ASTM F1992-99(2007)
(Practice)Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)
Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)
SIGNIFICANCE AND USE
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 infe...
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 addr...
General Information
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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: F1992 − 99(Reapproved 2007)
Standard Practice for
Reprocessing of Reusable, Heat-Stable Endoscopic
Accessory Instruments (EAI) Used with Flexible
Endoscopes
This standard is issued under the fixed designation F1992; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope drained to remove excess lubricant, dried, packaged, heat
sterilized and stored to prevent from being compromised
1.1 This practice covers reusable, heat-stable endoscopic
sterility before use.
accessory instruments (EAI) designed to be inserted into
flexible endoscopes and clearly defined in the user instructions 1.8 This practice describes only manual reprocessing and
as devices intended for reuse among patients. The EAIs does not address cleaning of an EAI by an automated repro-
covered by this practice may or may not have lumens or cessing device.
loosely joined surfaces, may or may not have access ports for
1.9 To ensure the proper adherence to this practice, repro-
flushing, and may or may not be capable of being completely
cessing personnel should meet certain requirements as speci-
disassembled prior to reprocessing.
fied in 5.5 to 5.7.
1.2 This practice is not intended to be applied to the
1.10 This practice does not address the steps necessary for
reprocessing of single-use, disposable EAIs specifically de-
the reprocessing of flexible endoscopes (see Practice F1518).
signed and labeled as such by their manufacturers.
1.11 This standard does not purport to address all of the
1.3 This practice is not intended to address reprocessing of
safety concerns, if any, associated with its use. It is the
heat-sensitive EAIs, for example, those not capable of with-
responsibility of the user of this standard to establish appro-
standing heat sterilization. Reprocessing of each heat-sensitive
priate safety and health practices and to determine the
EAI must be considered on an individual basis according to
applicability of regulatory limitations prior to use.
specific instructions from the manufacturers of the EAI and the
low-temperature sterilization device.
2. Referenced Documents
1.4 Thispracticeisintendedtocomplement,notreplace,the
2.1 ASTM Standards:
instructions provided by product manufacturers. EAI manufac-
F1518 Practice for Cleaning and Disinfection of Flexible
turers should provide properly validated instruction and label-
Fiberoptic and Video Endoscopes Used in the Examina-
ing necessary for users to understand the basic design,
tion of the Hollow Viscera (Withdrawn 2009)
specifications, nomenclature, and components of specific ac-
cessories and to properly inspect, prepare, use, reprocess, and
3. Terminology
store these instruments.
3.1 Definitions of Terms Specific to This Standard:
1.5 Endoscopic technique and the medical aspects of endos-
3.1.1 clean, adj—visibly free from external debris after a
copy are not covered in this practice.
thorough, manufacturer-validated regimen.
1.6 This practice details the basic steps necessary to repro-
3.1.2 critical medical device, n—an instrument that may be
cess a heat-stable EAI and render it patient-ready.
introduced directly into the bloodstream or into other normally
sterile areas of the body, that is, an invasive device.
1.7 A patient-ready EAI is one that has been thoroughly
cleanedusingavalidatedcleaningprocedure,rinsedwithwater 3.1.3 endoscopic accessory instrument, EAI, n—medical
to remove residual detergent, lubricated (if necessary) and instrument designed to be inserted into a flexible endoscope.
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.35 on GI Applications. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2007. Published January 2008. Originally the ASTM website.
approved in 1999. Last previous edition approved in 1999 as F1992 – 99. DOI: The last approved version of this historical standard is referenced on
10.1520/F1992-99R07. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1992 − 99 (2007)
3.1.3.1 Discussion—EAIs may be critical- or semi-critical 4.3 To prevent patient-to-patient transmission of infection,
devices. EAIs may or may not have lumens, porous or loosely heat-stable EAIs should be thoroughly cleaned, rinsed, lubri-
joined surfaces, or access ports for flushing and may or may cated if necessary, dried, packaged, and sterilized using a
not be capable of being completely disassembled during heat-based process, for example, a steam autoclave or a
reprocessing. forced-air dry heat oven.
3.1.4 flexible endoscope, n—a flexible tubular instrument
4.4 After sterilization, a packaged EAI should be stored in a
that utilizes fiberoptic or video imaging technology to examine
limited-access, well-ventilated area that provides protection
the interior of a canal or hollow viscus.
fromdust,moisture,andextremesoftemperatureandhumidity
so as not to compromise sterility before use.
