ASTM F1518-00
(Practice)Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)
Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera (Withdrawn 2009)
SCOPE
1.1 This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, and sigmoidoscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.
1.2 This practice is intended to complement, not replace the instructions and labeling provided by product manufacturers. Endoscope manufacturers must provide instructions and labeling necessary for users to know the basic design, specifications, nomenclature, and components of specific flexible GI endoscopes and to properly inspect, prepare, use, clean, disinfect, rinse, dry, and store these instruments.
1.3 Endoscopic technique and the medical aspects of gastrointestinal endoscopy are not covered in this practice.
1.4 This practice details the steps necessary to properly reprocess flexible GI endoscopes and render them patient-ready.
1.5 A patient-ready endoscope is one that has been rendered visibly clean after being subjected to a validated cleaning procedure, subjected minimally to a high-level disinfection process, and rinsed so that it does not contain residual reprocessing chemicals in amounts which can be harmful to humans.
1.5.1 It is recognized that in some circumstances, portions of endoscopes that neither contact patients directly nor contact fluids that may contact patients probably do not have to be subjected to high-level disinfection.
1.6 This practice details manual reprocessing as well as automated reprocessing of flexible GI fiberoptic and video endoscopes.
1.7 The application of all practices relating to endoscopic reprocessing will ultimately fall into the purview of the individual assigned to that task in an endoscopic area.
1.7.1 To ensure the proper adherence to this practice, those personnel should themselves meet certain requirements as specified in 4.8.
1.8 This practice does not detail the steps necessary for the reprocessing of endoscopic accessories.
1.9 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 determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Notes 1 and 2.
WITHDRAWN RATIONALE
This practice covers the flexible fiberoptic and video endoscopes that are fully immersible in liquid and are used in the examination of the hollow viscera (that is, colonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes, and enteroscopes). These endoscopes will be referred to as flexible gastrointestinal (GI) endoscopes.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in January 2009 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1518–00
Standard Practice for
Cleaning and Disinfection of Flexible Fiberoptic and Video
Endoscopes Used in the Examination of the Hollow Viscera
This standard is issued under the fixed designation F 1518; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 1.6 The application of all practices relating to endoscopic
reprocessing will ultimately fall into the purview of the
1.1 This practice covers the flexible fiberoptic and video
individual assigned to that task in an endoscopic area.
endoscopes that are fully immersible in liquid and are used in
1.6.1 To ensure the proper adherence to this practice, those
the examination of the hollow viscera (that is, colonoscopes,
personnel should themselves meet certain requirements as
gastroscopes, duodenoscopes, sigmoidoscopes, and entero-
specified in 4.8.
scopes). These endoscopes will be referred to as flexible
1.7 This practice does not detail the steps necessary for the
gastrointestinal (GI) endoscopes.
reprocessing of endoscopic accessories.
1.1.1 It is strongly recommended that only immersible
1.8 This standard does not purport to address all of the
endoscopes be used in order to assure that all parts of the
safety concerns, if any, associated with its use. It is the
endoscope will be high-level disinfected; however, it is recog-
responsibility of the user of this standard to establish appro-
nized that, in some instances, portions of endoscopes that
priate safety and health practices and determine the applica-
neither contact patients nor patient fluids may not be immers-
bility of regulatory limitations prior to use. Specific precau-
ible. In these instances, care must be taken to disinfect the
tionary statements are given in Note 1 and Note 2.
nonimmersible portions to the highest degree with which they
are compatible, according to the manufacturer’s directions.
2. Terminology
1.2 This practice is intended to complement, not replace the
2.1 Definitions of Terms Specific to This Standard:
instructions and labeling provided by product manufacturers.
2.1.1 clean, adj—visibly free from debris.
Endoscope manufacturers must provide instructions and label-
2.1.2 endoscope, n—flexible GI endoscope, flexible fiberop-
ingnecessaryforuserstoknowthebasicdesign,specifications,
tic or video endoscopes used in the examination of the hollow
nomenclature, and components of specific flexible GI endo-
viscera (that is, colonoscope, gastroscope, duodenoscope, sig-
scopes and to properly inspect, prepare, use, clean, disinfect,
moidoscope, and enteroscopes).
rinse, dry, and store these instruments.
2.1.3 High-Level Disinfectant—A liquid chemical sterilant
1.3 Endoscopic technique and the medical aspects of gas-
used under the same contact conditions as for sterilization
trointestinal endoscopy are not covered in this practice.
except for a shorter contact time. A sterilant is a liquid
1.4 This practice details the steps necessary to properly
chemical germicide, which has passed the AOAC sporicidal
reprocess flexible GI endoscopes and render them patient-
test with no failures; therefore, to qualify for a high-level
ready.
disinfectionclaim,agermicidemustbeasterilantasdefinedby
1.5 This practice details manual reprocessing as well as
the AOAC sporicidal test. In addition, the claim should be
automated reprocessing of flexible GI fiberoptic and video
supported by efficacy data from potency tests, simulated-use
endoscopes.
tests, and in-use tests.
