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November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

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FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

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FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

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FDA Medwatch Alert 10-20-14

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ASA Offers Recommendations for Using SEDASYS®

Thursday, January 23, 2014

On January 22, 2014, ASA issued a guidance document with recommendations on sedation with regard to the integration of computer-assisted personalized sedation (CAPS) devices, including the SEDASYS® System, into medical practices in the safest and most efficient way.  The SEDASYS® System has been approved for use by the FDA in the delivery of the drug propofol to healthy adults undergoing sedation for upper (esophageal) and lower (colon) cancer screenings.

"As leaders in patient safety, physician anesthesiologists are eager to learn about developments in research and technology that may help advance the specialty," said ASA President Jane C. K. Fitch, M.D. "An important part of working with new technology, however, is investigating ways to ensure it is used safely. This document provides recommendations to physician anesthesiologists to ensure patient safety with the SEDASYS® System. Our goal with every patient is to make sure he or she receives the highest-quality care and optimal outcomes."

The ASA guidance document includes recommendations for practicing anesthesiologists and directors of anesthesia services who are in facilities that will incorporate the CAPS devices into their practices. Highlights of the recommendations are:

  • That directors of anesthesia service be familiar with the manufacturer’s recommendations and the FDA labeling information on the operation and safe use of the device.
  • That directors of anesthesia services revise their quality management program in procedural sedation to include data collection on all procedural sedation including these devices.  
  • That the Anesthesia Quality Institute has developed a guide to "Quality Management Metrics for Procedural Sedation" that directors of anesthesia services can use to create the recommended programs.
  • That, as the device labeling states, it should only be used in facilities where an anesthesia professional is immediately available to assist or consult as needed. "Immediate availability" could mean a code team or a rapid response team, which includes an anesthesia professional at a minimum.
  • As provided by the device labeling, that a member of the physician-led team be trained in the management of cardiorespiratory effects of propofol. The device labeling requires that the training must include pharmacology of propofol, identification of high-risk patients, recognition of the progression of sedation levels and actions needed to return a patient to the intended sedation level, use of capnometry and determination of adequate ventilation.

This document does not constitute an endorsement by ASA of the SEDASYS® System, nor does ASA make any assessment of, or representations regarding the safety of the SEDASYS® System.  This document is not intended to provide operating instructions for use of the SEDASYS® System, the operation of which must be consistent with manufacturer and governmental guidelines.

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