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Re-examine SPD best practices with foresight,
not hindsight

by Jeannie Akridge

With the FDA’s 510(k) clearance of the STERIS System 1E Liquid Chemical Sterilant Processing System on April 6, facilities now have a full variety of options to replace the STERIS System 1, which had been for many a longtime low-temperature sterilization workhorse solution. Named the successor to the System 1, STERIS System 1E is “indicated for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat sensitive medical devices in healthcare facilities,” according to the FDA 510(k) filing¹.

“STERIS continues dialogue with the agency to close out the remaining SYSTEM 1 issues and expects to announce a transition plan in the near future,” the company stated. “STERIS is also committed to providing System 1 customers with consum­ables, parts and service and accessories throughout the FDA-authorized transition time period. The company will begin accepting orders for System 1E as soon as the transition plan is announced, with delivery of the first units expected by the second quarter of fiscal year 2011.”

While healthcare facilities have until August 2011 to transition to an alternative system, astute professionals are using this time to take an introspective look at their operations and workflow. Healthcare Purchasing News spoke with a number of sterile processing experts in order to get their perspective on how facilities can work towards best practice.

Janet Prust, business development manager, 3M Sterilization, noted, “Improving sterilization processing is an ongoing effort driven by adopting best practice, education and following standards. It also usually includes investment. For many hospitals, the requirement to find alternatives to STERIS System 1 means that multiple types of technologies are needed, not just one type. This issue has put a major burden on the hospitals and can take both funding and focus away from process improvements. The unexpected expenditures are also directly impacting funding to other needed improvements.”  

Because there are multiple considerations when selecting any new equipment or adopting new processes, it’s important that facilities do their homework before settling on a solution.

Advised Rosemary Niewolak, senior product manager, STERIS Corp., “We encourage departments to utilize the transition period to make a thoughtful, well researched and carefully planned decision on alternative technologies. There are respected independent sources, such as FDA, AORN, ECRI, and SGNA, providing education and guidance to all healthcare facilities. In addition, AAMI offers guidance on ways to improve overall sterilization and disinfection processes.” 

Michele Dawn DeMeo, sterile processing manager with Memorial Hospital, York, PA, reasoned, “It will take every bit of the 18 months (and counting down) to transition. Specifically, we tend, as creatures of habit, to do some processes exactly as they had always been because it is ‘how we have always done it.’ With most difficulties come opportunities and this is no different. For the transition to occur (and to have it done well) each facility really needs to assess their current needs and analyze their options.

“This should include forecasting future anticipated needs: What do you anticipate your workload volume to be in 1, 3, 5, 10 years? In what specialties? What are the growth projects of your facility? What are your physician development plans for the next few years? As an example, maybe urology was a large portion of your facility’s surgical volume for the past 10 years, but has that begun to change? By what percentage? This type of information, supported by data, affects the type of processing your facility will be doing in the future.”

While this may be a time-consuming project, the extra effort will pay off in a reprocessing system that more effectively meets current and future needs. 

“This is not going to be easy or quick,” said DeMeo. “What will surface may show that some old practices may need to be eliminated. Or there may be an opportunity to remove some devices that are no longer used. Perhaps moving towards terminal sterilization for some of the devices that had previously been processed in the STERIS System 1 is now a more plausible option. I do believe, however, waiting until the 18 months is nearly up to make the move may not be wise. As with any process change, program change or development early starts may be best for numerous reasons.” 

Despite the FDA’s extension of the transition period, postponing an analysis will only result in hasty decision-making, cautioned Nancy Chobin, R.N., CSPDM, corporate consultant/educator, Saint Barnabas Health Care System; West Orange, NJ; executive director, CBSPD Inc., and president and CEO, Sterile Processing University LLC. “Since the FDA gave additional time for the conversion away from STERIS System 1, people think they can wait it out. This is a mistake. The FDA has made it clear that facilities should transition to an alternative system as soon as feasible.”

Sources emphasized the need to use manufacturers’ instructions for use (IFUs) as primary guidance. “Make sure they have specific information from device manufacturers regarding the validated methods for cleaning, disinfection or sterilization, [and] make sure they comply with those recommendations,” said Chobin. “If they obtain and comply with the device manufacturers’ instructions for processing, there should not be any patient safety issues. Staff must know how to operate/monitor the alternative system with competencies verified.” 

Charles Hancock, medical device sterilization consultant, and president, Charles O. Hancock Associates Inc., noted, “The individual device manufacturer may not have provided detailed IFUs for all different means of cleaning and sterilizing devices for re-use. Today, this issue is high-lighted with the STERIS/FDA action in that not all device manufacturers have available IFUs for all of the alternative cleaning and sterilization technologies on the market.

“If there is one area where HCFs are frustrated,” continued Hancock, “it is this lack of valid, concurrent and complimentary information from both the individual medical device manufacturer and the process equipment (washers, sterilizers, etc.) manufacturers. HCFs must beware and challenge suppliers of both devices and process equipment to furnish truthful, accurate and complete information regarding reprocessing instructions. The user must become better educated regarding the technology and science behind the equipment, packaging and consumable supplies they use in order to get past the marketing hype of suppliers. Suppliers may make all kinds of assurances, but in the end the HCF user is liable and responsible for doing the job correctly.”

