Endoscope Care in 2020 and beyond

Oct. 26, 2020
How does SPD navigate through a pandemic with an eye on future crises?

Outside of healthcare, and arguably independent of the Sterile Processing & Distribution (SPD) department, few comprehend the complexity, demands, intensity and pressure of SPD, along with SPD’s nascent desire to be accurate, effective, efficient and understanding of their essential contribution to high-quality patient care. 

Sterile processing duties extend well beyond the tasks of a restaurant scullery, for example. SPD professionals – both management and technicians – must grasp the science (microbiology, for one) and the technology (how to disassemble and reassemble complex devices and follow detailed instructions for use (IFUs)). Any deviation from those norms can lead to dangerous – if not fatal – patient outcomes and a barrage of negative media exposure. 

As part of its 16-year exhaustive coverage of endoscope reprocessing, Healthcare Purchasing News has explored the ins and outs, ups and downs of a foundational and fundamental service within the healthcare community. In fact, last year HPN detailed the broad spectrum of steps required to reprocess endoscopes. You can revisit that content here on HPN Online: https://www.hpnonline.com/sterile-processing/article/21110528/the-full-scope-of-reprocessing-introspection-and-intervention. 

This year HPN focuses in on the six primary priorities that SPD must learn, master and execute with as much precision, integrity and devotion as possible … on a daily basis, 24/7/365. HPN recruited 15 sterile processing executives, regarded as experts in their class and field and asked them to comment on the key areas for continued improvement that need to be monitored consistently for process breakdowns and challenges, particularly against the backdrop of the ongoing pandemic. 

These are the six: 

  • Pre-cleaning and treating
  • Visual inspections and leak testing
  • Manual versus automated cleaning (including cleaning verification testing)
  • HLD and rinsing versus sterilization
  • Aeration, drying, storage and handling (transportation)
  • Maintenance and repair 

Jean Sargent, CMRP, FAHRMM, FCS, President and Principal, Sargent Healthcare Strategies, and long-time HPN Editorial Advisory Board Member is a veteran in sterile processing circles with extensive experience in SPD and Supply Chain in hospitals, hospital systems, integrated delivery networks (IDNs) and consulting. She also serves as a frequent speaker at conferences and trade shows, including IAHCSMM and AHRMM. 

Sargent encapsulates the sterile processing’s Sturm und Drang in six ways of her own. 

Tools. “The fact that many have developed niche tools to support the cleaning process is amazing. What is disheartening is that all facilities that use scopes do not provide these tools, including the basics, to ensure patient safety.” 

Training. “The training of staff to learn over 100 steps to provide a scope that is safe for use on the next patient is daunting. Maintaining that diligence is also daunting, but necessary. With the outbreaks of infections passed from one patient to another, there has been a further understanding of this necessity.” 

Technique. “Competencies in this process are imperative to demonstrate the techs processing the scopes are indeed performing to the highest standard and are recognized for this type of attention to detail.” 

Time. “Allowing proper staffing to complete each and every step, without interruption, must be considered to ensure the patient will be safe and free from transmission of bioburden from the previous patient.” 

Teamwork. “There is now a team that includes SPD, GI, IP, SC, physicians and administration to ensure this process is afforded the tools, training, and time to ensure the process is effective, and there are enough scopes to allow for comprehensive processing.” 

Compassion. “As a patient I ask about tools, training, technique and time to ensure I am not putting myself at risk. It is not easy to question your physician, but it is necessary to protect your health. Do you ask?” 

Bryan Lord, CEO, Pristine Surgical, recognizes the burdens and pressures driving SPD professionals, which is why his company manufactures disposable/single-use scopes. 

“Our customer research shows that today’s SPD department is pulled in multiple directions, and that staying current on training is a constant challenge,” Lord said. “That’s because newer, more complex and larger devices often require more complex cleaning and sterilization protocols, increasing the strain on SPD departments that now need to clean, sterilize and house the new devices. Single-use devices reduce the workload burden on the SPD department and minimize the potential of exposure of patients and staff alike. 

“Most importantly, we believe single-use devices improve safety in two important areas,” Lord continued. “1. [They] eliminate the need to clean and sterilize endoscopes, which also eliminates the risk of cross-contamination or bioburden. 2. Regarding the COVID-19 pandemic, single-use devices expose fewer healthcare providers to equipment that may have been contaminated with the novel coronavirus or other infectious microbes.” 

HPN asked sterile processing executives to expound on each or as many of the six as he or she felt comfortable, based on their organization’s specialty. 

