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for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)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for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes (Withdrawn 2016)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
Relations
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
1
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
2
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-
3
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.
3
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
1
---------------------- Page: 1 ----------------------
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 thorough
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.