Accreditation & Regulatory Journal
March 2023


Reprocessing Of Endoscopes

By: Paula Sims
More healthcare–associated outbreaks have been linked to contaminated endoscopes than to any other medical device. Because of the types of body cavities they enter, flexible endoscopes acquire high levels of microbial contamination (bioburden) during each use. Today we are going to talk about appropriate cleaning and storage practices that will prevent the spread of healthcare–associated infections.
Association for the Advancement of Medical Instrumentation (AAMI) recommendations include removing clinical soil at the point of use as the first step in the cleaning process. Failure to promptly and properly initiate cleaning of endoscopes after use can increase the difficulty of cleaning and decrease the effectiveness of disinfection and/or sterilization. Immediately after use, scopes should be transported appropriately followed by meticulous manual cleaning in the endoscope processing area; all of which precedes the disinfection or sterilization process. Endoscopes should be visually inspected during all stages of handling and reprocessing – before, during, and after use, in addition to during and after cleaning and before high-level disinfection (HLD).
Prior to the disinfection process a leak test must be performed to validate the integrity of the scope. Heat sensitive endoscopes must be thoroughly cleaned using a high-level disinfectant after every use. The manufacturer can recommend what type of disinfectant to use for a specific device and make sure the disinfectants are compatible with the device. The Food and Drug Administration (FDA) also provides a list of approved chemical sterilants and high-level disinfectants that can be used for reprocessing. If the germicide is FDA-cleared, then it is safe when used according to label directions. Disinfectants that are not FDA-cleared and should not be used for reprocessing endoscopes include iodophors, chlorine solutions, alcohols, quaternary ammonium compounds, and phenolics.
The two products most commonly used for reprocessing endoscopes in the United States are glutaraldehyde and an automated, liquid chemical sterilization process that uses peracetic acid. The American Society for Gastrointestinal Endoscopy (ASGE) recommends glutaraldehyde solutions that do not contain surfactants because the soapy residues of surfactants are difficult to remove during rinsing.
Speaking of rinsing, thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergent. Purge water from all channels using forced air. Dry the exterior of the endoscope with a soft, lint-free cloth to prevent dilution of the HLD used in subsequent steps.
The device is now ready for disinfection/sterilization. There are a variety of methods available for disinfecting and sterilizing flexible endoscopes. To determine the method for a specific device, refer to the medical device manufacturer’s written instructions for use (IFU) and the intended use of the device. Validate that the method is cleared by the FDA for use in health care facilities.
To summarize, the cleaning process should be as follows:
  • point of use treatment to remove external bioburden
  • transporting the endoscope from the point of use to the processing area as soon as possible
  • leak testing
  • manual and/or FDA-cleared automated cleaning
  • thorough rinsing
  • exterior drying and channel purge
  • inspection and testing for cleanliness
  • disinfection/sterilization per manufacturer recommendations
The devices are now ready for storage. Newly disinfected and thoroughly dried endoscopes should be stored in an area that is clean, well ventilated and dust free as to prevent potential contamination. Endoscopes should be stored vertically or horizontally in a cabinet designed for scope storage and in accordance with manufacturers IFU’s. When sterilized endoscopes are stored vertically, the insertion tube should be as straight as possible, with the distal tip hanging freely. Scopes should not be touching each other.
Scope management is complex. Accrediting bodies will typically survey to compliance compared to what the manufacturers IFU’s demonstrate. This article only addresses cleaning and storage processes and does not demonstrate full compliance with AAMI/ANSI requirements for quality control, documentation, record keeping, and stock rotation, just to list a few of the required tasks.
ANSI/AAMI ST91:2021 Flexible and Semi-rigid Endoscope Processing in Healthcare Facilities
Centers for Disease Control (Updates, 2017), Disinfection of Healthcare Equipment
Multisociety Guideline on Reprocessing Flexible GI Endoscopes and Accessories (2020), approved by the American Society of Gastrointestinal Enterology (ASGE) Society of Gastroenterology Nurses and Associates (2018), Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes
Hospitals have not been immune to shooting events and workplace violence has become more prevalent in hospitals over the past several years. This rise in violence has been attributed to such things as suicide, gang fighting, disgruntled employees, euthanizing of ill relatives/spouses, prisoner escapes, and the overflow of violence from the community. Active shooter events in a hospital setting presents unique challenges due to the vulnerability of the patient population within the hospital.