Nancy Fellows, MSN, MPA, RN, CNOR, Senior Clinical Education Consultant, Advanced Sterilization Products (ASP) 

Challenges with endoscope reprocessing are not new, pandemic or not, and were recently addressed by Cori Ofstead, MSPH, in the article, “Challenges in Achieving Effective High-Level Disinfection in Endoscope Reprocessing,” published in the American Journal of Infection Control 2019.1 According to Ofstead’s article, concerning evidence exists that endoscope reprocessing may frequently be error-prone, ineffective and potentially represent danger of contamination exposure to patients.  

When one looks to key areas of continued improvement in the area of endoscope reprocessing, human factors need to be considered. Ofstead’s article identified several factors that contributed to reprocessing failures including the human factor; non-adherence with guidelines, standards, policy and procedures, and manufacturer’s written instructions for use (IFU). 1

  1. Human factors contributing to non-adherence with guidelines, standards, and manufacturer instructions for use (IFU)
  2. Clinical use of endoscopes with visible damage
  3. Use of products that may interfere with reprocessing (simethicone, lubricants, and tissue glue)
  4. Presence of residual soil after manual cleaning
  5. Rinse-water quality issues
  6. Retained moisture in fully reprocessed endoscopes 
  • Manual versus automated cleaning (including cleaning verification testing) 

Per SGNA, endoscope reprocessing includes the following:

  1. Pre-cleaning
  2. Leak testing
  3. Manual cleaning
  4. Rinse after cleaning
  5. Visual inspection
  6. High-level disinfection (manual or automated)
  7. Rinse after high-level disinfection
  8. Drying (alcohol and forced air)
  9. Storage2

One point of failure we want to address and that may contribute to ineffective endoscope reprocessing is the presence of residual soil after manual clean. Pre-cleaning removes organic material (e.g., blood, body fluids, body soil) and decreases the bioburden, making it much more likely that subsequent reprocessing steps will be successful. Pre-cleaning should be performed at point of use, before bioburden has an opportunity to dry and before complete decontamination. Per many manufacturers’ Instructions For Use (IFU), it is recommended that endoscopes remain moist and ideally reprocessed within an hour post-procedure. If more than an hour lapses, additional instructions and recommendations for processing are typically discussed. 

Another important step in the process is cleaning verification. AAMI ST 91 12.4.2 states that the cleaning verification of flexible and semi-rigid endoscopes should include: Visual inspection combined with other verification methods that allows the assessment of both external surfaces and internal housing and channels.3

  • HLD and rinsing versus sterilization

The automation of high-level disinfection can eliminate the multiple points of failure associated with improper high-level disinfection practices such as the use of expired products, improper HLD temperature, inadequate testing for the minimum effective concentration of HLDs and improper storage of MEC test strips.

While high-level disinfection is an acceptable reprocessing modality of semi-critical endoscopes, published articles and discussion have surfaced raising the topic for the consideration of a paradigm shift from high-level disinfection to sterilization.

  • Aeration, drying, storage and handling (transportation)

There has been a growing number of articles and discussions around the importance of drying, transport and storage of endoscopes, and the failure to do so properly can be a leading cause for microorganism proliferation and biofilm formation. As stated in a study by J Kovalena – Endoscope drying and its pitfalls, “inadequate drying and storage procedures, together with inadequate cleaning and disinfection, are the most important sources of endoscope contamination and post-endoscopic infection.” 4

Further, current professional guidelines and standards around transportation indicate that each endoscope should be isolated and transported  with its components in its own closed system to  the next stage of processing, as it is considered  contaminated.

  • The system should be marked with a biohazard label and must meet OSHA requirements for transporting hazardous items.5
  • “The system should be large enough to accommodate a single endoscope without the need to over-coil the  insertion or light guide tubes.”6
  • “Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that  prevents exposing staff, patients or the environment  to potentially infectious organisms.”7
  • Storage is another important factor to consider and as HICPAC states in their document “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC.”8
  • After reprocessing is complete, store endoscopes and accessories in a manner that prevents recontamination, protects the equipment from damage, and promotes drying.
    • Store processed flexible endoscopes in a cabinet that is either:
    • o   of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without touching the bottom of the cabinet
    • o   or designed and intended by the manufacturer for horizontal storage of flexible endoscopes.