3.1.5 heat-stable medical device, n—an instrument capable
of withstanding sterilization using a heat-based process.
4.5 Before use, the EAI should be tested for functionality.
3.1.6 lubrication, n—the application of a substance used to
reduce friction or wear. 5. Significance and Use
3.1.7 manual cleaning, n—removalofdebrisfromaninstru-
5.1 EAIs may have design features such as coiled metal
ment by hand using detergent solution, cleaning devices such
sheaths, pivoting joints, opposed surfaces, and internal lumens
as brushes, cloths, and irrigating devices, and water for rinsing.
or wires which make visual inspection for cleanliness difficult
3.1.8 patient-ready, adj—term used to describe endoscopic if not impossible.
accessory instrument that, following prior patient use, has
5.2 By nature of their design requirements, EAIs are more
undergone an appropriate reprocessing protocol, including heat
difficult to reprocess than many other types of medical instru-
sterilization, to render it safe, as established by contemporary
ments.
professional standards, for use on a subsequent patient; an
5.3 Because EAIs are used to diagnose and treat disease in
operational check to ensure proper functionality is an essential
both immunocompetent and immunocompromised individuals,
component of preparing the EAI for reuse.
caremustbetakentoensurethatonlypatient-readydevicesare
3.1.9 reprocessing, n—the precise sequence of cleaning,
used for examination.
lubricating (if necessary), and sterilizing steps that, when
5.4 The use of EAIs in patients having diagnosed or
performed properly and completely, will assure an endoscopic
suspected infections such as hepatitis B, hepatitis C, or human
accessory instrument is patient-ready.
immunodeficiency virus (HIV) is not contraindicated. Further,
3.1.10 reusable, adj—instrument designed and validated by
EAIs need not be dedicated for use only in these patients.
themanufacturertobeusedmorethanonce,providedthatafter
each use, an appropriate reprocessing protocol and functional- 5.5 Persons responsible for reprocessing must understand
ity check is performed. the specifications, nomenclature, function of component parts,
and interior design of EAIs in order to render them patient-
3.1.11 semi-critical medical device, n—an instrument in-
ready.
tended to contact only mucous membranes or non-intact skin
during use.
5.6 Persons responsible for reprocessing EAIs should fol-
low this practice and associated labeling and instructions from
3.1.12 sterilization, n—the complete elimination or destruc-
manufacturers after each endoscopic procedure to ensure that
tion of all forms of microbial life, including high numbers of
the EAI will be patient-ready.
bacterial spores.
3.1.12.1 Discussion—In this standard, the only methods of
5.7 Reprocessing of EAIs should be the specific responsi-
sterilization considered are heat-based, for example, saturated
bilityofappropriatelytrainedpersonnel.Temporaryemployees
steam under pressure (a steam autoclave) or a forced-air dry
without the requisite training should not be given these
heat oven certified for medical use.
responsibilities.
3.1.13 ultrasonic cleaning, n—a process in which ultra-high
5.7.1 The responsibility for reprocessing of EAIs should not
frequency sound waves are converted into mechanical vibra-
be delegated from person to person unless each has the
tions capable of cleaning via a process called cavitation.
appropriate training for the position.
3.1.13.1 Discussion—During cavitation, microscopic
5.7.2 Reprocessing personnel should have the ability to
bubbles in the cleaning solution implode (burst inward),
read, understand, and implement instructions from manufac-
resulting in a vacuum action that pulls soil and debris away
turers and regulatory agencies as they relate to EAI reprocess-
from the surface of items being cleaned.
ing.
5.7.3 Reprocessing personnel should have the opportunity
4. Summary of Practice
to become completely familiar with the mechanical aspects of
4.1 Each brand, type, and model of EAI has unique
the devices. They may gain this knowledge through study of
specifications, nomenclature, interior design, function, and
the manufacturer’s information and demonstration by repre-
components.
sentatives.
