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Driving best practices: A multi-faceted goal for SPDs
by Julie E. Williamson
A s virtually any sterile
processing professional can attest, achieving quality, maximizing
efficiencies and striving for the highest of standards within the discipline
cannot be adequately attained by simply adopting one – or even several – key
practices.
On the contrary, success in the SPD comes from the
acceptance and consistent adherence of a wide range of practices, not all of
which necessarily garner the same outcomes in all facilities. Because no two
SPDs are identical, it’s up to each department and organization to determine
the practices, policies, processes, and technologies that will drive the
best outcomes for their own staff and patient populations.
Still, there’s no question that the lessons SPD
professionals can learn from one another can be invaluable, which is why
Healthcare Purchasing News routinely seeks out SPDs that have witnessed
the value of their own so-called best practices firsthand and are willing to
share their experiences with others. As you will read, success comes in many
different forms, and stems from hard work, discipline and a department- and
facility-wide commitment to buck tradition and push best practices to new
heights.
Strong Memorial Hospital’s Materials
Processing Department
Breaking the bottlenecks, boosting performance
Like many other sterile processing departments, Strong
Memorial Hospital’s Materials Processing Department in Rochester, NY, was
facing some significant productivity and performance challenges that were
raising the potential for errors, bottlenecks and cross-contamination, and
leading staff morale on a downward spiral.
The primary source of their angst was two aging indexing
tunnel washers – purchased in 1997 — and one single chamber instrument
washer that broke down almost daily, slowed productivity to a snail’s pace
and, not surprisingly, led to some unhappy customers who often took out
their frustrations on the already beleaguered SPD team.
"When an individual chamber broke down, the entire indexing
tunnel washer was put out of commission," noted Frank Riggi, administrator
of Strong Memorial Hospital’s materials processing department, adding that
when it did go down, it was often for as long as four days. "During these
periods, our staff had no choice but to strain the capacity limits of the
second indexing tunnel washer in the effort to keep up with the demand for
surgical instrumentation." The department, which began using the TOSI test
to verify cleaning efficiency, saw TOSI failure rates of 25-50% on a daily
basis. This caused the department’s productivity to plummet even more
because of the need for more manual cleaning and reprocessing, according to
Riggi.
The frustrations from all sides were certainly
understandable. Not only was the processing department responsible for the
cleaning, decontamination and sterilization of all surgical instruments for
the University of Rochester Medical Center’s Strong Memorial, which includes
a 750-bed care center (the largest in the area), the hospital had also
recently added 12 new operating rooms to the 24 existing surgical suites.
Despite the increasing demand, the MPD still had to rely upon the
inefficient, poorly functioning washers.
It wasn’t uncommon for instruments in need of assembly and
washing to spill over to the next shift. Evening shift workers, for example,
would often arrive to find a large backlog of instruments, and needless to
say, they were less than eager to come to work given the anticipation of
bottlenecks and the mounting pressure to play catch-up before the next
morning’s procedures. Strong Memorial’s nearby sister hospital also felt the
pinch because it had to step in and help process the backlogged instruments.
Cross-contamination risks were another major concern and
occurred every time the indexing tunnel washer doors opened. Aside from
that, the aging equipment was extremely noisy, consumed valuable floor space
and gave off a tremendous amount of residual heat, which pushed the
temperature on the decontamination side to nearly 85 sweltering degrees.
Eventually Strong Memorial recognized that changes were in order and turned
to Getinge, which was literally up the road and was already helping repair
the existing equipment (which came from another vendor), for assistance.
Strong Memorial’s MPD opted for the integration of a series
of Getinge 8666 washer/disinfectors with the Getinge Air Glide Shuttle
System. The washer/disinfector would provide the MPD with large,
unobstructed racks to accommodate a wide array of types and sizes of
instrument sets and sterilization containers, and drive efficiencies through
energy-saving heat transfer technology that cut process times. The
integrated AGS would free up valuable floor space and its automation would
reduce the need for handling and lifting, and allow staff to allocate their
time elsewhere.
Getting to that point would take time and patience, however.
While the department waited for the new equipment to arrive and for the
required construction to take place, the old equipment needed to be
regularly serviced to stay operable (as much as possible). It was no easy
undertaking. Approximately one week before the new tunnel washers were to
arrive, one of the two existing tunnel washers officially died, leaving
Riggi and his team with just one.
"Obviously, it was a very difficult situation," said Riggi.
Fortunately, it was temporary.
In January 2007, the new six-unit system began operation in
the MPD. With the new system, a single shuttle moves along the soiled side
of the aligned washer/disinfectors, and another operates along the clean
side. Wash carts are placed on the loading conveyor at a single point and
don’t have to be manually moved again. Once a washer/disinfector completes a
cycle, the AGS shuttle automatically delivers the next soiled load to the
next available washer.