References:

  1. C.L. Ofstead et al. / American Journal of Infection Control (2019), Accessed 12/12/2019 www.ajicjournal.org/article/S0196-6553(19)30849-1/fulltext. This study was funded in full or in part by an educational grant from ADVANCED STERILIZATION PRODUCTS (ASP).
  2. Alfa, 2013; AAMI, 2015; Petersen et al., 2011; Gastroenterological Society of Australia [GESA] & Gastroenterological Nurses College of Australia [GENCA], 2010
  3. ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities, p 39
  4. Kovalena, 2017; Journal of Hospital Infection, Vol 97, Issue 4  – Endoscope drying and its pitfalls, p. 1, Summary
  5. OSHA 29 CFR 1910.1030 -Bloodborne Pathogens
  6. ANSI/AAMI ST91: [2015] Flexible and semi-rigid endoscope processing in Health Care Facilities. 12.4.2; 12.4.3; 12.4.4; p. 39-40
  7. SGNA:2018 Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes; pp. 16-17
  8. HICPAC: 2018 Essential Elements of a Reprocessing Program for Flexible Endoscopes; pp.2-3
Christian Escobar, Director of Marketing – Visualization, Ambu
  • Pre-cleaning and treating

Bedside pre-cleaning and manual cleaning continue to be the most important aspects of reprocessing as they physically remove soil and other bioburden from the device. Bedside pre-cleaning and manual cleaning are aspects of post-use that need a lot of attention on protocol building and verifications as the efficacy of disinfection/sterilization depends upon these processes being performed correctly and consistently, according to the manufacturer’s instructions for use. According to recent data from the FDA 522 studies, these processes are not adhered to consistently, which creates a significant patient safety risk. Consistency in reprocessing reusable endoscopes and oversight is crucial to rendering the devices safe and appropriate for clinical use.  

  • Visual inspections and leak testing

Again, depending on the systems and processes, visual inspections and leak testing can be highly variable. They are also dependent on human factors aspects such as adequate training and personnel competency, consistent performance, properly functioning reprocessing equipment, and protocols and processes that inhibit inadvertent corner-cutting for expediency. Hospitals should evaluate ways to reduce variability in reprocessing practices – or eliminate reprocessing altogether by switching to sterile, single-use devices.    

  • Manual versus automated cleaning (including cleaning verification testing)

What is most critical is that cleaning is correctly and consistently performed effectively on these devices. Verifying that devices have been cleaned effectively, not just “properly,” should be an area for improvement. Investing in reprocessing automation, verification checks, and other areas of validation should be considered.

  • ·          HLD and rinsing versus sterilization

Having sterile devices confirmed and ready for patients is increasingly desired both by patients and healthcare providers. Due to the complexity of reusable flexible scopes, moving to sterile devices should be a primary patient safety goal to reduce risks. One prime opportunity is to simply move to single-use, sterile endoscopes where possible and available.    

  • Aeration, drying, storage and handling (transportation)

Managing high endoscopic procedure volume in various departments makes managing scope inventory following reprocessing a challenge. This challenge can potentially be alleviated by shifting to single-use endoscopes where possible. That would reduce the burden for many of the logistics of handling endoscopes from point-of-care, through reprocessing, into storage, and transportation.             

  • Maintenance and repair

The service and maintenance of reusable endoscopes is a long-standing area in need of improvement. Often the primary solution is more significant and expensive service agreements. However, given endoscope design and inherent wear and tear during use from other devices and accessories, such as stents, reprocessing, transport, etc., there is an excellent opportunity to reduce or eliminate service/repair/logistics demands with single-use, sterile endoscopes. In addition, when devices are sent out to the device manufacturer, facilities are often provided with loaner endoscopes that can have an unknown service, maintenance, and cleaning history. That can create patient safety risk. 

Betty McGinty, RN, CGRN, CER, Fellow, Clinical Education Services, Boston Scientific Corp.
  • Pre-cleaning and treating 

Focus upon timeliness of initiation and follow through. The process should begin within the procedure room as soon as the endoscope is removed from the patient in an attempt to remove bioburden and to decrease the opportunity for biofilm formation.  Notation of times that the procedure ended and pre-cleaning was performed can allow the reprocessing staff to coordinate the manual cleaning that follows and may prevent the need to follow delayed reprocessing pre-soaking steps. 

  • Visual inspections and leak testing 

Employment of tools to aid visual inspection. Visualization of the endoscope for cleanliness as well as for damage is recommended to be performed at all stages of handling and reprocessing. Inspection via the naked eye has limitations. Tools that enhance visualization such as adequate lighting, magnification, and borescopic channel inspection offer opportunity to improve decontamination efforts and to detect endoscope defects that could interfere with cleaning. 

