"I’m a firm believer that every patient should
receive the same standard of care," said Strunk. "In order for that to
happen manufacturers need to be sure their IFUs are readily available to any
person(s) using their product. Technicians should never have to guess during
any step of the process. Safety is reliant on these documents and making
sure they can be accessed and are updated should be a top priority of all
But it is not just about the devices and
instruments. CS/SPD staff must be well versed on the sterilants and
disinfectants products and modalities they are using in order to ensure
effective and safe processing, according to Genti Koci, BA, CRCST, Sterile
Processing Professional, Medical Staffing Options,
Ohio State University
"Techs must understand the factors under which
sterilants and disinfectants must be used to work effectively, including
their required temperatures, concentrations and time frames," said Koci.
"Mixing products or diluting them is considered processing outside of label
and could be dangerous. Furthermore, it is a myth that alcohol is a good
disinfectant. Unless a manufacturer’s IFU calls for alcohol to be used in
prep and pack, it should not be used. Alcohol has adhesive qualities and
helps microorganisms stick on surfaces, which makes sterilization
Efficiency and cost considerations
In an ideal world, instruments and devices
would be processed through the CS/SPD without any consideration for
efficiency or costs. But in today’s cost-conscious healthcare environment
where most facilities are forced to do more with less, CS/SPD staff must
take into consideration how sterilants and disinfectants can help them
perform their jobs in an more efficient and cost-effective manner.
"Manufacturers must consult with their end
users when developing products, such as enzymatics or high level
disinfectants," said Williams. "They tend to test their products in
controlled environments, such as a lab setting, featuring ideal conditions.
But working in a hospital there are no ideal conditions — it is a very
fast-paced, chaotic environment. While 10 minutes of contact time on
instruments provides adequate kill, is it practical? We are a heavy ortho
facility and with the items we process we don’t have the room or throughput
to allow items to soak for long periods. If manufacturers took the time to
gain these types of insights they could develop products to better meet our
"Of course, in this economy, another driver is
price and managers should understand the price of the product they are
purchasing," said Koci. "When evaluating sterilants and disinfectants,
sterile processing managers should work in collaboration with their
purchasing departments to make sure those products are on contract."
"Cost is definitely in the back of my mind when
selecting products," added Williams. "Factors such as the price and whether
it is a one-time use versus multiple use product — we take those into
consideration. But overall it’s what is best for the patient. If we can have
a chemical that works well but may cost a few cents more than another
product, obviously if it works better I have no problem eating that cost —
we can justify it."
Beth Fritcher, Global Marketing Manager for
says ethylene oxide (EO) sterilization can provide a cost savings when
compared to vaporized hydrogen peroxide sterilization. According to Fritcher,
hydrogen peroxide systems are convenient when fast turnaround times are
needed; however, if the device(s) being processed will not be used until the
next day or later, EO sterilization can be a much more cost effective
sterilization method. She points out how larger chambers with capacities of
8 cubic feet and 5 cubic feet can accommodate more instruments and there are
no restrictions on the length or inner diameter of endoscope channels.
"Following recent high-profile CRE outbreaks,
multiple affected facilities reported adding Ethylene Oxide (EtO or EO)
sterilization to their endoscope reprocessing protocols; following the
change, no further cases of CRE were identified," said Fritcher, citing
recent studies. "This has many health care facilities looking at EO as a way
to reduce patient risk. It has also started discussions on benefits versus
risk of using EO."
With continued outbreaks of illness
attributable to contaminated scopes and instruments, governmental and other
regulatory agencies are taking a hard look at cleaning and disinfection
practices in U.S. hospitals, according to Robert B. Dybec RN, MS, CPSN, CNOR,
Nurse Manager, Operating Room,
Winthrop-University Hospital. He points out
that hospitals and institutions want to know exactly what enzymatic cleaners
and disinfectants are being used and at what dilution rates and temperature
in order reduce the risks of cross contamination.
"CS/SPDs must be cognizant of
cleaner/disinfectant concentration rates," said Dybec. "Some enzymatic
cleaners for example are more concentrated and require more dilution in
order to obtain proper dosing requirements. Sometimes end users see these as
being more expensive but when you consider that you may need to purchase
more of a less concentrated product it ends up costing more in the long run.
Check concentration/dilution rates versus usage to see if the product is
cost-effective. Automated detergent dosing systems take the guesswork out of
this critical step in processing and help the CS/SPD in being more
Coles recommends that facilities take soak
time, number of rinses, reuse period, and instrument manufacturers’
recommendations into account when considering a high-level disinfectant. The
shorter the soak time, fewer the rinses and higher the reuse by period the
more efficient a facility will be.
PCI Medical’s GUS Disinfection Soak Station with
new electric leak tester.
