Central Services
Piecing together the puzzle of sterilization quality assurance

by Jeannie Akridge

Certainly sterilization quality assurance is grounded in science, but having the confidence to release processed instruments for surgery also requires a bit of faith – faith in the equipment, faith in monitoring products, faith that the central sterile processing professionals are following proper procedures.

There’s no way to truly know beyond a shadow of a doubt that something is sterile – it’s simply a matter of reducing the probability of contamination down to a negligible number (a sterility assurance level of 10-6 to be exact) that the facility, the department, the doctor and ultimately, the patient, can live with.

Fortunately there’s an entire arsenal of products, services, guidelines and standards to help raise the overall confidence of sterility, and some new tools to make it easier to achieve.

 
Healthmark TOSI washer test

Standards lead the way

Important new guidance to help central sterile/sterile processing departments in their quest for sterilization quality assurance comes from the Association for the Advancement of Medical Instrumentation (AAMI). In June of this year, the association released a master document on steam sterilization called ANSI/AAMI ST79:2006, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. The new AAMI document, which becomes available to healthcare facilities this month, combines five previously released recommended practice documents on steam sterilization into a single resource comprising all AAMI steam sterilization recommendations, and provides updates and clarification on the use of monitoring products.

"This new standard is a comprehensive document that covers everything from facility design to sterility assurance recommendations," said Charles Hughes, general manager and lead educator for SPSmedical Supply Corp., Rush, NY. "While there are not a lot of changes, much of the information already in prior standards were not fully understood or complied to by facilities. For example, maintenance and daily recording of proper temperature and humidity year round, only flash sterilizing when certain conditions are met, and of course, not flashing medical implants," said Hughes, who noted that SPSmedical helped contribute to the new ST79 document.

"To me that’s one of the biggest take-aways from the standards – there’s not new information as much as there is a lot more simplification, and clarity around recommended practices," said Sue Wasserman, marketing operations manager, sterilization assurance for 3M’s medical division in St. Paul, MN. "It used to be that you’d have to reference the five different documents to figure out, ‘what should I do in this situation?’ Now it’s all in one document."

Among its recommendations, ST79 includes updated guidance on monitoring of loads that contain implants. For one, AAMI introduces new terminology, referring to a "test pack" as a "process challenge device", or "PCD". The document specifies that "loads containing implants must now be monitored with a PCD that includes both a Biological Indicator and a Class 5 Chemical Integrating Indicator," said Wasserman.

She stressed that while it’s still preferable to wait for the results of a Biological Indicator (BI) before releasing an implant load, "the reason that the AAMI standards have now changed is in the event of an emergency situation where you have to release an implant before the BI is available, then you have this Class 5 chemical integrator that you can use for some level of assurance." The new standard includes a form to be completed when a load with an implant is released before the BI results are available.

The new AAMI document also provides clarification on the terminology used to describe the various steam sterilization monitors as well as how and when they should be used. (For more information on ST79, see this month’s Self-Study Series from 3M, or contact AAMI directly at www.aami.org.)

"The standards that are developed by the industry experts that sit on the panel should be adhered to by all who perform decontamination and sterilization in any and all types of facilities," suggested Jean Sargent, director of supply processing distribution and receiving, UCLA Healthcare, Los Angeles, CA. "Obtaining compliance would be a boost to the patient population as the end product provided by Central Service would be more consistent than it is today." Sargent notes that the standards will be up for review annually instead of every five years to accommodate rapid change and updates in processes.

"Each and every CS/SPD should be required to have a copy since the entire hospital looks to the CS/SPD manager as the sterilization expert," said Chip Moore, sterilizer product manager for Getinge USA Inc., Rochester, NY.

Healthmark AquaChek

Monitoring technology

Choosing the right monitors for the right sterilizer in the right situation can be a daunting task to say the least. The continual push for faster turnaround of increasingly complex instruments has led to the development of more advanced monitoring technology that provide more meaningful snapshots of the sterilization process.

To accommodate the new ST79 recommendations for PCDs, 3M has developed a new PCD, called 3M Attest Rapid 5 Steam-Plus Test Pack, that includes the company’s Attest Rapid Readout BI and its Comply Steri-gage Class 5 integrating indicator. Steri-gage is unique in that it has an easy-to-interpret moving front that ultimately renders an "accept" or "reject" mark, instead of a color change indicator. 3M’s Attest Rapid Readout BI (#1292) provides results in 3 hours, versus 24 or 48 hours.