"We just load the manifold cart onto the conveyor and it
loads automatically," raved Riggi. Given that the department operates
round-the-clock and processes at least 400-500 trays each day, the improved
efficiencies and system reliability can’t be ignored. Unscheduled downtime
has been eliminated, the need for manual cleaning has been greatly reduced
and TOSI testing has become "100% successful." Bottlenecks, which would
often keep the decontamination area at a frenzied pace until midnight or
later, are also a thing of the past. These days, Riggi said the
decontamination area is "easily free of all instruments by 8:30 pm."
And the benefits didn’t end there. More efficient and
reliable equipment also resulted in less detergent use. "With the old
washers we were going through 30-gallon drums of [pre-wash and main-wash]
detergent about every other day. Now it’s only every couple weeks," said
Riggi.
Comfort levels in the decontamination area have also gotten
a much-needed boost. Noise levels have been dramatically reduced and the
once sky-high temperatures have now dropped to a cool 68-70 degrees. "The
changeover has been a tremendous morale and productivity booster."
Stepping up the standards
While consistent standard adherence is an essential element
in sterile processing departments’ quest for quality and process
consistency, some facilities operate under the assumption that merely
meeting standard requirements isn’t sufficient.
One such example relates to load monitoring with a
biological indicator. Although the Association for the Advancement of
Medical Instrumentation recommends monitoring sterilization loads with a
biological at least weekly, and preferably, daily – and the monitoring of
every implantable device —some SPDs have opted to up the frequency. Take
Detroit Medical Center and Knoxville, TN-based Fort Sanders Regional Medical
Center – both of which monitor each and every sterilization load and
wouldn’t dream of doing any less.
Although, admittedly, some in the sterile processing
industry may consider every load monitoring overkill, those at the helm of
these two hospitals contend it’s a practice that, despite going above and
beyond AAMI standards, is well worth the effort. For Fort Sanders Regional,
the move to every load monitoring occurred about ten years ago, after a
major recall left the facility reeling.
"We had been following the standard of once daily
monitoring, and monitoring of every implantable, but after that significant
recall and all the time, stress and [disruption] that went along with it, we
decided to become more proactive," noted Donna McLaughlin, CRCST, sterile
processing manager for Forth Sanders Regional Medical Center. The SPD, which
processes upward of 8,000 instrument trays a month, and operates out of a
facility across the street from the hospital – linked by an underground
corridor – now can quickly and easily track instruments with negative or
questionable biological monitoring results.
Much like Fort Sanders Regional, Detroit Medical Center’s
SPD, led by corporate director of sterile processing Patti Koncur, wanted
the same degree of accountability for every load processed, not just
implantables, and not just items subjected to steam cycles. Not only would
every load monitoring promote quality and better patient outcomes, DMC
reasoned, it would also result in far less headaches in the event of a
recall.
"Even in a small facility, if you’re monitoring loads once a
week and have a recall, it can be a nightmare having to track down
everything that was [processed] that week," she explained. "When you
consider the actual cost of a recall, including having to tell a doctor that
he may have used a [non-sterile item] on one or more of his patients, you
see that the cost of using a test pack is negligible." To be clear, DMC is
anything but small. The 24-hour SPD, run by 101 sterile processing
professionals, processes more than 3,000 trays per week and is responsible
for eight facilities on four different DMC campuses.
Every load monitoring is nothing new for Koncur. It’s a
practice she’s advocated for and implemented for at least 15 years, at every
facility she’s worked.
"Some people may think every load monitoring is overkill,
but when you consider all the variables of a cycle, I believe you can’t be
too careful," she said. "Standards are minimum guidelines, and I don’t
settle for the minimum." 
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Sterile
processing: How far we’ve come
As technology
continuously advances in the operating room and other direct patient
care areas, sterile processing’s capabilities have had to evolve right
along with it. Here vendors offer insight into what they believe has
been the greatest step forward – in terms of either improved processes
and practices, or their own industry-leading technology — in the sterile
processing discipline.
 Arguably,
the two most significant improvements with washers are their cleaning
effectiveness and the focus on reduced water consumption. Cleaning
efficacy has improved to the point that most pre-cleaning is not
necessary, saving time and costs for the SPD. Water conservation, which
is seeing rapid increase in attention and concern, is critical in many
parts of the country so features such as automatic adjustment of water
usage based upon load size are commanding consideration.
With sterilizers, the conversion from a water jet (Venturi) vacuum to a
vacuum pump also greatly reduces water consumption as well as improving
drying effectiveness. These two improvements, again, address the
continuing need for resource conservation, both natural and personnel.
