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Instrument being
tested with the
3M Clean-Trace Hygiene Management System |
Advanced monitoring tools increase
sterility assurance odds
by Julie E. Williamson
By
now, sterile processing professionals should be no stranger to the phrase,
"You can’t sterilize what isn’t clean." They also understand that bioburden
nestled in hard-to-reach nooks and crannies — and lingering microorganisms
that are invisible to the naked eye — can have devastating consequences on
patient outcomes.
That knowledge doesn’t always translate
into effective practice, however. In some cases, limited resources, such as
staffing, time and instrument inventory, can lead to haste and potentially
dangerous shortcuts. Insufficient staff education and training also play a
key role in processing-related missteps that call into question the
effectiveness of high-level disinfection and sterilization. And the risks
don’t end there. Even the most quality-focused, skilled and conscientious
technicians may have seen their device processing efforts fall short because
of somewhat limited testing product capabilities, and conflicting or
confusing instructions for use and standards, among other challenges.
Fortunately, that’s all beginning to
change. "The lack of global standardization and harmonization of practices
has been an issue which is now being addressed, and vendors are supplying
products that adhere to the standards and provide certification to prove
that they comply," said Crystal Shipley, Valisafe product manager at
Medisafe America.
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Medisafe America
offers a full line of Wash Checks to
detect residual proteins on devices and equipment. |
Product innovation
plentiful
Today’s sterility assurance products are
moving well beyond the capabilities of their not so distant predecessors.
One of the most notable improvements, sources agreed, is the addition of
cleaning verification tools, such as protein and Adenosine Triphosphate
(ATP) testing.
"In the past, we relied only on visual
inspection, which is very subjective," noted Rose Seavey, MBA, BS, RN, CNOR,
CRCST, CSPDT, president and CEO,
Seavey Healthcare Consulting LLC. "We now have many tools that we can
use to verify that our automatic washers are working properly and that we
have done a good job of cleaning the items before they go into the
sterilizer."
Standards are helping drive the development
and implementation of such products. Until 2008, there were no specific
professional recommendations relative to monitoring the cleaning process,
said Ray Taurasi, MBA, CRCST, CHL, FCS, ACE, director of clinical sales and
services for Healthmark
Industries’ eastern region. "Now, both AORN and AAMI recommendations
call for routine monitoring of the performance of automated cleaning
equipment, manual processes, and the cleaning efficacy of medical devices."
Aside from products that monitor automatic
washers, automatic endoscope reprocessors, ultrasonics, cart washers, and
the like, there are also tools that verify the cleanliness of complex
medical devices, such as endoscopes and cannulated instruments. Such tests
can detect residual soils like blood, protein and carbohydrates, which are
commonly found in difficult to clean devices.
|
SPSmedical's STEAMPlus Sterilization Integrator
is FDA cleared as equivalent in performance to a BI, giving users an
immediate indication whether their BI will pass or fail. |
"When soils are detected prior to
sterilization, the items can be re-cleaned, allowing for effective
sterilization outcomes," Taurasi explained. Healthmark’s ProFormance line of
monitoring tools provides an objective test of cleaning methods — from cart
washers, sonic cleaners, washer-disinfectors, and lumen and flexible scope
washers — and tests that check for residual soils on instruments and
surfaces.
Medisafe has seen its cleaning test product
line grow in popularity. The company offers a full line of Wash Checks, as
well as the Scope Check protein detection kit that detects protein residues
within one microgram sensitivity. "If protein is present, the test will turn
blue within ten seconds," said Shipley, adding that the higher the level of
protein contamination, the darker and faster the color changes.
3M’s Clean-Trace Hygiene Management System advances cleaning
verification beyond visual assessment by employing ATP bioluminescence
detection. This provides an objective, quantifiable approach to assessing
and measuring cleaning efficacy, according to Dorothy Larson, 3M technical
service representative for sterilization monitoring products.
Improvements are also apparent on the
sterilization monitoring side, with shorter incubation times for biological
indicators being one of them. "This advancement has allowed shorter load
release times, improving productivity," said Pam Rockow, senior endoscopy
product market manager,
Getinge USA Inc.
While BIs remain the gold standard for
sterility assurance, some FDA-approved products, such as
SPSmedical Supply Corp.’s
STEAMPlus Sterilization Integrator and STEAMPlus Integrator Test Pack, have
been cleared as "equivalent in performance to a biological indicator (BI),"
while also providing immediate verification that the parameters of
sterilization have been met," explained Matt Beauchaine, channel marketing
manager, SPSmedical Supply Corp. Still, he stressed that such products do
not replace the use of a BI. "They should be used in conjunction with
biological indicators." For the highest level of sterility assurance, staff
should monitor every steam sterilizer load with a process challenge device (PCD)
that has been FDA-cleared as equivalent in performance to a BI test pack,
while also including sterilization integrator strips in each pouch, wrapped
tray and rigid container, he continued.
