The Complex and Indispensable Requirements for Instrument Reprocessing

<p>One of the most common questions related to the sterile processing department (SPD) is this little gem, asked by surgeons, nurses and scrub techs: why does it take so long to get our sets up to the operating room (OR)? The demand for faster turn-around of surgical instruments is constantly hampered by a number of time-related challenges. In addition, when processes are fragmented and the instrument management process is less than ideal, turnaround time can also increase.</p>

By Tim Brooks

One of the most common questions related to the sterile processing department (SPD) is this little gem, asked by surgeons, nurses and scrub techs: why does it take so long to get our sets up to the operating room (OR)? The demand for faster turn-around of surgical instruments is constantly hampered by a number of time-related challenges. In addition, when processes are fragmented and the instrument management process is less than ideal, turnaround time can also increase.

Instrument set management is not much different from disposable sterile supply management when it comes to setting par or stock levels; demand determines inventory levels for both processes. However, surgical instrument reprocessing functions include production and handling expenses that are not incurred with disposable sterile supplies. And instrument inventory expense for hospitals can grow into millions of dollars and offer little depreciation value (compared to fixed capital assets), which can result in the belief that "less is better."

What does this have to do with time? Its an extremely complex question that must be answered by discussing the multiple factors that impact surgical instrument turnaround.

Diversity, Complexity and Multiple Stakeholders

Todays central service (CS) departments deal with more diverse instrumentation and more advanced sterile processing equipment than in years past. More importantly, the surgeons, who are the primary users of these instruments, generally do not understand the challenges to proper instrument handling that exist and the role the surgical staff plays in the complete reprocessing cycle. As a result, theres a gap between what CS professionals know and what the surgeons, operating room nurses and scrub techs know.

CS professionals, the ultimate experts on instrument reprocessing, need to educate themselves and then teach their customers about the many factors that can affect instrument turnaround. CS leaders may also need to make formal presentations to hospital leadership and to the health systems risk management, safety, and infection control departments.

Stakeholders also need to understand the impact of functions such as surgical case scheduling, preference card management, capital budgeting, and operating budgets. In addition, issues such as overbooking instrumentation, high add-on case percentages, too-low instrument set inventories, and the lack of a centralized instrument management program may be impacting turnaround times.

Time Factors

There are two types of time factors affecting instrument management; direct and indirect. Direct factors are those over which the sterile processing department has control. Once they are audited and evaluated for improvement, these factors can be optimized. Indirect factors are under the control of others and require CS staff to work collaboratively with these other stakeholders to effect improvements.

Each of the elements affects turnaround time in some way, and none should be ignored when evaluating overall time associated with instrument management. Evaluating these two lists of factors (see accompanying checklist) as they apply to a specific facility can help the sterile processing department better explain the "why" and build a case for improvement.

Instrument Inventory: How Much is Enough?

Heres the bottom line: the length of time that surgical instruments remain in the reprocessing cycle is in great part determined by how many instruments you have and who is managing them. The first steps toward improving turnover time are: having enough instruments to start with; and then centralizing instrument management to assure efficient, timely, and high quality reprocessing.

Surgical set inventories and individual set lists differ from hospital to hospital, even though we all do the same types of procedures. Although some surgical practices may be more specialized, we are all more similar than you think. In spite of the similarities, however, there is no global benchmark or magic number for how much surgical instrument inventory to maintain. Even instrument suppliers and sterilizer manufacturers cant provide a figure for the ideal number of sets to support our daily schedules. However, once that number is determined, some sterilizer manufacturers can provide an optimal throughput ratio of washers, sterilizers and staff to product volume.

Consultants have made some headway in assisting with inventory assessment, but they have often been limited by contract terms and an overarching mandate to reduce expenses and staff. In many cases once the consultants leave the hospital there is a tendency to revert to previous habits. It is truly up to us individually to gain the knowledge and direct the changes that can best support our facilities.

How much is enough can only be answered by studying the needs of the daily schedule and understanding how many sets are needed to respond to demand on a specific day of surgery. Its important to note here that on any given day a typical CS department will support all surgical service lines, not just one. Turnaround time for any one service line is slowed down by the total number of cases in a day, any add-on-cases that occur, and the days case mix. If, for example, you have a heavy orthopedic day with additional loaner trays to process, and have added urology and heart procedures, you may end up processing instruments on a first-come-first-served basis. A schedule with a lot of daily add-on and trauma cases causes additional instrument inventory demands. Typically, surgeons do not know what is scheduled in other service lines, nor do they realize the effect that their own add-ons and special requests have on instrument demands in their own service line.

