December 2010 - Central Services

INSIDE THE CURRENT ISSUE

December 2010

Central Services

Logging success:
Sterility assurance takes multi-pronged approach

by Julie E. Williamson

Basic principles of sterilization process validation

1. Establish that the process equipment (sterilizer) has the capability of operating within the required parameters.

2. Demonstrate that the critical control equipment and instrumentation are capable of operating within the prescribed parameters for the sterilizer.

3. Perform replicate cycles representing the required operational range of the sterilizer and employing actual or simulated product. Demonstrate that the processes have been carried out within the prescribed protocol limits and, finally, that the probability of microbial survival in the replicate processes completed is not greater than the prescribed limits.

4. Monitor the validated process during routine operation. Periodically, as needed, requalify and recertify the equipment.

5. Complete the protocols, and document steps one through four above.

Source: Charles Hancock, sterilization consultant, Charles O. Hancock Associates Inc., Fairport, NY

Any sterile processing professional worth their salt knows that effective sterilization is the most critically important role undertaken in the department. They also know that reaching that goal takes a systematic approach and an ongoing commitment to ensure that safe, effective processes are consistently followed for each and every instrument set – and, above all, every patient.

Still, even with this knowledge, sterile processing professionals face a long list of challenges that can impact sterilization outcomes – from inadequate (and, in some cases, unavailable) processing instructions, resource constraints and even pressure from other departments to take shortcuts in an effort to save time and keep procedures on schedule.

No question, any missing pieces to the processing puzzle can lead to potentially negative and serious consequences, including a greater risk for exposing patients to infection. The process of sterilization and sterility assurance is indeed a scientific one that simply can’t be rushed. Success hinges on a comprehensive program, as opposed to the adherence of a few steps or the reliance on a set of products. Getting there isn’t easy, but it is absolutely necessary, sources told Healthcare Purchasing News.

"Without a formalized process and procedures we would have no idea of the quality of the product and goods we are stating are safe for use," noted Michele DeMeo, sterile processing manager for Memorial Hospital, York, PA. "We need to have a full program developed that’s monitored and assessed, and periodically reviewed, to make sure what we are doing and producing is of a quality that can be used on each and every patient our instruments and equipment touch."

Further, effective sterilization can only be achieved if all staff who are essential for rendering decisions concerning instrument sterilization – whether it’s those who work in the SPD, operating room, infection control, materials management, or other departments – agree on and adhere to a sterilization philosophy, added Barbara Trattler, RN, MPA, CNOR, CAN, director of clinical education for ASP, Irvine, CA.

"This philosophy must utilize facts and data to determine what is sterile and what is not sterile. This is a black and white issue with no shades of gray."

Defining sterility

Before one can fully adopt an effective sterilization program, it’s imperative that sterile processing professionals (and others who bear instrument processing responsibilities) fully understand what sterility – and sterility assurance – entail.

"Sterility is the state of being free of all viable microorganisms. Sterility assurance involves keeping medical devices safe and requires effective sterilization procedures. Sterilization of reusable medical devices requires stringent procedures to ensure reliable and repeatable process conditions,"noted sterilization expert and consultant Charles Hancock of Fairport, NY-based Charles O. Hancock Associates Inc. Further, he noted, sterility assurance level (SAL) is the probability that a process makes a reusable medical device sterile – and an SAL of 10^-6 is the recommended probability of survival for organisms on a sterilized device. "This level means that there is less than or equal to one chance in a million that an item remains contaminated or nonsterile after reprocessing."

SPD professionals have a number of tools and resources at their disposal to help them determine that probability, not the least of which includes standards and recommended practices from the Association of the Advancement of Medical Instrumentation, the Association for periOperative Registered Nurses, The Joint Commission, and the Centers for Disease Control and Prevention.

"These guidelines are directed for surgical and other environments in healthcare facilities and are designed to help ensure safe and effective use of reprocessed devices used for patient care," said Janet Prust, global marketing manager, 3M Sterilization, 3M Infection Prevention Division, St. Paul, MN.

Genesis rigid sterilization
containers from CareFusion
provide cost saving
advantages over
disposable wrappers.