Early read out products are available, but
conventional BI results still require ten to 48 hours of incubation,
depending on the product, Beauchaine added. Recognizing that SPDs need
faster conventional BIs than this, the industry is working hard to meet that
need.
"It is not out of the realm of possibility
to see a conventional BI with a six- to eight-hour final readout in the next
five to ten years," he predicted.
Another major shift in the U.S. sterility
assurance segment is the recognition of the Class 6 emulating indicator by
the Food and Drug Administration and professional organizations, such as the
Association for the Advancement of Medical Instrumentation (AAMI). The
harmonized guidance document AAMI/ANSI/ISO 11140-1 refers to Class 6
indicators as "cycle verification indicators." These indicators are designed
to react to all critical variables of specified sterilization cycles, with
the stated values correlated to the actual sterilization processes,
explained Mary Beth Nooney, product manager,
STERIS Infection Prevention
Technologies. A steam Class 6 chemical indicator used in a 132-degree
Celsius (270-degree Fahrenheit), four-minute process would have the stated
value of 132-degree Celsius and four minutes, she noted.
|
The Getinge Assure SafeStep Contamination
Monitoring System is a handheld ATP testing device that allows
healthcare professionals to test all of the places where bacteria hide.
|
"Class 6 indicators are used to monitor
standard steam sterilization loads, as well as the internal contents of
packaged items. Class 6 technologies have also proven to be useful in
monitoring the extended exposure times required for some of the newer
medical devices and device containment systems, which have become
increasingly more complex," Nooney continued, noting that extended cycle
times are also being addressed by new Class 6 emulating indicator challenge
packs. "These are designed with the necessary chemical challenge to clearly
indicate when the exposure phase of a sterilization cycle has met a longer
time parameter."
Packaging that is validated with the
various sterilization modalities and cycles in a facility is another
critical factor to consider when it comes to sterility assurance.
Undetected, torn sterilization wrap, for example, can jeopardize
sterilization outcomes and place patients at risk. To address this issue,
many manufacturers offer closed rigid containers, said Janet Moran, RN, BSN,
MBA, CNOR, senior clinical education consultant for
Advanced Sterilization
Products. Systems, such as the ASP SteriTite sealed container system,
eliminate the need for wrap and protect packaged items for sterilization,
transportation, storage, and aseptic presentation of contents.
Competency critical
Despite the advancements in the sterility
assurance product segment, industry experts were quick to point out that
these tools alone cannot guarantee sterilization success. Among the greatest
barriers to success is sterile processing professionals’ lack of familiarity
with manufacturer instructions for use, which is often directly responsible
for products’ improper use.
One common example, according to Moran, is
the Instructions for Use (IFU) for BIs that states that the indicators
should be stored away from heat sources, such as incubators. "Many SPD staff
members do not follow this instruction," she said. "It is important to
always follow the manufacturers’ IFU, as well as professional organizations’
guidelines in determining when and how a BI is to be used for a particular
sterilization modality and cycle."
The list of common mistakes that negatively
impact sterility assurance goes on. As a consultant who visits many
facilities, Seavey has seen some very "creative" ways of positioning process
challenge devices or test packs. "I frequently see BI, CI or Bowie Dick PCDs
placed on their edge, leaning up against the side of the carts, under or on
top of a package or container, and often not even over the drain."
|
FDA cleared as equivalent in performance to an
AAMI BI Test Pack, SPSmedical's STEAMPlus Sterilizer Test Pack is a
compliant and cost effective way to monitor all routine loads. |
Running sterility assurance products
incorrectly, insufficiently, or using the wrong tool in a particular
sterilization process are also common mistakes, vendor experts acknowledged.
What’s more, the ongoing push in some facilities to turn instruments around
quickly to meet procedural demand is another factor that can contribute to
improper product use, expedited instrument processing and sterilization
failures.
"Busy healthcare facilities are
continuously searching for ways to improve instrument turnaround time. Since
many of the sterility assurance products out on the market require time to
read results, this time can equate to downtime for surgical staff and
increased inventory levels," explained Nooney of STERIS. "Manufacturers are
capable of producing products that provide faster results, but, ultimately,
it is the facility that must determine how to adopt the new technology to
assure maximum efficiency without introducing additional patient risk."