Thorough attention to detection of leaks. Leak testing of endoscopes precedes manual cleaning. A leak can allow fluid invasion that may be the cause of internal endoscope damage as well as a source of contamination with a risk for patient infection. Testing involves time dedicated to manipulation of endoscope controls, buttons and elevator mechanism with additional time to observe for a continuous stream of bubbles that signal a leak. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Ensuring an endoscope is clean prior to manual/automated high-level disinfection or sterilization. Manual cleaning of a soiled endoscope is a critical step that requires focused and deliberate attention. Its success (or failure) contributes to the outcome of the remaining reprocessing steps. Visual inspection of the cleaned endoscope is not a guarantee that the performed decontamination is complete, particularly within the internal channels. Use of a rapid audit tool for residual organic soil following manual cleaning serves to ascertain the need for additional manual cleaning prior to high-level disinfection or sterilization. Automated cleaning following manual cleaning can offer an additional level of safety. 

  • HLD and rinsing versus sterilization 

Allowance of enough rinsing of disinfectant/sterilant from internal and external endoscope components. Rinsing serves to prevent exposure and potential skin and mucous membrane injury due to chemical residue. Specific rinsing instructions (volume, number of rinses, type of water) are provided by the specific chemical manufacturer. Automated Endoscope Reprocessors (AERs) that provide rinse cycles require settings that support the prescribed rinsing as well as correctly attached connectors that enable all channels to be flushed and rinsed. 

  • Aeration, drying, storage and handling (transportation) 

Ensuring a dry endoscope, internally and externally, for each patient. Moisture supports survival and multiplication of microorganisms as well as the promotion of biofilm development. Endoscope external drying post reprocessing is accomplished with a clean, lint-free cloth, and the long, narrow internal channels require drying with forced instrument air. Literature suggests an infusion of air for a minimum of 10 minutes to dry the internal channels. Various mechanical devices for air infusion that include storage cabinets with air control filters and/or continuous endoscope channel air flow hook ups can be employed to help achieve a dry endoscope. Prevention of re-contamination of a reprocessed endoscope is the rationale behind handling the scope with clean gloves, protecting it with a covering during transport, and storing it in a cabinet that is clean, well-ventilated, and dust-free. 

  • Maintenance and repair 

Ensuring endoscope/accessory fleet is functional and free of defects. Visual inspection of endoscopes and accessories ideally occurs during all phases of handling. Damaged endoscopes and accessories not only fail to perform the procedure but also offer reprocessing hindrances and can contribute to microbial survival. Damaged devices upon discovery signal a need for repair or disposal. Manufacturers’ preventive maintenance schedules for equipment (i.e., endoscopes, flushing pumps and automated endoscope reprocessors) are designed to support intended functions. A challenge offered by the COVID-19 pandemic involved decreased/lack of use of endoscopic equipment due to canceled elective procedures. Resumption of procedures signaled a need for preparatory re-start practices (disinfection cycles, filter changes). Another challenge realized was the potential delay of handling repairs and routine equipment maintenance schedules due to staffing limitations of the manufacturer. 

References

  • Society of Gastroenterology Nurses and Associates. Standards of Infection Prevention in the Gastroenterology Setting. 2019.
  • Society of Gastroenterology Nurses and Associates.  Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.  2018. 
Marcia Frieze, CEO, Case Medical
  • Pre-cleaning and treating 

All facilities face the challenge of ensuring consistent and effective decontamination of devices from one degree to another. However, flexible endoscopes provide additional challenges. From misalignment over “whose job it is,” to unclear procedures with numerous steps, to evolving evidence and best practices, pre-cleaning and treatment remains a critical procedure prone to missteps and breakdowns. If your facility has not done so, convene a multidisciplinary team to review best practices and instructions for use to establish policies and procedures and to define endoscope reprocessing roles and responsibilities, including pre-cleaning immediately following the procedure while the endoscope is still attached to the video processor and light source. 

There are many solutions and methods on the market that include enzymatic detergents for treatment.  Some require diluting a concentrated solution. Others provide a sponge for wiping the surface of endoscopes, which can be messy and can spread soil across the device surface. A ready-to-use kit, like the Case Solutions Endoscope Bedside Kit, stocked in each procedure room will ensure that the proper supplies are close at hand when needed. The Case Solutions endoscopy kit includes a package of three lint free wipes treated with Safer Choice awarded PentaZyme detergent and a 250ml ready-to-use bottle of PentaZyme detergent. With a single pass, wipe from the clean end (posterior) to the soiled end (distal tip) to remove the gross soil on the surface of the endoscope. Repeat with each of the two remaining wipes. Follow by flushing the interior channel(s) using the bottle of PentaZyme. 

