is not only a process, it’s a science whose success hinges on diligent
adherence to precise actions and a keen understanding that even the most
seemingly benign shortcuts can transform that science into a potentially
dangerous, and even lethal, experiment.
Sterilization-related mishaps have been widely reported and
are known contributors to hospital-acquired infections and other negative
outcomes. Unfortunately, a number of factors continue to hinder sterile
processing professionals’ ability to deliver safe, sterile devices. In
addition to facing frequent pressure from the Operating Room and other
healthcare departments to turn instruments around quickly, SPD professionals
may also battle limited staffing, antiquated or poorly maintained processing
equipment, insufficient training, and perhaps even confusing (or altogether
missing) manufacturer instructions for use – and the list goes on. The
presence of any one of these factors can be a recipe for disaster, sources
told Healthcare Purchasing News.
"The discipline required in attempting to deliver a sterile
product predictably and reliably over time is a challenge that requires
constant attention," explained sterilization expert and consultant Charles
Hancock of Fairport, NY-based Charles O. Hancock & Associates Inc.
Those challenges and sterilization-related shortcomings have
government agencies, surveyors, healthcare organizations, and others, taking
notice. "Indicator suppliers, the Food and Drug Administration and
international standards organizations are working on standards, labeling and
training that will properly identify how indicators should be used and
educate the user on [sterility assurance tools’] limitations," said Terry
Langford, CEO of Langford IC Systems Inc., Tucson, AZ.
Product advancements abound
Sterile processing professionals have a bevy of
new-and-improved sterility assurance tools at their disposal that can offer
an increased level of assurance that the sterilization process was
effective. Still, it’s critical that those responsible for instrument
processing understand that no sterility assurance product can offer an
ironclad guarantee that the contents undergoing sterilization will, in fact,
be sterile at the end of the cycle.
"Quality assurance devices, such as the various chemical
indicators, process challenge devices and biological indicators are
excellent tools to verify that the sterilizer contents were exposed to an
effective sterilization process and conditions," said Ray Taurasi, MBA,
CRCST, CHL, FCS, ACE, director, clinical sales and service for
Industries’ Eastern region. "These devices can instill a high level of
confidence and assurance that the contents were sterilized, provided all the
‘ifs’ were fulfilled."
One of the biggest ifs, experts stressed: whether all
instruments and devices were thoroughly cleaned and decontaminated.
"The skeleton in the closet for providing sterility
assurance for reusable medical devices is the ability to evaluate whether an
instrument has been adequately cleaned in preparation for sterilization,"
confirmed Langford. It’s a challenge being addressed by the FDA,
international standards organization and healthcare organizations, he said,
as they work on establishing cleaning standards and standardized cleaning
methods for reusable medical devices.
Instrument manufacturers must also step up to the plate, he
added. "All reusable medical instruments should be required to achieve
validated cleaning endpoints established after a worst-case soiling with the
appropriate soil and then state the cleaning endpoint in their labeling
instructing the user how to achieve that cleaning endpoint and [verify] it
before presenting the instrument for all forms of disinfection or
Products that test the success of a cleaning process are
also factoring into the decontamination equation. "If it isn’t clean, it
can’t be sterile," reminded Jonathan Wilder, Ph.D., president,
Co., Rochester, NY. "Since you can’t see inside a lumened or complex
instrument, you can’t know if you got it clean" Using products, such as
Healthmark’s TOSI test and SteriTec’s Wash-Checks test, he stated that "real
challenges exist that users can check to close the loop on knowing that the
inside of an instrument is likely clean." 3M, which also makes a cleaning
verification test, goes beyond visual assessment with its Clean-Trace
Hygiene Management System. Clean-Trace employs ATP detection to provide an
objective and quantifiable approach to assess and measure cleaning efficacy.
With instruments thoroughly cleaned and decontaminated,
processing professionals can then rely on sterility assurance products to
help close the loop even further. And today’s products make that easier and
more effective than ever before. Shorter incubation times for biological
indicators and the availability of self-contained BIs for low-temperature
sterilization are two noteworthy developments, according to consultant Rose
Seavey, RN, MS, MBA, CNOR, CRCST, CSPDT, president and CEO of
Healthcare Consulting Inc., Arvada, CO. Beyond that, Seavey – who formerly
served as SPD director for The Children’s Hospital in Denver – said that
more advanced, easier-to-read chemical indicators are also simplifying the
sterility assurance process.
