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Monitoring
Frequency:
For
optimum control of hospital sterilized goods, we recommend that an
GSTest biological indicator be
used
to monitor every load of steam sterilized supplies containing
implantable products or at least once
a
day for each steam autoclave.
Instructions
For Use:
CAUTION:
After sterilization, the contents of the GSTest biological indicator are
hot and under
pressure.
Always allow to cool at least 10 minutes. Failure to cool at least 10
minutes may cause the
glass
ampoule to burst and may result in Injury from hot liquid.
A.
Exposure:
-
Remove an appropriate number of
GSTest units from the box.
-
Identify the indicators by labeling pertinent process
information.
-
Place an
GSTest biological Indicator in a suitable test pack
which is representative of the load
(e.g.,
a linen pack for the load of linen, a tray of instruments for metal
goods may be used).
-
Place this test pack in the most challenging area of the
sterilizer, generally on the bottom shelf
near
the door over the drain. NOTE: If a test pack Is not being used, the
GSTest unit should be
oriented
in a horizontal position during load processing.
-
Process the load as usual.
-
Remove from the sterilizer and allow the pack to cool for a
sufficient time to cool the indicator,
at
least 10 minutes.
-
Retrieve the
GSTest biological indicator from the test load.
-
The chemical indicator on the label changes from blue to
black
when exposed to steam. This
distinguishes
exposed from unexposed units.
NOTE: a black color does not indicate
acceptable
sterilization.
B.
Incubation:
Any
microbiological incubator that Is adjusted for 55 to 60°C will satisfy
the incubation conditions for
the
GSTest. To activate the media, place the indicator in an upright
position in a plastic crusher.
Gently
squeeze the crusher to break the glass ampoule. Place the activated
indicator In the incubator
rack,
and incubate Immediately.
C.
Interpretation
-
Examine the indicator at regular intervals for any color
change
(i.e. 18 hours, 24 hours, 48
hours).
The appearance of a yellow color indicates bacterial growth. No color
change indicates
adequate
sterilization.
-
Act on a positive test (a color change of yellow) as soon as
the
color change is noted. Notify
appropriate
hospital personnel (i.e. Infection Control). Always retest the
sterilizer with several
GSTest
biological Indicators throughout the test load.
-
The recommended incubation time Is 48 hours.
-
Record the results.
-
Dispose of all used
GSTest biological Indicators in accordance
with your institution's policy.
Incinerate
or autoclave any positive cultures at 250F (121 °C) for not less than
30 minutes.
Use
of Controls：
-
As a positive growth control, place an activated,
unsterililzed
GSTest biological indicator in
each
incubator on a daily basis.
-
Examine the positive Indicator at regular intervals such as
18
and 24 hours. The yellow color is
evidence
of bacterial growth. Record the results. Remove all positive indicators
as the yellow
color
is noticed, and dispose of as mentioned above.
-
If the positive control does not grow, do not use the units
from
this box. Contact FUZ Biotech.
Storage:
-
Store
GSTest biological indicators at controlled room temperature
conditions (15°C to 30°C)
and
20 to 70 percent relative humidity.
-
Do not store these Indicators near
sterilants or other chemicals.
-
GSTest biological indicators have a 24 month shelf life which Is
clearly designated on each
box.
Rotate your stock accordingly.
NOTE:
Do not use after expiration date printed on package. Dispose of expired
indicators by
autoclaving
at 121 °C for not less than 30 minutes.
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