While sterile processing managers and staff understand the value of recommended practices, it is difficult to stay up-to-date and modify policy and procedures and training programs to keep not only the policy, but the practice current – and to follow the best available recommendations for patient safety, according to Prust. To assist SPD professionals in this regard, 3M Sterilization developed a Standards Practice program that connects the standards to actual facility monitoring practice based on what is being monitored.

"Hospitals are looking for easy-to-follow programs to meet guidelines, not only for patient safety, but to ensure they are compliant," she said, adding that the program will also help SPD staff prepare for Joint Commission survey requirements for monitoring practices.

Indicating probability of success

Processing professionals also rely on other tools to help them with the sterilization process, including process monitoring devices that can provide another level of assurance that the process has been successful.

Vendors have met this need with a host of product advancements, including faster biological indicators for testing low-temperature sterilizers, and immediate readout steam test packs utilizing Class 5 indicators, which have been FDA cleared as equal in performance to BIs, noted Chuck Hughes, general manager and educator for SPSmedical Supply Corp., Rush, NY.

"Competition among suppliers has created these advancements, along with users demanding easier and faster ways of documenting sterilizer performance."

In regard to pack monitoring, best practice includes Class 5 Chemical Integrating indicators, as they provide more information than Class 3 or Class 4 indicators, explained Prust. "Class 5 chemical integrators are the only type of chemical indicator that is correlated to the performance of a biological indicator across a range of time and temperature conditions."

Today, full cycle integrators are available that extend to 3 ½ to 4 minutes in steam at 132° C to 135° C – an advancement that provides the user with additional security that packages within the load have received sufficient sterilant to cause sterility, according to Pam Butler, marketing manager, SteriTec Products, Englewood, CO.

The introduction of the Class 6 emulating indicator, which has precise timing margins, has been a significant addition to the sterility assurance segment – an advancement that some say will, among other things, address the challenge of extended sterilization cycles. "The commonly available biological and chemical monitoring products were not designed to monitor these longer exposure times. Although these products may withstand the steam sterilization process for extended cycle times, they can’t monitor the additional time required for longer cycles. Class 6 emulating indicators have the necessary chemical challenge that indicates when a cycle has met a longer time parameter," said Heide Ames, product manager, infection prevention technologies, STERIS Corp., Mentor, OH.

To further address the issue of extended cycles, manufacturers are looking at their sterilization instructions and retesting to determine if an extended cycle setting is required. "They are finding out that, in many cases, the extended times are not needed," noted Stephen Kovach, director of education, Healthmark Industries, Fraser, MI. "Along with this is the 25-pound weight limit of trays and sets, which has helped."

3M Attest Rapid 5 Steam Plus Test Pack (process challenge device) contains a 3-hour rapid readout biological indicator plus a Class 5 Integrating Indicator.

In late October, AAMI published its updated document ANSI/AAMI ST79:2010 and A1:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, which includes an amendment on the use of Class 6 chemical indicators, and a section on new product evaluation for products not covered in earlier AAMI documents.

"This is promising news for sterile processing departments looking for a conservative method of sterility assurance that can provide a more accurate challenge to sterility criteria and deliver drastic cost per load savings," added Chris Dudley, CSPDT, consumable products sales manager, Getinge Infection Control, Getinge USA Inc., Rochester, NY. The advent of the Class 6 emulator not only maintains the same level of sterility assurance, but actually provides a more accurate challenge at a fraction of the cost of a full biological and chemical indicator test pack Process Challenge Device, Dudley explained, noting that while BIs still have a prominent position in the sterility assurance process, such as for implant load release and the minimum weekly (preferably daily) biological test, AAMI has recommended that the Class 6 emulator be used as the sole criteria for release of non-implant loads if with a PCD.

"The basis for this recommendation is that the Class 6 emulator has a minimum stated value of time and temperature of exposure, which can be exceeded as it is purely a minimum," he reasoned. "The emulator must perform to within 6 percent of its stated time value and one degree C of its stated temperature value, and the product must not show a pass result prior to the biological test result for the applicable cycle."

Hancock agreed that the Class 6 indicator can be a valuable tool when used as part of a well-organized routine monitoring plan. Still, he cautioned that the Class 6 indicator "is not intended to be a substitute for a properly qualified sterilizer operated by knowledgeable and competent personnel."