SPSmedical offers the SporViewPlus Steam BI test pack, a dual indicator system, with an immediate readout Class 5 Integrator approved as "equivalent in performance to a BI" and a conventional 24 hour BI. The SporViewPlus Steam BI test pack, per AAMI standards, allows users to release processed loads immediately with final confirmation of spore growth after 24 hours incubation.

Getinge’s Biosign SSI Test Pack and the Chemipack provide Class 5 chemical integrators inside an appropriate Process Challenge Device. Both products allow for an instant release of loads based on the CI and the Biosign SSI includes a BI for further reassurance and release of implants.

For loads that do not contain implants AAMI recommends once daily BI monitoring, although some companies such as 3M recommend that a BI be placed in every load, whether it contains an implant or not. "The BI is still the only monitoring device that really does measure lethality," Wasserman said. "It’s the only device that has live spores, and if the live spores are killed in the sterilization cycle, that’s the best indication you have that your cycle works."

"The ST79 sets up some very good recommended practices but they’re not the highest standards that many hospitals follow," said Wasserman, who says that 3M is providing free copies of the AAMI ST79 Standards for its customers who are already using a BI in every load.

"It’s very interesting when diagnosing sterilization failures to see how many different factors contribute to a failure and the number of times things go wrong," Wasserman adds. "And if you’re not monitoring every load with a BI the risk is substantially higher."

While a facility might argue that placing a BI in every load is too expensive, Wasserman cautions, "If you get a failed result, a facility has to recall every pack that was sterilized since the last time they got a negative reading on their BI, and every patient that was treated with instruments that were sterilized during that time may have to be put on antibiotics.

"So now you’re talking about the time and expense of finding packs, recalling them, talking to patients, having doctors, physicians, surgeons sign off on the fact that there’s a chance an instrument might not have been sterilized properly…so you when you look at the added costs versus the effort, expense and patient impact, it’s really quite minimal to run a BI in every load."

Hughes notes that while the BI is definitely the current "gold standard" for sterility assurance, it’s important to use multiple indicators to get a complete picture. "It’s not really about one product excluding another but using a variety of tools to manage the sterilization process."

He notes that one area of concern surrounding monitors is the increasing need for extended cycles that can not only cause processing delays but also may cause issue with sterilization monitoring practices.

"We did put in ST79 that hospitals may want to consider a dedicated steam sterilizer for handling non-standard cycles," said Hughes. "That’s something that maybe sterile processing personnel can use with administration to help budget for additional equipment, because clearly running a wide variety of extended cycles can create sterilizer backlog."

"It’s so important that they actually have from device manufacturers, their written, validated instructions for use and processing," he continued. "And as they acquire these in writing, they’ll notice that some are different from standard cycles, i.e. complex instruments such as orthopedic sets."

"From an efficiency standpoint, if the O.R. elects to buy only a select amount of instruments because they’re awfully expensive, and then schedule back-to-back cases, this can create issues for sterile processing being able to turn these instruments in time," commented Hughes.

Hughes warns that while some facilities have responded by saying, ‘I’m just going to extend my standard cycle up to accommodate all of these other trays’, "that raises the issue of number one: Do you have enough sterilizers and time to be able to have that kind of delay routinely for each load? Number two: Regarding other devices you’re adding sterilization time to, can it have an adverse effect on the performance of these devices? I know that clearly there’s a number of devices on the marketplace with warnings not to over-sterilize," he said.

He explains that "extended cycles can have an adverse effect on the culture medium that’s in with the BI and it can actually create a situation where it would not grow anything. So if you’re running a biological for these long, long cycles, it’s assumed that the BI has killed its spores; however, you do not know if the medium has boiled and caramelized, or if it can even show spore growth."

 
TGX Medical Alex Gold

SPSmedical recently commissioned an independent laboratory to do a study on commonly used extended cycle times and what happens to the culture medium of the leading biological indicators on the market. "What I’m looking to find out is if the culture medium can even sustain any growth at all after running these extended cycles," said Hughes.

"There’s a delicate balance there because hospitals don’t run paper strips and then put the media in later, they use self-contained BIs. That’s really the issue, and it’s being overlooked by hospitals."

Another change in the area of sterilization monitors involves the ISO Standards1 that are used to ensure the proper performance of Class 5 chemical integrators. "The previous standard required only one stated value of time and temperature," said Wasserman. "The new standard requires three time and temperature stated values. So that is an important change and all manufacturers are working to test their products and make any changes if need be to demonstrate and document that they meet three stated values. In the future, healthcare facilities need to watch for and request proper documentation around the Class 5 chemical integrators."

