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CIDEX

OPA Solution has no offensive odor. In contrast

o glutaraldehyde, the Occupational Safety & Health

Administration has not set permissible exposure limits

or 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 r

euse 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 viabl

e or

ganisms r

emaining aft

er e

xposur

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 mark

eting

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 ar

ound the world and claims vary

by country, evaluations also have been done based on

other times and t

emperatures. 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

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.

Similar assays with Mycobacterium bovis (BCG) were

done with 0.2% OPA. Results showed a complete kill

(

.5 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.

Subsequent studies have provided more information

about the effic

acy of CIDEX

A Solution. For example,

a 2001 comparison of the mycobactericidal activity of

tho

-phthalaldehyde (OP

A), glut

aldehyde, and other

dialdehydes by quantit

ativ

e suspension testing found

Table 2: Bactericidal Efficacy Test with CIDEX

OPA

Solution, 5 Minutes at 20°C

Organism Tested Result

Staph

ylococcus aureus

TCC 6538) No growth

Salmonella choleraesuis (ATCC 10708) No growth

seudomonas aeruginosa

CC 15442) No growth

Methicillin-resistant

Staphylococcus aureus

(MRSA) (ATCC 33592) No growth

Vancomycin-resistant

Enterococcus faecalis

(VRE) (A

CC 51299)

No gr

owth

Staph

ylococcus aureus

(CIP 4.83) .5 l

og reduction

Enterococcus hirae (CIP 58.55) .5 log reduction

Pseudomonas aeruginosa (ATCC 103467) .5 log reduction

*When used or reused in a legally marketed AER that can be set to a

minimum of 25C.

1 2 3 4 5 6

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