By Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT
Health care professionals have the important responsibility of inspecting, detecting and examining multiple processes and products throughout the instrument reprocessing steps. What follows are some of the steps and tools necessary for completing these important tasks.
Adequate illumination of work surfaces should be provided in accordance with the recommendations of the Illuminating Engineering Society of North America (IES). Ancillary lighting should be considered for areas where instruments are manually cleaned and inspected. Three main things should be considered regarding lighting: employees’ age; the importance of the speed and accuracy of the work being performed; and the amount of light reflection in the work areas. The Association for the Advancement of Medical Instrumentation (AAMI) recommends that an illumination engineer, in consultation with the departmental manager, determine the appropriate lighting for each area. Table 1 in ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, provides recommended illuminance levels for work environments.
Cleaning inspection and verification
Inspection using enhanced visualization tools, such as lighted magnification and borescopes, are extremely helpful in identifying residue that is not observable by the unaided eye. The most common method is visual inspection, which should include the use of a lighted magnifying glass. Central Service/Sterile Processing (CS/SP) professionals should inspect every device for visible organic soil and contamination; this is typically done as part of the inspection, preparation and packaging procedure. Visual inspection alone might not be sufficient for assessing the efficacy of cleaning processes; therefore, methods that are able to measure or detect organic residues should be considered in facility cleaning policy and procedures.
Mechanical cleaning equipment performance should be tested each day the equipment is used, and all results should be recorded. After cleaning, personnel should visually inspect each item carefully for any residual soil. Sterilization cannot be assured unless proper cleaning of the device and reduced bioburden and soil was achieved. Verification and documentation of automated cleaning processes is an important aspect of quality control.
Annex D in ANSI/AAMI ST79:2017 lists available methods for cleaning verification tests [e.g., adenosine triphosphate (ATP) and chemical reagent tests for detecting clinically relevant soils such as proteins or carbohydrates]. The effectiveness of both manual and mechanical cleaning processes should be monitored and documented on an ongoing, periodic basis.
Brushing is a cleaning function and therefore should not be performed in the clean (preparation and assembly) area. If a medical device is found to be dirty upon inspection in the assembly area, the device should be returned to the decontamination area for re-cleaning.
Unloading the sterilizer
All items removed from the sterilizer, including items packaged in rigid sterilization container systems, should remain on the sterilizer cart and not be touched until adequately cooled. Facility policies should stress the importance of minimal handling of sterile items. When items are removed from the sterilizer cart, they should be visually inspected for external chemical indicators (CIs) that have reached their endpoint and for torn packaging or packages that appears to be wet. If a pack is torn or wet, it should not be used.
Handling and inspection
Sterile packages should be handled carefully. The contamination of a sterile item is event-related, and the probability of its occurrence increases over time and with increased handling. Health care professionals should avoid dragging, sliding, crushing, bending, compressing, puncturing or otherwise compromising the sterility of the contents. All sterile items should be thoroughly inspected visually to identify any damage to the integrity of the packaging materials before the items are dispensed.
Mechanical equipment should be inspected and cleaned daily, in accordance with the manufacturer’s IFU. Examples of items that require daily inspection and/or cleaning include recording charts; printers; printer ribbons; marking pens and ink; door gaskets; chamber drain screens; the internal chamber; and external surfaces. Weekly or other prescribed inspections and cleaning should be performed as specified in the manufacturer’s IFU.
Before being opened, sterile packages should be inspected for the appropriate appearance of the external CI and the physical integrity of the packaging. If the packaging is a rigid sterilization container system, the external latch filters, valves and tamper-evident devices should be inspected for integrity. The external CI should be examined after sterilization and before the item is used to verify that the item has been exposed to the sterilization process.
For all sterile packages, the internal CI should be inspected to confirm the appropriate response. Prior to placing the contents on the sterile field, the bottom of the wrapper or container system should be visually inspected for integrity and moisture. The circulator should inspect container systems for the integrity and proper alignment of the plate and filter or valve. Rigid container lids should be inspected for the integrity of the filter or valve and gasket.
– Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, is President/CEO of Seavey Healthcare Consulting and former Director of the Sterile Processing department at The Children’s Hospital of Denver. Seavey served on the Association of periOperative Registered Nurses (AORN) Board from 2008 to 2010 and is a Past President of ASHCSP. She received numerous awards, including AORN’s Award for Mentorship in 2012 and Outstanding Achievement in Nurse Education in 2001, and the IAHCSMM Award of Honor in 2013. Seavey authored the book “Sterile Processing in Healthcare Facilities: Preparing for Accreditation Surveys,” published by the Association for the Advancement of Medical Instrumentation (AAMI) and she serves on several AAMI committees where she helps write standards.