Sometimes, the IFUs themselves are to blame
for user error and sterilization failure. Getinge’s Rockow explained that as
different products, instruments and equipment all vary, it is sometimes
difficult to have them all work in unison. An instrument manufacturer may
say to process for 13 minutes at a particular temperature, for example, and
another instrument may require something entirely different. "The
instructions may require different sterilizer temperatures, and the process
challenge device instructions are outside the parameters," she said. "FDA,
AAMI and manufacturers will need to work in unison."
While each of these challenges, and more,
can negatively impact sterility assurance, the good news is most problems
can be corrected through comprehensive, ongoing staff education. "Overall,
misuse of QA tools occurs due to a lack of training and understanding of end
users. It is essential that all personnel using QA devices receive proper
training and education on the use and interpretation of the products they
use," said Taurasi. He noted that users must demonstrate their competency in
using such tools, and they should also have a complete understanding of the
sterilizers and various cycles they are using.
Nooney suggested that healthcare facilities
designate a team leader to assure that new hires are properly trained and
that departmental procedures are correctly followed. "These best practice
activities will make the department run smoother and, more importantly, help
reduce sterile processing errors."
Sterilizer qualification testing is another
factor that SPD staff cannot overlook. According to Sandra Velte, BA, CSPDT,
who serves on 3M Sterilization’s Technical Service Team, this testing is
sometimes performed incorrectly following a steam sterilization process
failure. "Qualification testing is conducted after events occur, which could
affect the ability of the sterilizer to perform. This testing is performed
after sterilizer installation, relocation, malfunction, major repairs, and
sterilization process failures," she stressed.
Checklists can prove invaluable for
ensuring that staff members follow proper protocol and performs routine
checks to ensure that equipment and monitoring devices are being used
correctly and are in good working order. According to Stephen Kovach,
Healthmark’s director of education, these checklists should include every
step leading up to and including sterilization — beginning with cleaning.
This checklist can then be used as staff training tools, he said.
Documentation of the entire reprocessing
workflow is also critical for identifying missing steps and mistakes,
according to Nooney. "The chart can even point out functions that need to be
improved and assist in identifying areas where additional monitoring would
be beneficial."
Digital documentation solutions are going a
long way toward driving process quality in the SPD and beyond. Tracking
systems available today allow departments to, among other things,
electronically store records, interface with BI incubators, alert users if
they are using the wrong cycle, or flag if there’s a positive BI, Seavey
noted.
The ANSI/AAMI ST79 "Decision Tree" and
"Checklist" are also valuable tools to assist in taking actions and
investigating when physical monitors, CIs, BIs and PCDs indicate a
sterilization failure, added Larson of 3M.
Of course, ST79, in its entirety, is one
document that every SPD should have on hand — and use often, stressed
Healthmark’s vice president, Ralph Basile. "Make sure all staff in the OR
and SPD are familiar with [this standard]." Joint Commission surveyors are
being trained on ST79 and are looking to see that policies are current and
aligned with the standards.
Knowledge on demand
More than ever, vendors, too, are playing a
more active role in ensuring that end users are competent and well-versed on
the products and equipment being used in their departments.
STERIS’ Clinical Education team, for
example, supports and delivers best practice-based educational activities.
This includes educating learners on the importance of following IFUs and the
importance of documentation of sterility assurance policies. Individual
customers may also join STERIS University, an online adult learning
environment that allows registered customers to complete clinical self-study
guides, e-learning courses, webinars, and other offerings that cover
relevant science and clinical topics, while also earning continuing
education credits.
Stressing the importance of providing SPD
professionals with easy access to current IFUs, Larson said that many
facilities store IFUs in three-ring binders or scan them into a local
digital archive, which can be difficult to maintain. "Another solution to
this information management challenge that is becoming more common is a
subscription-based online service," she said. 3M recently launched a
promotion with oneSOURCE Document Site, a subscription service that provides
healthcare facilities with unlimited access to manufacturers’ IFUs through
an online database, to offer limited-time, complimentary access to the
current IFUs for 3M’s sterilization assurance products.
At the very least, Seavey recommends the
periodic review of IFUs to stay abreast of updates. She’s also a proponent
of tapping vendor-provided educational offerings to train staff. At least
annually, she recommends having all staff perform competency checks that
include return demonstrations on sterility assurance monitoring. These
competency checks should be documented in employee files.
"There are way too many facilities or staff
reprocessing medical devices that are not getting the education — or
managers that are not enforcing best practices," Seavey stressed. "This is
another point to be made for the need for certification in the profession."