Taking a "blue sky" perspective, next generation products will need to
easily deal with an increasing number of sterilization requirements,
with minimal to no operator intervention. As load sizes vary, and tend
to increase, both washers and sterilizers will need to become "smarter"
in determining parameters such as wash and dry times in washers as well
as cycle times for sterilization. We could also see further improvements
in automation systems which will increase the flow throughput and
produce more repeatable processes. Of course, data sharing and
documentation of the cycle parameters will continue to evolve and become
increasingly automated.
John Nies, Product Manager, Belimed
Inc.
 The
increasing requirement for SPD staff to become certified in their
profession as "infection preventionists." This small step fuses
continuing education with training, thus improving the products and
services they deliver, which enhances SPD staff self-esteem and
increases their value to the institutions and customers they serve.
Mike Cain, director of
product management, Getinge USA
The continuing use of
advances in technologies to assist the end-users in their daily sterile
processing tasks is always a step forward. Ergonomic technology, green
technology, and automation technology have all contributed to making the
job of the CS worker physically easier, while at the same time enhancing
the quality of their work as it affects infection control in the
healthcare facility. Also, the growing focus on certification of the CS
worker by local and state agencies ensures a continuing and measurable
emphasis on training and professional advancement within the SPD
community — once again, favorably affecting infection control in the
healthcare facility.
Mike Carragher,
product manager, steam sterilizers, Getinge USA
 The
most noteworthy development in the last 12 months is the adoption by the
AORN of new guidelines for proper reprocessing of surgical instruments.
This includes the recommended practice of testing the performance of
automated cleaning equipment on a minimum weekly basis, after
installation and after a major repair. For the first time, a North
American standards body has not only advocated for the periodic testing
of cleaning process (as AAMI, for instance, has done in ST79 and other
documents), but has specified a minimum test interval - in this case
weekly. Now, sterile processing professionals have a powerful ally in
their mission of improving the quality and performance of their
processes. The specific citation is: Recommended Practices for Cleaning
and Care of Surgical Instruments and Powered Equipment, Section XXII.a
Ralph Basile, vice
president of marketing, Healthmark Industries Co.
 We
believe the greatest step forward in sterile processing is the
fundamental shift in how the Sterile Processing Departments reprocess
instruments for patient use. While the mission of SPD hasn’t changed (to
provide sterile instrumentation in an optimal condition for use at the
lowest possible cost), many factors impacting how they perform their
mission have. For example, there continues to be significant
advancements in medical instrumentation, often coupled with unique
requirements such as special cleaning instructions or extended
sterilization cycles. The complexity of these devices and the
wide-ranging decontamination and sterilization processes required to
ensure high-quality patient care has created a critical need for sterile
processing information systems. A busy SPD with no supporting
information system can quickly become inefficient and reactive.
Sterile Processing
Information Systems such as SPM Software with 3M Attest Monitoring
Interface (the only system that provides real-time availability of 3M
Attest Rapid Readout Biological Indicator results), represent the best
way to manage these new complexities while providing sterile devices in
the most cost effective manner. These systems provide information at the
point of need, collect data to ensure quality and compliance, provide
reporting capabilities on key productivity metrics, support lean
workflow design, and interface with equipment and other clinical
applications. In short, they are critical in helping SPD leaders provide
high quality care in light of changing requirements for instrument
reprocessing.
Tammy M. Torbert,
marketing manager, 3M Sterilization Assurance
 As
more and more medical devices come to market and infection control
standards are monitored by industry groups, there is an acute need to
provide accurate and up-to-date guidance to hospital staff on which
devices can be sterilized in a particular sterilization modality. When
visiting customers each week, I’m constantly surprised when I see the
mounds of outdated paperwork and thick manuals they need to sift through
to determine whether a device can be sterilized in a specific
sterilizer. To fulfill this unmet need and demonstrate its commitment to
following the Association for the Advancement of Medical Instrumentation
and Association of periOperative Registered Nurses Standards and
Recommended Practices, ASP took the lead and developed the STERRAD
Sterility Guide. This is indeed one of the most recent innovative steps
forward. The ASP STERRAD Sterility Guide is the first-of-its-kind online
tool designed to help healthcare professionals around the world quickly,
easily and accurately determine which instruments can be sterilized in
STERRAD Systems.
With the ASP STERRAD
Sterility Guide, STERRAD System customers can simply visit the STERRAD
website to receive a timely, accurate - and current - answer. By
following a few simple steps on the new website, www.sterrad.com/sterilityguide,
STERRAD System customers can immediately obtain confirmation 24 hours a
day, seven days a week as to whether a device can be sterilized in a
STERRAD System. All devices listed on the STERRAD Sterility Guide have
been approved for use in a STERRAD System by the appropriate medical
device manufacturer. ASP has partnered with medical device manufacturers
around the world to add new devices on a regular basis.
Barbara Trattler, RN,
MPA, CNOR, CNA, and director of clinical education at ASP
 We believe the most
important technological step forward is the advent of low cost, fast
cycle time, flexible capacity, room temperature sterilization methods.
The room temperature instrument sterilization approach demonstrated by
Germgard Lighting LLC utilizes a unique, oxidizing gas mixture called RG.
The gas mixture includes ozone, a proven sterilant for centralized
instrument sterilization, but it also contains oxidizers much more
powerful than ozone. The instrument or instruments to be sterilized are
placed in scalable, semi rigid, single instrument pouch or multi
instrument kit, which is then sealed and is impervious to pathogens or
gas flow. Using an innovative, patented approach, RG is continuously
created and maintained within the pouch or kit. No RG leaves the sealed
pouch or kit and it is converted back to harmless gases before the pouch
or kit is opened. The unwrapped surgical instrument, or set of
instruments, continue to remain sealed in the pouch or kit until used,
and there is no handling of the instrument until opened.
The total cycle time for
the process is much shorter than for steam sterilization; or any other
room temperature, gas sterilant process. Currently, we are running
validation testing placing Geobacillus stearothermophilus spores at the
center of 1 meter long, 3 mm diameter lumen test structures. The cycle
time is 20 minutes. We believe that even shorter times are possible.
Shorter cycle times are important since they reduce instrument damage
and accelerate inventory turn around. This short cycle time makes
Germgard’s method unique and ideal for clinical environments as well as
for rapid sterilization in the OR and mobile hospitals.The unit is
smaller than current table top offerings, but has flexible, expandable
capacity. Since the pouches are sealable, the efficiency is not
constrained by fixed capacity. Overall the short process is less
expensive. We calculate that it will be a 10× improvement over current
methods on a cost of sterilization per tool basis. It also will use very
little electricity per cycle, no water, produce very little waste, and
is not explosive or poisonous, so it will drive the trend towards more
environmentally friendliness and safe techniques.
Peter Gordon, vice
president of marketing and founder, GermGard Lighting LLC
 In the last several years,
automated washing technologies have advanced to provide the user with
more information about the cleaning process, specifically the
documentation of individual cycle parameters. In addition, cleaning
process challenge devices have evolved and added new resources to the
SPD quality assurance toolkit.
In addition, software
advancements now allow us to track reusable medical devices through the
various stages of reprocessing. More importantly, the SPD has gained
additional administrative support and acceptance, both in terms of
financial support and because they are now a recognized contributor to a
sound quality initiative for healthcare facilities. The sterile
processing department now has the ear of Sr. management in healthcare
facilities, who understand the importance of the return-on-investment
for infection prevention.
Richard Schule,
director of clinical education, STERIS Corporation
 SPSmedical believes the
greatest step forward in the sterile processing discipline has been the
recognition of this critical area of healthcare as a profession and the
development of standards. When I came into this industry over 25 years
ago, sterile processing was seen as a menial job that was done by people
hired off the street with no experience or training. It was common to
see SPDs without standardized procedures and a general lack of
understanding (and respect) for the reprocessing tasks throughout the
facility. Over the years, this has drastically changed primarily due to
the complexity of new instrumentation and their reprocessing procedures
which require special attention to cleaning, disinfection, inspection,
packaging, sterilization and handling. Sterile processing best practices
from AAMI and AORN, provides a reference for standardization and
recognition of the important role they play in patient safety. Today, we
have a large and growing number of certified sterile processing
personnel, an abundance of continuing education programs and materials
available, sterilization recommended practices adopted by ANSI as our
American National Standard, and respect for the profession of sterile
processing as a critical part of the surgical team.
Charles Hughes,
GM/educator, SPSmedical Supply Corp.
 The greatest leap forward
in the sterile processing disclpline has been the use of technology in
aiding the education of sterile processing staff. Utilizing the
internet, sterile processing professionals can explore various solutions
in one sitting and can communicate with many vendors without having to
take considerable time to do so, especially important in these days of
dual and multi-source contracts. This ability ensures that sterile
processing professionals are increasingly more informed about products
and services open to them and that they can do so on their schedules
being less and less reliant on the efforts of a sales representative.
This leveling of the playing field will continue to force products and
companies to stand on their own merits and will increase the exposure of
quality products and services offered from specialty and non-traditional
suppliers.
Dan Dwyer, Raven Labs |
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