INTRODUCTION
Otolaryngology–head and neck surgery has become increasingly reliant on high-quality visualization of the internal features of head and neck anatomy, and office endoscopy is perhaps the most powerful tool in our field for acquiring this data. Additionally, the increasing in-office procedural volume in otolaryngology–head and neck surgery relies on endoscopy for many procedures. It is therefore important for clinical practices to understand the workflow of reprocessing a scope.
Because a consensus statement regarding reprocessing of nasal endoscopes does not yet exist, , specific recommendations vary by device manufacturer, institution, and accrediting body guidelines. Here, we present a generalized framework for the management and reprocessing of clinical scopes. We specifically draw from our institution’s experience in processing more than 9,000 scopes each month to provide an overview of the process and practical considerations.
Infection Risk Associated with Endoscopy
Proper technique in reprocessing is crucial to prevent unnecessary pathogen exposures. These pathogens may arise from both previous patient encounters and staff handling of equipment. Unfortunately, unlike other clinical uses of scopes, such as gastroscopy, bronchoscopy, and arthroscopy, the patient-to-patient risk of disease transmission with nasal and oral endoscopy is not well studied. Nonetheless, minimizing potential transmission of pathogens is a key preventable measure to promote patient safety.
Specifically, nosocomial pathogens found in the nasal vestibulum include Staphylococcus aureus and methicillin-resistant S. aureus, Streptococcus pneumoniae and other Streptococcus spp., Candida albicans , and gram-negative bacteria such as Klebsiella spp., Escherichia. coli , Proteus spp., H. influenza , and P. aeruginosa. , More than 25,000 species are found in the oral cavity. While aerobe organisms are predominantly found in the oral cavity, anaerobes such as Actinomyces , Fusobacteria , and Peptostreptococci are found in the subgingival spaces. In the upper respiratory tract, viruses include rhinoviruses, coronaviruses, coxsackievirus A, influenza A viruses, respiratory syncytial viruses, adenoviruses, parainfluenza, and enteroviruses. Despite the population of microbes in surrounding structures, the paranasal sinus and larynx are not well-colonized themselves.
Key Terms in Reprocessing Medical Equipment
To understand reprocessing requirements, there are several important classifications to understand. First, reusable medical instruments are most commonly classified using the Spaulding scheme. , In this scheme, there are three tiers of medical instruments: “noncritical” instruments, which do not directly contact the patient or only contact skin (e.g., blood pressure cuff, stethoscope); “semicritical” instruments, which contact mucous membranes or nonintact skin (e.g., laryngoscopes); and “critical” instruments, which penetrate sterile tissue, enter the vasculature, or contact bone or blood (e.g., catheters).
Second, it is important to understand the tiers of sterilization and disinfection. Sterilization is considered absolute and refers to a process that destroys all types of microorganisms, including resistant bacterial endospores. This is the highest level of reprocessing and includes pressurized steam, ethylene oxide gas, and hydrogen peroxide plasma. Sterilization is necessary for “critical” instruments. Disinfection, on the other hand, is considered relative and is divided into three levels: “high-level disinfection” (suitable for most “semicritical” instruments), “intermediate level disinfection” (suitable for some “semicritical” and “noncritical” instruments), and “low-level disinfection” (suited only for “noncritical” instruments). High-level disinfectants, such as 2% glutaraldehyde, 7.5% peroxide, and 0.2% peracetic acid, destroy a greater variety of microbes in a shorter period than lower levels of disinfectants. For the reprocessing of rigid and flexible scopes in otolaryngology, high-level disinfection is necessary. ,
Processing of Reusable Flexible Scopes
While scope manufacturers are responsible for including adequate directions for use and reprocessing, the general disinfection process is similar across scopes. This process includes three steps: point-of-use precleaning, thorough cleaning, and final processing (including high-level disinfection or sterilization). At each step of processing and before use, it is appropriate to visually inspect the device.