Many hospitals have specialty services such as hyperbaric chambers and Magnetic Resonance Imaging (MRI) equipment and locked areas such as pharmacies, mental health units and maternity floors. If there was an active shooter in these areas, there is no single best method to respond to an incident. What is important is having prior planning in place that will allow you and your staff to determine the best option if an active shooter situation was to occur. Essentially, staff must always be prepared to respond to an active shooter situation. This is traditionally accomplished using an Emergency Action Plan (EAP) and conducting ongoing active shooter educational awareness and exercises. These exercises prepare your staff to effectively respond and assist in minimizing loss of life. However, certain locations within the hospital take additional preparation in the event of an active shooter.
If you evaluate your hospital’s exercises or events related to active shooter responses, most likely you will discover shortcomings such as staff being unaware of lockdown procedures or warnings, escape options, or knowing what to do with patients. What is commonly not evaluated or discussed are the “what if” situations. Let’s look at some of the “what ifs”.
  • What if an active shooter occurs in intensive care units? Patients in this area are, in most cases, unable to fend for themselves and protecting them will be left up to the staff in the area. Evacuation of these patients becomes extremely complicated depending on the evacuation egress path required for such patients. Additionally, these areas may be locked down hindering response by acting authorities.
  • What if an active shooter occurs in nuclear medicine or radiation laboratories? Dangerous materials are commonly housed in these areas such as radioactive sources or high does rate brachytherapy units (Gamma Knife). Coordination between law enforcement personnel and hospital staff is critical to the security of personnel and the hazardous materials maintained in these areas. Securing these rooms during an active shooter should be priority to prevent access to the radioactive material and prevent the release of such material within the hospital and surrounding community.
  • What if an active shooter occurs in maternity, newborn, or neonatal intensive care units? These areas are particularly vulnerable to an active shooter threat since it is very difficult to evacuate the units; not to mention the additional concerns surrounding newborn babies such as custodial disputes, domestic situations, or kidnappings. If an active shooter was to gain access to one of these areas, it creates a challenge for law enforcement personnel to access the areas even with the assistance of security staff.
  • What if medical gases are affected by an active shooter? Hospital operations utilize a magnitude of medical gases and law enforcement personnel should be aware of these areas and the dangers related to them. Gases such as oxygen, nitrous oxide, nitrogen, carbon dioxide and waste anesthesia gas disposal that are in the piping systems within the walls, stored in rooms, or on medical equipment carts. All these present hazards if compromised by responding law enforcement personnel. In larger facilities, some of these gases are stored outside of the hospital which can complicate reaction time if an active shooter was to gain access to such an area and barricade themselves within the enclosure where these gases are maintained
  • What if you have high profile patients in the hospital during an active shooter? Your hospital at any time has the potential to be visited from patients of all walks of life including high profile personalities. These personalities tend to draw crowds or select company that can heighten the active shooter potential at your hospital. These types of situations are extremely difficult to plan for since at any given time they could seek medical attention at your hospital. It is important that hospital security staff have been trained to effectively communicate with private or governmental protection details that may be providing security for this person.
  • What if an active shooter occurs when prisoners are being treated? What if the active shooter was a diversion tactic needed to assist in the escape of the prisoner. As a rule, these prisoners will be guarded by law enforcement or correctional personnel, and therefore, unaware of an active shooter within the hospital, and depending on the situation, may not be able to assist in an active shooter situation.
  • What if an active shooter occurs in the kitchen? The kitchen is not commonly thought of when discussing an active shooter event. What most people forget is that there are several ignition points within a kitchen and if staff evacuate the area during an active shooter and leave items on the stove, in the oven, in the deep fryer or on a grill, they have the capability of starting a fire. If a fire was to occur law enforcement personnel responding are now challenged with not only an active shooter but individuals responding to the fire.
At any given time, staff may be required to make life-changing decisions. During an active shooter situation, they will rarely have all the information they need to make a fully informed decision about the choices they have chosen. The goal in all cases is to survive and protect the patients, visitors, and coworkers when making decisions pertaining to the “what ifs” during an active shooter event.