ASTM F1992-99
(Practice)Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
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.
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Designation:F1992–99
Standard Practice for
Reprocessing of Reusable, Heat-Stable Endoscopic
Accessory Instruments (EAI) Used with Flexible
Endoscopes
This standard is issued under the fixed designation F 1992; 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 1.8 This practice describes only manual reprocessing and
does not address cleaning of an EAI by an automated repro-
1.1 This practice covers reusable, heat-stable endoscopic
cessing device.
accessory instruments (EAI) designed to be inserted into
1.9 To ensure the proper adherence to this practice, repro-
flexible endoscopes and clearly defined in the user instructions
cessing personnel should meet certain requirements as speci-
as devices intended for reuse among patients. The EAIs
fied in 5.5 to 5.7.
covered by this practice may or may not have lumens or
1.10 This practice does not address the steps necessary for
loosely joined surfaces, may or may not have access ports for
the reprocessing of flexible endoscopes (see Practice F 1518).
flushing, and may or may not be capable of being completely
1.11 This standard does not purport to address all of the
disassembled prior to reprocessing.
safety concerns, if any, associated with its use. It is the
1.2 This practice is not intended to be applied to the
responsibility of the user of this standard to establish appro-
reprocessing of single-use, disposable EAIs specifically de-
priate safety and health practices and to determine the
signed and labeled as such by their manufacturers.
applicability of regulatory limitations prior to use.
1.3 This practice is not intended to address reprocessing of
heat-sensitive EAIs, for example, those not capable of with-
2. Referenced Documents
standing heat sterilization. Reprocessing of each heat-sensitive
2.1 ASTM Standards:
EAI must be considered on an individual basis according to
F 1518 Practice for Cleaning and Disinfection of Flexible
specific instructions from the manufacturers of the EAI and the
Fiberoptic and Video Endoscopes Used in the Examination
low-temperature sterilization device.
of the Hollow Viscera
1.4 Thispracticeisintendedtocomplement,notreplace,the
instructions provided by product manufacturers. EAI manufac-
3. Terminology
turers should provide properly validated instruction and label-
3.1 Definitions of Terms Specific to this Standard:
ing necessary for users to understand the basic design, speci-
3.1.1 clean, adj—visibly free from external debris after a
fications, nomenclature, and components of specific
thorough, manufacturer-validated regimen.
accessories and to properly inspect, prepare, use, reprocess,
3.1.2 critical medical device, n—an instrument that may be
and store these instruments.
introduced directly into the bloodstream or into other normally
1.5 Endoscopic technique and the medical aspects of endo-
sterile areas of the body, that is, an invasive device.
scopy are not covered in this practice.
3.1.3 endoscopic accessory instrument, EAI, n—medical
1.6 This practice details the basic steps necessary to repro-
instrument designed to be inserted into a flexible endoscope.
cess a heat-stable EAI and render it patient-ready.
3.1.3.1 Discussion—EAIs may be critical- or semi-critical
1.7 A patient-ready EAI is one that has been thoroughly
devices. EAIs may or may not have lumens, porous or loosely
cleanedusingavalidatedcleaningprocedure,rinsedwithwater
joined surfaces, or access ports for flushing and may or may
to remove residual detergent, lubricated (if necessary) and
not be capable of being completely disassembled during
drained to remove excess lubricant, dried, packaged, heat
reprocessing.
sterilized and stored to prevent from being compromised
3.1.4 flexible endoscope, n—a flexible tubular instrument
sterility before use.
that utilizes fiberoptic or video imaging technology to examine
the interior of a canal or hollow viscus.
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee F
04.35 on GI Endoscopes.
Current edition approved October 10, 1999. Published January 2000. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1992
3.1.5 heat-stable medical device, n—an instrument capable 5. Significance and Use
of withstanding sterilization using a heat-based process.
5.1 EAIs may have design features such as coiled metal
3.1.6 lubrication, n—the application of a substance used to
sheaths, pivoting joints, opposed surfaces, and internal lumens
reduce friction or wear.
or wires which make visual inspection for cleanliness difficult
3.1.7 manual cleaning, n—removal of debris from an in-
if not impossible.
strument by hand using detergent solution, cleaning devices
5.2 By nature of their design requirements, EAIs are more
such as brushes, cloths, and irrigating devices, and water for
difficult to reprocess than many other types of medical instru-
rinsing.
ments.
