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Unfortunately, when it comes to some sterilization quality assurance practices a number of Central Service departments are, perhaps unknowingly, taking other shortcuts that could open themselves up to the very dangers and risks they try so hard to avoid.

The use – or misuse – of sterility assurance products, which are designed to monitor the effectiveness of the sterilization process by verifying that sterilization parameters have been met, is a prime example. Despite scads of scientific data, educational efforts and standards that address appropriate use of such devices, that hasn’t always been enough to make CS departments adequately address the err of their ways, sources told Healthcare Purchasing News.

"The fact is there’s still a great deal of confusion and misinformation circling around, and that’s leading to some less than appropriate practices taking place in SPDs," said Natalie Lind, educational director for the International Association of Central Service Materiel Management.

Numerous factors contribute to that confusion. For starters, many departments struggle to stay abreast of the latest sterilization standards, which makes them rely on outdated guidance documents – some of which may seem contradicting in light of technological advancements that may render previous recommendations less effective. In the absence of current standards, sterile processing staff may also rely solely on peers, neighboring hospitals, vendors and other sources for that information, which may further up the odds for misinterpretation or the spread of misinformation. The fact that sterile processing remains a somewhat revolving door profession only exacerbates the problem because supervisors must remember to continuously educate staff on proper protocols and sterility assurance-related issues.

"It’s been said so many times before, but it still holds true: ongoing education is critical," said Chuck Hughes, general manager and educator for SPSmedical Supply Corp, Rush, NY. "It’s not good enough to just teach something once and assume it’s going to stick, especially when you are talking about a department with such a high turnover rate. Not only do they need to know how to monitor the sterilization process, they need to be taught why it is important so they can really make the connection."

STERIS product manager Heide Ames echoed that sentiment, noting that, sadly, education is often the least-funded SPD activity. She explained that while internal hospital policies and procedures do generally receive the required training support, "it is often difficult, if not impossible, to help staff stay current on the latest national recommendations, to consistently send staff to off-site seminars and to obtain the most recent guidance documents for the facility."

While no sterility assurance product can ensure that a medical device is sterile, proper use of such testing devices can give CS staff a higher level of confidence that the conditions of the sterilization process have been met. Of course, that added layer of security is dependant upon the user’s knowledge of the capabilities and limitations of each type of sterility assurance product.

Perhaps the greatest source of confusion for many SPDs revolves around Class 5 integrating indicators and biological indicators. Although the two measure very different things – Class 5 integrators confirm that critical parameters (time, temperature and steam quality) of steam sterilization have been met, whereas biological indicators actually confirm spore kill – many SPDs are still operating under the false assumption that Class 5 integrators can be safely substituted for BIs.

"[Non-implant] loads can be released on the results of the Class 5 integrator, yes, but that is not the final step. It’s critical to grow out that biological in the test pack to determine spore kill," explained Tammy Torbert, marketing manager, 3M Sterilization Assurance. She added that while Class 5 integrators are a key component of sterility assurance, biological indicators are the gold standard for providing the highest level of assurance. [Note: Except in emergency situations, implant devices should not be released on the result of a Class 5 integrator; facilities must wait for the results of a biological indicator.]

Healthmark Advancing Bar Style Steam Sterilization Integrator

Facilities’ failure to rely on biological indicator results may come as a surprise to some, particularly because industry standards clearly outline appropriate use of sterility assurance products. Guidelines from the Association of periOperative Registered Nurses, for example, recommend biological monitoring for every ethylene oxide load, as well as in every steam load containing implants. Other steam systems should be subjected to daily monitoring, according to AORN.

Many sterilization experts believe cost implications are a part of facilities’ failure to routinely perform biological monitoring. Put simply, because loads can be released on a Class 5 integrator, some may attempt to curb costs by skipping the biological altogether. And even if facilities do grow out the biological, that doesn’t always mean the results are being read, Hughes pointed out.

Although hospitals certainly are not exempt from such shortcomings, the problem appears to be even more pervasive in the surgery center environment, according to Torbert. "Many times, someone from the OR has responsibility for CS [duties]. A big problem is that many surgery centers aren’t even aware of the [different standards groups], let alone the latest standards." To address the problem and promote ongoing education, 3M has representatives designated specifically to that market.

