Speed is a militant force against sterilization," writes John Perkins in Principles and Methods of Sterilization in Health Sciences. Speed reduces the overall factor of safety. It becomes the accomplice of trapped air and dried-on debris. Speed requires a high degree of reliability in functional and mechanical control of all the variables so as to affect a minimum margin of doubt in the end result.
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Perhaps nowhere else is speed more of an enemy than in endoscope reprocessing. This is partly because few rigid and even fewer flexible endoscopes can be steam sterilized. Instead, they need to be sterilized or high-level disinfected by various low-temperature chemical processes. Even if you can overnight sterilize by an EtO or plasma system, because instruments may be used four or more times per day, they often must be cleaned and disinfected between patients. Because there is often pressure to speed up the process, facilities may take risky shortcuts.
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In this article, I'll review what you need to know about how to reprocess rigid and flexible scopes.
Cleaning rigid endoscopes
Rigid scopes, because they are straight, relatively short and primarily metal, are easier to clean and sterilize than flexible scopes. However, the telescopes used in endoscopic surgery are delicate, high-precision and expensive optical instruments that require handling and specific reprocessing techniques. Here are the steps for cleaning a rigid scope.
1. Unless contrary to the manufacturer's recommendations, immediately after use place the scope in a container with an enzymatic cleaner to prevent any soil from drying in or on the scope. Inject enzymatic solution into the lumens to ensure that the solution is in contact with all internal and external surfaces. Then, cover the container and transport it to the decontamination area.
2. Disassemble the scope and wash it in an automatic washing machine designed specifically for this purpose. If you are hand washing in a sink, cushion the sink bottom with a silicone or rubber mat. Use the proper sized brushes for the lumens that you are cleaning. Too large will potentially cause damage to the scope and too small will leave debris behind.
3. Clean the telescope lenses and light post gently with a manufacturer-recommended detergent and a soft, lint-free cloth. Ultrasonic cleaning is usually not recommended.
4. Rinse well under running water. Alcohol may remove some of the adhesive holding the lenses in place; therefore, see if your vendor recommends wiping the lenses with cotton containing isopropyl alcohol to remove any leftover residue. Inspect the telescope image and the clarity of the light post. Hold the telescope up to a bright light to observe the lens image at the distal tip and assess the amount of light projected through the light post. This is a critical step, and you should be trained to be able to make this assessment. Ensure all the parts of the scope are clean and dry before assembly and packaging for sterilization.
5. Package each scope by wrapping it in a protective surgical (lint-free) towel or specially molded open cell foam designed for the type of sterilization you will be using. Better yet are the perforated containers with suspension inserts.
Types of sterilization
Your four choices for sterilization include steam, EtO, gas plasma and peracetic acid.
High-level disinfection
You can high-level disinfect rigid scopes as long as they are moisture stable. Here are my recommendations for high-level disinfection (HLD).
Whether you choose sterilization or HLD, remember that producing a safe endoscope requires that you consider the whole processing system rather than focus on the differences between disinfectants and sterilants. A sterilant used within a poorly designed system could produce unsafe endoscopes, while high level disinfectants used within a well-designed process can produce safe, and even sterile, scopes.
Improvements in Flexible Endoscope Reprocessing Techniques
In , the FDA conducted a study of 241 patient-ready flexible endoscopes in 80 healthcare facilities. The FDA focused its concerns on the methods, materials and procedures used to clean, disinfect or sterilize flexible endoscopes between procedures because of reported illnesses linked to inadequate reprocessing. Here's what the study found:
' 37 out of 80 facilities (48%) had a least one patient-ready endoscope whose lumens were visibly encrusted with debris.
' 26 of the 241 endoscopes of various ages (11%) had severely scratched channels providing pockets for debris.
' Only 3 of 56 facilities (5.4%) that attempted to dry their endoscopes between procedures were successful.
Part of the problem was that the problem of cleaning, disinfecting and sterilizing scopes never appeared on manufacturers' radar. Also, manufacturers of cleaning, disinfecting and sterilizing equipment hadn't caught up with the demand for products that could effectively do the job.
Some of that has changed in the ensuing decade. Many scopes are now easier to disassemble and clean. Some furnish disposable elements in place of elements that had proven to be a serious cleaning problem. Also, the makers of cleaning equipment have come up with a wide variety of automatic and semi-automatic machines to address this problem.
