February 2000

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Revised ASTM Standard Offers Solid Endoscope Reprocessing Protocol to GI Community
TO BRING uniform, common terminology and procedures to all communities working in the design, manufacture, and use of flexible gastrointestinal (GI) endoscopes, a task force of Committee F04 on Medical and Surgical Materials and Devices drafted revisions to Standard F 1518, Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera.

Used to diagnose and treat disease, GI scopes are intricate re-usable medical devices with unique specifications, nomenclature, interior design, function and components. In the task force's revision, a standardized reprocessing protocol is followed after each examination to ensure safe re-use.

“The clinical community is referencing this as the standard to be used for developing their standard reprocessing protocol in the clinical setting. SGNA [Society for Gastroenterology Nurses and Associates] has referenced ASTM standards in their guidance documents,” says Claire Dernbach, R.N., a consultant specializing in gastroenterology who chairs the task force.

“There have been a number of documented patient events as a result of inadequate reprocessing of endoscopes,” she continues. “It has been proven that if a standardized reprocessing protocol is followed—in conjunction with an appropriate chemical agent used according to the manufacturer's guidelines—that a scope will be safe for patient use.”

Originally developed in 1994, ASTM F 1518 covers flexible fiberoptic and video endoscopes that are fully immersible in liquid, as well as specialized endoscopes that may not be fully immersible, which are used to examine the hollow viscera (intestine, colon, and other cavities). Generally referred to as flexible gastrointestinal endoscopes, these semi-critical medical devices come in contact with mucous membranes of immunocompetent and immunocompromised individuals.

Revised under the jurisdiction of Subcommittee F04.35 on G.I. Endoscopes, F 1518 now includes sections on drying and storage, and the establishment of uniform, common terminology for manufacturers and users of GI endoscopes.

“Drying is the absolute critical final step in re-processing an endoscope, particularly when filtered water is not used in the process,” explains Dernbach. “Standard tap water contains micro-organisms, in particular pseudomonas that, given an opportunity to grow, will. The scope must be both internally and externally dry before it is stored. Even when filtered water is used, if the scope is not thoroughly dried, bacteria could have an opportunity to grow in the warm, dark, moist environment of the internal channels of the scope, and could become clinically significant in a 24-hour period.”

Numerous terminology revisions were incorporated to mesh with U.S. Food and Drug Administration and international terms. A credible cross-section of industry devised the F 1518 revision. Working on the task force were practicing nurses who are members of SGNA, GI medical doctors, scope and accessory manufacturers, microbiologists, and representatives of the APIC (Association for Practitioners in Infection Control), and FDA.

For further technical information, contact Claire Dernbach, R.N., 1204 Red Oak St., Fort Collins, CO 80525 (970/204-1783). Committee F04 meets May 24-26 in Toronto, Ontario, Canada. For meeting or membership information, contact F-4 Staff Manager Teresa Cendrowska, ASTM (610/832-9718).