Per AORN, “The collective evidence supports pre-cleaning of flexible endoscopes at the point of use as a mechanism for moistening, diluting, softening and removing organic soils (e.g., blood, feces, respiratory secretions) and reducing the formation of biofilm. If organic soil and biofilm are not removed completely, the subsequent HLD or sterilization process might not be effective.” 

  • Visual inspections and leak testing 

Damage to the interior of an endoscope provides crevices where microorganisms can hide and collaborate to develop a biofilm sanctuary. Once biofilm is established, it’s nearly impossible to remove. Visual inspection with a borescope and leak testing provide opportunities to identify endoscope damage before biofilm can take hold. Not only does early intervention allow for an endoscope to be sent for repair and maintenance, but it prevents another risk associated with biofilm—the swapping of genetic material allowing antibiotic resistance to be shared between different types of microorganisms. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Most endoscopes require numerous reprocessing steps, starting with point of use treatment, continuing to manual and automated cleaning. In some cases, over a hundred individual steps must be followed before an endoscope is considered fully decontaminated and safe for use on the next patient. A tracking program that identifies those steps; provides instructions for cleaning and post processing; and tracks the repair, maintenance and monitoring history of each individual scope is very beneficial as a training tool and for record keeping. Case Medical offers a software program specifically designed for endoscope care. The CaseTrak360 Endo module can be purchased as a stand-alone program or as part of the comprehensive CaseTrak360 software system. 

  • HLD and rinsing versus sterilization 

Both HLD and sterilization are dependent on effective cleaning, so cleaning is always paramount. When you consider the complexity of flexible endoscopes, the dozens of steps in the reprocessing cycle, the potential for human error, and the blurring of lines between semi-critical and critical uses of modern endoscopes, the risk of depending exclusively on high-level disinfection is just too high. Some manufacturers have introduced single-use scopes or replaceable components, such as elevator channels, that are a particularly challenging to clean and disinfect. 

With its greater margin of safety, sterilization should be considered as part of a thorough risk analysis that also considers proper cleaning tools, quality checks, likelihood of interventional use and even storage and processing requirements. Sterilized endoscopes in sealed containers can be stored without the limited hang time and reprocessing required when HLD is performed. 

However, not all sterilization containers are compatible with low-temperature sterilization nor have validated clearance for the lumen size and length of a specific flexible endoscope. As a result, it is important to review the IFU for the container system you are considering and check for compatibility.  Since the introduction of the SteriTite universal container system in 1997, Case Medical has validated its container system to be compatible with sterilizer manufacturers’ claims. 

  • Aeration, drying, storage and handling (transportation) 

Guidance documents include standards for aeration, storage and transport of endoscopes. A sealed sterilization container, properly labeled, has an advantage over wrapped sets, and certainly when compared to HLD scopes, as the same container provides reusable packaging for processing, handling, storage and sealed transport. A tamper-evident seal can be applied to differentiate containers with soiled endoscopes from those with processed endoscopes. One further advantage is the shelf life of an endoscope in a sealed sterilization container system compared to a disinfected endoscope. Case Medical’s SteriTite container has a validated one-year shelf life versus perhaps a seven-day shelf life or hang time when scopes are disinfected. 

  • Maintenance and repair 

The need for maintenance and repair of flexible endoscopes if often reactive, following the discovery of damage that may have existed for weeks, months or even years. Flexible endoscopes have a defined useful life, provided by the manufacturer; however, factors such as frequency of use, the effects of chemical agents on the device surface, and water quality for rinsing can contribute to wear and accelerate the need for repair and replacement. Disinfected but unused endoscopes must be reprocessed after a defined hang time, adding processing cycles (and wear and tear) even when not used on patients. The porous surface of flexible endoscopes is subject to damage and, when compromised over time, can contribute to aborted cycles in some low temperature sterilization cycles. 

Minerva Loran, President, Clinical Choice LLC 

  • Pre-cleaning and treating 

Determine fluid volume for flushing of the endoscope required by the IFU. OEM IFU volume requirements vary by model. For example, the Olympus TJF-Q180V IFU requires 1,000 ml of fluid. Larger fluid volumes help prepare the endoscope for manual cleaning. Standardizing to a volume sufficient to meet all OEM requirements is an opportunity to improve cleaning. 

