What’s The Difference?

Compare the Alternatives and Help Your Facility Determine the Best Choice for their O.R.

On November 12, Advanced Sterilization Products (ASP) hosted the fifth in a series of informational Webinars, “What’s the Difference? – Choosing the Right Alternative for Your O.R.” to review the key features and differences between the STERRAD^® NX^™ System and the STERIS System 1E™ (SS1E), in order to help healthcare professionals select the right alternative for their facility. The Webinar featured representatives from ASP, including registered nurses and a microbiologist, comparing the devices and highlighting the benefits of transitioning to a higher standard of care with the STERRAD^® NX^™ System.

If you were unable to attend the live broadcast of the Webinar, an archive is now available for on-demand viewing at www.aspjj.com/us/media/webinar_video.

Speakers included:

Barbara Trattler, RN, MPA, CNOR, CAN
Director, Clinical Education for ASP
Charles Roberts
Director of Research, Microbiology and Chemistry for ASP
Nancy Fellows, RN
Senior Clinical Education Consultant for ASP
Cathy Rocco, RN,
Senior Clinical Education Consultant for ASP

What’s the Difference? Take-Aways:

In her discussion of the need for hospitals to transition from the SS1 to an alternative device, Barbara Trattler, RN, MPA, CNOR, CAN, noted, “With less than 10 months until the FDA deadline to make the transition, and less than five months until medical device manufacturers remove SS1 from their instructions for use, many [healthcare facilities] are under increasing pressure.” She added, “…since the FDA mandate, ASP already has helped transition hundreds of hospitals nationwide to the highest standard of care, terminal sterilization.”
Charles Roberts, Director of Research, Microbiology and Chemistry for ASP spoke on the differences between the methods of processing, saying, “The STERRAD^® System provides a low-temperature sterilization solution for the OR. It is a dry, packaged system that terminally sterilizes surgical instruments. Devices are not exposed to rinse water at any time during the sterilization process, therefore filters or drain lines are not required. Instruments begin the sterilization process dry and end dry.”
Nancy Fellows, RN, discussed the environmental impact of each device and noted, “The hook-ups used by the SS1E to supply rinse water and power the UV light consume water and energy, which incur additional costs. An SS1E cycle can consume nearly nine gallons of water...The only process byproducts for the STERRAD^® NX™ System are water vapor and oxygen, as a result, no special heat boosters, plumbing, aeration or ventilation are required.”
Nancy also highlighted the benefits of a packaged system versus a wet system noting, “STERRAD^® NX™ System can help you optimize your instrument flow by processing typical rigid scopes, bridges, sheaths, forceps and light cords required to perform a routine procedure in one container all at once. The materials and lumen claims of STERRAD^® Systems extend even beyond heat- and moisture-sensitive devices, allowing you to process most procedure sets together.”
Cathy Rocco, RN, reviewed tools for determining the validated devices for the STERRAD^® NX™ System, including the STERRAD^® Sterility Guide, and explained, “ASP, through its medical device manufacturer program, or MDM program, is continuously working with medical device companies to help them determine if instruments are within the cleared sterility claims for STERRAD® Systems…Currently, KARL STORZ, Olympus, Gyrus and Richard Wolf have all released flexible endoscopes that can be processed in the STERRAD^® NX™ System.”

Q&A Session:

Following are the most popular and pressing questions answered regarding the differences between the STERRAD^®NX™ System and the SS1E:

Q: Is the SS1E a sterilization unit?

A: The SS1E is not a sterilizer. It is a liquid chemical sterilant processing system. According to the FDA, processed devices from the SS1E cannot be assured to be sterile.¹

Q: What types of scopes can be sterilized in the STERRAD^® NX™ System?

A: Some of the categories of devices that can be used in the STERRAD^® NX™ System include:

Autoclavable and non-autoclavable cameras used in Minimally Invasive Surgery
Flexible endoscopes
Rigid telescopes
Ultrasound transducers and probes
Orthopedic powered drills and accessories
Rechargeable batteries for powered instruments
Defibrillators
Laryngoscopes and blades

Please also consult the STERRAD® Sterility Guide and check with your endoscope manufacturer directly for the use of specific devices with the STERRAD^® Technology.

Additionally, remember that the FDA has given medical device manufacturers until February 2011 to remove the SS1 from their instructions for use. Medical device manufacturers are actively working right now in order to begin this process, which means that you may have begun to already see some changes in instructions for use. It is important for you to maintain contact with the medical device manufacturer to assure that you receive the latest changes in their instructions for use. We recommend that you speak to the manufacturer before replacing sterilization equipment.

Q: What is the actual difference between the System 1^® and System 1E™?

A: This is a question that should be directed to your STERIS representative.

But both the SS1E and SS1 do not offer terminal sterilization. The STERRAD^® NX™ System offers terminal sterilization, the highest standard of care in instrument processing, and provides sterile devices that can be used immediately or stored for later use.

Q: Since the SS1E has lidded containers, can I put processed devices on the shelf and use them later?

A: There is no storage claim with SS1E just as there is no storage claim with SS1. Processed devices from the SS1E must be removed from the processor at the end of the cycle and used immediately.² STERRAD^® Systems provide packaged terminally sterilized devices that can be put on the shelf and used now or later.

Q: If my facility decides to transition from the SS1^® to the STERRAD^®NX™ System, how quickly could I have it up and running in my OR?

A: ASP has supply on hand to get customers their STERRAD^® Systems shipped. In other words, we will work with you to get a legally marketed device that delivers the highest standard of care in your facility as quickly as possible.

More questions will be answered and continually updated on www.aspjj.com/alternatives.

View the Webinar

If you were unable to attend the live broadcast of the Webinar today, an archive is now available for on-demand viewing at http://www.aspjj.com/us/media/webinar_video.

This Webinar is just one of the new resources and educational initiatives ASP has recently launched to help smooth the transition to SS1^® alternatives. For more information about the STERRAD^® System and ASP products, please visit our newly re-vamped Web site at www.ASPJJ.com. You can follow ASP on Twitter @ASPJJ for the latest on infection prevention news from ASP (www.twitter.com/aspjj). In addition, we have also launched ASP’s Infection Prevention YouTube site, www.YouTube.com/InfectionPrevention. It offers helpful videos including the full archived presentations of ASP’s first four Webinar series installments.

For more information about these additional resources, please visit www.aspjj.com/alternatives.

STERIS System 1 is a registered trademark of the STERIS Corporation.

¹FDA website. STERIS System 1E (SS1E) Liquid Chemical Sterilant - K090036. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm207489.htm. Accessed 12 May 2010.
² Q & A from SYSTEM 1E™ Webinar http://www.steris.com/media/PDF/system1/QAWEBINARFINAL.pdf Accessed 4 October 2010