Planning for alternatives to the STERIS System 1Safety, financial impact and work flow are just some of the issues health care professionals are considering as they develop transition plans to alternative methods for reprocessing endoscopic instrumentation in light of the FDA notice regarding concerns with the STERIS System 1.
By Carina Stanton
Senior News Editor
In early February 2010 the FDA extended to 18 months the transition period for implementing an alternative to the STERIS System 1 processor for reprocessing endoscopic instruments. While many are breathing a sigh of relief with the news of this extension, Stephanie Davis, RN, MS, CNOR , assistant vice president of surgical services for HCA, Clinical Services Group in Nashville, Tenn., says now is the time to be actively addressing this issue.
“The longer transition time will allow for more careful assessment and planning by facilities, but [developing a transition plan] cannot be delayed because it will take time to go through the steps needed to determine what your plan will be. The larger your facility is and the more service lines you offer, the more complicated your plan is likely to be,” she stressed.
Davis recently hosted an AORN webinar titled Steris System 1 Issue and Transition Planning in which she presented the background information leading up to the current FDA recommendation that facilities transition away from using Steris System 1 to alternative methods. She also shared the safety concerns and other issues to think about when developing a transition plan, including the need to collaborate within a team to address the different needs of all staff members and departments impacted by the transition.
Facing the situation
The STERIS System 1 (SS1) processor is a low temperature sterile processing system for immersible surgical and diagnostic devices. On Dec. 3, 2009 the FDA issued a notice to health care facility administrators and infection control practitioners conveying agency concerns about the STERIS System 1 Processor, because “the FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices.” According to the notice, if health care facilities have an acceptable alternative to the SS1 to meet sterilization and disinfection needs, they should transition to this alternative as soon as possible to ensure continued patient safety.
On Feb. 2, 2010 the FDA extended this transition period to 18 months, allowing facilities until approximately August 2011 to have alternatives to SS1 in place. Prior to this Dec. 3 notice, the FDA had issued a Warning Letter to STERIS on May 15, 2008, identifying significant changes that STERIS made to the SS1 that could significantly affect the safety or effectiveness of the device.
On Jan. 20, 2009 STERIS sent a notice to customers, informing them of the FDA Warning Letter and the actions the firm was taking in response to the letter to stop marketing its device and to transition its customers to replacement products. This FDA recommendation applies to STERIS System 1 units within the United States. STERIS will support existing SS1 units through the extended transition period.
STERIS has submitted a 510(k) pre-market notification for an updated SYSTEM 1, which is currently under review by the FDA. "We are in daily discussions with FDA regarding a transition plan to assist customers with the transition to legally marketed alternatives," according to Stephen Norton, STERIS director of corporate communications. Learn more about the status of the replacement system for the SS1 here.
Find alternatives
In the mean time, healthcare administrators and infection preventionists are working with other healthcare personnel to determine which alternatives to the SS1 are best. Some potential alternatives for sterilizing critical items are steam sterilization include hydrogen peroxide vapor and ethylene oxide sterilization (EtO). Alternatives for semi-critical items may include high-level disinfection using automatic endoscope reprocessors (AERs) or manual soaking in a high level disinfectant (eg, glutaraldehyde, orthophthaladehyde , stabilized hydrogen peroxide and peracetic acid).
The challenge is that there is no exact “one to one” comparison to the STERIS System 1, which is described by some nurses as a “work horse” because complete reprocessing with the SS1 takes no more than one hour in most cases and the system is often placed safely nearby procedural settings, allowing for streamlined reprocessing that fits well within work flows.
As facilities work to select the best alternative, they are finding that the work flow processes to complete endoscope reprocessing will be more complex, Davis explained in the AORN webinar. “In most circumstances, transitioning will require the use of two or more alternative methods, which adds complexity to the process and longer wait times for reprocessing to be complete.”
Davis illustrates the simple process for reprocessing instrumentation with the Steris System 1 (SS1).
Source: AORN webinar, Steris System 1 Issue and Transition Planning. Used with permission.
In contrast, Davis shows the more complex process flow for reprocessing the same instruments with alternative methods. Source: AORN webinar, Steris System 1 Issue and Transition Planning. Used with permission.
Davis said facility leaders looking for alternatives to SS1 are also concerned that alternative methods may damage these instruments and with a potentially increased demand for these instruments and the supplies and equipment required for the alternative methods for the SS1, some health care professionals are concerned there won’t be enough supply in the pipeline to meet demand.
Due to longer time required for reprocessing, Davis also projected that scheduling concerns will arise. However, she stressed that safety is the biggest concern for everyone involved.