Pre-clean as soon as possible post-procedure. Endoscope withdrawal time to pre-cleaning is an area that should be monitored. When multiple scopes are used in a procedure, it can be difficult to meet maximum 60-minute timeframes between endoscope withdrawal and manual cleaning. Endoscopes that exceed maximum may require soaking, which prohibits the scope from being turned around for the next patient.  

  • Visual inspections and leak testing           

Leak testing is paramount to maintaining the integrity of your endoscopes and reducing maintenance costs. Dry leak testing technology has improved to the point where it can replace wet leak testing on some manufacturer’s scopes but not all scopes. Ensure your staff is educated on both dry and wet leak testing. 

Visual Inspections of the exterior surfaces should be performed every reprocessing cycle.  Pulling endoscopes with minor scratches or chips increase patient safety and decreases overall maintenance costs. Catching endoscopes requiring minor repair verses major repairs decreases endoscope downtime.      

  • Manual versus automated cleaning (including cleaning verification testing) 

Some AERs have automated cleaning claims to replace manual cleaning. Check out their cleaning claims before eliminating manual cleaning. AER cleaning claims of residual protein may be much higher than your current post manual clean requirements. For example, your manual clean requirements may be one microgram of residual protein or less. The AER claims may be 6.4 micrograms of residual protein.    

  • Aeration, drying, storage and handling (transportation)           

Aeration/Drying, storage and handling all play important roles in effective infection control. Properly drying the endoscope, prior to or during storage, helps prevent microbial growth.  Proper storage should include sufficient HEPA-filtered airflow to keep contaminated air out when the cabinet is closed or open, removable drip trays that can be removed without touching the endoscope tips, cradle systems to keep all endoscopes including Enteroscopes and Double Balloon endoscopes from coiling or touching the floor and support of the endoscope to prevent damage to the insertion and light guide tube and applicable internal channels.   

Kevin Anderson, Clinical Education Coordinator, Healthmark Industries Co. 

  • Pre-cleaning and treating 

As long as we are using reusable endoscopes, the pre-cleaning and treatment steps will be critically important to the safe processing of endoscopes. As we know, it only takes minutes to develop biofilms that can cause challenges to the cleaning process. Another layer to this is communication or documentation. Processing staff need to know when bedside cleaning of endoscopes took place due to the time constraints mentioned in the endoscope manufacturer’s IFUs. In order to implement a delayed processing procedure, staff at the point-of-use need to communicate and document their bedside cleaning procedure. 

  • Visual inspections and leak testing 

Visual inspection and leak testing are critically important for endoscope processing. Leak testing needs to be done correctly every time. Therefore, competency of the staff to perform this task is imperative. Another component to be conscientious about is whether your leak tester is functioning properly. The leak testers need to provide a specific amount of psi to detect leaks, so this should be checked regularly. Visual inspection is another competency that needs to be taught and encouraged. This is a step that can get skipped when turnover times are the priority. Secondly, everyone’s vision is not the same. We need to implement enhanced visual inspection tools like lighted magnification and borescope examinations in order to catch all the potential defects with the endoscope. 

  • Manual versus automated cleaning (including cleaning verification testing) 

With the complexity of flexible endoscope devices, it is important that we have effective manual and automated cleaning procedures in place. We know that there are now AERs on the market that claim to alleviate the need for a manual cleaning process. However, this manual cleaning process is where inspections are done, gross soils are removed, and the processing tech can identify potential problems. Secondly, following manual cleaning, cleaning verification tests may be performed to give another level of assurance that our manual process is working. 

  • HLD and rinsing versus sterilization 

HLD should be enough to safely process flexible endoscopes according to our current Spaulding classification. However, between the increasing complexity of the endoscopes themselves and the complexity of the interventional procedures being done with flexible endoscopes, consideration should be given to moving from HLD cleaning to sterilization modalities whenever possible. While moving to sterilization would be preferable, we need to be sure to get our cleaning process down because sterilization will not be effective on dirty endoscopes. 

  • Aeration, drying, storage, and handling 

Moving as much as possible to automated ways of drying flexible endoscopes external and internal surfaces is an important step that needs to be a point of focus going forward. We know that the AERs do not get our endoscopes dry. The best things that we have available are either forced air dryers that dry inside the scope, or a drying cabinet that dries both external and internal surfaces. No matter what methods we use to dry our endoscopes, we need to have a quality check in place to ensure that the endoscope that is ready for use, or in storage, is in fact dry as a bone. 

