This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.
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Today’s healthcare environment requires the highest standards of care for all patients. Central Service (CS) Department (CS) technicians and managers have recognized the importance of their responsibilities for years. However, until recently CS functions have not been a primary focus of regulatory and surveying agencies, and most patients did not even know the department existed. However, today’s very effective, diverse, and worldwide communication systems quickly relay healthcare practices, successes, and failures to the general public. Therefore and increasingly the work of all departments in healthcare facilities is more transparent.
This lesson is the first in a two-part series that addresses verification practices that CS personnel should use to ensure that reprocessing standards recommended by manufacturers and implemented within their departments are consistently achieved. This lesson defines and explains that differences between validation and verification and provides details about the verification processes required for CS decontamination.
Validation refers to “documented procedures for obtaining, recording, and interpreting the results required to establish that processes will consistently yield products complying with predetermined specifications.”(1) Validation is performed by the device manufacturer who must undertake validation testing to ensure that medical devices respond with the same results each time reprocessing procedures are performed. The manufacturers’ Instructions for Use (IFU) are based on these testing results. They will then indicate, for example, where chemical and biological indicators (CIs and BIs) should be placed, what cleaning chemicals and in what concentrations should be used, how to disassemble and assemble instruments, and the correct disinfection and sterilization procedures. If the IFU are followed appropriately, the product outcomes should be the same each time instruments are processed.
In comparison, verification involves documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met.”(1) In other words, CS personnel verify that following the IFU results in the intended outcome: sterile instrumentation is consistently achieved by whoever performs the process in the specific department.
Surveyors from The Joint Commission (TJC) and the Centers for Medicare and Medicaid Services (CMS) are now asking CS personnel to show how they confirm the sterilization processes they use actually are effective and to prove compliance with facility policy, manufacturer’s IFU, and the Association for the Advancement of Medical Instrumentation (AAMI) recommended practices. CS technicians and managers prove the processes they use are consistently accomplished by verifying what they do and how they do it.
Although this type of verification is extremely important, it is also necessary to verify that all of the processes performed within the CS department yield desired results: consistently high quality outcomes. For example, if washers/decontaminators in the CS department are not functioning optimally or are being overloaded, the instruments being processed may not be clean. This breakdown in the decontamination process, in turn, can lead to a failure of the sterilization process.How do CS managers ensure that all of their processes are working appropriately? They do so by creating a routine process verification system that is performed by multiple CS technicians in each critical area of the department. This strategy helps to ensure products are of consistent high quality, and it also keeps the department survey-ready.
If it’s not clean, it’s not sterile! This phrase is the foundation of all CSSD processes. Cleaning is the most important part of instrument reprocessing, and it is the first step. When a medical device is first used in a facility, cleaning verification should be performed to ensure that facility personnel can effectively disinfect or sterilize it. The development of a cleaning verification method involves establishing, clarifying, and documenting a standard cleaning process that is based on published and validated recommended practices or guidelines.
There are many processes in the decontamination area that must be routinely verified to ensure items are appropriately cleaned prior to assembly. Visual verification can be a first step. Examples include:
Equipment verification is another integral element necessary to confirm that facility personnel can consistently comply with manufacturer’s IFU. Cleaning equipment should be tested weekly, preferably daily, during routine use.(1) Several methods can be used to test the function of most cleaning equipment and to verify it is working properly. It is always important to follow the manufacturer’s IFU for the specific testing methods that should be used.
Equipment manufacturers develop schedules for preventive maintenance procedures which include changing filters and cleaning screens. Biomedical, equipment manufacturer, or a third- party service should perform preventive maintenance on internal components at intervals defined by the manufacturer.
Water quality is another vital part of the cleaning process. Slight changes in water hardness or pH (a measure of the water’s acidity or alkalinity) can reduce its cleaning effectiveness. Complete testing of the water should be performed at least annually by qualified facility employees if the necessary equipment is available or by outside vendors, if necessary. Note: manufacturers of cleaning chemicals and cleaning equipment frequently provide this service at no cost. Testing of the pH of water used for cleaning should be performed periodically and can be done by CS department personnel using commercially purchased test kits which are the same as those used to test swimming pool water.