"In the future there will be Class 6 CI’s as well," Wasserman continued. "But 6 doesn’t necessarily mean that it’s better than 5. What it does is it measures something very different. It’s going to be a series of indicators. Class 6 CI’s will have very specific time and temperature values. All of these changes are moving towards more precise documentation of time and temperature in a specific sterilizer cycle."

"The different classes of monitors merely give you different pieces of information. It’s not a hierarchal sort of grouping," she emphasized.

Hughes notes that "faster steam BI test packs utilizing biological equivalent devices to predict the full incubation of the conventional BI are now available from several suppliers. These devices are critical to users as the demand to release instruments as soon as possible continues to rise," he said. "Also, faster and more accurate sterility assurance devices for use with low temperature sterilization processes are not far away, as are better tools to verify proper cleaning of devices and compliance with important environmental conditions."

Is it really clean?

Besides the all-important BIs and CIs used in sterility assurance, there are tools to help ensure that instruments are clean, which of course is the first step in sterilization and decontamination. "It is axiomatic, if an instrument is not clean, it can not be rendered sterile," said Ralph Basile, vice president of marketing for Healthmark Industries Co., St. Clair, MI. "Cleaning is the removal of soils, organic and nonorganic, which themselves are a source of infection and also a vital food source and potential protection for microorganisms. Parameters for cleaning and disinfection include water quality, water temperature, time, chemical cleaning agents, and mechanical action."

Healthmark stakes claim as the only company to provide a family of products for monitoring the cleaning process and the equipment used for this purpose. The company’s TempaChek-DL is an affordable datalogger for recording the temperature profile of an automated instrument washer, explained Basile. TempaCheck-DL is placed in the washer at the beginning of cycle and retrieved at end. Data is then downloaded to a PC for analysis and permanent record keeping.

"With the ability to record temperature and time, TempaChek-DL can independently verify the conditions for thermal disinfection," said Basile.

Another unique product from Healthmark designed to help ensure cleanliness of instruments, is DetergiCheck, a test which is reactive to the presence of proteolytic agents, such as enzymatic and high alkaline detergents. "When present in the chamber of an automated instrument washer, these chemicals will cause a color change of the test, indicating these vital inputs to cleaning were delivered," said Basile.

"Assuring the instruments are properly cleaned and disinfected on the decontam side saves extra work on the clean side, as instruments do not have to be re-cleaned," he emphasized.

The devil’s in the details

The final and some may argue, most important part of sterilization quality assurance lies in record keeping. It’s a solid piece of evidence, sometimes the only evidence, that procedures were followed consistently. And if JCAHO shows up for one of their unannounced inspections that they’re starting this year, auditors will be asking central sterile workers not only what they’re doing and more importantly, why they’re doing it, they’ll also want to see those records.

"The documentation can’t be something that’s buried in a drawer, it has to be always updated and always current, so that facility is continually in compliance," noted Wasserman.

3M offers Record Keeping Software that not only automates the process but also allows for tracking and productivity management reports.

Wasserman notes that the company is looking into future applications with Radio Frequency Identification (RFID) technology, "3M has a real focus right now on what we call the ‘track and trace’ area, with RFID. Track and trace has some real opportunities in the future for working with the central sterile processing area to really improve the flow and tracking of instrumentation."

TGX Medical’s Alex Gold Asset Management system not only provides instrument tracking and paperless recordkeeping, but also provides guidance on sterility monitoring.

"Alex Gold has many fail safe features that, in addition to helping technicians maintain quality assurance measures it has alarms that prevent quality control measures from being skipped or forgotten," said Michael Good, senior vice president of sales for TGX Medical (Carmel, IN). "Alex Gold has the ability to track biological indicators to include all sterilization processes and also has full Load Recall capabilities."

Alex Gold also has timers and alarms to ensure that BIs are read within an acceptable time frame, explained Good as well as provides forced display of all procedures to ensure proper usage. "The program verifies that BIs and controls are of the same lot, BIs are being incubated for the proper amount of time and lastly that the parameters that you are basing your parametric release on are the same as or exceed your biological release points."

In addition, "Alex Gold helps identify bottlenecks for increased employee productivity, basically putting employees where you need them and ensuring the proper staff utilization while also serving as a training tool for both new staff and continued education for existing staff," said Good.

"Typically, hospitals keep 30 years of low temperature sterilization records and 7 years of high temperature sterilization records. This would fill an 8’x10’ room of bankers boxes. With Alex all this data can be kept on one CD Rom," he added.

TGX is in the process of currently developing interfaces with a variety of sterilizers in the marketplace.

