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ASTM E 1837 Document Information:
Title
Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
ASTM International
Publication Date:
Oct 10, 1996
Scope:
This test method is intended to describe a procedure for testing
the effectiveness of a disinfection process for reprocessing
reusable medical devices when it is tested with a challenge of
vegetative cells including mycobacteria. Disinfection normally
deals with testing activity against vegetative cells of bacteria,
viruses, and fungi. Since this test method is process oriented, the
user may wish to examine a variety of test organisms.
This test method is designed to provide a reproducible procedure
to verify the effectiveness of a previously validated disinfectant
or disinfection procedure for reusable medical instruments and
devices.
This test method is not meant to define the effectiveness of or
validation of the particular disinfection process used or its
kinetics, but rather, it is devised to confirm the effectiveness of
the disinfection process by simulating use situations with a
particular test process using medical devices and instruments.
Either manual or machine reprocessing can be tested.
This test method is intended for use with reusable cleaned and
previously sterilized or disinfected (high level) medical
instruments and devices. Endoscopes are described in this test
method as a worst-case example for contamination and sampling. The
selected sterilization or disinfection processes, or both, should
have been validated previously, as well as the effectiveness of
rinsing for residual sterilant/disinfectant removal determined.
An inoculum with high numbers of selected microorganisms is
applied to both test and control, cleaned and sterilized, or
disinfected medical instruments. Strains of microorganisms with a
recorded resistance to disinfectants are used to contaminate the
instrument sites known or suspected to be the most difficult to
reprocess.
It is impractical to test for recovery of survivors by immersion
of some instruments, for example, endoscopes or some laproscopic
instruments, in growth medium because of complexity, size,
difficulty in long-term incubation, or deterious effects resulting
from incubation. Elution of organisms from the inoculated surfaces,
therefore, may be performed to estimate the number of recoverable
organisms. Immersion can be used for smaller instruments.
Control instruments are inoculated in the same manner as the
test instruments and elution or immersion methods are performed to
determine the number of organisms recoverable from the instrument.
For channeled devices, such as endoscopes testing, the number of
organisms recoverable from the instrument (inside and outside) will
serve as the initial control count. It is expected that some
fraction of the number of organisms inoculated will be lost in the
process of inoculation/drying.
A testing procedure can be performed on a complete reprocessing
cycle or can be limited to just the cleaning or disinfection
portions of the cycle whether reprocessing is done in a machine or
manually.
After the test cycle has been completed, remaining inoculated
bacteria will be recovered from test instruments using the same
elution procedures as for the control instruments.
Efficacy of a disinfection cycle or reprocessing cycle, or any
part thereof, may be determined by comparison of the number of
microorganisms recovered from the control instrument (initial
recoverable control count) to the recovery determined for the test
instruments.
A knowledge of microbiological techniques is required to conduct
these procedures.3
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.
3 CDC-NIH Biosafety in Microbiological and Biomedical
Laboratories, 3rd ed., U.S. Department of Health and Human
Services, Washington, DC, 1993.
Keywords:
- disinfectant
- disinfection processes
- disinfector
- elution
- high-level disifectant
- recovery
- reprocessing
- reusable medical instrument
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