While monitoring devices have made some notable advancements, a lingering challenge is that the market still lacks sophisticated chemical indicators for low-temperature sterilization, according to Hughes. "Unlike steam, where highly reliable Class 5 and Class 6 indicators have been developed, only Class 1 indicators are available for hydrogen peroxide, ozone and peracetic acid sterilization processes," he reasoned, noting that suppliers are struggling because of the high cost associated with purchasing these new technology sterilizers and also because of FDA issues related to accepting data from hospital sterilizers that can only perform full cycles – instead of the partial cycles needed for validation testing of products, such as chemical indicators.

Valisafe Process Challenge Device (PCD) for monitoring of cleaning efficacy inside endoscopes. Holder is designed like a flexible endoscopic instrument.

SteriTec’s Butler added that an extended timing biological test pack would also be a welcomed addition to the field of sterility assurance – as well as regulated wash cycle monitoring. "We believe it is on the regulatory radar and will improve the decontamination process." SteriTec has developed washing monitors for the washer-disinfector, ultrasonic cleaner and hollow instrument loads – including both flexible and rigid scopes, and a rapid protein test. "We believe that the washing process must be monitored to ensure instruments are clean prior to sterilization."

A focus on IFUs

When it comes to sterility assurance, experts agree that the best tools, devices and products won’t offer value if they aren’t used properly and as intended.

"Instructions for Use continue to be the single most critical consideration facing sterility assurance professionals today. Now, some 14 years after both AAMI and FDA provided guidance concerning the information required by reusable medical device users, many device manufacturers still no not provide adequate information for cleaning and sterilization," stressed Hancock. "This is a major problem with our best understood technology – steam sterilization. When we consider alternative technologies, such as hydrogen peroxide, ozone and peracetic acid, we find complete chaos of understanding the limitations concerning cleaning and sterilization on the part of the user community."

The good news is various professional associations, including IAHCSMM, AORN, and others, are making an impact on the availability of pertinent information contained in standards, recommended practices and technical information reports. Further, Hancock pointed out, the FDA is beginning to comprehend the need to educate manufacturers, users and the public on matters concerning the industry so that all may appreciate what safety and efficacy really means.

Vendors are stepping up their educational and IFU efforts, however. "One common misconception is that [manufacturer] information doesn’t change, when it fact, it may change due to more current regulations placed on the manufacturer," stressed Susan Christensen, senior market manager, GENESIS Sterilization Containers, CareFusion. She acknowledged that changing old practices to new recommended practices are both the responsibility of the manufacturer and the user. Manufacturers should provide information in easy-to-understand language and the user must be sure to review the product literature for any changes to their common practice, she said. CareFusion has added directions for use to its website for easy access, so customers can stay current and access related educational opportunities on sterilization.

"Not keeping current with the manufacturer’s written recommendations could become an unrecognized issue, so periodically reviewing product information is important."

Photo courtesy STERIS Corporation

Opening a steam challenge pack

It’s a practice that DeMeo diligently follows. "You can’t trust that everything stays the same. It doesn’t. I thoroughly read – and then continue to reread – instructions for use and recommendations. And I always make sure these are available in my department."

Processing professionals must also be aware that guidance documents do not supersede a product’s IFU – and this is a point that’s present in AAMI recommended practices, stressed Ames. Despite the recommendation to adhere to manufacturer IFUs, hospitals have regularly used products as directed in a guidance document, even if the manufacturer’s instructions for use do not recommend that use, she said, adding that a perfect example of this involves AAMI ST79 directions on how to use sterilization pouches to "double pouch" a medical device. "For years, users would double pouch any vendor’s sterilization pouches. It became known recently that most pouch manufacturers had never validated that claim or provided instructions for double pouching. AAMI revised its standard (AAMI/ANSI ST79:A1:2008) to include a statement that users must obtain double pouch instructions or validations from the vendor if they practice doubling," Ames explained. "There are multiple examples of a vendor’s instructions for use differing from a recognized guideline. It is very important that users include a product’s instructions for use when establishing their policies and procedures. Recommended standards alone are not enough."

Ongoing inservice training for sterility assurance products is also critical, according to Kovach. He recommends at least annual training for all staff and shifts, and encourages SPD staff to do their homework on new products.