2.1.3.1 Discussion—A high-level disinfectant is a liquid
chemicalgermicideclearedbyFDAformarketwithaclaimfor
This practice is under the jurisdiction ofASTM Committee F-4 on Medical and
high-level disinfection.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2.1.4 high-level disinfected, adj—devoid of all vegetative
F04.35 on GI Endoscopes.
bacteria, viruses, and fungal spores and some but not all
Current edition approved April 10, 2000. Published July 2000. Originally
published as F 1518 – 94. Last previous edition F 1518 – 94. bacterial endospores.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1518–00
2.1.5 patient-ready endoscope, n—an endoscope rendered 4.5 Endoscopes made from elastomeric materials cannot be
clean after being subjected to a validated cleaning procedure, subjected to heat sterilization, thus requiring high-level disin-
subjected minimally to a high-level disinfection process, and fection or sterilization with compatible chemical agents. Con-
rinsed so that it does not contain residual chemicals in amounts tact the endoscope manufacturer for liquid chemical sterilant
that can be harmful to humans. compatibility.
2.1.5.1 Discussion—It is recognized that in limited circum- 4.6 Each user needs to understand the specifications, no-
stances, portions of an endoscope that neither contact patient
menclature, function of component parts, and interior channel
fluids nor contact the patient directly, may not be immersible design of endoscopes in order to render them patient-ready.
(for example, ultrasound endoscopes). In these instances, care
4.7 Persons responsible for the reprocessing of endoscopes
must be taken to disinfect the non-immersible portions of the
should follow this practice and associated labeling and instruc-
endoscope to the highest degree with which they are compat-
tions from manufacturers after each endoscopic procedure to
ible according to the manufacturer’s directions.
ensure that the endoscope is patient-ready for the next patient.
2.1.6 reprocessing, n—the cleaning and high-level disinfec-
4.8 Reprocessing of endoscopes should be the specific
tion necessary to render an endoscope patient-ready.
responsibility of appropriately trained personnel. Temporary
2.1.7 reprocessing chemicals, n—detergents and liquid
employees without the requisite training should not be given
chemical germicides used for reprocessing endoscopes.
these responsibilites.
2.1.8 residual chemical, n—freely extractable residual re-
4.8.1 The responsibility for this activity should not be
processing chemicals in amounts that can be harmful to
delegated from person to person unless each has the appropri-
humans.
ate credentials for the position.
4.8.2 Persons responsible for processing the endoscopes
3. Summary of Practice
should have the ability to read, understand, and implement
3.1 Each brand, type, and model of endoscope has unique
instructions from manufacturers and regulatory agencies as
specifications, nomenclature, interior design, function, and
they relate to endoscopic disinfection.
components.
4.8.3 Reprocessing personnel should have the opportunity
3.2 Endoscopes used in gastrointestinal endoscopy are con-
to become completely familiar with the mechanical aspects of
sidered semi-critical medical devices because they normally
the endoscopic equipment.This should be done by study of the
only come into contact with mucous membranes.
manufacturer’s information, and demonstration by the manu-
3.3 To prevent the spread of microorganisms during endo-
facturer’s representatives.
scopy, semi-critical medical devices must receive scrupulous
4.8.4 Reprocessing personnel should participate in an insti-
manual cleaning followed minimally by high-level disinfec-
tutionally developed, competency-based training program
tion.
dedicated to endoscope reprocessing.
3.4 Upon removal of the endoscope from the patient, the
4.8.4.1 The competency-based training program should in-
instrument should be manually cleaned followed by high-level
corporate currently published national standards, such as
disinfection, rinsing, and drying. If due to time constraints, it is
ASTM, SGNA, APIC, and ASGE.
not possible to complete the reprocessing immediately, the
4.8.5 Reprocessingpersonnelshouldbemadefullyawareof
endoscopeshouldbeleak-tested,flushed,brushed,andallowed
the potential chemical and infectious hazards for patients and
to soak in a detergent solution until it can be thoroughly
health care personnel associated with the reprocessing of the
reprocessed.
endoscope.
3.4.1 Follow the endoscope manufacturer’s recommenda-
4.8.5.1 Training should include a thorough background
tions for the maximum liquid exposure time.
regarding the potential for negative patient outcomes resulting
3.5 After cleaning and high-level disinfection, endoscopes
from lapses in compliance with written reprocessing guide-
must be stored in a manner that allows air to circulate around
lines.
the endoscope.
4.8.5.2 Training should include a thorough background in
3.6 Refer to the endoscope manufacturer’s instructions for
infection control principles and concepts based on written
proper storage.
in-house infection control procedures.