Good noted that among the many ROI benefits available through Alex Gold is the ability to track repairs. "This helps us track damages and educate surgical staff to prevent damages, and helps identify which instruments are ready to be returned to circulation. We track repairs based on usage, not time, eliminating costly unnecessary repairs."

The program helps to eliminate time-consuming and costly facility-wide searches for instruments. "Location is at your fingertips," said Good. "Staff productivity increases across the board, and surgery downtime is minimized since instruments are easily located."

With the reporting engine available through Alex Gold, users can more easily report on regulatory compliance issues. If and when a recall is implemented, Alex Gold will show all existing locations of every set on that load and include a sub report of all instruments/trays that have already been used, as well as what case numbers they have been used on. "Recalls are no longer a three person job," said Good.

STERIS Corporation recently launched the ConnectAssure Instrument Tracking Interface that enables cycle data to be transferred between STERIS sterilizers and instrument tracking systems.

"The ConnectAssure Interface, in conjunction with STERIS Instrument Management Solutions powered by Censis, enables the transfer of sterilization cycle data for easy management, storage and retrieval, and eliminates the need to manually print and store sterilization cycle tapes and load logs," said Nathan Carver, product manager, STERIS Corp., Mentor, OH. "In addition, with appropriate peripheral hardware, customers can attach an electronic image of sterilizer indicator test results to the sterilizer load in the Instrument Management Solution."

"With STERIS’s instrument management solution, which uses data matrix bar codes on individual instruments, targeted patient notification can be conducted when instrument-level recalls are required for CJD cases," added Carver.

The following are just a few of the benefits of STERIS Instrument Management Solutions and the ConnectAssure Interface: Supports greatly improved tray content accuracy; Reduces staff training time; Improves staff accountability; Reduces the time needed to locate trays; Improves inventory management; Allows instrument-level maintenance scheduling; Permits instrument-level recalls; Provides assistance with benchmarking and faster tray assembly through its full suite of reporting tools; Improves management of loaner trays and equipment; and reduces errors in tray set-up through its database of instruments and tray images.

Getinge also offers an instrument tracking program called T-DOC (Total Documentation). The system tracks the location of instrument sets, processing history, and maintenance status. T-DOC interfaces in real-time with washer-disinfectors and sterilizers.

Perfecting processes

Even with AAMI guidelines as an authoritative reference for sterilization practices, ultimately if a facility doesn’t have solid internal procedures in place, there is no foundation for success.

"Really when it comes right down to it, it’s organization and simplicity that help a facility really maintain a good process," Wasserman said.

"We just completed some marketing research with our customers — we call it ‘Voice of Customer’ — and we talked to them about what really impacts their ability to assure themselves that they’ve done things right, that they’re really minimizing the risk of having a sterilization failure. And they didn’t mention there were certain products they needed, they didn’t talk about new technology. They said it’s all about teaching our people to do things the right way, every detail, every day, every step," she said.

Wasserman said 3M is also exploring studies in human factors, "a science that looks at how we can minimize errors by designing into products and procedures ‘safe checks’. For example, you cannot start your car unless it is in park, whereas it used to be you could start your car engine no matter what gear your car was in. You could find yourself rolling down a hill while you were trying to get your car started. So human factors is all about looking at the way people work, and trying to minimize the risk of errors, by just stepping back and watching people. That’s going to be a focus for us in ’07…looking at how more awareness of human factors helps sterile processing minimize the risk of errors."

3M Attest Rapid 5 Steam-Plus Test Pack

A company called TSO3, based in Quebec, is capitalizing on the power of simplicity with its 125L Ozone Sterilizer, which it introduced to the U.S. market earlier this year. Using only oxygen, water and electricity to achieve high-powered, yet low-temperature sterilization, the 125L frees the operator from making decisions regarding cycle time, temperature or sterilant, because there are no cycle choices and the sterilizer generates its own sterilant, ozone. This is not only a big money-saver at less than $1 per cycle to operate, it’s also a sure-fire way to eliminate the possibility of running a cycle incorrectly, thus helping to contribute to an environment of sterilization quality assurance. The sterilizer eliminates problems with outdated sterilant or insufficient quantities of sterilant, since it’s made fresh for each cycle; and it eliminates problems with improperly saturated steam and wet packs, since it doesn’t use steam.

The company describes its ozone sterilizer as complementary technology to sterilizers on the market today. It recently received expanded FDA clearance for sterilization of a significantly broader range of lumen diameters and lengths. Ann Hewitt, vice president, sales and marketing, TSO3, notes that ozone is able to sterilize places in an endoscope that other low temperature technologies such as gas plasma are unable to reach. The 125L’s large chamber capacity allows for high throughput at low cost.