  • Maintenance and repair 

Flexible endoscopes are expensive hospital assets that also present a mode for transmitting infections to the patients, or even causing trauma to the patients. Maintenance and repair are critical components for any endoscope program to mitigate these risks. Partnering with OEMs or repair vendors is a great way to educate and identify ways to isolate potential hazardous endoscopes before they go back into rotation for use on a patient. You would not drive your car for 100,000 miles and never do preventive maintenance on it. You should not presume that endoscopes can take the kind of beating that we put them through and think that they will perform without proper maintenance and repairs. 

Jahan Azizi, Special Projects Manager, Healthmark Industries Co.
  • Visual inspections and leak testing 

You cannot clean what you cannot see with naked eyes. The most basic verification of the performance of a cleaning process is by carefully inspecting the cleanliness of instruments and materials with your eyes. Many standards and guidance’s recommend for enhanced visual inspection.  

[You] need to assure that all leak testers are in good working condition and have sufficient output pressure (> 2 PSI). This can be achieved by performance and preventive maintenance at regular intervals. 

  • Maintenance and repair 

Reasoning: There is a need to perform enhanced visual inspection (both external and inside lumens using a borescope) on regular intervals (i.e., monthly) as a quality approach. This will help to identify problems that missed during busy schedule [and] during the cleaning/disinfection process.  

Natalie Reece, Endoscopy Clinical Educator, Key Surgical
  • Pre-cleaning and treating 

Point-of-use cleaning is important for all surgical instruments, but due to the increased risk for biofilm growth inside of flexible endoscopes, the emphasis on pre-cleaning of endoscopes immediately following use cannot be overstated. Dangerous biofilms can start to grow in a matter of hours, and sometimes quicker, but if cleaning is done quickly the risk of biofilm formation is minimal. (See Charles G. Roberts, “The role of biofilms in reprocessing medical devices’ published in AJIC in 2013.) A lot of attention has been paid to the areas that come in direct contact with patient fluids, such as the suction channel and biopsy port valve, but the air and water channels could pose an equal threat for contamination. 

Unfortunately, many facilities are overlooking the importance of using an air/water cleaning adapter during point-of-use cleaning. As we have seen, the air/water valve is not a sufficient “back-flow-prevention valve,” and contamination from blood, stool or other patient fluids can travel through endoscope tubing and channels. (See FDA guidance, “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes,” Nov 29, 2016.) You should always use an air/water channel cleaning adapter during point-of-use cleaning to ensure that you are adequately flushing both the water and air channels of potential contamination. Ignoring the air and water channels of your endoscope could leave you vulnerable to biofilm growth and potential patient transmission or infection. 

  • Visual inspections and leak testing 

Visually inspecting for damage, loss of function, and gross soil (paying close attention to the distal tip) is important at every step of the endoscope reprocessing cycle. Though the human eye cannot detect microbial contamination, inspecting for gross soil and damage that may harbor microbes could prevent biofilm formation. In addition to the human eye, “tools such as video borescopes of an appropriate dimension (length and diameter) may be used to visually inspect the internal channels of some medical devices,” states ANSI/AAMI ST91:2015 12.4.2. 

In addition to the endoscopes themselves, don’t forget to inspect the water bottle and tubing, biopsy forceps, cytology brushes, cleaning brushes or any other devices used during the procedure. If damage has occurred, the scope must be immediately removed from use and should be sent for repairs. Alert your manager and contact your repair team right away to ensure that no additional damage is incurred during reprocessing. Failure to communicate when damage is found can present an enormous risk to patient safety. According to the 2013 Kovaleva et Al. study, “Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy,” the use of damaged endoscopes is one of the most common factors associated with microbial transmission. In a study published in 2017 by Ofstead & Associates, they tested 20 different scopes at three different facilities and found that all of the scopes had visible irregularities such as discoloration, scratches gouges, non-intact channel lining, debris and damaged distal ends. With this information, we can assume that visual inspection is lacking in many facilities and therefore is an opportunity for improvement. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Manual cleaning is hands-down the most important step in endoscope reprocessing. If this process is not performed correctly, no other efforts will matter. As we often say in the sterile processing world, “if it cannot be cleaned, it cannot be sterile.” A good rule of thumb during manual cleaning is to clean the least dirty part of the endoscope first, moving toward the distal tip/most dirty part, cleaning that last. This way, you are not contaminating an otherwise clean part of the instrument. An easy way to remember this is the phrase, “tail to tip.” If your scope has open channels, the IFU may require you brush it during manual cleaning. Cleaning brushes should be single-use, and of the correct size for the endoscope channel or port. (See the 2008 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities.) 