3.1.8 patient-ready, adj—term used to describe endoscopic
5.3 Because EAIs are used to diagnose and treat disease in
accessory instrument that, following prior patient use, has
both immunocompetent and immunocompromised individuals,
undergone an appropriate reprocessing protocol, including heat
care must be taken to ensure that only patient-ready devices are
sterilization, to render it safe, as established by contemporary
used for examination.
professional standards, for use on a subsequent patient; an
5.4 The use of EAIs in patients having diagnosed or
operational check to ensure proper functionality is an essential
suspected infections such as hepatitis B, hepatitis C, or human
component of preparing the EAI for reuse.
immunodeficiency virus (HIV) is not contraindicated. Further,
3.1.9 reprocessing, n—the precise sequence of cleaning,
EAIs need not be dedicated for use only in these patients.
lubricating (if necessary), and sterilizing steps that, when
5.5 Persons responsible for reprocessing must understand
performed properly and completely, will assure an endoscopic
the specifications, nomenclature, function of component parts,
accessory instrument is patient-ready.
and interior design of EAIs in order to render them patient-
3.1.10 reusable, adj—instrument designed and validated by
ready.
themanufacturertobeusedmorethanonce,providedthatafter
5.6 Persons responsible for reprocessing EAIs should fol-
each use, an appropriate reprocessing protocol and functional-
low this practice and associated labeling and instructions from
ity check is performed.
manufacturers after each endoscopic procedure to ensure that
3.1.11 semi-critical medical device, n—an instrument in-
the EAI will be patient-ready.
tended to contact only mucous membranes or non-intact skin
5.7 Reprocessing of EAIs should be the specific responsi-
during use.
bilityofappropriatelytrainedpersonnel.Temporaryemployees
3.1.12 sterilization, n—the complete elimination or destruc-
without the requisite training should not be given these
tion of all forms of microbial life, including high numbers of
responsibilities.
bacterial spores.
5.7.1 The responsibility for reprocessing of EAIs should not
3.1.12.1 Discussion—In this standard, the only methods of
be delegated from person to person unless each has the
sterilization considered are heat-based, for example, saturated
appropriate training for the position.
steam under pressure (a steam autoclave) or a forced-air dry
5.7.2 Reprocessing personnel should have the ability to
heat oven certified for medical use.
read, understand, and implement instructions from manufac-
3.1.13 ultrasonic cleaning, n—a process in which ultra-high
turers and regulatory agencies as they relate to EAI reprocess-
frequency sound waves are converted into mechanical vibra-
ing.
tions capable of cleaning via a process called cavitation.
5.7.3 Reprocessing personnel should have the opportunity
3.1.13.1 Discussion—During cavitation, microscopic
to become completely familiar with the mechanical aspects of
bubbles in the cleaning solution implode (burst inward),
the devices. They may gain this knowledge through study of
resulting in a vacuum action that pulls soil and debris away
the manufacturer’s information and demonstration by repre-
from the surface of items being cleaned.
sentatives.
4. Summary of Practice
5.7.4 Reprocessingpersonnelshouldbemadefullyawareof
the potential chemical and infectious hazards for patients and
4.1 Each brand, type, and model of EAI has unique speci-
health care personnel associated with the reprocessing of EAIs.
fications, nomenclature, interior design, function, and compo-
Training should include:
nents.
5.7.4.1 A thorough background in infection control prin-
4.2 Most EAIs are critical medical devices because they
ciples and concepts based on written in-house infection control
come into direct contact with the bloodstream, enter normally
procedures.
sterile areas of the body, or break normally intact mucosal
5.7.4.2 A thorough background regarding the potential for
surfaces.
negative patient outcomes resulting from lapses in compliance
4.3 To prevent patient-to-patient transmission of infection,
with written reprocessing guidelines,
heat-stable EAIs should be thoroughly cleaned, rinsed, lubri-
5.7.4.3 FamiliarizationwithOSHAregulationsandin-house
cated if necessary, dried, packaged, and sterilized using a
heat-based process, for example, a steam autoclave or a policies regarding the appropriate and safe handling of chemi-
cal reprocessing agents and equipment used during reprocess-
forced-air dry heat oven.
