No question, when it comes to driving quality, safety and efficiency in the Central Service department, there are many best practices that should ideally be followed. Here, vendor experts share with Healthcare Purchasing News those they believe to be most critical to CS’ success.

As a consultant who provides both fee-based and courtesy sterilization audits, SPSmedical works with healthcare facilities to document non-compliance areas with recommendations for quality improvement. Each audit focuses on three areas: facility design; personnel; and reprocessing procedures. We inspect and teach sterilization best practices as defined by AAMI Standards (CSA in Canada) and AORN Recommended Practices, with the understanding that a common goal of every sterile processing department is to deliver instrument sets that are: sterile, on time and complete. Instead of sharing the many areas of non-compliance we find, allow me to share the solution. First, require all sterile processing staff to be or become certified so they can document their knowledge of current best practices. Be sure everyone maintains certification and increase their knowledge of best practices with monthly CE programs. Second, assign an experienced manager (each shift) to ensure proper work flow, including pace of work and compliance with best practices in all areas, including decontamination, inspection, assembly, packaging, sterilization, storage, and distribution. Third, establish a Sterilization Continuous Quality Improvement Team with representation from the operating room, infection contro, CS/SPD, materials management and environmental services to address issues, review policy and procedures, and recommend changes. With the complexity of new sterilization processes and new instrumentation, it is vital that every healthcare facility (as well as suppliers) make a commitment to adhering to best practices — not some of the time, not most of the time, but all of the time.

Charles Hughes, general manager/educator,
SPSmedical Supply Corp.

The managing of tray weight and proper storage of sterilized packaging are two specific practices that may be overlooked in today’s busy SPDs. For the last several years, there has been a trend toward heavier and heavier trays. And for the last several years, our guidance on this issue has been a little vague. However, in the last two years, both AAMI and AORN have published clearer guidance on the issue of tray weight and how to best manage it. According to AAMI guidelines, the combined weight of the containment device, the instruments, and any accessories or wrappers shall not exceed 25 pounds when the containment device load is configured according to the manufacturer’s instructions. The rationale behind this is when containment devices, including their contents and any accessories or wrappers are too heavy, sterilization and/or drying time may be compromised. Additionally, there may be ergonomic issues associated with heavy containment devices, which can lead to injury for the healthcare worker.

Another best practice is ensuring appropriate storage of sterilized packages, so they do not become contaminated prior to use. Here are some tips: Packages should be handled only when necessary. The probability of package contamination increases with increased handling. Minimum handling helps ensure that a sterile package is delivered to the point of use. When moving a wrapped tray, always lift the tray off the surface it is resting on first, and then move it. This can be done by first lifting the front of the tray, and then putting a hand in the center of the bottom of the tray. Never drag a tray across a storage shelf, sterilizer cart or table, even if the surface is smooth. This helps reduce the chance of damage to the packaging. A damaged package must be considered contaminated and re-processed. Try to position heavier trays on middle or waist-high storage shelves, where it is much easier to lift and control the tray. Since many microorganisms prefer a warm moist environment, controlling the temperature and humidity in the storage area may help mitigate microbial growth. The temperature in the sterile storage area should not exceed 75 F (24 C) and relative humidity should be controlled not to exceed 70%. Always practice "First in, first out" (FIFO) with stock rotation. Each package should be stored for the shortest time necessary as the chance of package contamination increases over time.

Overall, collaboration between SPD and the OR is extremely important to the proper storage and handling of sterilized packages. Building strong relationships between these two departments will increase the flow of communication and help ensure proper handling of sterile supplies.

Laurie Clark, sterilization product technical specialist,
Kimberly-Clark Health Care.

It’s important to find an instrument traceability and asset management system that increases the quality process, rather than hinders it. For instance, some advanced systems on the market improve processes by preventing non-sterilized sets from being used, or those whose biological indicators come back positive. One area where these systems have demonstrated their need is in the packing and assembly area. We have seen a notable increase in focus and improvement among staff [who] have everything needed in their workplace. Some of these advanced systems enhance this by providing an on-screen list of instrument, pictures, video, voice, handling and processing instructions, and almost anything else needed for that technician to confidently and accurately assemble the set. Whatever system you choose, make sure it’s one that not only concerns itself with an instrument inventory, but also takes the entire process into account. This includes electronically documenting washer and sterilizer processes, biological indicators, tracking repairs, loaner equipment, missing instrumentation, implants, and of course, anything else that comes in contact with the patient. Overally, any good system should be an integral part of the process, capturing the production statistics, detailed costs and staff performance, while providing reports to ensure your practices are indeed the best practices.

Hana Scheichenost, national manager,
T-Doc Instrument Traceability & Asset Management Systems,
Getinge USA

One best practice that an increasing number of sterile processing departments across the country are implementing is the monitoring of every steam sterilization load with a biological indicator. A variety of factors are motivating department managers to move from the standard practice of using a BI daily, plus for all implant loads, to the best practice of monitoring every load. These factors include the desire to provide the highest, most consistent level of care to all patients; to minimize the cost and facility disruption associated with a multi-load recall triggered by a positive BI; and to ensure that all loads containing implants do indeed get BI monitored. The change is typically implemented with the approval of the hospital’s infection control committee. Diane Gantt, a former consultant at the Detroit (Michigan) Medical Center, shared her experience with this process: ‘We told them it would cost more money to monitor every load with BIs, but that the benefit far outweighed the cost. We were completely supported. We talked about having the same standard of care for every site, and the advantage of only one load to pull, in the event of a recall, instead of an entire day’s worth of work. The committee indicated that they heartily approved the same standard of care for all processing.’"

