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Manufacturers of rigid container systems turn for guidance to ANSI/AAMI ST77 Containment devices for reusable medical device sterilization. ST77 covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. Rigid container manufacturers are responsible for provid- ing thorough IFU that include safety and effective use, routine maintenance and inspections, generalized information on their medical device validation testing, weight limitations and design character- istics, and the proper cleaning and decon- tamination modalities to use. For example, Section 4.3.2 – Decontamination states that containment devices and their reusable accessories need to be properly cleaned and decontaminated after each use via manual or automated processes per the manufac- turer’s IFU. Section 4.5.2 – Instructions for use discusses several components needed by the end users to assist with the use of the manufacturer’s containment devices.
Guidance for container users Users of rigid sterilization container sys- tems typically defer to the appropriate guidance document for each sterilization method used at the facility. These include: • ANSI/AAMI ST79: 2017. Comprehen- sive guide to steam sterilization and sterility assurance in healthcare facilities.
• ANSI/AAMI ST41: 2008/(R)2012 Eth- ylene oxide sterilization in healthcare facilities: safety and effectiveness.
• ANSI/AAMI ST58:2013 Chemical ster- ilization and high-level disinfection in healthcare facilities
• AORN Guideline: Packaging Systems These guidance documents help SPD managers establish standard policies and procedures for work ow instructions in their departments. The container manufac- turers’ IFU also play a vital role in estab- lishing care and use instructions. Before purchasing a new container system, sterile processing management should conduct a pre-purchase evaluation and request written manufacturer’s IFU to ensure that their department can follow the validated cleaning and decontamination steps required for that containment system. The validated method of cleaning containers can be very detailed and can include the required cleaning agent, manual clean- ing steps, mechanical cleaning steps, and disinfection process to use before loading instrument sets for sterilization. Both AAMI and AORN state that con- tainers should be cleaned and disinfected as soon as possible after each use. They also advise to:
SELF-STUDY SERIES
a. Follow the manufacturer’s written IFU b. Include instructions for manual cleaning, mechanical cleaning or both
c. Use cleaning agents that don’t damage the container or its components (seals, fi lter retention plates)
d. Follow accepted practices for decontami- nation and employee safety, including wearing of PPE
Cleaning and decontamination processes Container systems follow the same clean- ing and disinfection processes as other reusable medical devices. First, used containers must be disassembled, and all disposable components discarded. Exter- nal process indicators and locks, single-use fi lters and retention plates, silicone mats and liners are removed, and accessory devices are disassembled per IFU.
Manual cleaning may involve several steps, and every step must be completed. The cleaning methods and chemistries must be compatible with the rigid con- tainer system. Abrasive cleaning agents can cause corrosion or damage external surfaces of the container, which could cause cracking or degradation. For alumi- num and plastic containers, a neutral pH detergent is often recommended to avoid the adverse effects of harsher chemistries. Following manual cleaning, all com- ponents of the container system must be rinsed with critical water to remove deter- gent and soil residuals. After rinsing, they are dried with a soft, clean, lint-free cloth. If any residual soils or cleaning chemistry are found during visual inspection, the cleaning process must be repeated. The disinfection step is necessary to make the containers safe to handle. To assure an effective process, it’s important to use com- patible disinfectants formulated specifi - cally for disinfecting medical devices and thoroughly removing cleaning chemistries.
Next, all surfaces and accessories must be thoroughly pre-cleaned using a proper brush or sponge as directed by the con- tainer manufacturer. Remove and rinse out any excess debris, soil, and pretreat- ment cleaning product with the sponge or brush before the manual or mechanical cleaning process.
Automated cleaning Container cleaning can also be automated. Mechanical cleaning equipment cleans, rinses and thermally disinfects the contain- ers. When using mechanical equipment to clean containers, end users must follow the system’s IFU and must use the required washer accessories to avoid negative out- comes or a lapse in the processing cycle. It’s also important to note that even if an automated process is being used, contain- ers must still be disassembled and rinsed thoroughly per container IFU before they are placed in the automated system for processing. It may also be necessary to perform some manual pre-cleaning. When loading containers into a washer- disinfector, it’s important to use the racks and other accessories designed specifi cally for processing containers in that system. Special racks are often needed to assure thorough cleaning of container systems and their accessories. Some washer- disinfectors use a single rack or basket, while others can have multiple shelves or baskets. Knowing how to load a rack is essential. Detergent can only clean what it reaches. Shadowing, stacking and other improper loading techniques block proper distribution of water and cleaning chemis- tries within the equipment, which prevents cleaning and thorough rinsing. Automated systems often have impinge-
ment technology that disperses water and cleaning chemistries to all surfaces of the containers. Spray arms and nozzles
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Self-Study Test Answers: 1. C, 2. D, 3. A, 4. D, 5. A, 6. D, 7. B, 8. D, 9. D, 10. A
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