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ISSUE TWO—2011  

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EVOTECH® Endoscope Cleaner and Reprocessor Helps MedCentral Health System Deliver Excellence

Study Shows CIDEX® OPA Solution Does Not Damage Endoscopes

Latest FDA Guidance

ASP Launches GLOSAIR™ Healthcare Environmental Decontamination System

CIDEZYME® XTRA Multi-Enzymatic Detergent—New Name, New Manual Cleaning Claim

Reprocessor Q&A

ASP Launches Educational Video Series


Charles Roberts, MS
Director of Research,
Microbiology &
Chemistry, ASP

Barbara Trattler,

Director of Clinical
Education, ASP

Candy LeBlanc, BSN, RN
Senior Manager
Global Training, ASP

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ASP Launches Educational Video Series

ASP will be offering a series of educational videos covering key topics of interest to instrument processing, operating room, and infection prevention professionals. Initial topics include:

Optimal Packaging: Improving Efficiency, Saving Money
This chapter discusses the benefits of terminal sterilization and the flexibility it provides for immediate or later use of processed devices.

Monitoring & Documentation
This chapter highlights the importance of biological indicator monitoring, chemical monitoring, administrative monitoring, and physical monitoring.

ASP’s new educational video series is a great way to keep up with best practices in the fast-moving instrument processing field. The videos are complimentary and can be accessed on the ASP Web site, or by visiting the ASP page on Facebook. Stay tuned for additional videos in the series!


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For More Information
To learn more about ASP and the topics featured in this issue, or to let us know what you’d like to see covered in future issues, please call 888–783–7723 or e-mail

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EVOTECH® Endoscope Cleaner and Reprocessor Helps MedCentral Health System Deliver Excellence

MedCentral Health System in north central Ohio was faced with a challenge. Its two acute care hospitals were looking for alternative reprocessing methods for flexible endoscopes as they completed the transition from the STERIS System 1* to a legally-marketed alternative device as directed by FDA. Their search led them to Advanced Sterilization Products (ASP) and its EVOTECH® Endoscope Cleaner and Reprocessor (ECR) .  Now, more than one year after the EVOTECH® ECR systems were installed, MedCentral’s two hospitals (Mansfield Hospital and Shelby Hospital) are achieving superior results, including consistently cleaned and high-level disinfected flexible endoscopes and optimized instrument availability due to a decrease in instrument repairs. READ MORE

Study Shows CIDEX® OPA Solution Does Not Damage Endoscopes

In light of the impending deadline to transition from the STERIS System 1* processor to a legally-marketed alternative device as directed by FDA, many facilities are reviewing alternative reprocessing options. Clinical studies may help with the decision-making process. For example, a 2007 study published in the Journal of Endourology demonstrated that CIDEX® OPA Solution from ASP does not damage endoscopes, but STERIS System 1* sterilization rendered them unusable after repeated reprocessing.1

Independent researchers at the University of California evaluated the effects of CIDEX® OPA Solution and STERIS System 1* reprocessing on flexible ureteroscopes. Since the research involved a lab study, there were no differences in how the scopes were used between high-level disinfection (HLD) cycles. In the study, two new, identical ureteroscopes were reprocessed
200 times each—100 times in each system

Latest FDA Guidance on Liquid Chemical Sterilant Processing

The U.S. Food and Drug Administration has recently provided important new guidance and recommendations for liquid chemical sterilant processing.1 This guidance is important for healthcare facilities that process critical devices and are evaluating options to replace the STERIS System 1.* Click here to read the new guidance from the FDA.

As an alternative, the ASP STERRAD® NX® System uses a hydrogen peroxide gas plasma sterilization process that provides the sterility assurance level of 10-6 required for processing heat-sensitive critical devices—providing patients the highest standard of care. The STERRAD® CYCLESURE® 24 Biological Indicator (BI) provides evidence of proper sterilization conditions as recommneded by AAMI, AORN, and CDC.

U.S. Food and Drug Administration. Liquid Chemical Sterilization. 2011. . Accessed September 7, 2011..

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ASP Launches GLOSAIR™ Healthcare Environmental Decontamination System to Protect Against the Risk of Deadly Infections in Healthcare Facilities

ASP recently launched the GLOSAIR™ Healthcare Environmental Decontamination System—an innovative infection prevention technology that provides safe and thorough disinfection of hospital rooms and operating suites to reduce the risk of patient contact with infection-causing pathogens when used to augment manual cleaning processes.

A recent survey found that more than one in three Americans have, or know someone who has, acquired an infection resulting from hospital stays.1 

Environmental contamination plays an important role in the transmission of many superbugs that cause infections.2 Research indicates that some microorganisms, such as methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Escherichia coli, are tougher to eliminate than others and can continue to persist on environmental surfaces after standard cleaning approaches.3 Healthcare facilities can reduce the number of these pathogens in the hospital environment by introducing enhanced, deep cleaning and disinfection protocols to current practices.4 The GLOSAIR™ System works by creating a fog of approximately 5% hydrogen peroxide that is uniformly dispersed to disinfect all hard nonporous surfaces, including difficult-to-reach areas.

For more information about the GLOSAIR™ Healthcare Environmental Decontamination System, click here.

1. Survey Finds More Than 1 in 3 Americans Have Been Personally Affected by Infections Resulting from a Hospital Stay. 2011. Accessed August 31, 2011.
2. Weber D, Rutala W, Miller M, Huslage K, Sickbert-Bennett E. Role of hospital surfaces in the transmission of emerging health care-associated pathogens: norovirus, Clostridium difficile, and Acinetobacter species. Am J Infect Control. 2010;38:S25–S33.
3. Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infectious Diseases. 2006;6:130.
4. Hota B. Contamination, disinfection, and cross-colonization: Are hospital surfaces reservoirs for nosocomial infection? Clin Infect Dis. 2004;39:1182–1189.

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CIDEZYME® XTRA Multi Enzymatic Detergent—New Name, New Manual Cleaning Claim

ASP is pleased to announce some exciting changes in connection with its leading multi-enzymatic detergent. CIDEZYME® GI Enzymatic Detergent has a new name—CIDEZYME® XTRA Multi Enzymatic Detergent, which better reflects its role as a next-generation detergent that can be used to clean medical instruments throughout multiple hospital departments, as well as for bedside precleaning.

In addition, CIDEZYME® XTRA Multi Enzymatic Detergent is now labeled for manual use in addition to use in the EVOTECH® Endoscope Cleaner and Reprocessor (ECR). CIDEZYME® XTRA Detergent also now comes with a pump dispenser for added convenience. Importantly, the detergent contains the same combination of multiple enzymes and surfactants to provide extra cleaning strength, allowing for the most effective cleaning needed to prepare scopes for high-level disinfection. While the product name and label have changed, the product code remains the same—22591.

Click here to access a new Materials Safety Data Sheet for CIDEZYME® XTRA Multi Enzymatic Detergent. The updated IFU is available online at

ASP recently published a white paper titled “Effective Cleaning of Flexible Endoscopes: The Essential Role of Multi-Enzymatic Detergents.”

Click here to download a copy.

Is the STERRAD® System just for sterilizing heat- and moisture-sensitive instruments?

No. The STERRAD® System, which is a low-temperature hydrogen peroxide gas plasma sterilization system, has material and lumen claims that extend beyond heat- and moisture-sensitive devices. In fact, STERRAD® Systems can sterilize most medical devices and surgical instruments safely and effectively, without the instrument damage associated with high-temperature steam sterilization. Transitioning more of your instruments from steam to a dry, low-temperature sterilization process can produce a measurable return on your sterilization investment. Based on three studies,1-3 a typical hospital could save 33 percent annually on repairs—that’s approximately $18 every time a scope is processed.

In addition, while many facilities break up sets and process only the heat- and moisture-sensitive instruments in the STERRAD® System, there are significant advantages to processing instrument sets together. Breaking up instrument sets may increase the likelihood that pieces may be lost, interfere with efficient workflow by requiring central service or OR staff members to disassemble and reassemble the sets, and increase the risk of instrument damage in the case of steam sterilization. As an alternative, many instrument sets can be safely processed together using hydrogen peroxide gas plasma sterilization, which may increase efficiency, mitigate the problem of missing components, and reduce instruments damage.

1. Schafer B. Decreased number of repairs of rigid scopes as a result of low temperature sterilization with H2O2 gas plasma. Zentral Sterilization. Vol 17 2009.
2. Skogas J, Marvik R. Measures taken to reduce damage and repair costs of rigid endoscopes during their handling and processing in surgical practice. Min Invas Ther & Allied Technol. 2003;12:76–81.
3. Thallmayer K. From steam to dryness: STERRAD® sterilization process noticeably reduces repair costs for rigid scopes. Management & Krankenhaus. May ed: Wiley-Blackwell; 2009:17.


How can we reduce use of immediate-use sterilization in sub-sterile areas?

According to Janet Moran, RN, MBA, CNOR, senior clinical education consultant at ASP, immediate-use sterilization, formerly known as flash sterilization, has been used for years as a means to sterilize instruments that were needed in the operating room. However, over the past several years, through education, guidance, and direction from organizations such as the Association of periOperative Registered Nurses (AORN) and Association for the Advancement of Medical Instrumentation (AAMI), this practice is changing. Although immediate-use sterilization has decreased in many facilities, Moran said that some are “holding out” from making the transition. The reasons include not wanting to lose ownership of the process, not enough time to turn over the instrumentation in another sterilization modality, or not having enough devices in inventory to meet OR scheduling needs. “If we follow Best Practice guidelines, these reasons are not valid,” Moran said.

The transition away from immediate-use sterilization can be daunting, but Moran suggested that breaking up the process into categories can help.

  1. What: List the instruments that are being processed with immediate-use sterilization.
  2. Why: List why the instruments are being immediate-use sterilized. Is it because they are one of a kind (inventory)? Is it because of time? Is it because of ownership? Is it because the instrument was dropped? Is it because of an emergent situation?
  3. Where: Which areas or specialties within the OR are utilizing immediate-use sterilization? Is it occurring more often in one specialty or with one particular physician/staff member?
  4. How: Can these instruments be processed using other sterilization modalities? If so, what are they, and what is the processing time? How will that affect your turnover time? Is there a way to schedule procedures so that coordination of needed instrumentation can occur?

Once this information is collected and evaluated, Moran said that steps can be taken for moving away from the practice of immediate-use sterilization. “Surgical site infections can be devastating to patients, as well as financially to the institutions,” Moran said. “As a result, it is critical that everyone does their due diligence in implementing Best Practice actions, which include using monitored terminal (wrapped/container) sterilization modalities for processing surgical devices.”

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© Ethicon, Inc. 2011

*STERIS System 1 and 1E are trademarks of STERIS Corporation.

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