In healthcare, the prevention of Healthcare-Associated Infections (HAIs) is a high priority. These infections, often stemming from contaminated instruments or improper sterilization practices, pose a significant risk to patient safety and can lead to extended hospital stays, increased medical costs, and even loss of life.
At the heart of this fight against HAIs lies the Sterile Processing Department (SPD), a specialized unit in medical facilities responsible for the decontamination, inspection, sterilization, and assembly of surgical instruments and medical devices.
Designing and equipping an assembly sterilization room requires a thorough understanding of the unique needs of the SPD. From advanced sterilization equipment to ergonomic workstation layouts, every detail must support the meticulous workflows essential to maintaining sterility.
This comprehensive guide explores:
- CDC guidelines for assembly sterilization room workflow,
- essential equipment required for an efficient sterilization room,
- features to look for in quality sterilization room equipment.
CDC Guidelines for Assembly Sterilization Room Workflow
According to the CDC, assembly sterilization rooms should have a designated workflow to ensure instruments move from high contamination areas to clean areas. The workflow should prioritize thorough cleaning before sterilization, proper storage of sterile items in covered cabinets, regular monitoring of sterilization processes with chemical indicators, and maintaining appropriate ventilation to prevent contamination. A specific focus on ensuring all surfaces are cleaned and disinfected according to the Spaulding classification is essential.
Essential Medical Equipment for Assembly Sterilization Rooms
Well-equipped sterilization rooms and sterile processing departments help improve patient and staff safety by ensuring instruments and devices are thoroughly cleaned and sterilized. Carefully selected equipment can boost efficiency, help hospitals comply with regulations, and ultimately save costs by helping reduce the risk of HIAs.
Here is a representative checklist list of capital medical equipment essential for a well-equipped assembly sterilization room.
Washer-Disinfectors
The washer-disinfector used in an assembly sterilization room is a specialized device designed for automated cleaning and disinfection of medical instruments and other equipment. It uses a combination of spray-based water, detergent, and heat. This combination of intermediate disinfection, often called thermal disinfection, ensures medical instruments are safe for handling during preparation and packaging for sterilization and is a critical part of the instrument processing workflow.
Washer/Disinfectors are available in several types:
- Single Chamber Washer/Disinfectors
- Multi-Chamber Washer/Disinfectors
- Cart and Utensil Washer/Disinfectors
- Ultrasonic Washer/Disinfectors
Medical washer-disinfectors differ from medical washers in their level of disinfection. Medical washers remove contaminates with low or no disinfection but do not prepare materials for safe handing as washer disinfectors do.
Ultrasonic Cleaners
Often considered a type of Washer-Disinfector, Ultrasonic cleaners are also used to clean and disinfect medical instruments prior to sterilization. While washer-disinfectors use a water-based cleaning process, ultrasonic cleaners use high-frequency sound waves to create cavitation bubbles for deep cleaning. This method of cleaning is considered more effective as the focus is on deep cleaning, particularly the hard-to-reach areas of intricate instruments with crevices and serrations.
Sterilizers
Sterilizers are the backbone of any sterilization room. They are considered the most reliable method for sterilizing medical equipment and decontaminating biohazardous waste. Their ability to eliminate all forms of microbial life on surgical instruments and other medical tools makes them indispensable. Because not all medical devices and instruments are compatible with all methods of sterilization, there are several types of sterilizers.
Here are the most common:
- Autoclaves
- Gravity Displacement
- Vacuum or Pre-Vacuum
- Ethylene Oxide (EO)
- Hydrogen Peroxide Gas Plasma
- Low-Temperature
- Cold Sterilization
Medical sterilizers also come in a variety of sizes to accommodate different healthcare settings and sterilization needs. The exact number of sizes depends on the manufacturer, but sterilizers can be categorized into three size groups, with multiple variations within each:
Tabletop Sterilizers
Tabletop sterilizers are available with chamber volumes ranging from 1.8 to 6.6 gallons and are commonly used for sterilizing smaller instruments or small surgical packs in small clinics and outpatient environments.
Medium-Sized Sterilizers
Medium-sized sterilizers feature chamber volumes ranging from 12-53 gallons and are used in hospitals and ambulatory surgical centers to sterilize instrument trays, surgical sets, and a moderate volume of items. Often these are floor-standing models with a footprint appropriate for smaller SPD departments.
