How to Successfully Plan for Space, Equipment, Staff, and Workflows in Sterile Processing Departments

Celebrating Sterile Processing with Infection Control Today

Sterile processing departments (SPDs) clean, decontaminate, and sterilize equipment, medical devices, and surgical instruments critical to keeping the operating room (OR) running on time and efficiently. Whether you work in a hospital, ambulatory surgery center, or offsite facility, how you plan your department directly impacts the team’s ability to keep up with the work, minimize backlogs, and remove bioburden in a timely manner. To plan properly, you will need to address 5 critical areas.

Workload Volumes

You can’t plan what you need until you know what you are being asked to do.
Step 1 forecasts the workload volumes for today and the future while considering daily and seasonal fluctuations that drive busy days with greater workloads on SPDs. A common and good number to plan for is a 20% increase in volume on busy days due to surgical schedule fluctuations. Seasonality can affect workloads by another 10% to 20% as well.

Starting in the decontamination area, create a design to minimize backlogs on busy days so bioburden can be removed as soon as possible to eliminate biofilm. If you are unfamiliar with biofilms, you should know they can form within hours on a surgical device if blood or other patient substances are left on the instrument. Once formed, biofilm is difficult to remove; protects the microorganisms, bacteria, and viruses from cleaning and sterilization efforts; and can cause surgical site infections. While planning for the average day and allowing backlogs to build on busy days may be acceptable on the clean side of sterile processing, it is not recommended on the dirty decontamination side. Plan for the busy days, and you will be prepared to handle the cleaning requirements timely and effectively.

Other attributes you need to consider in your workload volumes include segregation of steam sterilization items vs low-temperature items, percentage of trays in containers, vendor-consigned trays and vendor loaner trays, clinic instruments, peel packs, and specialty items such as robotics and ophthalmology instruments. You must also understand the instructions for use (IFU) requirements for cleaning and sterilizing the instruments. These data points will help determine your equipment requirements.

Equipment

Now you have workload volumes in hand. Step 2 determines the equipment requirements to maintain continuous flow through the department (lean concept). The lean concept of continuous flow focuses on keeping instruments flowing through the department with minimal backlog or wait time and is best practice for production environments such as sterile processing. To achieve continuous flow, you need to know the time of day the work arrives. Using the OR’s “wheels out” report is a good starting point to understand what time surgeries end, translating into the arrival of dirty instruments to the decontamination area.

With arrival times in hand, you can determine the equipment needed to process the work by hour. To do so, it is vital to understand the difference between capacity and throughput. Capacity is the absolute amount of work the equipment or process can produce. Throughput is the actual amount of work that is done in real-life situations. For example, an instrument washer can wash 9 trays per load (capacity), but if you have one 2-level vendor tray that requires you to separate the levels when washing, you will wash 8 trays in the load (throughput). When calculating your equipment needs, be sure you understand whether capacity or throughput is being used.

Additional considerations are human interaction with and automation of the equipment. Consider load and unload time in your calculations and determine whether there will be delays between cycles. This helps ensure that what you plan on paper represents reality. You should also consider equipment redundancy to maintain continuous flow if equipment goes down for repair.

Typical equipment considerations include cart washers, sinks, sonic cleaners, instrument washers, assembly tables, steam sterilizers, and low-temperature sterilizers. Pay close attention to IFU requirements, especially in decontaminating sinks, sonics, and instrument washers. Based on our experience in assessing departments, a lack of sufficient sinks and sonics is the most common reason that SPDs are unable to comply with IFUs and maintain continuous flow while staying compliant.

Workflows

Planning the sterile processing space is more than just placing equipment.
Step 3 focuses on visualizing the workflows and movement of instruments, carts, and people to understand space requirements. The objective is to ensure all workflow activities are included in space planning while minimizing the movement of instruments and people (lean concept again). Start by visualizing dirty case carts arriving in the decontamination area, then scanning trays, breaking down the cart, placing containers on a container rack, moving the instrument trays to the sinks, and loading carts and containers into the cart washer. Ask yourself how to minimize movement, ensure space is available for the number of case carts that may arrive from the OR during a peak hour, and ensure staff have room to move and efficiently work.