In addition, theres the challenge of individual surgeon preferences, which dictate instrument set lists. This can lead to a decrease in standard service line instrument set inventories. Having many surgeons requesting their own preferences reduces the departments ability to evaluate supporting set level volumes in a given service line. This generally is due to having only one or two trays for a given surgeon that are being flash sterilized to support his or her case turnover. If there are also high numbers of add-on cases, the number of trays being flash-sterilized has a tendency to go up even more. Surgeons who are allowed to bring in their own instrument sets (also used at other hospitals) create additional usage confusion.

Managing Complex Inventories

Perioperative and CS managers must strive for optimal service line inventories for instruments, supplies, and equipment. Effective manage-ment of these three inventories supports the surgeon and the service, whether its orthopedics, plastics, urology, cardiovascular, gynecology or general surgery. Two of these inventories, instrument sets and surgical equipment, must also be managed to meet the time constraints of scheduling and case turnover.

To add more complication, instrument inventories are typically divided into service lines that include back-up peel-pouched instruments. In addition, each instrument service line has requirements for additional handling, methods of sterilization and quality assurance. For instance, the urology inventory for cystoscopy instruments and scopes can require all four methods of sterilization steam, EO, peracetic acid and gas plasma and can present a number of cycle time challenges. And if flexible scopes are being used, they require even more different processing methods and quality assurance processes.

And let us not forget that change is just as constant in healthcare as in any other industry. Hospitals and surgical procedures change and advance over time. So, the instrument set inventory must evolve with current demands. It cannot rely on the capital budget process to address immediate needs for inventory changes due to such things as new services, new procedures or new surgeons. For this reason, instrument purchases are best handled by using operating budget dollars with additional contingency capital for new service lines under the management of experienced individuals within the CS department who understand process and production management.

To understand the sheer numbers a CS department deals with, here is an example: a hospital completing 10,000 surgeries annually can easily support 650 different set types with more than 1000 instrument sets, including orthopedic loaner sets containing 35,000 individual instruments with a value of more than $5 million or more. The instrument set inventory supports well over 3000 different instrument types. This same hospitals reusable instrument inventory is subject to sterile processing, inspection and repairs, with an operating cost that can easily exceed $500,000.00 annually. In the course of a year this same hospital will sterilize 50,000 instrument sets handling more than 1.5 million single instruments!

As this example illustrates, the responsibility for managing surgical instruments and the facilities, systems and people to reprocess them is enormous, and very complex. Installing new assistive technologies such as instrument tracking systems can provide managers with excellent support for data and instrument management; some systems can even provide tracking down to the individual patient on whom each repro-cessed instrument is used. Tracking systems also provide assistive tools for the CS staff such as checklists and guidance on proper set assembly along with single instrument and set pictures.

Where Cleaning Begins

Disinfection time is divided into two categories; variable time associated with manual processes, and fixed times associated with automated mechanical cleaning. The variable manual process time is dependent on how much gross contamination is left on the instrument post-use and how many instruments/devices require manual cleaning. The amount of cleaning time increases when the OR staff does not separate instruments, clean from dirty and by set. Mixing up dirty instrument sets in the OR increases the time needed for sorting and reassembly in decontamination, and can also result in delays and mistakes.

Time is also extended when OR staff does not remove gross contamination immediately after use in the OR. It cannot be stressed enough; the longer instruments sit with gross bioburden on them, the longer the manual cleaning time will be and the greater the chance of additional through-put delays. The longer the bio-burden remains on an instrument, the faster the instruments passivated layer breaks down eventually requiring repairs and refurbishing. For these reasons, the most efficient manual cleaning process starts in the OR immediately after the instru-ments use, initiated by the OR scrub techs.

Another complicating factor is the need for speed, which is common in surgical suites. A focus on fast room turnover can result in instrument losses, the overuse of flash sterilization, and damage to instruments. The practice of rushing case turnovers should be carefully evaluated to ensure that patient safety isnt compromised, and that careless handling of surgical instruments doesnt result in additional repair and replacement costs.

Outpatient surgery centers can speed their turnover because they typically have less total service line inventory and supporting equipment. However, hospitals performing instrument-intensive orthopedic total-joint cases, for example, should reconsider the wisdom of a 15-minute turnover time. A practical alternative is the practice of flip-flopping rooms, a scheduling technique used at some facilities, which allows the additional room cleaning and instrument management time needed to support safe practices. Scheduling staff, equipment, and instruments is much more efficient in a flip-flop environment.