Flexible endoscopes
Reprocessing of flexible endoscopes differs from rigid scopes and other surgical equipment primarily because flexible scopes are made of elastomeric materials and have numerous lumens to perform the various functions of irrigating, suction, observing, excising, retrieving, etc. Some of these lumens are exceedingly small, which makes them difficult to clean and disinfect.
Flexible endoscopes cannot be steam sterilized, and very few can be EtO or plasma sterilized. The Steris system is the most widely used sterilization process. Because it is a liquid contact process without packaging and most of what we will say applies to liquid sterilization and HLD, this discussion will be limited to those processes (Steris and HLD) equally with noted exceptions.
The FDA helped determine that initial cleaning, rather than sterilizing or high level disinfection, is the most critical issue. The right time, temperature and concentration of sterilant or disinfectant on inner and outer surfaces will always provide safe and effective devices. Surfaces that are occluded with debris left over from the procedure cannot be disinfected or sterilized no matter how efficient the process.
The following is a small sample of a training skill checklist for endoscope cleaning staff. Only those who can demonstrate competence in each of these skills should manage any part of endoscope reprocessing:
1. Identify types of endoscopes and their intended use.
2. Be able to take apart and reassemble each type of scope that will be used.
3. Identify all the components by name and describe what they do.
4. Demonstrate each step in the cleaning and decontaminating/sterilization procedure, preferably from a printed checklist.
5. State supplies that will be needed and the rationale for each product.
6. Describe protective attire and their rationale for use.
7. Describe in detail the steps to be taken after a scope is used and transported to the cleaning area.
8. States the correct (min/max) time for the enzymatic soak.
9. Describe safety precautions and the functions of exhaust hoods, badges worn, etc. in the processing area.
10. Demonstrate how the automatic cleaning and disinfecting/sterilizing equipment works.
11. If hand cleaning, show how to identify proper brush size for each channel and demonstrate proper channel cleaning techniques.
12. Describe how to check for leaks.
13. Describe rinsing and drying protocol and rationale.
14. Show how to check for proper disinfectant concentration and temperature.
15. Describe proper soaking time and the problems of too short or too long a soak.
16. Describe rinsing and drying protocol and rationale after disinfecting/sterilizing.
17. Describe handling and storage after disinfection/sterilization.
You should spell out all of the above in a procedure manual that has been signed off by the various equipment and supplies vendors and the department supervisor responsible for furnishing safe-to-use scopes.
Equal-standard-of-care
There are some who feel that by sterilizing their scopes overnight each day and then disinfecting them between cases that they violate the code of "equal standard-of-care". This is not true. The Joint Commission has gone on record as saying that occasional sterilization is recommended even though you disinfect between cases. They make the point that "equal" does not mean "the same". By following the above recommendations, you are producing equally safe-to-use scopes regardless of the method used. That's an equal standard-of-care.
Now, in response to the above question, ST91 states that &#;at a minimum two sinks or one sink with two separate basins should be used. &#; One sink or sink basin should be designed for leak testing and manual cleaning and the other only for rinsing.&#; Therefore, based on the terminology used, this is a recommendation&#;and rightly so. We do understand, however, that limitations do exist (e.g., lack of physical space, volume of endoscopes or probes processed). Again, when this is not possible, we see the true importance of disinfecting your sink after every use.
Must is used for external constraints. It describes unavoidable situations, including those that are mandated by the government. The word must is not an alternative for shall.
Shall and shall not are used to denote requirements. When this term is used, it is to be followed strictly in order to conform to recommended practice.
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Before answering this question, it is necessary to discuss the importance of word meanings. In this instance and throughout many AAMI guidelines and standards, terms are used to indicate a requirement, an option, or a recommendation. The following terms are defined in ST91:
Here's another situation where we need to consider the sink/tubing manufacturer's IFU for frequency of disinfection and proper method of disinfection. Some sinks have manifolds with detachable adapters/tubings used for flushing that require cleaning and disinfection. Another consideration is that some sinks have internal piping that will never come in contact with disinfectants and, in some instances, can require disinfection on a regular basis. Moreover, IFUs can change at a moment's notice, regardless of whether the sink in your SPD has been upgraded or received an addition, so make sure you have the most updated IFU versions available. In some instances, sink manufacturers may call out routine maintenance (e.g., daily, weekly), which requires a more in-depth internal disinfection process outside of the surface disinfection. If this is the case, such routine maintenance should be documented according to your current documentation practices.
Considering the sink manufacturer's instructions for use (IFU) for frequency of disinfection, as well as approved disinfection methods, is important in this area. We clean and disinfect scopes and probes after each use&#;or should be doing so&#;and only after being used on one patient. Disinfecting the sink that was used to process that scope or probe, each and every time, also is essential. Rinsing off the additional detergent remnants is insufficient. (That would be similar to getting in a bubble bath, then simply rinsing off the bubbles, without also engaging in proper cleaning!) ANSI/AAMI ST91: states that &#;sinks should be cleaned, disinfected, and rinsed between uses&#; Although the word term should is used, it is best practice to disinfect the sink every time. 1 (Note: The importance of terminology is discussed in greater detail below.) In a report from Stjärne Aspelund et al., 2 the authors noted: &#;Pseudomonas aeruginosa may colonize water systems via biofilm formation. In hospital environments, contaminated sinks have been associated with nosocomial transmission.&#; Such findings underscore the importance of cleaning and disinfecting decontamination sinks after each use.
The condition of decontamination sinks, in particular those in an endoscope processing area, has been a frequent topic of conversations during the past few years. This article focuses on improving understanding of what is needed for sterile processing department (SPD) professionals' decontamination sinks.
The authors have found that having a brief refresher training during staff meetings or department huddles can be very helpful, especially with end-user department staff, who may need a brief reminder. As mentioned at the beginning of this article, it is wise to remember that no matter the job, career, or direction you go in life, some degree of training will be involved.
Training should begin upon initial hire and reassessed at least annually thereafter. Training and competency verification should also be done when new equipment or products are brought into one's setting. However, training does not have to stop there; it should include ongoing education and in-services.
As noted in ST91, &#;Personnel providing orientation, education training or competency verification for personnel processing flexible endoscopes should maintain the confidence necessary to provide education including the effective use of technologies to optimize practice and adhere to hand hygiene practices.&#; This underscores the importance of trainers being capable of demonstrating their competence. All trainings and competency verifications should be documented and placed in employee files.
A highly skilled, trained, and/or certified department manager, supervisor, or coordinator should conduct the training program. An educator also could perform the training, but only if they are very knowledgeable in endoscope processing.
Every training program should include a description of what the training entails and what is expected of the trainee. The training program may also include timelines. It should include a review process to ensure that knowledge and skills have been retained, as well as competency verification in &#;all aspects of endoscope processing prior to the first assignment to perform these tasks independently&#; (from ST91). This of course would apply to the scopes that will be processed by the employee.
First, we would want to consider exactly what it is that we do in our department or areas of work. We want to see if we have policies and procedures in place. If policies already exist, then they will inform the foundation of our training program. If policies are lacking, now is the time to inventory what types of endoscopes we have, review manufacturers' written IFUs, and look at current guidelines to see how we can appropriately build our policy based on what we have and what we do. These tasks should be carried out by a multidisciplinary team consisting of, but not limited to, staff from the operating room, gastroenterology, sterile processing, infection prevention, risk management, and safety.
Rather than simply teaching, this notion involves facilitating the retention of information in employees' memory banks. As is fundamental to the well-known concept of &#;developing critical-thinking skills,&#; a training program will help to explain the why behind what we do. In essence, a training program provides a rationale.
What is behind a training program? One article describes a training program as &#;a planned sequence and combination of activities designed to equip employees with knowledge and skills to become better professionals&#; that is &#;aimed at achieving specific business goals&#;&#;goals that typically have a long-term aim. 3 In ANSI/AAMI ST91:, Flexible and semi-rigid endoscope processing in health care facilities, training also is defined as a &#;process or organized activity designed to help an individual attain the necessary skill or behavior required to perform or improve an individual's performance of a particular task.&#; 1
No matter the job, career, or direction you go in life, some form of training and education always is involved. Even in parenting, the parent trains and educates the child, and in essence, a training program is used.
Preparing for an accreditation survey from The Joint Commission (TJC) or another accreditation body can be a nerve-racking experience for all parties involved, from hospital administrators all the way down to frontline staff, including those in the SPD.
Along with the anxieties of preparing for a survey is the idea that surveyors are only there to find &#;the wrong&#; in a healthcare facility and close its doors, so to speak. That's far from the truth. We should all look at the survey process as a way to show others how well we are doing compared with the previous survey. It also gives us the opportunity to have an extra pair of eyes to review our processes.
To illustrate this idea, consider an individual who has to wear glasses in certain situations having an &#;extra pair of eyes." Having an outside source definitely is as beneficial as wearing glasses when needed. If we are being honest with ourselves, we can admit that all too often, we in the healthcare setting can become complacent in our processes. Truth be told, many became comfortable, especially during the uncertain years of the pandemic, when a lack of personal protective equipment (PPE) caused many to reuse single-use PPE. Also, during that time, all surveys were put on hold, causing many to become lax in their processes. It's like the old saying, &#;When the cat's away, the mice will play.&#; Now, things are getting back to the new normal and surveyors are back.
Because endoscope reprocessing breaches or shortfalls are still on the forefront and the focus of surveying bodies such as TJC, we should always be &#;survey ready.&#; The emphasis here is on patient safety. There's an old adage that says, &#;If you stay ready, then you don't have to get ready.&#; Some like to call this &#;continuous readiness.&#; Well, where does the readiness begin?
The readiness should begin upon initial hire. This could include transferring from one department to another or even from one hospital to another, even if it's the same organization. Another old adage in healthcare is, &#;If you've seen one hospital, you've seen one hospital,&#; as no two hospitals are 100% alike, even under the same leadership. The need and value of education, training, and competency verification cannot be understated.
In the authors' experience, from the moment a surveyor walks in the door, immediately following a greeting, they are likely to be on the lookout. But for what are they looking? You should expect that any and everything can prompt a conversation.
For example, a surveyor may want to talk to staff and not management. Why? For some, it's obvious that leadership would know how things operate, but they also understand that at times, certain information about updated guidelines and processes does not trickle down as it should. When dealing with instruments, endoscopes, or probes, storage is a huge thing. A surveyor wants to know and see how items are being stored. Are they being stored according to the manufacturer's written IFU? Is there a quality control system put in place to monitor and retrieve expired/damaged packaging? They also may ask whether that process is written out in the organization's policy. They may ask what your process is after a device is used on a patient. What steps do you take (e.g., point-of-use treatment, transport)? They also may request to review your policy&#;if they have not already done so. They may want to know how familiar you are with current updated guidelines.
Surveyors are better equipped than ever before. Now is the time to prepare.
The SPD is where the authors have witnessed the greatest anxiety regarding accreditation surveys. During the last few years, the focus on endoscope and probe processing has intensified. Gone are the days of the 15-minute surveys in the SPD world. In our experience, the length of time surveyors spend in the SPD has increased to a minimum of one hour. And it may sound a little odd, but we appreciate that level of thoroughness. Why? Because we put so many hours into maintaining compliance. We spend so much time educating and performing competency verification on employees, and we want our work to be noticed. We prepare our physical environment and quiz staff on knowledge retention. Conducting mock surveys with leadership, infection prevention, and the quality department helps us to ensure everyone is prepared and ready for action.
Although it may seem easier to shy away from surveyors: don't! Welcoming them into your department with open arms is important. During a recent survey, the surveyor observed, from start to finish (i.e., inspection, leak test, manual cleaning, high-level disinfection, drying, storage), the process of cleaning an endoscope. While the observation was going on, the surveyor continued to ask the employee to explain what he was doing in the process and to give a rationale. Let's just say that no stone was left unturned.
Surveyors are also concerned about who is performing the training on the individuals doing the job. Similar to what they may ask an end user, surveyors may request the endoscope or probe processing policy. They may compare that with the most current guidelines for processing, as well as compare it with the manufacturer's written IFU. They do this to ensure that your policy reflects the IFU and that you are in fact following your own policy.
Competency verification, as mentioned previously, is of utmost importance. As noted in ANSI/AAMI ST91::
&#;All personnel performing endoscope processing shall complete formal training and competency verification in all aspects of endoscope processing prior to first assignment to perform these tasks independently. &#; Personnel involved in endoscope processing shall be provided education, training, and complete competency verification activities related to their duties upon initial hire; annually; at designated intervals; or whenever new endoscope models, new processing equipment, or products such as new chemicals are introduced for processing.&#;
This competency verification is not solely for SPD staff. End users will have to be retrained upon initial hire, annually, and when new scopes/updates become available.
In conclusion, what should we expect when expecting TJC or other accreditation survey? Expect them to spend time with you. Expect an interchange of knowledge between parties. Expect them to learn from you as you learn from them. At the end of it all, expect an accreditation report that tells your leadership and, more importantly, your patient community that they are receiving the best care possible&#;and that they are in good hands when they walk into your facility.
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