Continue visualizing the flow to the sinks where a linear flow from sink to sonic to washer is recommended. Manual wash items should have a direct path to a pass-through window or dryer. Specialty items such as robotics or ophthalmology instruments may need specific equipment and space for processing.

On the clean side, visualize the movement of instruments from washers to assembly tables or staging racks. Plan for a backup instrument location. Determine how vendor trays will be checked in, flow through the department, and checked out. How will containers move from the cart washer to the assembly tables? Will you have a shared wrap and container table that all trays move through? Visualize how instruments move to the sterilizers while segregating steam instruments from low-temperature instruments to reduce potential incorrect sterilization. Plan space for building and scanning sterilization loads and cart cooling after sterilization. Where will biological indicators be incubated and sterilization load information be entered? How will instruments move to storage? Lastly, visualize where case carts will be staged when empty and how the case cart picking process will occur.

Space

Step 4, space planning, brings everything together. It begins with having the equipment to ensure you are prepared to handle today’s busy day and space to add future equipment for future growth. This includes running utilities to the future equipment locations and addressing physical building standards and codes. Multiple organizations publish standards that may impact your SPD design. The Association for the Advancement of Medical Instrumentation (AAMI) provides general design guidance in their ANSI/AAMI ST79:2017 standard in Section 3, Design Considerations.¹ For heating, ventilation, and air conditioning (HVAC), AAMI states that health care facilities should identify which version of American National Standards Institute/American Society of Heating, Refrigerating and Air-Conditioning Engineers/American Society for Health Care Engineering (ANSI/ASHRAE/ASHE) 170 they will use based on when the HVAC system was installed or last upgraded.²

Another source for building standards is the Facility Guidelines Institute website.³ This independent, not-for-profit organization is dedicated to developing guidance for the planning, designing, and constructing of hospitals; outpatient facilities; and residential health, care, and support facilities. Lastly, if your local government has published building codes, then your organization must meet the most restrictive requirement.

Ensure you have space for the previously visualized workflows and add nonworkflow activities such as the donning and doffing of personal protective equipment and handwashing, as well as eye wash stations and detergent rooms. Add in space for storage, staging, supplies, and administrative areas. You should also consider locker rooms, break rooms, and vendor spaces. If you take the time to detail your requirements in the first 3 steps, you will have the information and data to support and justify your space requirements.

Staff

Step 5 is the last piece of the puzzle, calculating your staffing requirements. Begin by listing all activities your staff will perform. This is usually more than the standard instrument decontamination, assembly, and sterilization activities. Add in daily checklist items and room setup, testing of equipment, handling returned unused items, taking phone calls and running to the OR, clinic pickup and deliveries, training and meetings, indirect time, managing missing and extra instruments, picking case carts, and any other activity your team performs.

Next, determine how often each activity will be performed (volume) for an average week. Using weekly volumes includes considering weekends. Add in time standards for each activity in 1 of 2 ways. The first option is to use the average time for staff performance variations. This approach uses your current performance as the staffing requirement for the future and typically does not require a productivity factor. The second option is to set time standards for completing the activity. Use a trained staff member who regularly performs the activity efficiently according to the documented standard work. Using this method requires the application of a realistic productivity factor, perhaps 85%, to account for staff members who will not be as efficient. The productivity factor ensures you are staffed to handle the volumes while working toward improving your team’s productivity.

Lastly, add administrative and leadership positions, time off, and breaks to ensure you have included all relevant labor requirements.

Summary

If done correctly, planning sterile processing space, equipment, staff, and workflows in the SPD can be fun and rewarding and position your department for future success. It will take time, data, and effort to include the smallest details to ensure you have captured everything necessary. Utilizing lean concepts and workflow visualization provides many benefits as well. Many vendors offer facility planning and design services to assist in the process and are valuable resources to ensure your department is planned effectively.

REFERENCES

1. ANSI/AAMI ST79:2017: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Association for the Advancement of Medical Instrumentation; 2017:24-40.
2. ANSI/AAMI ST79:2017: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities. Association for the Advancement of Medical Instrumentation; 2017:33.
3. Resources. Facility Guidelines Institute. Accessed February 26, 2024. https://www.fgiguidelines.org/resources/