ASTM F1992-99(2007)
Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes

Standard No.

ASTM F1992-99(2007)

Release Date

1999

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F1992-99(2007)

Scope

EAIs may have design features such as coiled metal sheaths, pivoting joints, opposed surfaces, and internal lumens or wires which make visual inspection for cleanliness difficult if not impossible.

By nature of their design requirements, EAIs are more difficult to reprocess than many other types of medical instruments.

Because EAIs are used to diagnose and treat disease in both immunocompetent and immunocompromised individuals, care must be taken to ensure that only patient-ready devices are used for examination.

The use of EAIs in patients having diagnosed or suspected infections such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) is not contraindicated. Further, EAIs need not be dedicated for use only in these patients.

Persons responsible for reprocessing must understand the specifications, nomenclature, function of component parts, and interior design of EAIs in order to render them patient-ready.

Persons responsible for reprocessing EAIs should follow this practice and associated labeling and instructions from manufacturers after each endoscopic procedure to ensure that the EAI will be patient-ready.

Reprocessing of EAIs should be the specific responsibility of appropriately trained personnel. Temporary employees without the requisite training should not be given these responsibilities.

The responsibility for reprocessing of EAIs should not be delegated from person to person unless each has the appropriate training for the position.

Reprocessing personnel should have the ability to read, understand, and implement instructions from manufacturers and regulatory agencies as they relate to EAI reprocessing.

Reprocessing personnel should have the opportunity to become completely familiar with the mechanical aspects of the devices. They may gain this knowledge through study of the manufacturer''s information and demonstration by representatives.

Reprocessing personnel should be made fully aware of the potential chemical and infectious hazards for patients and health care personnel associated with the reprocessing of EAIs. Training should include:

A thorough background in infection control principles and concepts based on written in-house infection control procedures.

A thorough background regarding the potential for negative patient outcomes resulting from lapses in compliance with written reprocessing guidelines,

Familiarization with Occupational Safety and Health Administration (OSHA) regulations and in-house policies regarding the appropriate and safe handling of chemical reprocessing agents and equipment used during reprocessing of EAIs, and

Information on the safe handling of EAIs contaminated with patient tissue and fluids after use, including familiarization with principles and practices of standard (universal) precautions.

Note 18212;Although healthcare workers and patients may benefit from adhering to the regulatory guidelines issued by federal and state OSHA agencies, these guidelines are directed only toward healthcare worker safety and health. They may not be sufficiently inclusive for optimum safety and health of patients. Therefore, contemporary infection control guidelines should be consulted in addition to OSHA guidelines.

This practice is not intended to replace the reprocessing instruction provided by the manufacturers of EAIs or suggest specific equipment or chemical reagents to be used for reprocessing. Rather, it is to be used together with manufacturers'' instructions that provide specific instructions for specific products. See Appendix X1.1.

This practice is not intended to cover endoscopic techniques, patient care, or other medical aspects of flexible endoscopy.

This practice does not include instruction for reprocessing flexible endoscopes.

1.1 This practice co......

ASTM F1992-99(2007) Referenced Document

• ASTM F1518 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera *， 2024-04-19 Update

ASTM F1992-99(2007) history

• 1999 ASTM F1992-99(2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
• 1999 ASTM F1992-99 Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes