INSIDE THE CURRENT ISSUE
Aiming lethal weapons against microbial foes
Education, innovation give disinfectants more ammunition
by Julie E. Williamson
Spectra-Moist spray-on lubricant
by Spectrum Surgical
Instruments Corp. helps
prolong instrument life
Recent media reports of contaminated endoscopes
that may have
exposed thousands of patients to hepatitis C or HIV have underscored the
importance of safe, appropriate and consistent instrument disinfection.
While the two endoscope mishaps – one of which stemmed from endoscopy
equipment being rinsed, but not disinfected – occurred at separate Veteran
Affairs facilities, it’s important to recognize that instrument
processing-related errors can occur at virtually any healthcare facility,
although many of these incidents go undetected and never make headlines.
Among the most critical points raised by the recent endoscope debacle:
sterile processing professionals and others involved in instrument
processing can make grave mistakes, with potentially life-threatening
consequences, if they don’t consistently follow industry standards and
device and disinfectant manufacturers’ instructions to the letter.
Many factors can contribute to processing shortcuts and decontamination
and sterilization errors. One of the greatest challenges, according to Matt
Rudolph, senior corporate trainer for Stow, OH-based
Instruments Corp., is having less time to properly clean, disinfect and
sterilize instruments (and having to do it with less staff).
"The instruments are constantly changing and becoming more complex. With
fewer employees, hospitals are being asked to do more with less," he said.
"This increases the chances of mistakes in the decontamination area. If the
instrument is not clean, it is not sterile."
Ruhof’s Endozime Xtreme Power super-concentrate,
multi-tiered enzymatic detergent
Insufficient instrumentation levels coupled with increasing case loads
that put pressure on staff to rapidly turn around devices is another common
SPD complaint that can lead to dangerous processing mistakes. And the
challenges don’t end there, either. Lack of ongoing training and consistent
direction from SPD managers can contribute to misunderstandings about how to
properly clean, disinfect and sterilize devices. What’s more, many sterile
processing technicians may find manufacturer instructions vague or
confusing. Even industry standards, which some say may not be defined or
rigid enough to direct users on best practices, may further increase the
risk for error.
"Such standards leave too much room for interpretation or variation in
practice, which results in some people doing an excellent job, but many
doing a poor job," noted Dixit Gandhi, product manager, central sterile
products, Medline Industries Inc., Mundelein, IL.
Consultant Charles Hancock, president of Charles O. Hancock Associates
Inc. in Fairport, NY, addressed the shortcomings further.
"In the standards, we talk a lot of cleaning and sterilization, but
there’s a big gap in knowledge and understanding regarding disinfection.
Even the Spaulding Classification is loosely defined, so it’s no wonder
people are struggling."
Set internal standards
While the challenges are very real, the onus of responsibility for
ensuring safe, effective instrument processing ultimately falls upon the
healthcare institution. The bottom line? In the absence of clearly defined
standards, it’s up to each healthcare institution to ensure that challenges
impacting staff are addressed as extensively as possible so they don’t
interfere with proper protocol and the delivery of clean, effectively
Metrex MetriCide OPA
One SPD manager said it’s essential for managers to fight for adequate
staffing levels and promote ongoing staff education of all aspects of
instrument processing – from before instruments arrive in the
decontamination area to their completion of disinfection and sterilization
cycles, and beyond.
"Education isn’t something you do once and then just assume that everyone
is going to be doing the right thing all the time," noted David Narance, RN,
BSN, CRCST, sterile reprocessing manager for MedCentral Health System in
Mansfield, OH. "Education should be a never-ending
For starters, technicians should have a solid understanding of which
devices will require either high-level disinfection or sterilization, as
well as which products are appropriate for use on each type of instrument
and piece of equipment. This requires that technicians be knowledgeable
about instrumentation to know a device’s purpose, its composition and how it
is used – information that will enable them to properly classify a device.
Such recommendations may seem like common sense, but sources indicated that
some SPDs routinely struggle with even these basic requirements.
"If you don’t know enough about the instruments or the [disinfectants
being used], you can really damage instruments. Many of the instruments
today have exotic and delicate components, which may or may not be able to
withstand certain disinfectants. Some disinfectants aren’t safe to use on
certain metals and plastics can be destroyed if you make the mistake of
using a product that wasn’t approved for that device. So before you
disinfect, you have to ensure compatibility," stressed Narance.
Carefully reading instructions and spec sheets – both for the instruments
and the germicidal solutions – is imperative. But even then, confusion can
sometimes set in and jeopardize the process’s effectiveness. Concentration
and dilution ratios, for example, can trip up even the most diligent
technician, especially as facilities switch to more concentrated products.
"In some cases, the calculations are very complicated and manufacturers
of these products assume the users have the compounding skills of a
pharmacist, which isn’t the case," explained Hancock. "Errors are easily
Medline disinfectant Meritz Plus
Narance does his best to tackle the issue head-on. "You don’t leave it to
[chance]. Any time there’s a new or more concentrated product introduced you
have to make sure staff is fully aware of the differences. Again, it boils
down to education," he said. "To make sure we’re getting to the correct
concentration, we carefully do the math and measure it out beforehand.
Guesswork won’t cut it."
The same concern goes for detergents. "If they are not dosed properly or
used in their intended manner they cannot be effective," stressed Eric
Willman, PhD., senior healthcare program leader for Ecolab Inc., St. Paul,
And don’t forget to turn to the vendors themselves with any questions.
"If you bring in a new instrument and are unclear how to process it, or if
you have any questions about a detergent, disinfectant or sterilant – or any
other product used in the process — go straight to the source," suggested
Today, vendors are taking a more active role in user education – at times
even going beyond practice standards to ensure that clean instruments are
being used on patients. As Medline’s Gandhi explained, that involves
providing education to help train staff, producing product literature on how
to best use products, participating in trials to promote best practices, and
continuously evolving products to clean more efficiently.
ASP CIDEX OPA Solution provides high level
disinfection with a rapid 5-minute immersion time
From pre-decontamination through high-level disinfection or
sterilization, SPDs now have access to an ever-growing array of products and
technologies to maximize effectiveness, boost efficiencies and eliminate
some of the burden (both physical and financial) associated with instrument
Products that prevent soil from drying on devices post-procedure and
begin breaking down bioburden even before instruments make their way into
decontamination are prevalent today, and a growing number of these products
are becoming more eco-friendly.
"Enzymes are very effective at removing blood soil at neutral pH. It can
be shown that a neutral enzyme solution has the same cleaning power as a
high pH detergent, without the corrosive side effects," Willman explained,
adding that because enzymes are derived from biological sources, they have a
strong sustainability aspect. Ecolab offers a variety of multi-enzymatic
detergents to use in different decontamination processes. The Asepti-Zyme
Foaming Detergent removes a wide range of soils and its crystal clear
solution allows visibility of instruments during the manual cleaning
Ruhof’s ENDOZIME Xtreme Power super-concentrate multi-tiered enzymatic
detergent with rust inhibitors delivers fast and thorough soil contamination
removal with less detergent usage. Designed for use in all endoscope
washers, washer disinfectors, ultrasonic washers and for manual cleaning,
Endozime XP features Advanced Proteolytic Action (APA) that greatly
increases protease enzyme activity. The detergent penetrates into the
hardest- to-reach channels of scopes and cannulated instruments, instantly
and actively breaking down gross contaminants upon contact. Endozime XP
contains biological additives that speed the process of liquification and
solubilization, facilitating enzymatic action and contributing to the
product’s overall effectiveness.
Detergent Spray, (24-oz.bottle)
begins the process of
breaking down medical soils
and keeps devices moist.
(1-gal. pump bottle and 5-gal. refill) penetrates and breaks down
contaminants including proteins, fats and carbohydrate-based soils.
Spectrum Surgical has made product enhancements to increase safety for
the end user. A new gel formula for its Spectra-Moist product, for example,
is biodegradable, phosphate-free, petrochemical-free and VOC-free. The
company routinely educates on the importance of keeping devices moist
post-procedure. Although products, such as Spectra-Moist are designed for
that purpose, Spectrum stresses that even spraying devices with water at the
end of the case (and keeping them covered with a wet towel en route to
decontam) can go a long way toward assisting in the cleaning process.
The trend toward concentrated solutions is also catching on – a move that
is helping reduce waste and per-cycle costs, while also making it easier for
staff to handle. Not only do these higher concentrated products perform as
well (and, sometimes, better) than standard formulas "the super-concentrate
items come in a 2.5-gallon jug and can replace 15-gallon drums," Medline’s
Gandhi said. "It is more environmentally-friendly, provides cost saving, is
easier to handle and stock, and is more ergonomic for the user." Medline’s
super-concentrate line of detergents and lubricants, for example, decrease
cost per cycle by up to 25%.
With a nod towards operational efficiency and cost-effectiveness,
MetriCide OPA Plus solution features a slight increase in strength allowing
it to deliver up to 32 more reprocessing cycles when compared to the
competing ortho-Phthalaldehyde (OPA) based high-level disinfectant brand.
The added active ingredient content in MetriCide OPA Plus enhances the
product’s use life (within the stated 14-day reuse period). Moreover,
MetriCide OPA Plus test strips read 33% faster, increasing back office
efficiencies while reducing the threat of healthcare acquired infections.
One Getinge USA product manager also considers new concentrations to be
among the most noteworthy disinfectant-related enhancements. "This new
chemistry enables users to minimize logistical costs and storage space, and
maximize disinfectant efficacy and efficiency," reasoned Christopher Dudley, Getinge Infection Control consumable products sales manager. Getinge’s
detergents and disinfectants are also color-coded for ease of identification
and application – even for non-English-speaking users. Also, for automated
dispensers of these products, Getinge includes tube stickers to ensure that
the proper wand is inserted into the correct container.
"All of our safety and MSDS information, including kill claims, are
included in our product literature, as well as published on our website,"
noted Dudley, adding that Getinge customers also receive free training and
inservice information on an initial and recurring basis, as necessary, to
ensure proper education during initial start-up, as well as during periods
of staff turnaround.
Photo courtesy Spectrum Surgical Instruments Corp.
Damage caused by saline solution.
Of course, advancements have also been made on the disinfection and
sterilization side. Today, SPDs have an ability to sterilize at lower
temperatures and with shorter cycle times – both attributes that help turn
inventory faster and minimize damage to instruments, which lowers
operational and replacement costs, stressed Peter Gordon, vice president of
marketing for Germgard Lighting LLC. Gordon explained that Germgard’s room
temperature process and operational mode is different from conventional low
temperature gas or steam sterilizers.
"We overcome the limits of fixed capacity," he said, noting that the
Germgard approach is scaleable and allows parallel processing. Kits, of
various sizes, of instruments can be prepared and filled with the
proprietary gas sterilant and then set aside while the gas does its job.
Kits of instruments can be filled in a minute or so, removed and set aside,
with their loads then processed in parallel, thereby allowing large
throughput from a small tabletop system, Gordon reasoned. Also, the overall
system is "environmentally-friendly, using less electricity, requiring no
water and no wasteful sterile wrap." And when users open the kit to remove
the instruments, it only contains air, added Gordon.
Advanced Sterilization Products’ STERRAD 100NX System, which provides
low-temperature hydrogen peroxide gas plasma sterilization, can safely
reprocess heat-sensitive devices. "Key to the technology is the plasma
phase, which is an active biological process that efficiently eliminates
hydrogen peroxide residuals on instruments by breaking them down into water
vapor and oxygen," said Charles Roberts, MS, director of ASP’s research and
development for biocides. "As a result, aeration and external venting are
Major advancements have been made regarding endoscope disinfection, with
user safety and efficacy serving as the driving factors in product
development. ASP’s EVOTECH Endoscope Cleaner and Reprocessor system was
designed to eliminate labor-intensive manual endoscope cleaning (when
selecting a cycle that includes a wash stage) and the variability inherent
to it. [Note: The EVOTECH system does not eliminate bedside precleaning
in procedure rooms, and no manual cleaning is required when selecting a
cycle that has a wash stage.]
"The system uses a separate pump for each endoscope channel, which allows
for lumen blockage and leak testing," noted ASP’s director of clinical
education Barbara Trattler, RN, MPA, CNOR, CNA. "Also, the system reduces
worker exposure to chemicals and delivers CIDEX OPA Concentrate and CIDEZYME
GI for each cycle automatically, ensuring that fresh solution is used every
time for every scope."
SPD manager’s take-home tips for safe product use
When it comes to safe, effective and consistent use of
chemical solutions in the SPD, David Narance, RN, BSN, CRCST, sterile
reprocessing manager for MedCentral Health System in Mansfield, OH,
prides himself on being proactive.
"It’s a manager’s job to know what’s going on in the
department and to help [staff] make the right decisions," he said.
Here are several of his top suggestions for diligent,
• Educate often. Make product MDS sheets readily
available to staff and ensure that technicians fully understand which
solutions (and the precise amount and concentration) are compatible
with which instruments. Rely on manufacturers to answer any questions
and fill in any training gaps.
• Be a super-sleuth. Regularly check under cabinets
and on shelves to ensure that no unapproved chemicals or solutions are
being used. Teach technicians that they should never introduce new
products without input from the manager or infection control
professional (this includes product samples received from healthcare
• Avoid chemical confusion by never reusing containers
or storing chemicals in unmarked jugs or spray bottles. Make a habit
of drilling holes in container bottoms as an additional safety
measure… then recycle.
Focus on the future
So what can SPDs expect from the disinfectant and sterilization market
According to one ASP expert, the biggest improvements will likely come on
the process side. "Sterilants and disinfects on the market today are already
very effective," said ASP R&D manager Chris French, PhD. "Advances in
sterilization and disinfection will, therefore, most likely be in the area
of process improvements. Reprocessing equipment will become easier to use
and more automated to ensure consistency of reprocessing and to minimize
operator training requirements."
French further forecasted that technology will likely be embedded to
ensure flawless tracking of medical instruments, and data may be logged and
integrated with medical user data management software. What’s more,
reprocessing chemistries will be entirely contained to minimize or eliminate
exposure, he said, and advances in microbial analysis will allow for the
automatic identification of pathogens of concern from trace residues on
Moving forward, Getinge’s Dudley predicts manufacturers will be
developing even more adaptive disinfectant solutions that will be more adept
at providing effective performance quality – even in the face of more
"Our biggest challenge is rapidly mutating organisms and the
recertification process to ensure comprehensive kill claims," he said. "I
believe that the creation and implementation of an ideal sterility assurance
program with extremely conservative assurance products, using the most
innovative technology, is the key to minimizing the [overuse] of antibiotics
during hospital stays, especially now that healthcare facilities are being
held responsible for nosocomial infections." Dudley sees increased testing,
claim certification and proper use, along with procedural compliance, as an
even greater necessity.
In the future, SPDs may also see the development of more productive
partnerships between key constituents – from instrument and reprocessing
product and equipment manufacturers to SPD staffers and infection control
professionals – to promote seamless integration of technologies.
"Our mission is to develop integrated solutions in partnership with our
customers and use innovative technologies that dramatically reduce the human
and financial costs of nosocomial infection," said ASP’s Roberts. "Only then
may seamless integration of device and reprocessing technologies occur to
the benefit of all parties, and as a result, raise the bar for the standard
of care and eliminate the tremendous impact of errors and accidental misuse
of sterilants and disinfectants."