergonomics, exposure assessment
(focusing on Video Exposure Monitoring), occupational hygiene,
engineering controls, and epidemiology. He has been conducting research
in the areas of molecular diagnostics and molecular epidemiology, and is
the Director of www.MolecularHub.org,
a portal dedicated to advancing the science of molecular diagnostics. He
is the Director of the Graduate Program in Occupational and
Environmental Sciences, and Co-Director of the Center for Virtual
Reality of Healthcare Center Design at Purdue University. He is one of
the founders for the Regenstrief Center for Healthcare Engineering
(RCHE). He served on the University Senate and on the Senate Advisory
Committee to President Cordova and Provost Sands. Also, he has served on
the Education Policy Committee as a member and as the chair. Prior to
Dr. McGlothlin’s appointment to Purdue UniversityJanuary 4, 1999 he was
a senior researcher in ergonomics and occupational hygiene engineering
controls with the Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health (CDC/NIOSH).
Forward-Looking Statements
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management’s current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. These risks and
uncertainties are identified and described in more detail in our filings
with the Securities and Exchange Commission, including our Annual Report
on Form 10-K.
Teleflex, ClearAir, Hudson RCI and ISO-Gard and are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates.
© 2013 Teleflex Incorporated. All rights reserved. 2013-1769.
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References:
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1.
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FDA 510(k) number K123176 – February 14, 2013
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2.
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Inpatient Surgery data. Centers for Disease Control and
Prevention. http://www.cdc.gov/nchs/fastats/insurg.htm.
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Updated May 16, 2012. Accessed February 13, 2013.
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Data purchased from IMS Institute for Healthcare Informatics on file
at Teleflex.
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Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR,
Berry WR, Gawande AA. An estimation of the global volume of
surgery:
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a modelling strategy based on available data. Lancet.
2008 Jul 12;372(9633):139-44. doi: 10.1016/S0140-6736(08)60878-8.
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http://www.ncbi.nlm.nih.gov/pubmed/18582931
Accessed February 13, 2013.
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WHO Guidelines for Safe Surgery. WHO/IER/PSP/2008.08-1E http://gawande.com/documents/WHOGuidelinesforSafeSurgery.pdf.
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Accessed February 13, 2013.
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3.
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Occupational Safety and Health Administration, Anesthetic Gases:
Guidelines for Workplace Exposures.
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http://www.osha.gov/dts/osta/anestheticgases/index.html.
Accessed February 13, 2013.
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4.
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Study was funded by a grant from Teleflex. Study has not been peer
reviewed or published. IRB study was not an outcome study to support
an FDA submission. Sample size was not statistically significant.
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5.
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Waste Anesthetic Gases–Occupational Hazards in Hospitals. Centers
for Disease Control and Prevention.
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http://www.cdc.gov/niosh/docs/2007-151
Accessed February 13, 2013.
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Source: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836