Another counterproductive practice is holding back instruments such as cameras and scopes in the operating rooms, which only increases reprocessing time. Removing instruments from the rooms as soon as possible improves reprocessing efficiency allowing for faster turnover.

The Reprocessing Time Cycle

Travel time between surgery and CS departments varies from hospital to hospital and can add anywhere from five to fifteen minutes to overall reprocessing logistics. Although the travel time differs for everyone, it is safe to assume it takes at least five minutes to deliver soiled instruments to the CS department. Manual cleaning on average takes around five minutes for an average-sized tray in the decontamination area. This allows time for removal of gross visible bio-burden, racking in a washer pan or basket and placing on an automated washer rack. A three-level washer rack can hold three sets on average, which translates to a total of 15 minutes to assemble a complete load for the washer. So the time total for manual cleaning with travel is now at 20 minutes for one set of instruments.

Decontamination and Washing

Washer cycle times vary by the type of machine, with a range of 20 to 45 minutes. Using an Amsco® Reliance® 444 Washer-disinfector* as an example (it is a unit commonly found in hospitals), the wash cycle takes 45 minutes. At this point in the logistics timeline, we have 65 minutes devoted to one load (or three instrument sets). The use of a sonic washer will add additional time, on average 10 minutes, but not to every set (unless that is part of your processing standard).

The next time variable is the post-wash dry and cool-down phase, which is directly affected by load configuration, the washers drying ability, and room temperature and humidity. Poorly arranged loads take longer to cool and sort through, and can easily add up to another 10 minutes or more. Using a proper racking process, whether its stringing or an instrument cradle, will decrease drying and cool-down time substantially; however pre-stringing instruments in the decontamination area adds to the overall cleaning time. At this point in the reprocessing cycle, the total time for manual wash, fill rack, automated wash and cool down has reached 75 minutes. However, this time is not an absolute number it will vary from hospital to hospital and will depend on the CS departments equipment mix and processing ability. Also, the figure is calculated for more than one tray of instruments. If only one instrument set at a time was being processed, the manual cleaning time would decrease by approximately 10 minutes.

Assembly and Sterilization

Although tray assembly time averages about five minutes per set, that is not the total handling time for assembly. Similar to decontamination the sterilizer cart holds a number of trays and peel-pouches. An average load size is about 12 large trays; so the total time to fill the sterilizer cart is about 60 minutes. The larger the sterilizer or load cart, the longer this time becomes. Smaller sized trays will add to the overall cart loading time; possibly doubling it.

The total steam sterilization cycle time is 60 minutes, followed by a cool-down time averaging about 30 minutes (this time is dependent on room temperature, humidity, load mass, and load content). However this time is required to insure condensation does not occur during transport to the OR. The total time now adds up to about 3.67 hours for a single tray working its way through the process.

Restocking

Now we must add the time for travel back to the surgical suite and restocking of sterilized instruments in the proper storage location. The time can also vary for this logistical segment based on the distance to and from the CS department to the OR storage location and the time it takes to properly store the inventory in the appropriate labeled locations (this is not always done).

So, on any given day the average reprocessing cycle time from decontamination to OR sterile storage is around four hours for one instrument set, give or take a few minutes.

What Slows Down the Reprocessing Cycle?

Factors that can make this time increase are such things as having decentralized processes, having too low a set inventory, the total case volume, the specific case mix, what the add-on case percentage is, whether trauma cases are included, and the quality of the production management function (washer to sterilizer ratio).

If instrument management is fragmented or decentralized, communication breakdowns can result, leading to delays, surgeon dissatisfaction, and problems with determining adequate inventory levels. The OR schedule is directly tied to how many sets are available and how long it takes to turn them around. Efficient management of surgical inventory requires a centralized function that can be effectively managed to control all these critical factors and keep the cycle moving.

The Interconnected Elements of CS Scheduling

Surgical cases are attached to a procedure, which generates a preference card that has the instrumentation requirements for each case. The time for processing instruments can be entered for each instrument set, which should result in a total processing time similar to that above; approximately four hours. The scheduling system also has a calculation for room turnover by case and cut time, which can significantly affect instrument scheduling.

Depending on your OR scheduling system, the database for each piece of equipment and instrumentation supporting the preference card has an equipment conflict alert capability. When the system reaches its maximum instrument or equipment requirement, meaning that all available equipment will be in use, the scheduling system alerts the scheduler of a conflict. However, if schedulers skip past the conflict messaging, they can cause overbooking of resources, instrumentation, and equipment.

