Updated ASA Standard Requires Capnography During Procedural Sedation Cases

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Oridion heralds capnography monitoring requirement for procedures involving moderate or deep sedation

Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN), creator of the Smart Capnography™ family of decision support tools for the monitoring of effective ventilation, today heralded a standard from the American Society of Anesthesiologists (ASA) that requires capnography monitoring for procedures that involve moderate or deep sedation.
On July 1, the American Society of Anesthesiologists (ASA) updated the Basic Anesthetic Monitoring Standard, Section 3.2.4, which now reads: "During moderate or deep sedation, the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure or equipment."

Extending Capnography Beyond the Operating Room
“With this updated ASA standard, anesthesiologists are extending patient safety beyond the operating room and into procedural sedation areas,” said Gerry Feldman, president of Oridion Capnography Inc. “At Oridion, we are certain that this broadened application of capnography monitoring will indeed save even more lives.”
Capnography, the continuous monitoring of exhaled CO2 or etCO2, has long been a standard of care in the operating room. While other respiratory parameters are commonly used during procedural sedation, only capnography can properly measure adequacy of ventilation. The ASA defines a standard as those documents which “provide rules or minimum requirements for clinical practice. A standard is regarded as a generally accepted principle of patient management that may be modified only under unusual circumstances, e.g., extreme emergencies or unavailability of equipment.”

Standard Addresses Patient Risk During Procedural Sedation
The Basic Anesthetic Monitoring Standard addresses increasing concern over the risks associated with procedural sedation cases. An ASA analysis of the last twenty years of closed claims data reveals that cases outside of the operating room more frequently lead to severe patient injury and a higher proportion of patient deaths. The authors of the analysis concluded that 62% of these patient events could have been prevented with better monitoring.
These risks were further underscored in June when a Los Angeles-area ambulatory surgery center was ordered to pay USD 2.25 million in damages to a patient who suffered an anoxic brain injury during a routine eye procedure. According to court documents, the patient was administered sedatives, i.e., versed, fentanyl and propofol, and slipped into a deeper state of anesthesia than intended. The patient’s attorney successfully argued that over-sedation is a known risk that could have been detected with capnography monitoring.
“The ASA recognizes the significant risk of death or brain injury due to over-sedation,” said David Lain, Chief Clinical Officer at Oridion. “This standard further validates capnography as a standard of care for patient monitoring during procedural sedation.”

For further Oridion information please contact:

Investors, Analysts, Financial Media
Alan Adler, Chairman and Chief Executive Officer
Walter Tabachnik, Chief Financial Officer
Elena Gerberg, Investor Relations

e-mail                 investor(at)oridion(dot)com
website                 http://www.oridion.com
phone                    +972 2 589 9159

Trade Media, Customers
Greg Spratt, Director of Clinical Marketing
e-mail: greg.spratt(at)oridion(dot)com
Marla Marom, Director of Marketing Communications
e-mail: marla.marom(at)oridion(dot)com

About Oridion
Oridion Systems Ltd. (http://www.oridion.com) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in the United States and Israel.

Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream® technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide (CO2) in a patient’s breath. These products provide effective and proven airway management and are used in various clinical environments, including procedural sedation, pain management, critical care units, post-anesthesia care units, emergency medical services, transport, alternate care and other settings where patients’ ventilation may be compromised and at risk.

Certain statements made herein that are not historical are forward-looking. The words "estimate" "project" "intend" "expect" "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, our ability to maintain profits, the market demands for our Capnography products, our ability to focus our team on the Capnography business, changes in general economic and business conditions, inability to maintain market acceptance to the Company's products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for the Company's products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company's proprietary technology. The Company does not assure any obligation to update the forward looking information contained in this press release.    

1 ASA Standards for Basic Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Delegates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011) - Viewed 3-21-11 at http://www.asahq.org/For-Members/Clinical-Information/Standards-Guidelines-and-Statements.aspx

2 Standards Guidelines and Statements – Viewed 3-21-11 at http://www.asahq.org/For-Members/Clinical-Information/Standards-Guidelines-and-Statements.aspx

3 Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations: the US closed claims analysis. Current Opinion in Anesthesiology. 2009. 22:502–508

4 Tsikitas, Irene. ASC Found Negligent, Must Pay $2.25 Million for Eye Surgery Patient’s Brain Injury. Outpatient Surgery Magazine – Viewed 7-12-11 at http://www.outpatientsurgery.net/news/2011/06/27-ASC-Found-Negligent-Must-Pay-2-25M-for-Eye-Surgery-Patient-s-Brain-Injury


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Dean Ouellette