“Each alternative has distinct issues to consider, including financial implications, staff education and safety, for both patients and health professionals.”
Maintain safety
In addition to adding complexity to the reprocessing process, finding an alternative to SS1 also requires training staff members to ensure they are safely practicing the alternative.
The time and costs required in training staff to safely practice alternatives to the SS1 should be a part of any facilities transition plan, according to Ramona Conner, RN, MSN, CNOR, AORN manager of recommended practices. “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.”
Reviewing safety practices for alternatives such as manual soaking with high-level disinfectants (eg, glutaraldehyde, orthophthaladehyde) is an important part of this training because this method requires careful adherence to recommendations for proper ventilation and specific personal protective equipment, which may need to be purchased to safely practice this alternative method. (To learn more about safety when using high-level disinfection read AORN’s Recommended Practices on High Level Disinfection in Perioperative Standards and Recommended Practices, 2010 edition.)
“While using manual high-level disinfectants is not the optimal alternative, it is one alternative health care professionals can use, but this method has been phased out in most facilities and many health care professionals may not be aware of the safety dangers that must be addressed to keep personnel and patients safe when using high-level disinfectants for sterilization,” Conner stressed. “I can’t stress enough how critical adequate staff training is, prior to the implementation of any alternative to the SS1.”
Plan for the financial impact
Conner and Davis both acknowledge the costs facilities need to be considering for all aspects of transitioning to these alternatives, including the potential purchase of equipment, instruments and supplies, any structural or environmental modifications needed for installation of new reprocessing equipment or for ventilation requirements, and the staff training required to get everyone practicing these alternatives safely.
As healthcare professionals across the country try to project these costs, some are seeing total estimates up to a millions dollars for a 200-bed facility.
Ambulatory facilities are also realizing the financial impact this transition will have. Beverly Primeau, RN, MBA, the administrator in a small multi-specialty ASC, is currently trying to work these transition costs into her facility budget. “We have two OR's, and two STERIS System 1 processors that are used daily and were vital to quick turnovers in our ASC,” Primeau explained. “We are now faced with making an unbudgeted purchase for an alternative system which could cost anywhere between $60,000 and $100,000. And our SS1s are not fully depreciated yet, so this new investment will have a significant impact on us financially.”
Collaborate
While the FDA extension will give facilities more time to plan for these expenses, now is the time to gather a team of stakeholders to determine the safest and most cost effective approach, particularly for those service lines most impacted by this transition, including endoscopy, general surgery and surgical specialties such as orthopedic, gynecology and urology, Davis said.
Infection preventionists and representatives who handle central sterile processing, purchasing and those in charge of facility spending will also likely be part of this collaborative planning team, Conner added. “Finding the safest alternative that also fits within a facility’s budget and personnel work flows will take careful planning among multiple stakeholders.”
Davis also suggested ECRI Institute’s Guidance for Developing a Transition Plan for alternatives to STERIS SYSTEM 1 because it provides the necessary steps this transition team will need to take to address key issues impacting multiple stakeholders affected by this transition. This plan is available to ECRI Institute members at ECRI Institute’s online STERIS System 1 Resource Center. Information on steps for this transition are also included on the FDA Web site.
Conner said collaboration with stakeholders outside of the facility may also be important to consider, including with the facility’s accreditation organization to get a better understanding of what surveyors may be looking for regarding demonstration of moving toward alternatives to the STERIS System 1.
For example, according to Ann Scott Blouin, PhD, RN, executive vice president in the division of accreditation and certification operations for The Joint Commission, “The Joint Commission is aware of the FDA recommendations and has communicated this information to our surveyors. If during a survey, the surveyors determine that an organization is utilizing the STERIS System 1 for reprocessing endoscopes, the surveyors will discuss the FDA recommendations to enable the organization’s awareness and actions toward the recommended FDA steps.”
AORN members can access up to date information on the STERIS System 1 issue via AORN’s new Clinical Info Link page dedicated to addressing questions regarding the transition from STERIS System 1.
As facilities continue to develop their plans for transitioning away from the STERIS System 1, Davis stressed how important it is to stay aware of any warning letters issued by the FDA regarding a product, like the letter sent in May 2008 to STERIS regarding the STERIS System 1. “We will be taking such letters very seriously so we are prepared if the FDA chooses to take action on a product.”
Look to AORN News for continued coverage on the transition from STERIS System 1 and other FDA warnings and recommendations that impact perioperative practice.
Read more news in AORN Management Connections.