By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS
In October, the Association of periOperative Registered Nurses (AORN) released its newly revised “Guideline for Care and Cleaning of Surgical Instruments,” and numerous changes directly impact the sterile processing (SP) discipline.
Specifically, this document provides evidence-based guidance for cleaning surgical instruments, including point-of-use treatment, transport, decontamination, inspection and general care of reusable medical devices.
Emphasis on SP environment
Several changes to the guideline will have an impact on the quality of processing in SP areas. Note: Industry changes that occurred since the previous revision of this guideline are reflected in this updated version. One change pertains to the SP environment’s heating, ventilation and air conditioning (HVAC) parameters. The guidelines have been changed to recommend that the HVAC system be designed in accordance with the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and local regulatory requirements to reduce the number of environmental contaminants and provide a comfortable environment for occupants in the area. Additional changes to the guideline include replacing the recommendation for “medical-grade compressed air” with “instrument air,” and replacing the recommendation for “treated water” with “critical water.” The previous version of the guideline offered specific recommendations for the design of the SP area; these design features are now outlined in the “AORN Guideline for Design and Maintenance of the Surgical Suite.”
A key addition to the “Guideline for Care and Cleaning of Surgical Instruments” addresses pre-purchase evaluation. Many SP professionals have been concerned that they may not be included in the purchase decision of medical devices – a perplexing oversight given that some devices may be sophisticated and complex and require numerous time-consuming processing steps that require SP technicians to have a higher skill level. This is now addressed under Recommendation 1.3. Pre-Purchase Evaluation. Another new recommendation is that the manufacturer’s written instructions for use (IFU) should be evaluated before the purchase and use of reusable surgical instruments and other medical devices, to determine whether the processing methods can be performed as stated in the IFU. The revised guideline also addresses personnel education and competency needs and assurance that the time required for all processing can be allocated. Having resources to properly process instrumentation continues to be addressed under 1.3: “Before purchase and use of reusable surgical instruments and other medical devices, determine whether the resources are available to perform the processing methods provided in the manufacturer’s validated IFU, including a listing of necessary resources equipment needed for transport methods to the decontamination area and environmental conditions required for handling and storage.” The previous recommendation stated that, “Some instruments may require special cleaning, packaging, sterilization or maintenance procedures that cannot be provided by the facility without modifications to processes and equipment.” The updated recommendation now includes the consideration of a need to modify space.
A key addition to the Sterile Processing Area section under Recommendation 2 involves consideration of sinks used in the decontamination area. Specifically, the recommendation states that the decontamination area should have the appropriate number, size and configuration of sinks, with the sinks being at a height that is ergonomically correct for those who perform manual cleaning (in accordance with the manufacturer’s IFU for items that will be processed). The recommendations also state that the sink should be marked at the water level needed for cleaning solution measurement, and a process for frequent cleaning of sinks and the sink area needs to be in place.
An eye on water quality
Recommendation 4, Cleaning Products and Equipment, provides more focused guidance on the type of water to use (poor water quality results in reducing the effectiveness of some disinfectants and cleaning chemicals, and chlorine can pit stainless steel instrumentation). A new recommendation is that the health care organization should have a water management program in place that encompasses the utility water and critical water used during decontamination; the SP department should be included in that program; and a collaborative team consisting of clinical engineering personnel, facility engineering personnel and infection preventionists should establish a process and frequency for monitoring water quality. The updated guideline also provides recommendations – in a table format – for specific substances that should be monitored and controlled for critical and utility water.
New recommendations have been added for the loaned instrument section that begins with forming an interdisciplinary team that is appointed by the health care organization to establish standard operating procedures for managing loaned reusable surgical instruments. Also, the revised guideline’s “Cleaning After Use” recommendation has been replaced with “Point-of-use Treatment,” terminology that is reflected in other guidelines and standards. The purpose of this change it to include all steps that need to occur at the point of use. Recommendations for point-of-use treatment include removing gross soil from instrument surfaces with a sterile radiopaque surgical sponge moistened with sterile water during the procedure. The use of saline to wipe instruments is still NOT recommended. Lumened instruments should be irrigated with sterile water at frequent intervals during the procedure.
Safer device and solution handling
The guideline states that sharp instruments should be separated from other instruments and confined in a puncture-resistant container before transport to the decontamination area. Disposable sharps such as scalpel blades and suture needles should be removed and discarded into a closeable, puncture-resistant container that is leakproof on its sides and bottom and labeled or color coded as “Biohazardous.” Instruments should be kept moist until they are cleaned by using either saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments.
During the instrument manual cleaning process, it is recommended to change the cleaning solution per the cleaning solution manufacturer’s IFU or between each use (if the manufacturer’s IFU does not make a recommendation). This is because bioburden deposited in the cleaning solution during the cleaning process can interfere with cleaning process effectiveness, and frequent changes of the cleaning solution can help minimize bioburden. Also, the cleaning solution should be changed when the solution temperature does not meet the temperature specified in the manufacturer’s IFU. Water should not be added to existing solution because it would dilute the cleaning solution concentration. There is also the recommendation to use cycles that exclude the use of lubricants in mechanical washers for instruments and devices that are not compatible with lubricants, such as orthopedic implants.
Additionally, recommendations related to ultrasonic cleaners have been expanded and now include using accessories that are compatible with the ultrasonic cleaner, such as a metal open weave basket. This is because porous materials, such as silicone mats, can absorb the cavitation, negating its effect.
Borescopes (a relatively new inspection tool for use in health care instrument processing) are now recommended for use during the inspection phase of surgical instrumentation for lumened devices. This is because it is difficult, if not impossible, to visualize the inner walls of lumened devices; therefore, an endoscopic camera or borescope can make it easier to detect soil.
Prion and TASS precautions
Recommendation 13, Prion Disease Transmission Precautions, recommends consulting the mechanical washer-disinfector manufacturer for instructions on decontaminating the mechanical washer-disinfector after processing instruments that may have been contaminated with prions.
Processing eye instrumentation requires special methods to prevent toxic anterior segment syndrome (TASS), a non-infectious acute postoperative anterior segment inflammation caused by a noninfectious substance that enters the anterior segment, resulting in toxic damage to intraocular tissues (this condition appears to be related to instrument processing). Based on recent research, an additional support for processing eye instrumentation has been added to the section Intraocular Ophthalmic Instruments, which recommends keeping the ophthalmic viscoelastic (OV) and organic material moist to aid in their removal. This supports the continued recommendation to wipe ophthalmic instruments with sterile water and a clean lint-free sponge or cloth, and flush or immerse them in sterile water, in accordance with the manufacturer’s written IFU (a process that should be done immediately after use during the procedure). Another change that may need to be implemented when processing eye instrumentation is that some intraocular instrument manufacturers’ IFU may require dedicated ultrasonic cleaners that are not used for other types of instruments.
This article has highlighted some (but certainly not all) of the major changes to the updated “AORN Guideline for Care and Cleaning of Surgical Instruments.” This based guideline is available to AORN electronic subscribers on eGuidelines+ and will also be included in the “2021 Guidelines for Perioperative Practices” print edition of the “Guidelines for Perioperative Practice.”
Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, is a clinical educator at IAHCSMM.