Activeforever CIDEX Plus Solution - Manual (Page 3)

CIDEX ® OPA Solution has no offensive odor. In contrast
to glutaraldehyde, the Occupational Safety & Health
Administration has not set permissible exposure limits
for CIDEX OPA Solution and does not require special
venting or air monitoring in areas where the solution
is used or monitoring of staff who work with it. Local
regulations may vary, but generally the solution can be
discarded with running water into an ordinary drain.
CIDEX ® OPA Solution is ready to use from the bottle
and requires no mixing or activation. Test strips are
used to verify that the germicide has maintained
the minimum effective concentration (MEC) of 0.3%
CIDEX OPA Solution. Tests have shown that even
reused, stressed solution diluted to the MEC remains
bactericidal, sporicidal, virucidal, fungicidal, and
tuberculocidal at room temperature.
13–17 CIDEX OPA
Solution has a 14-day reuse life and an open-bottle
shelf life of 75 days. Unopened bottles have a shelf
life of two years when stored at 15–30°C. Although
provided at a near-neutral pH of 7.5, the solution is
stable for use over a wide range of pH (3-9).
Efficacy
The efficacy of CIDEX ® OPA Solution as a high-level
disinfectant has been established through extensive
evaluation by ASP over the past 10 years. A summary
of key efficacy testing follows.
Methodology
Two types of quantitative tests have been used
predominantly to evaluate the efficacy of CIDEX
® OPA
Solution. The first type utilized suspensions of
microorganisms diluted 1:10 into the solution at a
specified concentration and temperature. After a
specified period (usually minutes), a neutralizer was
added or the microorganisms were removed from the
suspension by vacuum filtration and then rinsed. The
number of viable organisms remaining after exposure
to the solution then was determined by quantitative
assay and compared quantitatively with organisms
that had no exposure to the solution. The reduction
in viable microorganisms is expressed as a log of the
number of organisms.
A second, more stringent test type evaluated the
efficacy of CIDEX
® OPA Solution in inactivating
microorganisms, including methicillin-resistant
Staphylococcus aureus (MRSA), vancomycin-resistant
Enterococcus faecalis (VRE), and viruses that had dried
onto a flat solid surface. After exposure to CIDEX OPA
Solution, the microbes were recovered, rinsed, and
quantitatively assayed.
CIDEX ® OPA Solution has been cleared for marketing
in the United States as a high-level disinfectant for
reusable medical and dental equipment processed at
20°C (12 minutes) and at 25°C (5 minutes).* Because
the solution is used around the world and claims vary
by country, evaluations also have been done based on
other times and temperatures. Testing shows that
CIDEX OPA Solution is bactericidal when instruments
are processed at 20°C for five minutes.
Mycobacteria
Effective control of mycobacteria is crucial in preventing
the transmission of disease by contaminated medical
devices. Mycobacteria demonstrating resistance to
aldehyde-based disinfectants (i.e., glutaraldehyde and
formaldehyde) have caused nosocomial infections in
the United States and elsewhere, and glutaraldehyde-
resistant mycobacteria have been isolated from flexible
endoscope reprocessing machines.
18,19 To address this
problem, the efficacy of reused CIDEX ® OPA Solution
was tested against glutaraldehyde-resistant
Mycobacterium chelonae. The test was based on a
protocol determined by the Environmental Protection
Agency (EPA) to simulate clinically reused disinfectants.
Suspensions of M. chelonae were exposed to reused
0.5% OPA at 20°C. The result: 5-log reduction after
5 minutes and complete kill (of 10
6 colony-forming
units/mL) after 15 minutes. By comparison, a solution
of reused 2.0% glutaraldehyde showed a 4-log
reduction in 20 minutes at 20°C.
13
Similar assays with Mycobacterium bovis (BCG) were
done with 0.2% OPA. Results showed a complete kill
(Ͼ5 log10) of viable mycobacteria after 5 minutes at
20°C. In contrast, although this mycobacterium was
not resistant to glutaraldehyde, 2.0% glutaraldehyde
gave a 2-log reduction after 10 minutes at the same
temperature.
13
Subsequent studies have provided more information
about the efficacy of CIDEX
® OPA Solution. For example,
a 2001 comparison of the mycobactericidal activity of
ortho-phthalaldehyde (OPA), glutaraldehyde, and other
dialdehydes by quantitative suspension testing found
Table 2: Bactericidal Efficacy Test with CIDEX ® OPA
Solution, 5 Minutes at 20°C
Organism Tested Result
Staphylococcus aureus (ATCC 6538) No growth
Salmonella choleraesuis (ATCC 10708) No growth
Pseudomonas aeruginosa (ATCC 15442) No growth
Methicillin-resistant Staphylococcus aureus
(MRSA) (ATCC 33592) No growth
Vancomycin-resistant Enterococcus faecalis
(VRE) (ATCC 51299) No growth
Staphylococcus aureus (CIP 4.83) Ͼ5 log reduction
Enterococcus hirae (CIP 58.55) Ͼ5 log reduction
Pseudomonas aeruginosa (ATCC 103467) Ͼ5 log reduction
3
*When used or reused in a legally marketed AER that can be set to a
minimum of 25C.