"[There are] CIs that are designed to react to all critical
variables, that have stated values equivalent to the performance
requirements for BIs, and clear wording, such as ‘accept,’ ‘reject’ or
‘pass,’ ‘fail,’" she said.
Increased CI sensitivity to the steam sterilization process,
by means of new manufacturing techniques that allow for more specific
response to sterilization parameters, is another key advancements, according
to Pam Rockow, senior consumable & endoscopy product manager,
Inc., Rochester, NY.
"This technological advance has also resulted in improved BI
PCD products, which are generally better indicators of the effectiveness of
the sterilization process than the majority of early-read BIs on the
Getinge’s new Assure AccuFast Biological Test System, which
combines a high-tech integrator with BI technology, offers true biological
confirmation for faster, accurate sterility assurance, the company notes.
"With the BI monitoring of the Getinge Assure AccuFast System, users are
alerted to inadequate sterilization by actual spore growth, along with an
alarm and printed documentation, so users quickly know of a failed cycle,"
Rockow stated. Following incubation of exposed BIs, positive results are
available in as short as three to five hours.
Improved user knowledge gained through attempts to better
understand and promote proper use of sterilization monitors – driven by the
introduction of various new CIs – is another recent change, noted Hancock.
"Users have had to reexamine their understanding of the information provided
by such devices in order to evaluate how such devices could be incorporated
The acceptance of a Class 5 integrator inside a PCD for the
immediate release of routine items and implants in an emergency is one more
positive advancement, sources said. "Prior to this, users were trying to
wait for BI results, but unable to [because of] limited instrument inventory
and late-delivered loaners," noted Charles Hughes, general manager and
educator for SPSmedical Supply Corp., Rush, NY.
New BIs have surfaced for low-temperature hydrogen peroxide
gas plasma sterilization, including the introduction of the self-contained
BI utilizing the most resistant spore, geobacillus stearothermophilus,
within a 24-hour readout, according to Janet Moran, RN, MBA, CNOR, senior
ASP clinical education consultant.
At the same time, product improvements are taking a turn for
the environmentally conscious – a move that’s come from an increasing vendor
commitment to move to more environmentally responsible products and
practices. One such trend is the shift away from products that use
lead-based chemistries. "Lead is considered a ‘hazardous waste’ under the
Federal Resource, Conservation & Recovery Act (RCRA) and is thus subject to
U.S. Environmental Protection Agency regulations for hazardous waste,"
explained Susan Flynn, sterilization assurance technical service,
Infection Prevention Division, St. Paul, MN. 3M has reformulated the ink
chemistry in both the 3M Comply Bowie-Dick test packs and 3M Comply
Indicator tapes for steam sterilization to be lead-free. As Flynn pointed
out, these lead-free products can help SPDs avoid the hassles and expense of
managing and disposing of potentially hazardous waste.
STERIS Verify SixCess
270FP Extended Timing Challenge Pack
The recognition of the Class 6 emulating indicator for use
in the U.S. has been yet another critical development in the sterility
assurance segment. These indicators, which have been used for years outside
the U.S., are designed to react to critical variables of specified
sterilization cycles. They are used to monitor standard steam sterilization
loads, as well as the internal contents of packaged items, explained Mary
Beth Nooney, product manager, sterility assurance,
STERIS Corp., Mentor, OH.
"The stated values are correlated to the actual sterilization processes. For
example, a steam Class 6 chemical indicator used in a 132 degree C (270
degree F) four-minute process would have the stated values of 132 degree C
and four minutes."
Nooney cited the movement toward global harmonization among
several guidance and standards organizations as a significant advancement
for the sterility assurance segment, and she credited this harmonization to
the U.S.’s recognition of the emulating indicator. One such "harmonized
guidance document" is AAMI/ANSI/ISO 11140-1, she said, which refers to Class
6 emulating indicators as "cycle verification indicators."
Given emulating indicators’ precise timing margins, they
have proven useful in monitoring extended sterilization exposure times
required for some of the newer devices and device containment systems. "The
complex nature of some of these newer instruments and containers is known to
impede air removal and steam penetration during steam sterilization cycles,"
Bridging the gaps
While the sterility assurance products on the market today
are an essential tool for any quality-focused SPD, experts were quick to
point out some lingering mistakes and challenges that, if not properly
addressed, could render sterility assurance tools useless.
Aside from diligently engaging in thorough, appropriate
cleaning, SPDs must also follow to the letter manufacturer IFUs for their
various instruments, equipment and sterility assurance products.
Unfortunately, as Hancock explained, "many device manufacturers still lack
cycle-specific instructions appropriate to available hospital sterilizers
and the recognized cycles cleared by the FDA."
Rockow, of Getinge, shares those concerns, adding that the
amount of different times required to run loads is contributing to setbacks
in the SPD. "There are too many cycle parameters and an increasing incidence
of extended cycle requirements," she said. "Sterility assurance vendors,
combined with efforts from the FDA and AAMI, are attempting to provide a
more consistent standard cycle for end users." Rockow further stressed the
need for the industry to push for instrument companies to validate their
products for a 4-minute or 10-minute exposure, which, she said, will reduce
confusion and cycle parameters in the SPD.
And the problems don’t end there. Another big concern,
according to sterilization expert and consultant Martha Young, is the
release of implants before BI results are available. Beyond that, processing
professionals commonly make the mistake of assuming that a malfunctioning
sterilizer is the cause of a positive BI when, in fact, operator error is
often to blame.
Another problem, added Hughes, is that some SPDs fail to
send positive BIs to the microbiology lab for gram stain identification, per
AAMI and AORN standards.
"The use of a Class 5 integrator with all steam loads,
proper use of BIs and correct sterilizer procedures should effectively
eliminate recalls in today’s healthcare facilities," he said. In addition to
recommending the use of a Class 5 PCD to bridge the gap between routine BI
testing of steam sterilizers, Hughes encourages SPDs to document the lot
numbers for both Test and Control BIs during routine testing. "All BIs
should be from the same lot and course."
Other common BI-related errors, according to Langford,
include using a BI with the wrong microorganism or inappropriate resistance
level, and using a BI without correlating its resistance to the resistance
of the product.
Seavey has also seen several facilities that run gravity and
Prevac cycles in the OR, but fail to run any Bowie-Dick tests. "I have seen
facilities use BIs designed to test for gravity on Prevac cycles and vice
versa. I have also seen many facilities that don’t monitor and document the
incubator, especially those for monitoring non-self-contained BIs."
And don’t neglect the importance of proper storage for
sterility assurance products, urged ASP’s Moran. "I remind our customers
that BIs should be stored away from excessive heat or chemicals.
Another of Young’s concerns is that healthcare facilities
are changing the original manufacturer’s packaging and sterilization cycle
instructions based on the results of product testing.
"Product testing verifies the manufacturer’s validated
instructions for use, but in no way provides the same level of testing
required for manufacturers," Young explained. "This poses a risk to the
patient if the medical devices are not sterile."
Often, user error stems from unresolved confusion. Seavey,
for example, has witnessed several instances where non-sterile items are
used on a patient because someone wasn’t clear about the correct color
changes on the external indicators. "The confusion is caused because of lack
of standardization with color changes," she said, noting that the colors can
be tan, black, pink, blue, orange, purple, and so on, depending upon the
manufacturer and whether or not they were processed. "Standardization would
be great, although I do understand there are proprietary chemicals involved.
Meanwhile, it’s up to us to educate each of our customers regarding what the
indicators should look like before and after sterilization."
The Getinge Assure S.M.A.R.T.Green Bowie & Dick type
That education will also go a long way toward helping
facilities scale other hurdles associated with proper product usage,
including improper product placement.
"As a consultant, an issue I see is that the CI is placed
right on top of the items to be wrapped or containerized instead of the
placing the indicator in the most challenging place in the pack, which is
usually the geometric center for wrapped items or the corners for rigid
containers," Seavey continued. "When I question the processing staff, I am
told that is the way the OR, clinic, etc., wants it," she said, noting that
it’s up to processing professionals to educate their customers why they can
or cannot do something requested. "We must step up to the plate as the
experts on reprocessing and share our knowledge with our customers."
Using products that are too simplistic in their diagnostic
capabilities and, therefore, not providing the sterility assurance
perceived, is another common mistake, explained Crystal Shipley, CRCST,
Valisafe product manager,
Medisafe America LLC. "[Users] should ensure that
all products used are compliant with the relevant standards and have
technical certification to substantiate their claim."