Large-Capacity Sterilizers
Large-capacity sterilizers offer chamber volumes exceeding 53 gallons, with some models exceeding 265 gallons. These sterilizers are designed for high-throughput sterilization of multiple instrument trays, larger equipment, or bulky items like surgical carts and containers in large hospital sterile processing departments. This equipment, often referred to as a bulk sterilizer, commonly features double-door-pass-through design to segregate clean and dirty equipment.
Specialty Sizes
Endoscope Sterilizers: Designed for the unique requirements of delicate, flexible instruments, with specific chamber sizes tailored for endoscopic devices.
Custom Large Sterilizers: Extra-large sterilizers may be custom-built for specialized hospital needs, such as sterilizing beds, mattresses, or entire surgical carts.
To summarize, sterilizers are available in a wide range of sizes to meet the diverse needs of healthcare facilities, from small clinics to large hospitals.
Learn more about the variety and features of sterilization equipment.
Shop Sterilization Trays, Baskets, and Accessories
Stainless Steel Case Carts
Stainless steel case carts are used in assembly sterilization rooms to securely transport and store sterile surgical instruments and supplies between the sterile processing department (SPD) and the operating room (OR). They maintain sterility by providing clean, sealed, and easily sanitized surfaces that prevent contamination.
Stainless Steel Processing Carts
While case carts transport sterilized surgical instruments between the SPD and the OR, processing carts are used in an assembly sterilization room to transport instruments within the sterilization workflow. For example, cleaned surgical instruments and supplies need to be transported from the decontamination area to the assembly station where technicians organize them onto trays, and then later to the sterilization equipment. These carts are essential for an efficient workflow within the sterile processing department.
Learn more about the features and benefits of carts.
Sterile Processing Workstations
In an assembly sterilization room, sterile processing workstations are dedicated spaces where healthcare professionals sort and package medical instruments and supplies onto sterile trays. Packaging ensures the proper placement and configuration of instruments for use in the OR before they are sent for sterilization.
Workstations may incorporate features like barcode scanners or tracking systems to ensure the accurate identification and documentation of assembled instrument sets.
Drying Cabinets
In sterilization departments, drying cabinets are used to actively and thoroughly dry medical instruments and devices after cleaning, ensuring they are completely moisture-free before sterilization. Residual moisture could promote bacterial growth and compromise the sterilization process. Typically, drying cabinets are stainless steel and use HEPA-filtered air to circulate and dry hard-to-reach areas caused by crevices within instruments. Additional features include temperature settings, timed drying cycles, and pass-through capabilities to minimize the risk of cross contamination.
Following sterilization, items must be stored in such a way that sterilization is preserved. Both closed cabinets and open wire shelving have a role in the sterile processing department. However, deciding what should be stored in closed cabinets or open wire shelves requires consideration of several key factors:
- Sterility Maintenance: Open shelving is suitable for short-term storage and frequently accessed items, while closed cabinets are better for long-term storage or when more protection is needed.
- Environmental Conditions: Closed cabinets may be preferred in high-humidity or high-dust environments.
- Regulatory Compliance: Hospitals must comply with infection control guidelines (e.g., AAMI and CDC standards) to determine appropriate storage solutions.
Continuing the checklist of equipment essential for an efficient and compliant sterile processing department is a review of storage solutions.
Sterile Storage Cabinets
Sterile storage cabinets are used to store already sterilized medical instruments in a temperature and humidity-controlled environment that prevents contamination and preserves sterility. Constructed primarily of stainless steel, sterile storage cabinets may be stationary or mobile and feature solid or glass doors. Most include integrated HEPA filters to ensure the air within the cabinet is clean.
Here is a representative list of items often stored in sterile storage cabinets:
Rarely Used or High-Sensitivity Items
Instruments or supplies that are not used frequently but require additional protection from dust, moisture, and airborne contaminants.
Long-Term Storage Items
Supplies or instruments meant to remain in storage for extended periods.
Highly Sensitive or Specialized Equipment
Fragile or high-value sterilized instruments that require extra physical protection.
Sterile Implants
Items like surgical implants or orthopedic devices that must be stored in controlled environments.
Items in Humid or High-Traffic Areas
Closed cabinets provide an extra layer of protection in areas where the risk of contamination is higher due to foot traffic or environmental conditions.
Sterile Packaging
Bulk packs of sterile wraps or sealed pouches not yet in use.
