Definitions

For the purpose of this document, SGNA has adopted the following definitions:

Endoscopic Accessory Instruments are medical instruments designed for insertion into a flexible endoscope (ASTM, 2000). These are devices used during endoscopy other than the endoscope. These include, but are not limited to, biopsy forceps, snares, bite blocks, guide wires, irrigation tubes, and dilators. These devices may or may not have lumens, porous or loosely joined surfaces, or access ports for flushing; and may or may not be capable of being completely disassembled during reprocessing.

Critical Medical Devices are those instruments that may be introduced directly into the bloodstream or into other normally sterile areas of the body (ASTM, 2000). These devices break the mucus membrane and/or come into contact with sterile tissue or the vascular system.

Reprocessing refers to the sequence of cleaning, lubricating (if necessary), and sterilizing (ASTM, 2000) or high-level disinfecting steps that will assure and endoscopic accessory is patient-ready.

Reusable Device is an instrument designed and validated by the manufacturer to be used more than once, provided that after each use, an appropriate reprocessing protocol and functionality check is performed (ASTM, 2000).

Single Use Device, also referred to as a disposable device, is intended for one time use only, on one patient, during a single procedure. The manufacturer did not intend it to be reprocessed (cleaned, disinfected/sterilized) and/or used on another patient. The labeling may or may not identify the device as single use or disposable and does not include instructions for reprocessing (FDA, 2000).

Valves include the air/water valve, suction valve, and biopsy port cover to the flexible endoscope.

Background

Proper reprocessing of endoscopic accessories and valves is critical to the safe and successful treatment of patients. SGNA supports increased research in the areas of accessory and endoscope design in an effort to manufacture devices that can be easily disassembled, cleaned, high-level disinfected and/or sterilized.

The FDA requires the manufacturers of reusable devices to provide instructions for cleaning and high-level disinfection or sterilization.

Position

The Society of Gastroenterology Nurses and Associates, Inc. supports the following positions:

A. All accessories labeled as reusable are reprocessed according to manufacturer's instructions.

Accessories that are classified as critical medical devices require sterilization.

Critical items labeled for single-use should not be reprocessed and/or reused.

B. Following each use of the endoscope, valves must be removed, manually cleaned and high-level disinfected or sterilized according to the manufacturer's instruction. This must occur as part of the cleaning and disinfecting process for the endoscope.

When using an automated endoscope reprocessor (AER), follow the AER instructions regarding reprocessing of valves in the AER.

References