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Hospitals are scrambling to transition away from the STERIS System 1 processor (SS1) to legally marketed alternatives, as mandated by the Food and Drug Administration (FDA). In its Dec. 3, 2009 notice, the FDA explained that it had not approved or cleared the SS1 for its safety or effectiveness according to its labeled claims; because STERIS Corporation chose not to seek FDA clearance of this device, the agency declared that its use should be discontinued as soon as possible.
In a Feb. 3, 2010 letter to customers, Walt Rosebrough, president and CEO of STERIS Corporation explained that the company submitted a new premarket notification for an updated STERIS System 1, and that the updated system includes the changes outlined in the May 15, 2008 FDA warning letter as well as other technology updates. STERIS submitted this new 510(k) to the FDA on Jan. 5, 2009 and is continuing to seek clearance of this new device. Rosebrough added that STERIS also continues to communicate with the FDA about a transition plan for System 1 users. The SS1 is a low-temperature sterile processing system for endoscopes and other immersible surgical and diagnostic devices.
The FDA extended out the transition deadline by 18 months to August 2011, due in part to healthcare professionals’ concerns about meeting the FDA’s demands. During this time, STERIS will continue to support existing SS1 units, through provision of currently-marketed components, accessories and sterilant, throughout the extended transition period. The FDA will also monitor the availability and supply of legally marketed replacement products.
While this extended transition time facilitates a more thorough assessment and planning strategy by ASCs, experts say it behooves facilities to expedite the process to continue to uphold patient safety. Adding to the need for immediate action is the FDA’s stance on the issue; while it says it does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period, it states, “These facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims. Healthcare facilities should therefore transition to alternative reprocessing devices as soon as practicable.”
“Hospitals and ambulatory surgery facilities are taking steps as quickly as possible to transition to alternative methods of sterilizing heat-sensitive instruments within the time frame required by the FDA in the notification published on Feb. 2, 2010,” says Ramona L. Conner, RN, MSN, CNOR, manager of standards and recommended practices at the Center for Nursing Practice of the Association of periOperative Registered Nurses (AORN). “Facilities are challenged to assess their sterilization needs, evaluate the alternatives, initiate the necessary purchases, educate their personnel, and prepare a smooth transition in a manner that will not compromise patient safety or impact their ability to provide care.”
“I think the sense of urgency is still in the marketplace and is definitely warranted,” says Barbara Trattler, RN, MPA, CNOR, CAN, director of clinical information for Advanced Sterilization Products (ASP). “What healthcare professionals need to understand is that this is not an FDA-cleared device for use, and so facilities are taking a risk every day that they wait to transition away from the SS1. It’s a required transition and that’s not going to change, so why wait if there is an opportunity to improve a standard of care? It is an opportunity to move from a just-in-time sterilization practice to terminal sterilization.”
“There is no time to waste,” confirms independent clinical consultant Cynthia Spry, RN, MSN, CNOR. “Facilities must use the extra transition time to plan wisely. Take advantage of the educational resources out there such as Webinars and the information that manufacturers are offering right now. And of course be sure to go to the FDA Web site to see what alternatives they suggest and then determine what’s right for your facility.” Spry adds, “Right now it’s a tough time; hospitals and ASCs are terribly busy but they must conduct their due diligence before they buy a replacement technology, and figure out what the implications involved in the transition are, and then put together a plan. People are short on time and money these days, so no matter what they do it will be difficult, but in the end I think it will be a good thing.”
Trattler encourages facilities to thoughtfully identify their sterilization and high-level disinfection needs and examine their current processes in order to better identify the infection prevention solutions that will meet those needs. She says that ASP’s clinical consultants can partner with healthcare professionals to provide additional resources and educational information to help guide ASCs through the transition planning process. “ASP can provide a number of tools that speak to all the considerations that exist when identifying which solution will work best for them,” Trattler adds. “With these tools we can help transition facilities to our Sterrad technology for their sterilization needs as well as our EvoTech technology for their high-level disinfection needs.”
“This is a complex issue that will require thorough assessment, evaluation, staff education and training, and the development of an implementation plan,” Conner emphasizes. “Sterilization and high-level disinfection are very complex and high-risk processes. Any change in the methodology and associated procedures requires knowledgeable and careful planning and education. If changes are not accomplished well, patient safety may be adversely affected. Facilities that do not begin immediately may find that they do not have adequate time to accomplish all this in a proper and thoughtful manner. Errors in the purchasing decision and lack of attention to proper personnel training could lead not only to unnecessary expense, but potentially to patient injury. Facilities should contact the manufacturers of the effected instruments and the sterilizer and high-level disinfector equipment for information. They should also consult the FDA Web site for lists of alternatives.“
Spry notes that this forced transition is not unlike other migrations as the marketplace matures and technologies evolve. “When the System 1 first came to market, it provided a tremendous upgrade from gluteraldehyde for high-level disinfection. It was a contained process, and it was revolutionary at the time. That was a long time ago, and technology changes. There is much more focus on sterilization these days and I think when there is newer technology out there, people are going to embrace it because it’s the future. When new technology comes out, everyone’s a little bit jumpy at first. Consider when the microwave was introduced; that product required change but people did it, and I think it will be the same with sterilization technology. I don’t think anyone ever really wanted to use gluteraldehyde but it was expedient. STERIS System 1 offered an alternative to glutaraldehyde, and in the same way, this latest transition offers an opportunity to improve one’s processes. It’s a win-win for terminal sterilization.”
Conner concurs, noting, “This is a great opportunity to educate healthcare personnel on the various complex science of sterilization and disinfection. There is not one single solution or methodology. A well-educated work force is the best answer."