Wire Shelving
Open wire shelves promote airflow, reducing the risk of moisture retention and contamination. They are often used in sterilization departments for their efficiency, practicality, and compliance with infection control. However, the use of wire shelving depends on the specific set-up and flow of the department.
Here’s how wire shelving can be used:
Storage of Instruments Awaiting Assembly
Clean but unassembled instruments are sometimes staged on open wire shelving to keep them organized and off work surfaces while maintaining airflow around them.
Storage of Wrapped or Assembled Instrument Sets
Once instruments are cleaned, assembled, and wrapped, they may be temporarily stored on open wire shelves before being moved to sterilizers. The open design minimizes dust accumulation and allows visibility for efficient handling.
Drying and Ventilation
Open wire shelving can hold trays of instruments after decontamination, allowing airflow to support drying before assembly.
Supplies for Assembly
Packaging materials like sterilization wraps, pouches, and indicator tapes may be stored on open wire shelves for easy access during the assembly process.
Space Optimization and Mobility
Mobile wire shelving units are often used to organize and transport supplies or instruments between work areas in the assembly room.
Both open wire shelving and closed cabinets play crucial roles in maintaining an organized, sterile environment in SPDs.
Features to Look for in Quality Sterilization Room Equipment
Given that preventing HAIs a never-ending priority for healthcare facilities, choosing quality sterilization room equipment is essential. From sterilizers to storage cabinets, each piece of equipment plays a vital role in ensuring the safety and efficiency of surgical activities. By focusing on quality, compliance, and scalability, hospitals and ASC’s can create sterilization rooms that meet today’s demands and prepare for tomorrow’s challenges.
While the distinct types of equipment used in assembly sterilization rooms each have features specific to their purpose that need to be weighed, there are several general points to consider when planning and evaluating sterilization room equipment:
Construction and Size:
- High-quality stainless-steel construction: Resistant to corrosion and easy to clean.
- Size and capacity: Match the volume of instruments you need to sterilize and storage regularly.
User Interface:
- Intuitive controls: Easy to operate with clear instructions and visual indicators.
- Digital display: Precise monitoring of parameters.
- Automatic start and end features: Minimize user error.
Safety Features:
- Overheat protection: Automatic shut-off mechanism in case of malfunction.
- Door interlocks: Prevents opening during use.
Cleaning and Maintenance:
- Easy access for cleaning: Removable parts and smooth surfaces for thorough cleaning.
Other Considerations:
- Noise level: Minimal noise during operation.
- Warranty and support: Reliable manufacturer(s) with biomedical equipment services.
Partner with CME for Assembly Sterilization Room Medical Equipment
As the United States’ largest equipment-only specialty distributor of equipment used in healthcare, we have built long term relationships with industry leading manufacturers of equipment essential for well-equipped assembly sterilization rooms.
Our expert account managers will collaborate with you and the manufacturers’ representatives to help you equip sterilization rooms for efficiency and compliance with sterilization standards and regulations.
Complementing CME’s expert focus on medical equipment are project management, direct-to-site delivery, and biomedical services. We are the only medical equipment distributor nationwide, able to say we are truly a one-stop shop.
Order Management Services
Our single point of contact project management team helps simplify sterilization room equipment procurement by working with facility administrators, procurement professionals, and manufacturers on your behalf to ensure delivery dates are met and any issues that may arise are resolved.
Direct-To-Site Logistics and Delivery Services
In addition to delivering medical equipment fully assembled when it is convenient for staff, CME Direct-to-Site services can off-set many of the person-hours associated with receiving large orders by receiving, inspecting and warehousing the equipment for a single delivery. Our Direct-to-Site team will deliver assembled sterilization room equipment to the sterile processing department and remove all packing debris, so the equipment is ready for immediate use.
Biomedical Services
Biomedical services have been at the heart of CME for over forty-five years. We are the only medical equipment distributor nationwide with an in-house team of biomedical technicians available to perform asset tagging, asset validation, equipment check-in, preventative maintenance, and repair.
Click CHAT to begin a conversation about your equipping your assembly sterilization room.
About CME: CME Corp is the nation’s premier source for healthcare equipment, turnkey logistics, and biomedical services, representing 2 million+ products from more than 2,000 manufacturers. With two corporate offices and 35+ service centers, our mission is to help healthcare facilities nationwide reduce the cost of the equipment they purchase, make their equipment specification, delivery, installation, and maintenance processes more efficient, and help them seamlessly launch, renovate and expand on schedule.