PCI Medical’s GUS Disinfection Soak Stations
provide a vapor control system that is compatible with all high-level
disinfectants and improve the disinfection process by allowing the CS/SPD to
use less disinfectant while disinfecting multiple instruments at a time. The
GUS TC-3, for high-level disinfecting TEE probes, now comes with electrodes
on the tubes to facilitate leak testing with PCI Medical’s new electric leak
tester. The electric leak tester is programmable to a probe manufacturer’s
test limits, enabling compatibility with upcoming Intersocietal
Accreditation Commission (IAC) leak testing requirements.
Staff safety and
While the effectiveness of killing "bugs" is a
top priority when selecting sterilants and disinfectants, healthcare
facilities must also keep in mind the safety of the CS/SPD staff handling
these products, as well as their impact on the environment.
"On any given day, I can come in contact with
as many as five different types of sterilant/disinfectants," said Strunk.
"These products, ranging from OPA to peracetic acid, all have very specific
exposure times, temperature requirements and rinsing instructions just to
name a few of the items listed on an IFU. Educating your staff to safely
utilize these products is of the utmost importance not only to keep
themselves safe, but to make sure patients are receiving equipment that has
been properly disinfected and will not cause harm to them."
Balch notes how some may select the most
powerful or expensive chemicals on the market thinking they are the most
effective, but fail to consider the ramifications of this choice. He points
out how these products usually have the greatest requirements for
ventilation and safety given their chemistry.
Fritcher notes that despite the recognition of
EO as a tool in the fight against endoscope-associated infections, concerns
persist, often based on outdated notions of EO sterilization. She explains
that much of the misunderstanding about EO today is related to the past. It
was the mixed gas systems, installed in the 1970s and early 1980s (and now
outlawed in the U.S.) that were a risk to the healthcare worker.
"In reality, the EO sterilization systems of
today are nothing like the EO sterilization systems of yesterday," said
Fritcher. "The latest systems use small, single-dose cartridges of 100
percent EO, run under negative pressure cycles with mandatory locked
aeration, have sophisticated software controlled programs that detect
malfunctions and, importantly, have a long track record of safe and
effective use. The two newest EO sterilizers on the U.S. market received FDA
510(k) clearance this year in January 2015—the 3M Steri-Vac
Sterilizer/Aerator models GS8 and GS5."
Sterilizer/Aerator GS Series
3M Steri-Gas EO Gas Cartridges, single-dose
cartridges of 100 percent ethylene oxide, are one of the many safety
features and engineering controls built-in the 3M Steri-Vac
Sterilizer/Aerator GS Series, available in models with 8 ft3 and
5 ft3 chambers.
Another consideration is the environmental
impact of sterilants and disinfectants. According to Coles, more and more
facilities are requiring neutralization/deactivation of high-level
disinfectants before disposal, with California and Hawaii having passed laws
"High-level disinfectants are still highly
biocidal even after they have been used," said Coles. "Neutralizing these
disinfectants prior to disposal is a very important step in protecting the
users and also the sewer system and environment."
Williams notes that in Seattle, where his
facility is based, environmental standards are extremely strict so the CS/SPD
must be very conscious of what they are disposing down the drain.
"When we are disposing of glutaraldehyde for
example, we have to use certain products because the load of these
contaminants going into the sewer systems is too high — that is a huge
concern," said Williams.
According to SteriPro Medical Device
Reprocessing Manager Garry Bassi, the oxidative chemistry sterilant/disinfectant
his facility is using (see sidebar below) does not require neutralization
prior to disposal and hence is safe for the environment. SteriPro is
currently working with vendors to publish white papers showing the measured
fumes emitted into the environment from sterilants and disinfectants and if
they comply with the standard established safe exposure values.
SteriPro boosts efficiency, cuts costs through
SteriPro Canada, which performs reusable
medical device reprocessing and sterilization for hospitals and
healthcare centers, reduced its costs by 21 percent by switching from
glutaraldehyde chemistry to oxidative chemistry as a sterilant and/or
According to SteriPro Medical Device
Reprocessing Manager Garry Bassi, the oxidative chemistry test strips
also have a longer expiration date from time of opening the bottle
compared with ortho-phthalaldehyde (OPA) strips, 180 days versus 90 days
respectively. By switching from the OPA strips to the oxidative
chemistry strips, SteriPro reduced its costs for this product by 56
percent. He notes that the oxidative solution itself is viable for a
longer period from date of opening bottle, 90 days versus 75 days for
the OPA solution.
Furthermore, the oxidative chemistry solution
is less toxic, requiring no special ventilation requirements versus the
ten air exchanges per hour, which are recommended for OPA. SteriPro
recommends all reprocessing departments in Canada conduct an assessment
of their departments to ensure they have the appropriate air exchanges
per hour in accordance with Canadian Standards Association (CSA).
"The switch from OPA to oxidative chemistry has also
reduced the number of rinses required and facilitated a shorter soaking
time. We now turn around items quicker and save on the cost of sterile
water, while fulfilling the needs of the operating room priorities and
maintaining patient safety," said Bassi.