It is important to verify that cleaning chemicals are correctly feeding into the chamber of ultrasonic cleaners if the units are automated, and CS technicians must verify the chemicals are being diluted appropriately in manual units. The cavitation process must also be verified. (Cavitation is the process used by an ultrasonic cleaner in which low-pressure bubbles in a cleaning solution burst inward to dislodge soil from instruments.) To verify the cavitation process, fill the tank as is normally done to process instruments; degas the solution, and then run one of the following tests:
Document the results. If they are not as expected, remove the ultrasonic unit from service until repairs can be made. If the machine has irrigation capabilities, check the tubing to be sure it is not clogged and that water flows freely through the entire length of the tubing. Ultrasonic units with disinfection cycles should be checked to ensure the disinfection chemical correctly feeds into the chamber. Routine preventive maintenance recommended by the manufacturer must be consistently performed and documented.
Verification procedures are also required for thermal washers, cart washers, and automated endoscope reprocessors.
Check to ensure the chemicals are being feed into the equipment appropriately and that there is low foaming during the cycle. Check spray arms; are they free of debris? Are they correctly attached? Do they spin freely? Confirm that the instrument trays/sets are arranged so water and chemicals can reach all surfaces and confirm that multi-layered trays are separated for cleaning. The washer must be loaded correctly, the manifolds and baskets must be intact, and spray arms on the manifolds must move smoothly. The screen and drains must be clean, chemicals must be fed to the equipment correctly, and the conveyors must be clean and operating properly.
Water temperatures for all phases of the thermal washer’s cycle should be checked weekly, preferably daily. This can be done by in-house personnel if the appropriate equipment is available or with use of a commercially- available product.
The washer’s cleaning ability must be checked weekly, preferably daily. Test the equipment using a commercially-prepared and purchased surrogate device that best represents what is being cleaned. A best practice is to place the device inside the washer following the manufacturer’s IFU. Run the cycle and, when it is completed, retrieve the device and inspect it for results. If the test plate is clean at the end of the cycle, the equipment is cleaning effectively. Document the results. If the test results are not as expected, remove the washer from service until it is repaired.
Routine preventative maintenance must always be performed and documented as recommended by the manufacturer.
Ensure the cleaning chemicals are low foaming and being fed into the equipment appropriately. Check the spray arms; are they free of debris? Are they correctly attached? Do they spin freely? Are screens and drains clean? Are the loading racks clean, in good repair, and is the wheel moving smoothly? If the cart washer has an instrument cleaning cycle, the water temperature and cleaning ability of the washer should be tested during this cycle in a manner similar to that used for thermal washers. Document all test results. If they are not as expected, remove the cart washer from service until repaired. Routine preventive maintenance as stated by the manufacturer should be consistently performed and documented.
Automated Endoscope Reprocessors (AERs)Confirm that the appropriate connectors are available. Routine preventive maintenance recommended by the manufacturer should be consistently performed. The expiration date of the disinfectant should be clearly labeled on the equipment, and the documentation of each cycle tested must be complete and legible.
After the manufacturer completes validation testing on a device, CS personnel are responsible to verify that the cleaning and sterilization methods recommended by the manufacturer in the IFU can be duplicated by and are used correctly and consistently by the facility’s CS personnel.
The second part of this two-part series reviews the use of product families for verification and procedures to verify instrument assembly, sterilization, and transportation and storage.
(1) ANSI/AAMI. ST 79. Comprehensive guide to stream sterilization and sterility assurance in health care facilities. Arlington, Va. 2010.
Anne Cofiell, CRCST, FCS
Scott Davis, CMRP, CRCST, CHMMC
Susan Klacik, ACE, CHL, CRCST, FCS
Patti Koncur, CRCST, CHMMC, ACE
Natalie Lind, CRCST, CHL
David Narance, RN, CRCST
Series Writer/ Editor: