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 Healthmark 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 sterilization."

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, SteriCert 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 Seavey 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, Getinge USA 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 market."

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 into practice."

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.

STERIS Verify SixCess 270FP Extended Timing Challenge Pack

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, 3M 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.

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," Nooney explained.

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."

 

The Getinge Assure S.M.A.R.T.Green Bowie & Dick type test pack

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."

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 concerns Hancock.

"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.

 

ASP STERRAD NX100

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.

"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, CareFusion Corp. "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."