4.2 Most EAIs are critical medical devices because they 5.7.4 Reprocessingpersonnelshouldbemadefullyawareof
come into direct contact with the bloodstream, enter normally the potential chemical and infectious hazards for patients and
sterile areas of the body, or break normally intact mucosal health care personnel associated with the reprocessing of EAIs.
surfaces. Training should include:
F1992 − 99 (2007)
5.7.4.1 A thorough background in infection control prin- instruction for minimum radius of coiling of specific accesso-
ciples and concepts based on written in-house infection control ries. Basins needed are:
procedures. 7.1.1 Cleaning basin, and
5.7.4.2 A thorough background regarding the potential for 7.1.2 Lubrication basin.
negative patient outcomes resulting from lapses in compliance
7.2 Cleaning Tools—Soft, lint-free cloth, brushes, adapters,
with written reprocessing guidelines,
sponges, syringes, and other manufacturer-recommended
5.7.4.3 FamiliarizationwithOccupationalSafetyandHealth
cleaning items.
Administration (OSHA) regulations and in-house policies
7.3 Personal Protective Equipment:
regarding the appropriate and safe handling of chemical
7.3.1 Gloves—High-quality latex, butyl, or nitrile rubber
reprocessingagentsandequipmentusedduringreprocessingof
gloves that fit properly and are of adequate length to prevent
EAIs, and
skin exposure to liquids.
5.7.4.4 Information on the safe handling of EAIs contami-
7.3.1.1 Glovesmustbechangedatappropriatetimestolimit
nated with patient tissue and fluids after use, including famil-
cross contamination and must be removed prior to leaving the
iarization with principles and practices of standard (universal)
designated reprocessing area. They must be discarded if they
precautions.
are cracked, peeling, punctured, or when their ability to
NOTE 1—Although healthcare workers and patients may benefit from
function as a barrier has been otherwise compromised. Hands
adhering to the regulatory guidelines issued by federal and state OSHA
must be washed thoroughly with soap and water before each
agencies, these guidelines are directed only toward healthcare worker
donning and after removal of gloves.
safety and health. They may not be sufficiently inclusive for optimum
7.3.2 Gowns—Fluid impervious protective clothing must be
safety and health of patients. Therefore, contemporary infection control
guidelines should be consulted in addition to OSHA guidelines. worn when handling contaminated EAIs and when working
with reprocessing chemicals.
5.8 This practice is not intended to replace the reprocessing
7.3.2.1 Gowns used during EAI reprocessing must be re-
instruction provided by the manufacturers of EAIs or suggest
moved prior to leaving the designated reprocessing area.
specific equipment or chemical reagents to be used for repro-
7.3.3 Protective Eye Wear—Face masks and protective eye-
cessing. Rather, it is to be used together with manufacturers’
wearorfaceshieldsshouldbeworntoprotectthefaceandeyes
instructions that provide specific instructions for specific prod-
from contact with reprocessing chemicals and potentially
ucts. See Appendix X1.1.
infectious material.
5.9 This practice is not intended to cover endoscopic
7.4 Ultrasonic Cleaner—Must be large enough to totally
techniques, patient care, or other medical aspects of flexible
immersetheEAIswithoutcoilingthemtootightly,andmustbe
endoscopy.
able to operate within a frequency and power range that will
5.10 This practice does not include instruction for repro-
not damage the instruments. See the EAI manufacturer’s
cessing flexible endoscopes.
instructions for specifications regarding the minimum radius of
coiling of specific models, the required frequency range of the
6. Reagents
ultrasonic cleaner, and the maximum power of ultrasonic
transducers.
6.1 Air—Air flow provided by a syringe or compressed air
source. (Refer to the EAI manufacturer’s instruction to avoid
7.5 Sterilizer—Mustbeaheat-basedprocess(forexample,a
the use of excessively high air pressure.)
steam autoclave or forced-air dry heat oven) and capable of
meeting the conditions for the sterilization cycle validated by
6.2 Detergent—A low foaming, neutral pH detergent, with
the EAI manufacturer.
or without enzymes, used for initial soaking and manual
7.5.1 The sterilizer also should be used to dry the packaged
cleaning that is compatible with EAIs and is specifically
EAIs at the conclusion of a moist heat sterilization cycle.
formulated for use with medical devices.
7.5.2 Biological and chemical (temperature/color change)
6.3 Ultrasonic Cleaning Detergent—A detergent that is
monitoring of the sterilizer should be done routinely according
compatible with EAIs and specifically formulated for use in an
to the facility’s protocol or national standards, or both.
ultrasonic cleaner.
7.5.3 General operation, maintenance, and calibration of the
6.4 Water—Fresh, potable water.
sterilizer should be done according to the sterilizer manufac-
turer’s instructions.
NOTE 2—In areas
...
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