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Scope

1.1 This practice covers reusable, heat-stable endoscopic accessory instruments (EAI) designed to be inserted into flexible endoscopes and clearly defined in the user instructions as devices intended for reuse among patients. The EAIs covered by this practice may or may not have lumens or loosely joined surfaces, may or may not have access ports for flushing, and may or may not be capable of being completely disassembled prior to reprocessing.

1.2 This practice is not intended to be applied to the reprocessing of single-use, disposable EAIs specifically designed and labeled as such by their manufacturers.

1.3 This practice is not intended to address reprocessing of heat-sensitive EAIs, for example, those not capable of withstanding heat sterilization. Reprocessing of each heat-sensitive EAI must be considered on an individual basis according to specific instructions from the manufacturers of the EAI and the low-temperature sterilization device.

1.4 This practice is intended to complement, not replace, the instructions provided by product manufacturers. EAI manufacturers should provide properly validated instruction and labeling necessary for users to understand the basic design, specifications, nomenclature, and components of specific accessories and to properly inspect, prepare, use, reprocess, and store these instruments.

1.5 Endoscopic technique and the medical aspects of endoscopy are not covered in this practice.

1.6 This practice details the basic steps necessary to reprocess a heat-stable EAI and render it patient-ready.

1.7 A patient-ready EAI is one that has been thoroughly cleaned using a validated cleaning procedure, rinsed with water to remove residual detergent, lubricated (if necessary) and drained to remove excess lubricant, dried, packaged, heat sterilized and stored to prevent from being compromised sterility before use.

1.8 This practice describes only manual reprocessing and does not address cleaning of an EAI by an automated reprocessing device.

1.9 To ensure the proper adherence to this practice, reprocessing personnel should meet certain requirements as specified in to .

1.10 This practice does not address the steps necessary for the reprocessing of flexible endoscopes (see Practice F 1518).

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

Keywords

cleaning; endoscopic accessory instrument (EAI); flexible endoscope; heat stable instrument; heat sterilization; reprocessing; reusable; ultrasonic cleaning; ICS Number Code 11.040.30 (Surgical instruments and materials)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.30 (Surgical instruments and materials Including surgical dressings, sutures, etc.)

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