If there’s one guidance document that should reside on every CS department’s shelf, it’s the Association for the Advancement of Medical Instrumentation’s newly-released standard ST:79, Comprehensive Guide to Steam Sterilization and Sterility Assurance for Health Care Facilities.

One reason is that ST:79 combines and revises five previously released documents into one comprehensive standard making it unnecessary for CS professionals to cross-reference other documents. "This is really an important step in the right direction," said Alex Vrancich, operations manager for Spectrum Surgical Instruments Corp., Stow, OH. "Not only is ST:79 information-rich, it’s also very user-friendly."

The document incorporates some major sterility assurance-related changes that SPDs simply cannot afford to ignore. Per ST:79, AAMI now calls for all loads containing implants to be monitored with a process challenge device containing a Class 5 integrating indicator and a biological indicator, or a PCD containing a biological indicator and an enzyme-only indicator.

"When we’re talking about something as important as sterilization, it’s important to remember that the more tools that are used to monitor the process the better," continued Vrancich. "It’s definitely worth the time and the effort."

Interestingly, 3M’s Torbert said the push for the addition of the integrators came from the users themselves. "In the case of an emergency, they wanted a higher level of assurance that [the sterilization parameters have been met]," she said, adding that the presence of a Class 5 integrator gives them more confidence if they must release an implant before the biological has incubated.

Another notable standard change relates to new sterilizers that are installed, relocated or subjected to major repair. In these instances, ST:79 states that three PCD tests be performed in an empty sterilizer for three consecutive cycles. If gravity displacement cycles are available, the gravity cycle must also be tested with a biological, followed by three dynamic air removal tests (also known as Bowie-Dick tests). Another plus with ST:79 is that it addresses and clarifies some formerly gray areas that left some SPDs scratching their heads. According to Torbert, ST:79 "does an excellent job of defining the parameters of what constitutes an emergency," so users have a more clear picture of when it’s acceptable to release loads containing implants on Class 5 integrating indicator results.

Because technology is ever-evolving, ST:79 will undergo annual review to maintain the content’s relevance (previous standards were reviewed every five years.) Those who purchased the $200 document in 2006 will receive free annual updates – a perk that will allow facilities to further maximize their investment.

Unfortunately, extended cycles is one problematic issue that has yet to be addressed by standards. More and more, manufacturers are recommending extended cycles for their devices even though many sterilizers haven’t been designed to accommodate these longer durations. That, in turn, is causing some major sterility assurance stumbling blocks.

"If there’s no set standard related to extended cycles, and sterilizers aren’t equipped to handle longer cycles, that means there’s no real effective method to monitor the effectiveness of the sterilization in these instances," surmised Ralph Basile, vice president of marketing, Healthmark Industries Co., St. Clair, MI. "Without that, facilities are doing the best with what they have, which unfortunately, isn’t going to be adequate."

With knowledge of recent sterility assurance standards in check, CS departments will find an ever-growing array of process monitoring devices on the market to help them effectively tackle the task.

Although some vendors’ product portfolios feature just one or two types of monitoring devices, such as Spectrum Surgical which offers its Class 5 SteriScan Steam Integrator that can be used in flash, gravity and vacuum steam sterilization cycles, many companies’ product offerings run the gamut from single- and multi-parameter indicators and integrating indicators to biological indicators and indicator test packs that feature both an integrating indicator and a biological.

Healthmark is one supplier of both chemical and biological indicators – all of which offer easy-to-interpret color changes that simplify the determination of a sterilization cycle’s effectiveness. The company’s Gas-Plasma indicator is unique in that it’s not light-sensitive and will only change color in conditions necessary for sterilization.

STERIS offers an exhaustive sterility assurance product lineup as well, including several designed to monitor steam, ethylene oxide and dry heat sterilization systems, and also the manufacturer’s System 1 Sterile Processing System. Also included in STERIS’ testing product portfolio are Bowie-Dick tests, biological indicator test packs, Class 5 integrators and external process indicators. STERIS’ Verify chemical indicators have a range of performance characteristics, from simple Class 1 indicator tapes to complex Class 5 integrating indicators – the latter of which Ames says is STERIS’ most exciting product.

