, is a seasoned health care management professional who helps leadership teams and sterile processing departments (SPDs) optimize operational performance. Leveraging 10 years of nonhealth care management consulting experience, he joined STERIS in 2001. He merged lean operational approaches with health care’s clinical requirements, creating a new vision for sterile processing. He has 30+ years of experience in operations process improvement and 20+ years of experience in sterile processing (SPD/CSSD)

John Kimsey

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.

You can’t plan what you need until you know what you are being asked to do.


 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.

 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.

Planning the sterile processing space is more than just placing equipment.


 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 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 

 standard in Section 3, Design Considerations.

 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.

is the Facility Guidelines Institute website.

 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.

, 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.

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.

Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities

. Association for the Advancement of Medical Instrumentation; 2017:24-40.

to Steam Sterilization and Sterility Assurance in Healthcare Facilities

. Association for the Advancement of Medical Instrumentation; 2017:33.

Resources. Facility Guidelines Institute. Accessed February 26, 2024. https://www.fgiguidelines.org/resources/

Articles

A well-organized SPD not only keeps the surgical schedule on track but also minimizes backlogs and ensures the timely removal of bioburden—a crucial factor in preventing infections. To achieve this level of efficiency, attention to 5 
 pivotal areas is essential.

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

(Adobe Stock 321775514 by sharafmaksumov)

In 2021, AAMI released its updated standard, ST91, on flexible and semi-rigid endoscope processing. The standard is truly comprehensive and aimed at helping mitigate the risks of endoscopy procedure infections. Understanding the standard’s intent, recommendations, and requirements is critical for successful endoscope processing and positive outcomes. While this article covers some of the standard’s message, important changes, and recommendations, it is advised to purchase, read, and digest the entire standard to fully understand the requirements.

, is where the new standard’s impact is first felt. The new standard reaffirms design recommendations for unidirectional flow with additional statements that the processing area should be designated for processing only and have 2 separate rooms for processing endoscopes. While the standard states, “Until such a time (major renovations or new construction) that two separate processing rooms can be provided, strict unidirectional processing should be in place”

, the intent is to prevent cross-contamination and maintain separation between clean and dirty through appropriate room designs. Further recommendations are provided for single-room processing areas that cannot be renovated to the preferred 2-room design.

Additional design recommendations include utilizing a closable pass-through window or pass-through automated endoscope reprocessors (AER) to fulfill the dirty and clean separation requirements while maintaining air pressure differentiation. Guidance is provided on suitable endoscopy storage, including separation from the procedure room. A designated drying area with pressure-regulated forced instrument air or a minimum of HEPA-filtered air is recommended and covered in more detail in Section 8.

Additional design recommendations cover sink basins, general inspection lighting with magnification based on the Illuminating Engineering Society of North America (IES) recommendations, procedures for monitoring and maintaining the HVAC system, and monitoring of water supply quality (see new AAMI standard ST108:2023).

, provides recommendations for routine cleaning and disinfection of the reprocessing area with the intent that a clean environment reduces the transmission of microorganisms. This is also the first use of “multidisciplinary team” language that is utilized throughout the standard to bring together personnel with vested interests in processing outcomes to ensure adequate action is taken to meet the standard’s recommendations, identify and minimize risks, document policies and procedures, and improve the reprocessing quality.

The standard provides recommendations for the multidisciplinary team to ensure effective environmental cleaning is performed and verified.

, highlights that “institutions should ensure that reprocessing personnel are provided sufficient time to complete steps in accordance with regulations, standards, guidelines, and manufacturer IFU (instructions for use).”

While this statement may seem straightforward and common knowledge, every facility should ensure endoscopy staff and leadership understand the regulations, standards, guidelines, and IFU requirements, the time needed to properly perform the necessary reprocessing tasks, and ensure staff has the time required to perform the tasks properly. This section includes information on 

Standard precautions, Hand hygiene, and Attire

Policies and procedures recommendations, plus Education, training, and competency verification

 section provides content recommendations, such as being consistent with available and current IFUs, for processing activities and ensuring adherence to the policies and procedures is monitored. They should also be reviewed by the multidisciplinary team and updated regularly.

, the standard confirms the common understanding that all endoscope processing personnel shall complete formal training and competency verification before performing the tasks independently. The use of “shall” is important here as that denotes a requirement versus a recommendation. Additionally, the standard supports the benefit of certification by stating staff be certified in flexible endoscope processing within 2 years of employment and maintain their certification.

ST91 also clarifies a critical point in staff competencies by stating they should include each specific endoscope make and model, equipment, equipment connections, and cleaning verification procedures. This requirement means that if the company has 8 different endoscopes, each employee performing tasks on those endoscopes must demonstrate training and competencies specific to each make and model.

, Decontamination processes, begins the standard’s recommendation on actual scope reprocessing. The standard provides general comments and procedures for point-of-use treatment, transport of contaminated endoscopes, leak testing, manual and automated cleaning, rinsing, drying, inspection, and cleaning verification. Actual facility procedures should be based on written IFUs, with ST91’s procedures providing a starting point to ensure the inclusion of necessary areas.

New to the standard is a required hand-off communication from the point of use to the decontamination area, including the patient identifier, date of procedure, and time at which point of use treatment was completed. Recommendations for proper transport of dirty endoscopes are provided, as well as stating that cleaning should start within one hour of point-of-use treatment unless otherwise stated in the manufacturer’s IFU. Remember that leak testing must be done before actual cleaning starts, so the 1 hour includes transportation, leak testing, and any waiting time before cleaning must begin.

The standard covers leak testing recommendations for calibration and maintenance, with 3 acceptable options for handling detachable parts and valves, reviews sink cleaning solution management, and brush usage recommendations.

Subsection 7.8 clarifies the difference and need for visual inspection with lighted magnification recommendations and cleaning verification. The most significant change and impact is the requirement to perform a cleaning verification test on all high-risk endoscopes (examples provided in the standard) after each use. Additionally, cleaning verification tests are required for all non–high-risk endoscopes on established intervals based on the number of uses.

High-Level Disinfection (HLD) and Sterilization

High-level disinfection, liquid chemical sterilization, and terminal sterilization systems for flexible endoscopes

, focuses on 3 critical aspects: high-level disinfection versus sterilization, water quality, and drying requirements. This section opens with the statement, “All flexible endoscopes that are introduced directly into the bloodstream or that contact a normally sterile tissue or body space during use are critical devices and shall be sterilized.”

 Each facility must determine which scopes this applies to. The section also provides general comments and procedures for high-level disinfection, liquid chemical sterilization processing, automated high-level disinfection, manual disinfection, and terminal sterilization modalities.

For water quality, ST91 makes multiple mentions of the microbial quality of the rinse water while following the endoscope and processing equipment manufacturer’s IFUs. With the release of AAMI’s new standard ST108:2023, Water for reprocessing medical devices, ST108 should now be referenced for endoscope processing water quality instead of TIR34:2014 (R2021).
ST108 defines tap, utility, critical, and steam water quality measurements based on the processing use and requires testing at the point of generation and point of use. ST108 also references a multidisciplinary committee responsible for water quality and water management programs, including risk analysis and water quality monitoring.

Drying of endoscopes also receives considerable attention in the new
ST91 standard. A minimum 10-minute dry time is recommended using pressure-regulated forced instrument air or HEPA-filtered air. If moisture is still observed, active drying should be continued until no moisture is visible. The standard also discusses how to detect moisture and recommended procedures for manual drying.

Sterile endoscope sheaths used as protective microbial barriers

, provides recommendations for storing high-level disinfected, liquid chemically sterilized, and terminally sterilized endoscopes. For example, storage cabinets should be designed to allow air circulation as described by the endoscope manufacturer’s IFU, and valves and accessories shall be removed during storage. This section also complements Section 8’s comments on drying by stating that scopes should be dried before being placed into HEPA-filtered storage cabinets that do not have drying capabilities. Definitions, differences, and recommended use of endoscope drying cabinets versus conventional cabinets are provided.

The standard provides recommendations for the identification of endoscopes during storage. As for expiration dates, ST91 states that “The accepted maximum safe storage time (previously referred to as ‘hang time’ or shelf life) for processed endoscopes before they can no longer be considered safe for patient use is not well defined.”

 The standard recommends that the health care facility’s multi-disciplinary team conduct a risk assessment to determine the maximum storage time for an endoscope before processing.

, provides brief recommendations on handling and transporting endoscopes. 

, is a lengthy 24-page section that covers multiple aspects of quality control and process improvement. The standard states a multidisciplinary quality assurance program for all aspects of endoscope processing should be created and then lists the 20 areas that should be included. Full traceability of the endoscope use and processing documentation should be maintained (instrument tracking systems often meet this requirement).

Endoscope visual inspection and cleaning verification are reaffirmed and stated as part of the quality control process. Methods to verify cleaning equipment is working and effective should be established, including routine testing of automated cleaning equipment. Process monitoring and quality process improvement recommendations are provided for continuous improvement programs. Lastly, there should be a systematic and ongoing process for verifying compliance with procedures, risk analysis should be performed annually, and root cause analysis should be completed for any problem identified.

, covers general considerations and recommendations for detecting repair needs, communication, handling, and documenting endoscope repairs. Routine preventive maintenance should be addressed in the facility’s policy and procedures, including a thorough inspection of all channels and working mechanisms. 

, shares considerations associated with conducting product evaluations.

Following the standard’s 15 sections are 11 informational annexes that share additional information, reasoning, and background for the standard that provide more understanding. Overall, ST91 is a thorough and well-written standard that provides numerous requirements and recommendations to effectively process endoscopes in a manner that will help mitigate the risks of endoscopy procedure infections. To purchase your copy of the standard, go to AAMI’s website.

1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021: Flexible and semi-rigid endoscope processing in health care facilities. 2021.

2. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021: Flexible and semi-rigid endoscope processing in health care facilities. 2021;13.

3. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021: Flexible and semi-rigid endoscope processing in health care facilities. 2021;22.

4. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021: Flexible and semi-rigid endoscope processing in health care facilities. 2021;40.

5. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST91:2021: Flexible and semi-rigid endoscope processing in health care facilities. 2021;54.

6. ANSI/AAMI ST91: 2021: Flexible and semi-rigid endoscope processing in health care facilities. Accessed January 2, 2023. https://www.aami.org/st91.

AAMI's ST91 standard for endoscope processing covers design, cleaning, personnel, decontamination, storage, transport, quality control, repair, new product evaluation, and more.

John Kimsey

Articles

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

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