Further, Shipley said there’s a lack of training within
departments about the impact of human error when washing or packing
instruments, and loading washers or sterilizers. It’s a problem that also
"Most users do not consider the consequences of an error or
misinterpretation of the information provided by a monitor," he said. "Few
users think in terms of a recall being the potential result of their
actions." In the event of an unexpected outcome, he stressed that users must
understand every malfunction or fault indication. "Monitoring is intended to
provide information relating to the effectiveness of an operating cycle.
When the expected outcome does not occur, understand why. Then fix it."
And don’t underestimate the importance of having OR and SPD
staff on the same platform, added Rockow, who noted that doing so drives
much-needed consistency between the two areas.
Tapping supportive resources
Vendor education is essential for promoting proper and
consistent product use and result interpretation, and the good news is more
manufacturers are stepping up their educational offerings – whether through
clearer, more comprehensive IFUs, comprehensive training tools or more
advanced technical support.
"We recognize that staff education is key to both addressing
sterility assurance challenges and ensuring a user’s success," said Moran,
who helped develop ASP’s STERRAD NX System tutorial series, a video series
comprised of four chapters that discuss a variety of topics related to
sterilization best practices. "Given the importance of sterility assurance,
we have dedicated one of the chapters to monitoring and documentation in
order to assure sterility."
To help customers overcome product-related confusion and
ensure their effective use, STERIS has developed a range of educational
products and services for the SPD and beyond. "Not only do we educate
healthcare providers to ensure proper use of our products, but we strive to
build an awareness of industry guidance and to help departments develop best
practices and adapt to today’s new technologies and instruments," said
Nooney. In the case of sterility assurance monitoring, this includes
educating learners on the importance of following all instructions for use –
for sterility assurance products, medical devices and containment systems,
pouches, and wraps – and the importance of proper documentation of sterility
assurance policies. "Proper documentation with evidence-based data is
critical for developing best practices. It is also a useful tool during
audits with accrediting agencies," Nooney added.
Of course, having the most current standards on hand and
making them readily available to processing staff is paramount to
sterilization success. Not only do they serve as a reliable resource for
day-to-day processing activities, they serve as the foundation for the
development of effective sterility assurance monitoring policies. "The Joint
Commission recently stated that their surveyors will continue to pay
attention to instrument processing this year. They also shared that recent
Joint Commission surveyor training on sterilization included a review of
AAMI ST79, so [facilities should] be sure that their departmental policies
are up-to-date and reflect the guidance found in this valuable resource,"
said Flynn of 3M. Through its products that facilitate compliance,
educational posters and technical support provided by knowledgeable sales
representatives, 3M Standards Practice for Sterilization Assurance program
supports a facility’s efforts to monitor sterilization processes according
to AAMI, AORN and CDC standards and recommendations.
ASP STERRAD NX100
"Healthcare facilities can draw on the recommendations found
in AAMI ST79 to develop policies and procedures around the use of
commercially-available sterilization monitoring products," Flynn continued.
"And for any novel, FDA-cleared products for which application guidance
isn’t available, AAMI ST79 includes a new section entitled New Product
Evaluation, which provides a framework for a multidisciplinary committee to
assess the utility of newly introduced products in the clinical setting."
Facilities looking to elevate the quality of their sterility
assurance monitoring should also consider incorporating QA protocols into
their practices, such as process flow charts that can readily pinpoint
missing steps, errors or challenges. As Nooney reasoned, the chart can even
identify functions in need of improvement and determine where additional
monitoring – such as washer indicators – would be beneficial.
Instrument tracking systems are another tool that can
improve documentation and data-gathering. As one vendor expert explained,
instrument tracking systems can help healthcare facilities overcome some of
the many instrumentation-related challenges and concerns, such as
immediate-use sterilization, proper cleaning and sterilization, and on-time
delivery to the OR. "Layer on the sterilization parameters for all of these
types of products and facilities can have a real challenge on their hands,"
said Jodi Rummelhart, senior marketing manager, IMPRESS,
"Automated tracking systems provide functionality to address these issues."
Healthmark’s Taurasi also encourages SPDs to implement QA
protocols that monitor the entire reprocessing cycle, and also factor
personnel performance and relative competencies into the equation.
"Sterilization QA devices are just part of the entire QA process," he said.
"They should not be used as a crutch for inferior practices."