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FREQUENTLY ASKED QUESTIONS |
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What is the cause of a failed test? |
The spore test had
inadequate exposure to the sterilant used by the sterilizer (steam,
chemical vapor, dry heat or Ethylene Oxide). Operator error is a
common cause of failed tests. Often users load the sterilizer
beyond its capacity inhibiting the sterilant’s exposure to all areas
of the sterilizer (including the test). See your sterilizer
manufacturers’ instructions on load capacity and placement of the BI
test (biological indicator). Worn out sterilizer door seals,
inadequate water level, clogged air-trap jet and blocked safety
valves are other reasons for sterilizer failure. When a failed test
occurs, you will be notified immediately and confidentially by
phone. Most of our programs include a retest which will be sent
with your failed test results immediately. IMPORTANT NOTE: Testing
frequently will catch operator error and/or sterilization failure
sooner.
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What procedure should
be followed after being notified of a failed test? |
If possible, use
another sterilizer until you receive back the results of the
retest. The operator should review the test reports’ content of
load to verify it wasn’t overloaded and check that the manufacturers
operating instructions are being followed. After sterilizing the
retest BI
(biological indicator),
verify that the Class 5 Steam Integrator (that comes with the BI)
color change is complete or has moved into the “pass area”, which
allows you to release the sterilized load. If the Steam Integrator
is a shade of gray, sterility has not been achieved and most likely
the BI results will be positive again (failed test). We will
notify you of failed BI’s immediately. After two failed BI tests,
we recommend contacting your sterilizer repair company. We have a
dealer contact list if you need a repair company in your area to
assist you.
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What is an Integrator?
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An Integrator is a
Class 5 rated
chemical indicator
that ensures all parameters of sterilization have been met, which
includes temperature, time and pressure of
steam
sterilizers. Integrators have been correlated to the performance of
biological indicators as per labeled condition of its use. They are
recommended to be used in every sterilizer run and to be placed
inside every pouch or tray. Integrators have accurate and
easy-to-read results with a color change that is irreversible. This
allows you to keep permanent records which can be attached to
patient records or sterilizer run records. Passed results allow for
immediate release of the sterilized items.
They
are extremely cost effective; as low as 4˘
per Integrator! (See
Sterility Assurance Products).
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What is a “PCD”?
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A “PCD” is a
process challenge device. This device is to be equal or greater
than the most difficult item that is routinely sterilized such as a
large pack or tray. Often the device is assembled ‘in-house’ using
towels folded and stacked with a BI (biological indicator) or CI
(chemical indicator) in the center of the stacked towels. A PCD
should be representative of a package or tray that routinely is
processed through the sterilizer. PCD's are
also sold commercially (See
Sterility Assurance Products)
that are FDA cleared, although there is no universally accepted PCD
for table top sterilizers. PCD’s that are commercially available
present a challenge to your sterilizer using a BI or CI in the
center of the pack, but it may not represent your own particular
tray or pack, which is why we recommend that the user sets up their
own PCD “device” as noted above. For more technical information,
contact us at
info@autoclavesporetesting.com.
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Is it OK to use tap water for my
autoclave? |
Only distilled or
de-ionized water is acceptable for autoclaves (steam sterilizers).
Tap-water will corrode the internal components of your sterilizer,
reduce the quality of the steam, and possibly cause sterilizer
failure. Follow your sterilizer manufacturer’s recommendations on
proper maintenance and care of your equipment.
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Is it necessary to spore test a new
sterilizer before using it? |
YES. In fact,
it’s recommended that qualification testing is done after
installation by monitoring three consecutive cycles using BI
(biological indicator) tests in an empty chamber. For
dynamic-air-removal sterilizers, it’s recommended that three
consecutive cycles be run with a
Bowie-Dick test pack (see Sterility Assurance Products).
These provide a rapid means of detecting air leaks or inadequate
air removal or inadequate steam penetration.
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We just had our sterilizer
repaired; should we spore test it before using it? |
YES. It’s
recommended that qualification testing is done following any major
repair by monitoring three consecutive cycles using BI’s in an empty
chamber. As mentioned in #5 above, if the sterilizer is a
dynamic-air-removal sterilizer, three consecutive cycles should be
run with Bowie-Dick test packs which detect air leaks, inadequate
air removal or steam penetration. NOTE: Check with your repair
company to see if they did a qualification test already. See
Sterility Assurance Products
for our
Qualification Test Reports.
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How often should biological
indicator testing (e.g. spore testing) be done? |
ATS, Inc.
recommends at least weekly monitoring of your sterilizer. Weekly
testing is also recommended by the CDC (Center for Disease Control
and Prevention) and is also recommended by AAMI, ADA and The Joint
Commission. You can also check your State guidelines as to what
testing frequency is required. In the dental field, there are 39
states now requiring sterilizers to be tested WEEKLY (see
Dental Regulations). State
guidelines are constantly changing too for the tattoo and body
piercing industry. (See
Tattoo
Regulations for what is required in your state). We also
recommend 3 consecutive BI tests for
qualification testing (done
after installation or repair of a sterilizer).
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I use chemical indicators to test
our sterilizer. Is this enough proof? |
NO. Chemical
Indicators should be used in conjunction with biological indicators
and physical monitoring of the sterilizer. Chemical indicators
range from Class 1 to Class 5, and are manufactured for specific use
to monitor certain parameters of sterilization. The ‘Class’ of an
indicator is selected depending on how many parameters are to be
monitored and what information is desired of the sterilizer. If a
chemical indicator read-out isn’t complete or isn’t responsive, it’s
possible the entire load is not sterile. Error in loading or
packaging can result in indicator failure which may only apply to
that package or tray, and not the whole sterilizer load. This is
why internal indicators are so essential to ensuring every tray and
packaged item was exposed sufficiently to the sterilant. See our
high quality chemical indicators by clicking on
Sterility Assurance Products.
A full explanation of what each ‘Class’ represents is outlined
there.
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Is it necessary to keep
sterilizer records? Are there record books available on the market
to buy?
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YES and YES!
Record keeping is a must, and is easy to do and manage using our
20-page log record books. Every sterilizer should have its own log
book kept up to date which should record: Date of test, Operator,
Load contents, Temperature and time of sterilizer run, Integrator
and spore test (BI) results. Most of our programs include the
20-page log book but you can also purchase them separately (see
Sterility Assurance Products).
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Is your question not
answered here? |
Please forward your question(s) to
info@autoclavesporetesting.com and we’ll gladly respond the same
hour, or call us at 877/ATS-1199.
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ATS Inc. | Autoclave Testing
Service, Inc. | Dental Daily Testing | Spore Strip Testing | Ontario
Spore Testing Requirements | Products for Daily Testing |
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