4. Significance and Use
4.8.5.3 Training should include familiarization with Occu-
pational Safety and HealthAdministration (OSHA) regulations
4.1 Because endoscopes are used to diagnose disease in
and in-house policies regarding the appropriate and safe
immunocompetent and immunocompromised individuals, care
handling of liquid chemical reagents and equipment used
must be taken to ensure that only endoscopes that are patient-
during the reprocessing of the endoscopes. OSHA guidelines
ready are used for each examination.
are directed only toward healthcare worker safety and health
4.2 Endoscopy of patients with diagnosed or suspected
but also may benefit patient safety.
infections such as hepatitis B or human immunodeficiency
4.8.5.4 Training should include information on the safe
virus is not contraindicated. Further, endoscopes do not need to
be dedicated for use in only these patients. handling of endoscopes contaminated with patient tissue and
fluids. This should include familiarization with principles and
4.3 By nature of their design requirements, endoscopes are
practices of standard (Universal) precautions.
more difficult to reprocess than other medical instruments.
4.4 Endoscopes have long narrow internal channels making 4.8.6 Each endoscopic unit should have appropriately mo-
inspection for cleanliness difficult if not impossible. tivated individuals with the proper educational background or
F1518–00
experience, or both, to assume the responsibility for the 6.3 Basin(s), must be large enough to totally immerse the
reprocessing of endoscopes. Temporary employees without the endoscopeswithoutcoilingthemtootightly.Seetheendoscope
requisite training should not be given this responsibility. manufacturer’s instructions for maximum coiling of specific
4.9 This practice is not intended to replace the cleaning and endoscopes:
disinfection instructions provided by the manufacturers of the 6.3.1 Cleaning basin, and
endoscope, endoscope disinfector, or chemicals used for clean- 6.3.2 Disinfectant basin for soaking:
ing and disinfection. Rather, it is to be used together with the
6.3.2.1 Nonmetal, and
manufacturer’s instructions that provide specific instructions 6.3.2.2 Must include a tight-fitting lid to minimize escape of
for specific products.
disinfectant vapors.This lid should be kept in place at all times
4.10 This practice is not intended to cover the endoscopic except when transferring instruments into or out of the solu-
techniques, patient care, or other medical aspects of gas-
tion.
trointestinal endoscopy.
6.3.3 Automated Disinfector, must include a tight-fitting lid
4.11 This practice does not include instructions for the use
to minimize the escape of disinfectant vapors.
or reprocessing of endoscopic accessories.
6.4 Cloth—Soft, lint-free cloth or sponge for wiping the
exterior of the endoscope.
5. Reagents
6.5 Personal Protective Equipment:
5.1 Alcohol—seventy percent isopropyl or seventy percent
6.5.1 Gloves:
ethyl alcohol. Keep alcohol in a closed container. Alcohol
6.5.1.1 High-quality, impervious latex, butyl or nitrile rub-
stored in an open container is a fire hazard and may not remain
ber gloves should fit properly and be of adequate length to
effective because of evaporation. Do not reuse.
prevent skin exposure.
5.2 Air—Air flow provided by an air pump or compressor.
6.5.1.2 Gloves must be changed regularly as needed or as
Refer to the endoscope manufacturer’s instructions and avoid
recommended by the manufacturer. They must be discarded if
using excessively high air pressure.
they are cracked, pealing, punctured, or when their ability to
5.3 Detergent—Low-sudsingdetergentformulationsrecom-
function as a barrier is compromised.
mended by the manufacturer of the endoscopes.
6.5.2 Gowns:
5.4 High-Level Disinfectant—A liquid chemical germicide
6.5.2.1 Impervious protective clothing must be worn when
as defined in 2.1.3.
handling contaminated endoscopes and when working with
5.4.1 A high-level disinfectant is a liquid chemical sterilant
liquid chemical germicides.
used under the same contact conditions as for sterilization
6.5.2.2 Gowns used during endoscope reprocessing must be
except for a shorter contact time. A sterilant is a liquid
removed prior to leaving the decontamination area.
chemical germicide, which has passed the AOAC sporicidal
6.5.3 Face masks or shields and protective eye gear should
test with no failures; therefore, to qualify for a high-level
be worn to protect the face and eyes from contact with
disinfectionclaim,agermicidemustbeasterilantasdefinedby
reprocessing chemicals and infectious material.
the AOAC sporicidal test. In addition, the claim should be
6.6 Adequate Air Ventilation—A large well-ventilated area
supported by efficacy data from potency tests, simulated-use
with eight to ten air exchanges per hour is necessary to help
tests and in-use tests.
protect personnel from chemical vapors.
5.4.2 A high-level disinfectant is a liquid chemical germi-
cide cleared by the FDAfor market with a claim for high-level
7. Procedure
disinfection.
7.1 Cleaning:
Subject valves and other removal parts to high-level disin-
7.1.1 Put on all necessary personal protective equipment.
fection by soaking in a basin of disinfectant, or if possible,
7.1.2 Prepare detergent in accordance with the manufactur-
place the valves and other removable parts in the designated
er’s specifications.
accessory basket of the automated disinfector.
7.1.3 Immediately after removing the endoscope from the
5.5 Water—Clean, potable water or potable water that has
patient:
been filtered by passage through a 0.2-µm filter or otherwise
7.1.3.1 Wipe all debris from the insertion tube using a soft
treated by a method documented to improve the microbiologi-
l
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