In addition, surgeons may add on elective cases without any awareness of what instruments are in use or available. Add-on cases generally override scheduled procedures and take over available instrumentation. They pose a significant problem for schedulers and cause even more reprocessing delays. Once the add-on procedures have exceeded maximum service line set inventory, all bets are off in terms of scheduling. Add-on cases also affect support services such as lab, X-ray, pharmacy, staffing and insurance billing authorization.

Clearly, excellent and timely communication among the schedulers, the OR resource coordinator, instrument technician, and the CS depart-ment is critical for keeping the schedule running smoothly and assuring that you have sufficient instrumentation and supplies available to meet changing demands.

The higher the number of add-on cases, the longer the overall processing time gets. Too often, the response to add-ons is flash sterilization, which adds time to room turnover and should not be the standard to address increased case volume. The concern here is the lack of a standardized cleaning process in the operating area to achieve high-level disinfection before sterilization. In addition, if the CS staff is not managing flash sterilization, they do not have a realistic idea of the actual surgical instrument volume that is needed to support the total daily schedule.

Heavy use of flash sterilization is an indicator of several possible causal factors; low service-line instrument inventory, the use of physician-named sets and one-of-a-kind sets, and allowing for add-ons rather than proper scheduling. Although it is difficult to measure, the reprioritizing of the surgical schedule due to trauma cases and other procedures also adds time to the day when scheduled cases are bumped to fit them in. Instrument sets used in trauma are also used in scheduled cases, so the more of this supporting inventory thats used for unplanned cases, the higher the risk of case delay and cancelation. In addition, the practice of "leveling" by surgeons and anesthesiologists to get their particular cases added can also have an overwhelming impact on instrument management.

Other scheduling snafus that add to surgical case delays involve the improper scheduling of late cases on second shift and of non-emergent cases on weekends. These off-time cases are often scheduled without coordinating with CS to assure proper staffing and available instrument set inventory. Case scheduling after hours directly affects the next days schedule if there is no on-call CS staff to insure reprocessing of priority instrument sets during after hours.

In a scheduling time crunch, instrument quality can suffer as well. When turnaround speed is the primary concern and instrument inventory is too low, the QA inspection of instruments before set assembly may be eliminated in favor of getting the set back up to the OR. Avoiding QA procedures can result in poorly functioning instruments and unhappy surgeons. This vital part of the reprocessing cycle should never be skipped in favor of saving time.

Put the Focus Back on the Patient

The standard of care for patients can be drastically compromised when short cuts are the norm. As an industry we cannot afford to take short cuts in the name of speeding things up so that we can squeeze in more surgical cases. Unlike disposable sterile supply management, instrument management requires thorough step-by-step processes to ensure patient safety; these functions should not be based solely on how fast one can get each job done.

An instrument tracking system is a best practice tool that is an invaluable data source for CS departments. In fact, I believe that tracking systems should be required for all hospitals and surgery centers to address par levels, patient tracking, repairs and productivity tracking. Orthopedic surgical instrument manufacturers are even researching the possible use of RFID technology to track their loaner instrument sets nationwide, to protect the enormous capital investment they have in these reusable borrowed assets. Not all hospitals currently support computerization of the sterile processing function, but it may become the standard eventually.

CS departments require strict management processes and sufficient budget dollars to support best practices. They are handling one of the most extensive and expensive inventories in todays hospitals and are responsible for delivering a clean and sterile "product" to the ORs every day, for every case, and on time. This is hard to do without an investment in sufficient instrument inventory, the optimal use of systems and tools to manage and process them adequately, and the focused support of all who touch the instruments. Patient safety and physician satisfaction drive positive outcomes in todays changing healthcare arena; we need to structure our services around sound practices and business models to support them for future growth.

* Amsco® and Reliance® are registered trademarks of STERIS Corporation, Mentor, Ohio.

Tim Brooks is the director of surgical services materials management/CSSPD at a major U.S. regional healthcare center. He has 30 years of management experience, 23 of them in hospital materials management focused on the central sterile processing department and the operating suite. Brooks serves on the centers Infection Control Committee, Hospital and OR Value Analysis Committee and the Code Committee. He is currently a member of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and has published a number of articles and delivered presentations on a number of OR and CS-related topics. He currently hosts a website devoted to OR materials and CS management, www.csspdmanager.com.

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