"This chemical indicator is correlated to biological indicator death and monitors all the critical parameters for sterilization," she explained, noting that what makes it different from others on the market is the specialization of the indicators for the cycle they are monitoring. Most integrators, for example, offer one strip for use in both three-minute and ten-minute gravity flash sterilization cycles. Aside from exposure time, the cycles are identical; that means regardless of whether a three-minute or ten-minute exposure time is chosen, the indicator will show a "pass" reading at the same time for both cycles.

"The Verify Class 5 Flash Integrator is unique in that it has two indicator spots, one for the three-minute cycle and one for the ten-minute cycle," added Ames. "This means that the ten-minute gravity flash cycle is being specifically monitored for the lethality required in that cycle, and will not show a ‘pass’ result until ten minutes of exposure has been completed."

Recognizing that time is of the essence for virtually every healthcare organization, it’s no surprise that vendors are striving to develop products with even faster read times. Adding to SPSmedical’s already wide array of cost-effective, user-friendly chemical and biological indicators is the SporView PA, which is touted as the fastest biological monitoring system for the STERIS System 1 peracetic acid sterilization process.

"It’s unique in that it provides a final readout in only 24 hours [as opposed to the earlier version that required three-day incubation] and requires no refrigeration," Hughes said.

3M also offers many testing products including indicator tape, indicators, integrators and Bowie-Dick type test packs. The company added the 3M Attest Rapid 5 Steam Plus Test Pack just three weeks after ST:79 was released in support of the guideline change that calls for the use of a Class 5 indicator to be used along with a BI for all implant-containing loads. The new product is designed to monitor steam- sterilized implant loads and contains both a rapid readout BI and a Class 5 integrating indicator. The test pack’s BI provides three-hour results, making it easier for users to quarantine every implant load until the BI result is available, and includes the 3M Comply (SteriGage) moving front Class 5 integrating indicator, which provides immediate results and does not require color interpretation.

The family of sterilization monitoring products from Getinge USA Inc., Rochester, NY, consists of air removal test packs, a range of chemical indicators, integrators and integrator test packs, and its extensive line of Biosign biological indicators. The Biosign EZ-VU Test Pack features a viewing window to make it easier to verify the BI’s integrity prior to processing.

Among other user-friendly developments are products designed for use in narrow devices, such as in lumens. Omaha, NE-based Raven Biological Laboratories’ micro-Strip spore strips, for example, are significantly scaled down (just 2mm X 10mm), allowing them to be used in areas where other BIs are too large. Raven’s product line also includes self-contained biological indicators (SCBI’s), ProPACT for the System 1, suspensions, specialty carriers, custom BI’s, incubators, Chemical Indicators and Integrators, and Bowie-Dick (daily air removal type) tests.

Raven is also developing a new Class 5 integrating indicator that can address the issue of extended cycle times. ProChem EXT, an extended timing Class 5 integrating chemical indicator for use in steam, is currently being evaluated by the FDA and is awaiting 510(k) notification.

"It will be especially useful for those running extended cycles as its timing is designed to go beyond biological kill," noted Dan Dwyer, director of marketing for Raven Biological Laboratories. He added while many devices now require longer and longer sterilization times, few products have been designed specifically to monitor these cycles. ProChem EXT changes from green to black only after 7 minutes of exposure at 275°F (135°C) and 20 minutes at 250°F (121°C).

Aside from offering an ever-growing product portfolio, vendors are also doing a good job of providing customers with ongoing education and keeping them apprised of the latest guidelines. Under its educational resource Attest Sterile U Network, for example, 3M Sterilization Assurance conducts what it calls "Sterilization Roadshows" and has also developed a tutorial and DVD that highlights recommendations and changes related to ST:79.

While vendor-driven education can be a vital component of CS professionals’ knowledge advancement in regard to sterility assurance, sources generally agreed on the importance of departments buying their own standards so they can refer to them frequently and be clear on the recommended practices.