(See sidebar for more from Hancock on healthcare facilities and FDA regulation.)

Assessing the options

ASP STERRAD NX

First, a full operational assessment should be made, according to DeMeo. “Clearly, there are some standard principles that should be used that will help to guide the transition, such as conducting a fresh inventory of all items currently processed into the System 1 and verifying their processing validations with other processors,” she said. “It is not a simple matter nor is it going to be a straightforward move to an alternative. Not all items that were validated for the System 1 are going to be validated for alternative processors. In addition, space, utility and other infrastructure considerations will impede on the decision for a facility. Using any system is not as simple as replacing the unit and processing each item as you always had, potentially. So, without doing your homework, you could be adding a new system that will require many more pre or post steps that might not suit your department or facility well.” 

Sue Klacik, manager, central services, St. Elizabeth Health Center, Youngstown, OH, offered this tip to help users gain a clearer picture of sterile processing needs. “What I would suggest doing is making a spreadsheet and listing all the items that are going in the STERIS System 1 and then reviewing the manufacturers’ written recommendations for each item. On the spreadsheet, looking at manufacturers’ instructions and what are the alternatives, as you systematically go through that you can start to see ways to transition away from the STERIS System 1. Along with that, as you’re looking at this you need to [determine]: Is it a critical item requiring sterilization or is it a semi-critical requiring high level disinfection? And again, marry it up with the manufacturers’ recommendations and you can start to see where you need to go. As you do the analysis, the answer follows.”   

SPD vs. OR challenge

While the STERIS System 1 has primarily been a mainstay for point-of-use sterilization in surgical suites, endoscopy settings and ambulatory care centers, due to its broad processing capabilities and quick turnover, these areas will need to work hand in hand with CS in order to ensure best practices are incorporated on all fronts.   

Described Candy LeBlanc, R.N., BSN, senior manager global training, Advanced Sterilization Products (ASP), “One of the reasons that customers have chosen to use the STERIS System 1 in the OR is because of point-of-use sterilization, meaning that they can have it right there on the spot, process those instruments that they need fast turnaround time with – which would be your arthroscopy, laparo­scopy sets, single channel flexible scopes, because they’re expensive and they want them to get turned around very quickly. They don’t have time to send them down to the CS department for somebody to process them there and then send them back up, because those procedures are back-to-back typically. They have chosen that type of technology for that reason.”

Lacking the ability to process instruments in a timely manner nearby the procedural setting could put a definite damper on OR workflows.  

“If they don’t have a point of use sterilization system,” continued LeBlanc, “they’re going to need to now send all of that instrumentation down to the CS department to be processed, which means that you have a potential of more instruments becoming damaged or lost. In addition to that, the turnaround time is going to be greatly increased and they may not get the instruments back up to the OR in a timely manner, which could mean the OR will need to purchase even more instrumentation.”

She explained that the STERRAD NX low-temperature hydrogen peroxide gas plasma sterilizer can serve as a point-of-use sterilization system for the OR in place of the System 1. “The biggest difference is going to be that they’re going to have terminally sterilized product. So they’re going to have product that they can either use right away or can be stored,” said LeBlanc.

Transitioning from point-of-use sterilization to terminal sterilization will require ORs to become versed in proper packaging techniques, she noted.

“I look at it as a joint endeavor that needs to be taken between the CS and the OR, and the communication and the knowledge from the CS with terminal sterilization needs to transfer up to the OR as well,” said LeBlanc. “First off, they are the experts as it relates to how to properly clean, dry and package instrumentation. I would encourage that their skill sets be utilized to assist the OR in making the transition and showing them the proper way of how to transition to a terminal wrapped product.” 

Included as part of ASP’s Operating Room (OR) Solution introduced at the AORN Congress in March, ASP SteriTite Containers are designed for use with the STERRAD NX systems. The containers provide a convenient solution for packaging terminally sterilized instruments, including complete sets, without the need for wrapping, noted LeBlanc.

Klacik urged deep collaboration with the OR for several reasons. “CS needs to work in harmony with surgery because if they’re buying equipment, it may be something that they have in CS already, or CS may have budgeted for it,” she said. “The two departments definitely need to work together because there’s also that issue of timeliness. One of the things they like about the STERIS System 1 is it turns devices really quick. That’s one of the things you need to evaluate – do we need to turn these instruments quick? It may be that you do need more instruments if that’s the case.”

Beyond equipment selection, a successful transition to any new technology will require effective change management.

“When making the transition to alternative technology, the foremost concern should be safety and the risks a change will introduce,” cautioned Hancock. “People fear change. People resist change. People are the biggest problem when change is made. Mistakes happen. Anticipate the worst and be prepared to deal with errors.” 

A comprehensive approach should consider every potential safety risk to both patients and staff. “Understand that when changing technologies we must broadly look at all of the potential risks posed to the patient who will be treated. Further, the workers reprocessing patient care devices with new technology processes will encounter unforeseen hazards to their own health and safety,” said Hancock. “Education will serve to mitigate some of those risks but they will not be eliminated. Finally, when new technologies are introduced, new environmental concerns will surface. Most responsible process equipment manufacturers build in preventive measures as part of the equipment design to deal with foreseeable hazards. None the less, unanticipated and unplanned circumstances may be expected to challenge the health and safety of patients, workers and the environment/public.”

Education will be the keystone to ensuring continued best practice in the midst of change.

For example, noted Chobin, CBSPD offers competency-based certification testing on six levels. “There are websites (e.g. Sterile Processing University) that offer textbooks, workbooks and on-line courses to help keep staff current.”

A survey conducted by Millennium Surgical Corp. asking SPD and OR staff about their greatest challenges to instrument sterilization showed, “A variety of staff members with different levels of sterilization training and experience” is the overwhelming obstacle. (See the survey at http://survey.constantcontact.com/survey/a07e2r19lbwg60xywan/results)

Millennium is offering free instrument reprocessing steps posters to eligible organizations. Developed in partnership with 2008-2010 AORN elected board member Rose Seavey, R.N., the posters contain the critical steps of instrument sterilization as outlined by AORN, ANSI/AAMI, Joint Commission and CDC, and can help serve as compliance reminders. Facilities can request the posters at www.millenniumsurgical.com/poster.

As part of the newly introduced OR Solution, ASP has increased its staff of registered nurses who serve as clinical education consultants in order to advise hospitals throughout the transition process. Also, ASP’s STERRAD Sterility Guide, available at www.sterrad sterilityguide.com, provides STERRAD customers with a database of devices that fall within cleared sterility claims. For information on alternatives to the System 1, as well as questions to ask when selecting new technology, visit www.aspjj.com/alternatives.

To minimize and resolve unexpected issues before switching to a new process, some facilities are bringing in one new process at a time, noted Prust, 3M, who also emphasized the importance of using more than one technology to reduce dependence on a single sterilizer manufacturer.

Alternative technologies

A Feb. 2010 AORN Management Connections article² described acceptable alternatives for the System 1: “Some potential alternatives for sterilizing critical items are steam sterilization [if compatible], 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 (e.g., glutaraldehyde, ortho­­phthal­adehyde, stabilized hydrogen peroxide and peracetic acid).”

According to STERIS, the new System 1E addresses all of the issues noted in the FDA’s May 2008 Warning Letter, plus additional enhancements:

• 20 percent improvement in cycle time (23 minute cycle)

• 30 percent reduction in water consumption
(2 rinse cycles versus 4 in SYSTEM 1)

• Enhanced sterility assurance monitoring with a filter integrity test during every cycle

• A new UV technology for rinse water. (The UV light addresses FDA questions associated with the tap water used in the rinse cycles. The UV light provides pretreatment of water entering the chamber, potable water passes through the A&B prefilters, then the UV light treatment and then into the device.)

• The S40 Sterilant is environmentally safer.

Besides the System 1E, STERIS currently offers three recently developed oxidative options for reprocessing heat-sensitive devices: Amsco V-PRO 1 and 1 Plus Low Temperature Sterilization Systems; Reliance EPS endoscope Processing System; and Resert XL HLD High-Level Disinfectant.

ASP’s STERRAD NX systems are based on the company’s next-generation technology with capabilities to allow the processing of single channel flexible scopes. ASP is offering a $6,000 trade-in price for any STERIS System 1 directly one-on-one to a STERRAD NX system, as well as special terms and processes for those hospitals that would like to lease or have some type of different financial arrangement for acquiring the equipment, said LeBlanc.

In addition, she noted, “We accelerated our production so that equipment will be available for those customers needing to make the transition so that they’re not having to wait long extended periods of time to get it installed after they purchase it. Along with that, we have new additional field service engineer staff that are currently in training as we speak who will be in place to meet the demands of the installation so that there won’t be any lag time in making the transition.”

According to Prust, ethylene oxide systems, such as 3M’s Steri-Vac sterilization systems, “are still the only type of low temperature sterilization process without restrictions on materials or lumen configurations.” Further, 3M will be offering a low-temperature sterilizer to acute care facilities. As per an exclusive agreement signed with TSO3 in December 2009, 3M will distribute a new ozone and hydrogen peroxide-based low-temperature sterilization technology under the 3M Optreoz brand. “The sterilizer is currently under U.S. FDA review,” she added.

“There are currently well-defined (FDA cleared) alternatives to the use of the STERIS System 1,” emphasized Hancock. “I think users should concentrate on those alternatives that are currently available and not engage in wishful thinking about what may be next on the market. Users should recognize that they should concentrate on the IFUs of the devices their HCF will be asking them to reprocess, very specifically. I expect a great deal of frustration to grow among users in that many medical device manufacturers are not able to provide IFUs for all of the cleaning and sterilization equipment cleared by the FDA for market.”

References:

1. http://www.accessdata.fda.gov/cdrh_docs/pdf9/K090036.pdf

2. http://www.aorn.org/News/Managers/February2010Issue/STERIS