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FDA DRAFT ANESTHESIA APPARATUS CHECKOUT RECOMMENDATIONS

This article was originally published in The Gray Sheet

Executive Summary

FDA DRAFT ANESTHESIA APPARATUS CHECKOUT RECOMMENDATIONS conflict with instruction manuals for anesthesia devices manufactured by North American Drager, the company says in recent comments to the agency. NAD emphasizes that it supports FDA's efforts to modify its 1986 guidelines for use of anesthesia apparatus; however, the firm maintains that a leak test suggested for low pressure systems "drastically conflicts with the test outlined in NAD's instruction manuals" and therefore would be confusing to its customers. NAD also says that the guideline's leak check for breathing systems "is not appropriate for some NAD anesthesia machines with minimum flow capabilities." The company explains that "minimum flow can mask the ability of this test to detect a leak." NAD suggests that both leak assessments be removed from the FDA document and replaced with alternative methods outlined in the company's letter. The 14-step draft recommendations, made available through an Oct. 6 Federal Register notice, are revisions to an August 1986 document that is designed to serve as "a generic checklist for use by anesthesia professionals to check out anesthesia equipment before use." According to the notice, FDA decided to revise the recommendations because "changes have occurred in both anesthesia equipment and the practice of anesthesia which have caused FDA to reexamine the checklist." The agency says its objectives in modifying the document include streamlining the checklist, increasing the clarity of language, modifying "certain steps to facilitate a more thorough and complete execution," and developing "an educational initiative to improve effectiveness by encouraging daily use of the recommendations and understanding of the equipment." NAD is one of several organizations to submit comments on the draft before the close of the comment period on Feb. 16. For example, the University of Florida College of Medicine says that it trained its beginning anesthesia residents to check equipment using the agency's protocol and submitted suggestions for the document based on the residents' difficulties. The university's recommendations include clarifying the step involving assurance of "proper scavenging connections and waste gas vacuum" because "beginning residents had trouble remembering" what this step would involve. The university suggests this recommendation should be divided into two steps: first, users should be advised to ensure "proper scavenging connection between APL valve and scavenging system, and between ventilator relief valve and scavenging system," and then they should be directed to "adjust waste gas vacuum." The University of Wisconsin Hospital and Clinics note two minor discrepancies between the recommendations and instruction manuals for machines manufactured by the firm Ohmeda. In addition, the organization says that "a test of the low O[2] on the oxygen analyzer" was eliminated in the new checklist. "A proper functioning low FiO[2] alarm is critical to patient safety," the university asserts. Among other organizations to submit comments were the American Society of Anesthesiologists, the Hospital for Sick Children in Toronto, Ontario, the Canadian Anesthetists Society and the American Association of Nurse Anesthetists.
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