|
Cleaning verification; what to do after a steam
outage; cleaning channeled medical devices
by Ray Taurasi
Q AAMI recommendations now
call for weekly, preferably daily monitoring of the cleaning process.
I have opted to conduct daily cleaning verification testing as I
believe that would be a best practice policy. We have four relatively
new 4-level washers. For the first few weeks I conducted testing all
the results came out perfect indicating that the washers were
performing properly. Over the past couple of weeks I have been getting
conflicting results. One day all of the washers will pass, then the
next day one will fail for no apparent reason. The next day the same
washer passes but another one fails. I started conducting additional
testing on all four washers and kept getting conflicting results. On
consecutive testing a washer may pass one test but then fail the very
next test. I have tried a few different testing devices but get
similar results. All of my print-outs look fine, instruments look
clean and the washers seem to be functioning fine. I really question
the validity of these testing methods. What are your thoughts?
A I am a strong advocate and
supporter of the AAMI and AORN recommendations relative to cleaning
verification. A failed cleaning verification test is a serious matter
indicating that your equipment and cleaning processing is not at
optimum performance and that your instruments may not be effectively
cleaned. Often, conflicting results, such as those you have described,
are a result of a faulty washer rack being used between washers. You
must recognize that a washer rack is actually in and of itself a piece
of equipment. Spray arms might be occluded, misaligned or defective.
Bushings could be cracked or broken; the rack may not align properly
to the coupler and water source affecting water flow and pressure. If
you are using racks interchangeably between your four washers I would
suggest that you identify and label each rack and that when you
conduct your cleaning verification testing you include the rack
identification on the record sheet. In that way you will be able to
identify if the conflicting results are caused by a defective rack.
Q
From time to time we experience steam outages and I was wondering if
we are required to re-validate/verify the sterilizers’ performance
prior to running a sterile load once the steam is turned back on?
A
The need to verify the sterilizer’s proper function
after a steam outage would depend on the reason of the steam
shut-down. If the steam service was interrupted due to a major repair,
such as the replacement of the boiler, plumbing, water source, etc.,
then retesting is recommended. This would include running three
consecutive Bowie Dick Tests, and three consecutive tests using PCDs
with BI. All test results would need to be satisfactory. Steam outages
for other reasons, e.g. routine maintenance, emergency testing, etc.,
would not require you do testing prior to reuse of the sterilizer. It
is important you know the reason/nature of the interrupted steam
service and act accordingly. If you are ever in doubt then you should
definitely do the testing.
Q
I am the director of Sterile Processing at a large teaching hospital
which includes a very large Clinical Research Center (CRC). The
Clinical research Center utilizes many unique products and medical
devices; many are prototypes which require reprocessing and
sterilization. Recently the CRC introduced a new procedure set which
includes several small cannulated devices and specialty needles. I am
concerned about cleaning these items effectively; although they do
appear to be visibly clean and when flushed the water is clear. I am
concerned about invisible soils, films and the like that might be in
the channels and pose a risk for cross contamination. I would like to
feel more confident that these items are being cleaned effectively and
are free of contaminants. Is there any way I might be able to ensure
the channels are clean and free of soil residuals?
A
Effective cleaning must include the removal of visible
as well as invisible soil. Channeled and cannulated medical devices
are among the most challenging to clean – residual soils remaining in
the lumen of these devices can inhibit the sterilization process and
indeed result in the transmission of infectious agents from one
patient to another. With the widely publicized reports in the media of
breaches in cleaning procedures, which have placed thousands of
patients at risk, coupled with recent AAMI1 and AORN2
recommendations; cleaning verification is fast becoming the standard
of practice. Both AORN and AAMI recommendations call for routine
Quality Assurance (QA) monitoring (cleaning verification).
In its Recommended Practices for Cleaning and Care
of Surgical Instruments and Powered Equipment (Recommendation
XXII.a), AORN states, "A quality management program should be in place
to test mechanical cleaning equipment.
• Mechanical instrument washers should be tested for
proper functioning before initial use, weekly during service, and
after major maintenance.
• Manual cleaning should be evaluated when new types
of instruments are reprocessed, and periodically, at intervals
determined by the health care organization."
The AORN recommendation also states, "Periodic testing
provides an opportunity to evaluate the performance of personnel.
Manual cleaning is a learned skill and subject to human error. New
instruments can pose unique challenges when cleaning. Protein
indicators are commercially available to assist with this evaluation."
One commercially available quality assurance test to
validate cleaning efficacy of cannulated medical devices is
ChannelCheck, an easy-to-use dip stick test. It is economical, at
about a dollar per test, making it affordable for testing every
reprocessable device with a lumen including, flexible and rigid
scopes, suction tips, needles, channeled instruments and the like. The
test strip consists of three pads for residual soil detection which
are highly sensitive to protein, carbohydrates, and hemoglobin. The
test is simple to use: Following cleaning, the channel of the medical
device is flushed with sterile water which is captured in a small cup.
The test strip is dipped into the captured water, and the pads are
observed for color change which indicates and identifies soil
residuals which were found in the channel.
References:
1. ANSI/AAMI ST79:2006 and A1:2008, A2:2009 7.5.3.3
2. AORN Recommended Practices for Cleaning and Care of
Surgical Instruments and Powered Equipment. http://www.aorn.org/docs_assets/55B250E0-9779-5C0D-1DDC8177C9B4C8EB/EE0C9FD6-0A0C-569E-EB966FF667D40858/08RP%20
Inst_Equip_10-29_pub%20com.pdf
Ray Taurasi is Eastern Regional Director of Clinical Sales and
Services for Healthmark Industries. His healthcare career spans over
three decades as an Administrator, Educator, Technologist and
Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past
president of IAHCSMM and has served on and contributed to many
national committees with a myriad of professional organizations,
manufacturers, corporations and prestigious healthcare networks.
Taurasi has been a faculty member of numerous colleges teaching in the
divisions of business administration and health sciences. In addition
to this column he has authored several articles and has been a
featured speaker on the international scene. |