Stage 1: Point-of-Use Precleaning
After use, the scope should be placed in a designated area. It is recommended that point-of-use precleaning occur as soon as possible after use to prevent debris from drying. Therefore, this step of processing typically occurs immediately after the clinical encounter by clinical support staff.
All disposable portions of the scope and associated waste are discarded. The scope must be wiped clean of visible debris and be scrubbed with a detergent-soaked cloth or sponge, such as an Endozime sponge, to remove initial contaminants. Alternately, PRE-KLENZ, a detergent spray used to initiate the pre-cleaning process, may be used. If a suction channel is present, detergent is run through the channel. It is recommended to alternate between suctioning detergent and air in order to create agitation and enhance cleaning. The channel is then rinsed with water and dried by suctioning air alone. Finally, the scope is removed from the patient area and transported in a closed container to a designated work area for further processing.
Stage 2: Thorough Cleaning
This stage of reprocessing aims to render the device safe for handling and further steps of reprocessing. As applicable, the scope should be disassembled to facilitate thorough cleaning. The scope is immersed in a multienzymatic detergent, such as EcoZyme, per manufacturer instructions for initial decontamination. The scope, including any channels, is washed manually with a sponge and thoroughly rinsed with water. Finally, the scope is dried with a lint-free cloth. It is important to completely dry the scope to prevent detergent dilution in future steps.
Stage 3: Final Processing (High-Level Disinfection or Sterilization)
Thoroughly cleaned devices require a final stage of processing to be safe for patient use per the Food and Drug Administration’s high-level disinfection protocols. The scope is next placed in an automatic sterilization machine, which uses both heat and high-level disinfectants to achieve a final level of reprocessing. Alternately, if an automated reprocessor is not available, timed immersion in a high-level disinfectant, such as an orthophthalaldehyde solution (CIDEX) or 2% glutaraldehyde-containing agent, can be used for manual reprocessing. It is preferable to use an automatic reprocessor to improve standardization. Finally, the scope is rinsed with sterile water and dried with pressurized air. The scope is hung to dry for a standardized period of time before it is used again in clinical practice.
Reprocessing of Reusable Rigid Scopes
The reprocessing of rigid scopes is similar to the above, with a notable exception in stage 3. Rather than using a high-level disinfectant soak or automatic reprocessor, rigid scopes may be steam sterilized as their stainless-steel housing can withstand this processing.
Storage and Maintenance
After reprocessing, proper storage of scopes is necessary to maintain the level of disinfection achieved. Flexible scopes should be hung vertically in a clean, dry, well-ventilated, and dust-free area or storage cabinet. It is not recommended that the flexible scope be coiled, stored horizontally, or in a closed container until needed for use. Scopes should not be placed in a patient’s room until it is determined that the scope will be used for that patient. A scope placed in a patient room, even in an unopened container, should be considered contaminated and therefore undergo reprocessing, increasing costs.
Routine maintenance is recommended for all scopes to ensure proper functioning and minimize risk to patients. While specific recommendations may differ by scope manufacturer, minor and full maintenance for flexible scopes is often recommended after every 100 and 300 procedures, respectively. Minor maintenance includes replacement of the angulator pulley, inlet seals, and air/water suction valve seals. Full maintenance additionally includes replacement of all channels and tubes (e.g., air/water supply tubes, working channels, suction tubes, forward water/air jet), seals, and O-rings.
Reusable medical devices are labeled for a maximum number of reprocessing cycles or provide a description of when a device is not appropriate for reprocessing. Instruments and devices in disrepair or with compromised surfaces, such as oxidation, pitting, cracking, or damage, may not be able to be effectively disinfected. Assigning a unique identifier to each scope allows for tracking of use, maintenance needs, and lifespan. While scopes are prone to damage by incorrect use, rough handling, or overflexion/overextension, a well-handled scope can be reprocessed numerous times.
Corporate representatives for scope manufacturers should provide recommendations on processing and maintenance on instrument purchase or on request.
Other Considerations
Central vs. Local Reprocessing
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