Susan Flynn, Technical Service Specialist,
3M Sterilization Assurance

We are seeing an exciting resurgence in the US infection prevention community in regard to pass-through sterilizers, resulting in three-zone Central Sterile Processing Departments. Certainly not a new concept, the three-zone CSPD, comprised of decontamination, clean and sterile zones, used to be a US standard and remains one internationally. The primary reason for this resurgence is a heightened awareness of good aseptic processing technique. An additional reason to investigate the possibility of three zones is that, in most cases, departmental flow is significantly improved. This improvement is even more dramatic when the pass-through sterilizers are equipped with automated loading and unloading, and can be pit-mounted for floor loading.

Andy Lordi, vice president, sales,
Eastern Zone, Belimed Inc.

One of the most challenging tasks in the Central Sterilization Department of a hospital is ensuring that all staff members have ready access to the resources they need to safely reprocess surgical instruments. Today, there is no convenient methodology available for CSD departments to update and maintain information on medical device manufacturers’ instructions for use, which the department staff must rely to ensure the safe reprocessing of instruments, according to the Association of periOperative Registered Nurses and AAMI ST79 standards.

Having a current version of IFUs available for CSD staff with easy access to the most up-to-date information at their fingertips is essential. ASP has developed innovative technology, which is the first of its kind, to assist customers with compliance in meeting AAMI and AORN standards requiring access to manufacturer’s instructions for instrument processing. This new online tool, called the STERRAD Sterility Guide, will be available to all STERRAD Sterilization System customers, and will provide real time up-to-date information on sterilizing instruments in STERRAD technology. The first phase of the new online database will be available beginning August 2008.

Barbara Trattler, RN, director of clinical education,
Advanced Sterilization Products

SterilTek professionals have a unique perspective because we specialize in sterile processing consulting in both the sterile processing department and in perioperative areas. We are concerned about the flow of instrumentation throughout healthcare facilities, so our best practices are focused on the entire flow of instruments. In our opinion, the elements most critical to the success of the sterile processing department, in order of importance, are:

• Excellent functional relationships: The process starts and ends with the OR and the SPD working well together on establishing processes, initiating changes, and following through on holding staff accountable to ensure that best practice is attained and sustained.

• Strong customer relationships: A collaborative customer-focused working relationship between the sterile processing department and its customers in the perioperative area is critical. The "products" the OR needs from the SPD must be 100% percent clean, complete, sterile, and delivered on time in order for the surgical teams to provide optimal care, in turn, to their ‘customers.’

• Careful post-case instrument handling in the OR: One of the greatest challenges SPD professionals face is the condition of dirty instruments used on complicated surgical cases when they are sent back to the SPD for reprocessing. The post-case handling of surgical instruments drastically affects the sterile processing department’s ability to reprocess the surgical instruments and get them back to the OR in complete sets and in a timely manner. Surgical staff is constantly under pressure to turn surgical rooms around, so there is a tendency to drift from the AORN recommended practices of wiping off bioburden, flushing lumens, counting instruments and putting them back in original containers for transport. Instruments are not only being sent to SPD in a jumbled, bloody mess, but they are not returned to their proper transportation container. In some cases, they are being left clipped to a drape that ends up in a hamper for laundering or in the trash and isn’t returned to the set, a practice that unnecessarily contributes to hospital instrument replacement costs. Returning contaminated instrument sets to SPD with missing instruments also slows down the overall reprocessing of instruments and often ends up frustrating the OR staff when they see those missing instrument labels on the outside of sterile trays. Focus on this pivotal step in the instrument flow process is still a challenge for hospitals today. Sometimes the SPD team has to work with OR management to create the ‘burning platform for change.’

• On-time delivery of surgical case carts and supplies: One of the contributors to a late start on an OR case is late, inaccurate or incomplete equipment, instruments and supplies. Sometimes the responsibility for these items falls under the SPD, but OR staff is intimately involved because they initiate the procedure preference lists based on the surgical schedule. This process often drifts away from best practice into a reactive, haphazard practice. It is important to have accurate preference lists, competent staff to pull items needed for a case cart, available sterile items for the case cart, and a system to facilitate the retrieval of missing items and items with limited availability.

• Proper care and handling of vendor-owned "loaner" instruments: Another challenge for SPD staff is handling loaner instruments that are brought in from the outside for a surgical procedure. There are many challenges with these types of instruments — timely delivery, customer demand for fast turnaround, assuring adequate cleaning and appropriate sterilization times and temperatures, and sterile storage and handling. Sterile processing management constantly nags vendors to bring trays in sooner to allow for thorough reprocessing. However, vendors can’t always control acquisition and delivery times, so there is a tendency to leave more trays on consignment in SPDs. Since the department usually is not issued a count sheet for these types of trays, they are at the mercy of the vendor to inspect, assemble and tell them when they are needed. It’s like having a house guest telling you how to organize and run your kitchen.