4.4 After sterilization, a packaged EAI should be stored in a ing of EAIs, and
limited-access, well-ventilated area that provides protection 5.7.4.4 Information on the safe handling of EAIs contami-
from dust, moisture, and extremes of temperature and humidity nated with patient tissue and fluids after use, including famil-
so as not to compromise sterility before use. iarization with principles and practices of standard (universal)
4.5 Before use, the EAI should be tested for functionality. precautions.
F1992
NOTE 1—Although healthcare workers and patients may benefit from
must be washed thoroughly with soap and water before each
adhering to the regulatory guidelines issued by federal and state Occupa-
donning and after removal of gloves.
tional Safety and Health Administration (OSHA) agencies, these guide-
7.3.2 Gowns—Fluid impervious protective clothing must be
lines are directed only toward healthcare worker safety and health. They
worn when handling contaminated EAIs and when working
maynotbesufficientlyinclusiveforoptimumsafetyandhealthofpatients.
with reprocessing chemicals.
Therefore, contemporary infection control guidelines should be consulted
7.3.2.1 Gowns used during EAI reprocessing must be re-
in addition to OSHA guidelines.
moved prior to leaving the designated reprocessing area.
5.8 This practice is not intended to replace the reprocessing
7.3.3 Protective Eye Wear—Face masks and protective
instruction provided by the manufacturers of EAIs or suggest
eyewear or face shields should be worn to protect the face and
specific equipment or chemical reagents to be used for repro-
eyes from contact with reprocessing chemicals and potentially
cessing. Rather, it is to be used together with manufacturers’
infectious material.
instructions that provide specific instructions for specific prod-
7.4 Ultrasonic Cleaner—Must be large enough to totally
ucts. See Appendix X1.1.
immersetheEAIswithoutcoilingthemtootightly,andmustbe
5.9 This practice is not intended to cover endoscopic tech-
able to operate within a frequency and power range that will
niques, patient care, or other medical aspects of flexible
not damage the instruments. See the EAI manufacturer’s
endoscopy.
instructions for specifications regarding the minimum radius of
5.10 This practice does not include instruction for repro-
coiling of specific models, the required frequency range of the
cessing flexible endoscopes.
ultrasonic cleaner, and the maximum power of ultrasonic
transducers.
6. Reagents
7.5 Sterilizer—Must be a heat-based process (for example,
6.1 Air—Air flow provided by a syringe or compressed air
a steam autoclave or forced-air dry heat oven) and capable of
source. (Refer to the EAI manufacturer’s instruction to avoid
meeting the conditions for the sterilization cycle validated by
the use of excessively high air pressure)
the EAI manufacturer.
6.2 Detergent—A low foaming, neutral pH detergent, with 7.5.1 The sterilizer also should be used to dry the packaged
or without enzymes, used for initial soaking and manual
EAIs at the conclusion of a moist heat sterilization cycle.
cleaning that is compatible with EAIs and is specifically
7.5.2 Biological and chemical (temperature/color change)
formulated for use with medical devices.
monitoring of the sterilizer should be done routinely according
6.3 Ultrasonic Cleaning Detergent—A detergent that is to the facility’s protocol or national standards, or both.
compatible with EAIs and specifically formulated for use in an
7.5.3 General operation, maintenance, and calibration of the
ultrasonic cleaner.
sterilizer should be done according to the sterilizer manufac-
6.4 Water—Fresh, potable water.
turer’s instructions.
7.6 Air Ventilation—A well-ventilated area with between 8
NOTE 2—In areas where water hardness may result in scaling or
and 10 air exchanges per hour to protect personnel from
corrosion of metal instruments, the use of distilled, deionized, or softened
potentially hazardous fumes or chemical or biological aerosols.
water should be considered as appropriate for rinsing and preparation of
cleaning reagent dilutions.
8. Procedure
6.5 Lubricant—A lubricant that is compatible with EAIs
8.1 Cleaning:
that require lubrication before sterilization and is specifically
8.1.1 Manual Cleaning:
formulated for use with medical devices.
8.1.1.1 Don all necessary personal protective equipment.
8.1.1.2 Prepare fresh aqueous detergent solutions for
7. Equipment and Supplies
manual cleaning in accordance with the manufacturer’s speci-
7.1 Basins—Must be large enough to totally immerse the
fications, at the dilution strength recommended by the deter-
EAIs without coiling too tightly. See the EAI manufacturer’s
gent manufacturer.
instruction for minimum radius of coiling of specific accesso-
8.1.1.3 Immediately after removal of the EAI from the
ries. Basins ne
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