"Network, read articles, both peer- and non-peer-reviewed, along with the manufacturer information. Use the FDA and ask them questions on how and why the product was cleared. The FDA has their own rules on the classification of indicators; learn them and understand the difference."

Don’t cut corners

Of course, education should also extend to other functions that factor into sterilization effectiveness – and the impact of human error when washing or packing instruments, loading washers or sterilizers, or otherwise cutting corners to save time. In the SPD, shortcuts can take many forms, including handwashing and soaking instruments that are recommended to be placed in a sonic process for thorough cleaning, or flushing and brushing lumened devices that have been proven to be cleaned more effectively in automated processes, pointed out Crystal Shipley, Valisafe product manager, Medisafe America LLC, Tampa, FL.

Wash-Checks Product line offered by SteriTec.

"It’s about the process – not the time the process takes. A great [SPD] director once told me – and I stress to all my students – ‘It’s 2 am and you are the only one around. No one will know. How do you reprocess those specific instruments?’ Do it the right way, every time."

Improper placement of indicators is another common problem that should be routinely addressed with SPD and OR staff. As Candy LeBlanc, BSN, RN, senior manager of global training for ASP, explained, it’s important to challenge a BI by placing it in the most difficult area of the sterilizer for the sterilant to reach, and processing it in a cycle that includes instrumentation. "Processing the BI by itself in an empty chamber does not reflect appropriate sterility challenge conditions."

Proper placement of chemical indicators is equally critical. Best practice includes use of a chemical indicator in the geometric center of each pack, peel pouch or unwrapped tray to be sterilized, noted Prust. "For rigid containers, an indicator is placed in opposite corners on each level. In multi-level wrapped containers, supplied by the manufacturer, place an indicator in the center of each level." Chemical indicators should also be used in trays and containers for immediate use sterilizations. Further, she pointed out, standards require that each pack or container have an external CI on the outside of each package.

"An important part of a compliant quality control system, exposure monitoring devices include indicator tape, container locks or arrows with a CI attached, or container labels with chemical indicators. New CIs used in the category are being introduced with easy-to-interpret, reliable color change with elimination of lead or other heavy metal components," Prust continued.

Staff must also be aware that chemical indicators are photosensitive and will revert back to the color indicating that they were not exposed to the sterilant, LeBlanc explained. "As a result, don’t secure a CI to the load record to document that the items in the load have been exposed to the sterilant." Even better: add a check-off box to the load list to acknowledge that the CI has changed color after a successfully completed cycle. This serves as documentation should the record require future review.

Because dirty instruments cannot be sterilized, it’s imperative that SPD staff also pay close attention to the washing process. This includes the maintenance of washer-disinfectors and an understanding on the importance of not overloading washer trays. "We have found that just because you see water in the washer it does not mean it is cleaning properly. Detergent hoses may be clogged or installed incorrectly," said Butler. Further, trays may be overloaded and loaners trays may have the lids on them in the washer.

Hughes said that some users also continue to struggle to recognize that it does not take time, temperature and sterilant to sterilize, but rather time, temperature and sterilant contact to sterilize. Beyond that, he emphasized the importance of ongoing education and the commitment to a systems approach to sterilization. This approach encompasses effective point-of-use preparation, cleaning, packaging, sterilization, and storage.

Ames urges SPD staff to carefully assess and document their entire workflow. "Sterility assurance is more than using biological and chemical indicators, Bowie Dick tests and pouches. As a quality process, the steps to assuring sterility start immediately after instrument use in the OR and continue through cleaning, packaging and sterilizing. Failure to perform any of these functions correctly could result in a failure to sterilize a device. It only takes one non-sterile device to potentially harm a patient." Drawing a process flow chart specific to the hospital’s process can help readily identify any specific missing steps or mistakes, she said, reasoning that the chart can even point out functions that need to be improved and assist in identifying areas where additional monitoring would be beneficial.

Of course, staff must also have a keen understanding of what process results really mean.

"Understand the product you are using and what it tells you if it fails. Also, if it passes, what does that mean?" reasoned Kovach. "This is very important because if something fails, you will have to ‘drill down’ and find out why it failed. This takes time and energy."