• Management of point-of-use sterilization in the OR suite: Hospitals still struggle to effectively manage the rapid turnover of instruments because some still do not have adequate instrument inventory for their scheduled OR cases. This results in the need for a rapid turnover and point-of-use sterilization of instruments in order to meet the scheduled case starts on time. Some surgical suites don’t have the appropriate sterilization and monitoring practices in place to perform this process. Sterile processing professionals should be considered the experts in reprocessing, yet in some hospitals the SPD has not been permitted to handle the rapid turnovers due to lack of trust, a previous history of poor performance and/or a lack of resources to provide this service to the OR. Now that regulatory agencies such as DHS, CMS and The Joint Commission are focusing on the management of this process, hospitals are under the gun to provide documentation of appropriate sterilization processes and of efforts to reduce unwrapped "flash" sterilization cycles. With the proper allocation of resources, the hospital’s SPD staff can collaborate with OR staff to convert those unwrapped flash cycles into wrapped standardized cycles and still meet their scheduling needs.

• Appropriate reprocessing of specialty items: Another area of focus for regulatory agencies is the reprocessing of heat-sensitive items such as TEE probes and laryngeal scope blades. The accepted practice for reprocessing these items has been to use a high-level disinfectant, but due to an increased occurrence of patient safety incidents, these types of items are being given more attention by sterile processing and perioperative departments. Often, hospitals do not have the appropriate point-of-use low-temperature reprocessing system available for specialty items, and it is not feasible to send very expensive probes to SPD for reprocessing. It’s important that the manufacturer’s recommendations for reprocessing are adhered to, and that the sterile processing professionals provide input on the best practices and systems for reprocessing these types of devices.

Cory Nestman, senior professional consultant, SterilTek Inc.,
a subsidiary of STERIS Corp.

We believe the following eight best practices are particularly beneficial for driving best practices in the SPD:

1. Test for sharpness. In many cases, people allow complaints to arise before reacting to them. One way to be proactive is to begin testing instruments for sharpness during the tray assembly function. Instruments such as scissors, rongeurs, punches, and ostotomes should be routinely tested for sharpness to ensure that we are delivering the sharpest instruments to our customers.

2. Brush properly. It’s imperative that all lumened or cannulated instruments (items such as take-a-part laparoscopic instruments, suction devices, and flexible bone reamers) be brushed during the decontamination process. Utilizing properly sized brushes for this task is also essential, as a brush that has a too large or too small diameter will not clean properly. Additionally, you must have a brush long enough to completely exit the channel that you are cleaning. If your brush isn’t long enough, dirt will be displaced within the lumen and not completely removed.

3. Lubricate adequately. An item that should be located at each workstation is a bottle of spray-on instrument lubricant. In today’s SPDs, most — and in some cases all — lubrication is left up to the washer decontaminator. Providing additional lubrication to instruments with moving parts (scissors, needle holders, hemostats, rongeurs, etc.) will prolong the life of an instrument and will also reduce repair costs.

4. Educate staff. One of the best practices to employ in the sterile processing department is continuing education. Be sure that vendors are providing in-services on the instruments you are required to clean and sterilize. In addition, all staff should be encouraged to achieve certification and join a professional organization. An educated staff improves the entire department, and ultimately improves patient safety.

5. Magnify instruments. Instruments should be viewed under magnification during the assembly and inspection of instrument sets. Some type of magnifier should be present at every workstation, whether a lighted, table-mounted unit or a hand-held magnifier. Remember that micro instrument sets are used under magnification during surgical procedures, so it’s important for those assembling the trays to see what the surgeon sees, and be able to find instruments that are misaligned, cracked, or may be missing teeth.

6. Use tip protectors. Utilizing instrument tip protectors is beneficial for two reasons, the first and most obvious being the protection they offer to instruments. Covering sharp or delicate tips can prolong an instruments useful life and reduce repair costs. The second and most important benefit is the safety that tip protectors provide. Using tip protectors helps prevent sharps injuries. Instruments such as verres needles and sharp scissors should always be covered with tip protectors.

7. Choose a good repair vendor. Your instrument repair vendor should be viewed as a partner in your mission to provide quality instruments sets to the surgery department.Your repair vendor should assist you by helping to establish repair frequencies for your entire tray inventory.You should also be working closely with your repair vendor to preventatively maintain your instruments, which is proven to reduce complaints and improve patient safety.

8. Use instrument stringers. Using instrument stringers will not only help to organize your trays better, they also assist in keeping instruments in the open position during the decontamination and sterilization processes. Further recommended are decontamination stringers, which are five inches wide, thus opening the instruments even wider and allowing for even more effective cleaning.

Alex Vrancich, vice president and general manager,
Spectrum Surgical Instruments Corp.

The information and opinions expressed herein are those of the vendor/experts and do not necessarily represent the view of this publication.