Activeforever CIDEX Plus Solution - Manual (Page 2)

H
ospital-acquired infections (HAIs) pose a
serious threat to patient safety, affecting
more than 2 million patients every year in
the United States and many more worldwide. 1 As a
result, they have received increasing attention from
healthcare professionals, as well as state and federal
regulatory agencies, hospital administrators, payors,
the media, and patients. A number of campaigns are
underway to reduce the incidence of HAIs, focusing on
prevention practices and changes in reimbursement.
The Joint Commission has added preventable infections
as one of its National Patient Safety Goals,
2 and the
Association for Professionals in Infection Control
and Epidemiology (APIC) has launched a campaign
emphasizing prevention of HAIs and other adverse
events.
3 In addition, the Centers for Medicare
and Medicaid Services will no longer provide
reimbursement for the added cost of care of patients
with several types of HAIs.
4 The implications of these
initiatives are far-reaching for hospitals and infection
prevention professionals.
With more than 10 million
gastrointestinal endoscopic
and 500,000 flexible
bronchoscopic procedures
performed every year in the
United States,
5,6 reusable
flexible endoscopes have
the potential to play a role
in HAIs. During clinical
use, endoscopes are
contaminated by multiple
microorganisms, and
failure to appropriately
clean, disinfect, or sterilize endoscopes has resulted
in nosocomial outbreaks and serious infections.
7,8 As
a result, proper cleaning and disinfection of expensive,
delicate endoscopes are crucial to ensure patient
safety and maintain optimal function.
7,9 The clinically
established efficacy of detergents and disinfectants
clearly plays a key part in instrument processing,
and their selection is an important clinical and risk
management decision.
High-Level Disinfection
Endoscopes and other devices that contact mucous
membranes but normally do not cross the blood
barrier are, by definition, semi-critical devices and
must undergo high-level disinfection. According to
APIC, this means elimination of many or all pathogenic
organisms, except bacterial spores.
10 High-level
disinfectants cleared for use with semi-critical
medical devices must demonstrate 100% kill of 10
5
to 10 6 mycobacteria in the presence of 2% horse
serum in quantitative tests and pass the sporicidal
test of AOAC International, the Association of
Analytical Communities.
11
Liquid chemical germicides that are high-level
disinfectants ideally should offer effectiveness, speed,
and ease of use and be compatible with a variety of
materials used in medical devices. These chemicals
also should not be noxious or toxic to personnel.
7
The high-level disinfectant CIDEX ® OPA Solution
(0.55% ortho-phthalaldehyde) (Advanced Sterilization
Products [ASP], Division of Ethicon, Inc.) meets these
criteria and, in nearly 10 years of clinical use and
efficacy testing, is proven effective against a broad
range of viruses, fungi, and mycobacteria.
CIDEX ® OPA Solution
CIDEX ® OPA Solution was introduced by ASP in
1999 to meet the need for effective, fast, easy-to-use
high-level disinfection and to address staff concerns
about the safety of glutaraldehyde. CIDEX OPA
Solution is bactericidal, sporicidal, virucidal, fungicidal,
and tuberculocidal. It achieves high-level disinfection
in 12 minutes at room temperature and also has been
cleared for marketing in the United States for use
in automatic endoscope reprocessors (high-level
disinfection in 5 minutes at 25ºC). Extensive
testing has shown that the high-level disinfectant is
non-corrosive and is compatible with a wide variety of
materials commonly found in endoscopes and other
medical devices. (See Table 1) It also is gentler on
flexible endoscopes than peracetic acid.
12
Table 1: Materials Shown To Be Compatible with
CIDEX
® OPA Solution*
Metals
• Aluminum • Anodized aluminum
• Brass • Carbon steel
• Chrome-plated brass/steel • Copper
• Nickel-plated brass • Nickel-silver alloy
• Stainless-steel/titanium • Tungsten carbide/
vanadium steel
Plastics & Elastomers
• Acetal • Acrylonitrile-butadiene-styrene (ABS)
• Nylon • Polyamide
• Polycarbonate • Polyethylene
• Polypropylene • Polystyrene
• Polysulfone • Polyvinyl chloride (PVC)
• PTFE • Kraton G
• Natural rubber latex • Polychloraprene (Neoprene)
• Polyurethane • Silicone rubber
• Polyethylene terephthalate • Polymethylmethacrylate
(polyester) • (acrylic)
Adhesives
• Cyanoacrylate • EPO-TEK 301 epoxy
• EPO-TEK 353 epoxy
Dental Materials
• Addition silicone • Polyether
• Polysulphide
*Data on file at ASP.
“CIDEX ® OPA
Solution...is proven
effective against a
broad range of
viruses, fungi,
and mycobacteria.”
2