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Standard for Surgical Devices that Open Airways During Anesthesia

The word “supraglottic” means “above the larynx.” ASTM Committee F29 on Anesthetic and Respiratory Equipment proposes to bolster patient safety by establishing standard requirements for devices that open airways in supraglottic areas of the throat during surgery. The committee invites producers and users of these devices, members of U.S. TAG to ISO TC 121, and others to develop a “Standard for Supraglottic Airways.” The standard will provide essential requirements for the safe use of devices that open, secure, and seal the supraglottic area typically during anesthetic administration, providing unobstructed airways in spontaneously breathing or ventilated patients.

A committee task group will draft the standard as an informational review of current literature and best practices with examples of known device design and construction. It will describe general essential requirements with a suggested risk assessment, and specific design attributes when required in the risk assessment.

“A review of the FDA CDRH MAUDE (Manufacturer and User Facility Device Experience) Database revealed 529 reports of adverse events involving supraglottic airway-like medical devices,” says committee chairman Julian M. Goldman M.D., Massachusetts General Hospital, Boston.

Examples of supraglottic devices are laryngeal-mask airways, cuffed-oropharyngeal airways, pharyngeal airways, laryngeal airways and seals, and glottic/laryngeal airways and seals not regulated by other tracheal or tracheostomy tubes, oral/nasal airway, laryngoscope, or anesthesia-mask standards.

“The subcommittee estimates that 'supraglottic airways’ are used in 10-20 percent of masked-anesthesia cases worldwide,” says Goldman. The standard will also cover devices that provide a breathing airway and guide the insertion of tracheal tubes, bronchoscopes, and suction devices.

According to Dr. Goldman, the committee gathered adverse effects associated with the use of supraglottic-airway medical devices from user-facility reports since 1991, all voluntary reports since June 1993 and distributor reports since 1993, and manufacturer reports since August 1996. Citations described both favorable and unfavorable aspects of device design and use.

The task group proposes to standardize aspects of terminology, design, production, manufacturing, testing, labeling, and promotion. Devices produced according to the ASTM standard will:

• Facilitate unobstructed access of respiratory gases to glottic inlet by displacing tissue;
• Not require an (external) facial seal to maintain airway patency;
• Terminate in a 15/22 mm connector to facilitate positive pressure ventilation via an anesthetic breathing system;
• Be capable of maintaining airway patency when the (15/22 mm) airway connector is open to ambient atmosphere; and
• Minimize escape of airway gases to ambient.

Direct technical questions to Julian M. Goldman M.D., Department of Anesthesia, Massachusetts General Hospital, Boston (phone: 617/724-2372). Committee F29 meets Dec. 2-6 in W. Conshohocken, Pa. For meeting or membership details, contact Steve Mawn, manager, ASTM Technical Committee Operations (phone: 610/832-9726). //

Copyright 2002, ASTM