Many CS/SPD departments are adopting methods from the business world designed to boost efficiency and standardize processes. For example, Healthcare Purchasing News’ 2006 CS/SPD Department of the Year winner, NYU Medical Center, has incorporated "lean manufacturing" principles and the Six Sigma philosophy to help improve departmental operations.

"CS/SPD Managers should look to industry and find out the methods employed to improve efficiencies and through put by reducing the number of workers," said GETINGE’s Moore. "Additionally, CS/SPD Managers should become more knowledgeable about the science of sterilization and look for products that offer innovative features that insure successful sterilization outcomes."

Education boosts confidence

With the focus on CS Certification, education is quickly gaining momentum and may ultimately be the catalyst for major improvements not only within individual departments, but for the industry as a whole.

Certainly AAMI highlights education in the new ST79 document. "CS certification is recommended to supervisors and staff as a means of documenting competency in this ever evolving and complex world of reprocessing," said SPSmedical’s Hughes, whose company provides Continuing Education programs and conducts on-site facility audits for compliance with sterilization standards.

"A better trained, better informed staff means greater awareness and knowledge of how to do things the right way. More astute and practiced staff means a better quality process and better quality patient care," said Healthmark’s Basile. "Money, of course, is always an issue. Often hospital administrators do not appreciate the vital role that Sterile Processing plays in preventing costly infections of patients and employees. More resources for training and equipment – in other words human capital as well as physical capital, is key."

3M provides a variety of educational opportunities for sterile processing departments including a new Attest Sterile U Network, an on-demand network of online learning materials. The site includes a series of self-study materials where a technician can earn CEU credits at no charge along with one-page tutorials on various topics, for example, extended cycle monitoring. In addition, 3M provides CS Certification scholarship opportunities, in-service materials that a manager could use to teach their staff, as well as audits of a facility’s sterile processing department to assess processes and procedures.

"Sometimes an audit is requested because of a sterilization failure, but as the standards prompt customers to look more at their practices and processes, having an audit is a good way to uncover gaps, or ways in which processes can be improved." It’s also a great way to prepare for JCAHO, she adds.

Having an educational program in place can also help to alleviate problems that develop as a result of high staff turn over in the CS/SPD. "Our advice would be to establish a consistent generation and maintenance of ‘in-house’ training aids and departmental in service programs," said Moore.

With over 700 highly experienced and trained technical service professionals, STERIS provides a variety of educational opportunities for CS/SPD including sterile processing process improvement consulting services and technologies; systems and facility design services to optimize SPD departments; and clinical education and training services.

TSO3 125L Ozone Sterilizer

CS certification may ultimately drive product improvements. "As more CS workers become certified, they will become better consumers and more knowledgeable about product improvement needs," said Getinge’s Moore.

By the same token, "Medical device manufacturers recognize that CS certification produces a more knowledgeable user and therefore, forces the manufacturer to be more forthright with their product label claims and instructions for use. Hopefully, the days are gone where manufacturers could get away with telling users to simply reprocess their devices using ‘whatever is standard procedure’ in their facility," said Hughes.

"We actively support numerous chapters and CS organizations across the U.S.," said TGX Medical’s Good. "We encourage CS professionals to obtain CEU’s and offer CEU’s when we are doing on-site training. The push for mandated certification is a welcomed one because we at TGX feel that knowledge is key and Alex Gold is only one of the many tools needed to succeed in the CS environment."

Good describes how Alex Gold can help improve education opportunities within the CS/SPD. "Alex simplifies the staff education and training process by only needing to train the new or veteran staff member on the Alex Gold system. We accomplish this by having detailed instructions for every lifecycle step in the process to include all unique instructions for every set in a facility taken out the guesswork in sterilization, assembly, decontamination and storage."

Hughes recently spoke on the topic of sterilization monitoring at a CS conference in Thailand with over 900 attendees and made the following observation: "Based on discussions with conference attendees and hospital tours, it is obvious to me that Thailand suffers from some of the same issues we have here in the USA: A lack of understanding from other departments as to the time and expertise it takes to properly reprocess medical devices, a lack of resources in staff and equipment to keep up with the growing demand. Fortunately, I also observed a strong commitment by and compassion for fellow CS personnel, as to the importance of their work. Sterile processing truly is part of the surgical team of every healthcare facility and their efforts are critical to reducing hospital acquired infections." HPN

Reference:

1. ANSI/AAMI/ISO 11140-1, 2005. Sterilization of Health Care Products - Chemical Indicators-part 1: General requirements.