If your scope has an elevator, move any elevator cables up and down several times and water pick this area with the help of a syringe and/or brush it with a specially designed elevator brush. Do not attempt to brush the scope backwards by starting at the distal tip as this may cause the brush to get stuck. So start at the port nearest to the control head. It is important brushing occurs under the water at all times to avoid creating aerosols or spraying contaminated water. Always inspect your brush and manipulate the bristles under water once it extends out of a channel to ensure that all bioburden, saliva, lubrication, etc. is removed before reintroducing brush into the channel. You will want to pass the brush through as many times as needed until it comes out visibly clean. Keep in mind, however, you won’t always be able to see bioburden or residual residue. If the instruments are not properly manually cleaned, the disinfection/sterilization and drying procedures can fail, which increases the possibility of transmission of infection from one patient to another. Even if your AER has a mechanical cleaning step, you should always perform manual cleaning before putting your scope into the AER. 

  • HLD and rinsing versus sterilization 

You should always check your scope manufacturer’s IFU to know whether your scope needs to be high-level disinfected or sterilized. According to the Spaulding Classification System, many flexible endoscopes fall into the “semi-critical” category and only require high-level disinfection. In 2016, however, AORN adopted a modification of the Spaulding Classification System that separates flexible endoscopes into two groups: The original designation of semi-critical and a critical designation for flexible endoscopes that enter directly or secondarily (i.e., via a mucous membrane) into sterile tissue and the vascular system. Bronchoscopes, cystoscopes and duodenoscopes fall into this modified designation as they increase the risk of infection if they are contaminated with microorganisms when used. Therefore, they should be considered critical devices, meaning they should be sterilized. 

Additionally, most rigid endoscopes are classified as critical items and must be sterilized. An important part that is often missed, however, is that the requirements are set for the bare-minimum. According to ANSI/AAMI ST91:2015, At a minimum, it is recommended that devices are subjected to high-level disinfection after each use. When possible and practical, flexible and semi-rigid endoscopes should be sterilized due to the greater margin of safety built into sterilization.” 

Another important area of concern is the residual diluted HLD chemistries that can be left behind if rinsing is inadequate. For example, AAMI states, “Water bottles may not drain completely, resulting in diluted HLD solution.” OPA causes discoloration of the skin and mucous membranes, irritation, anaphylaxis and other allergic reactions. Gluteraldehyde is known to cause hereditary virulence and is carcinogenic. PAA can cause chemical burns. One study investigated the use of GA in endoscopy and found that it can cause colitis (inflammation of the bowel) with necrosis and ulcerations. Patients afflicted with this experience severe abdominal cramps, rectal bleeding, a high temperature and chills. Studies have shown that these chemicals can be absorbed into the medical devices themselves, especially if they’re PVC or silicone or polyurethane and can be released later. Their uptake is thought to be cumulative, meaning the more repetitions of the disinfection process the water bottle has seen, the more toxicity is later released during procedures. (See Ryu, et. Al. “Cytotoxicity Assessment of Residual High-Level Disinfectants,” May 8, 2013.) 

Melissa Kubach, Clinical Education and Training Manager, Mobile Instrument Service & Repair 

  • Pre-cleaning and treating 

Despite improvements in pre-cleaning proficiency within the GI setting, compliance within the operating room remains a challenge. Small diameter flexible endoscopes of all types often receive little to no pre-cleaning in the OR. Unlike GI where training can be focused on dedicated reprocessing staff members, the number of applicable staff for the OR is much higher. Furthermore, the complexity of the required steps varies greatly between different manufacturers and models increasing the likelihood of insufficient cleaning. The operating room environment is inherently challenging from a pre-cleaning perspective. Case tear down often requires point-of-use cleaning for additional items such as instrumentation and video cameras. OR turnover minutes are closely monitored; not to mention the greater need for post patient care.   

  • Visual inspections and leak testing 

Visual inspection under magnification is required after manual cleaning and prior to high-level disinfection or sterilization. This step is often rushed or overlooked, which increases the risk of debris remaining in recesses of damaged epoxy or components. If documentation for each overall inspection were required, the increased attention would improve compliance and reduce the risk of cross-patient contamination as well as incidents such as an aged or chemically damaged glue ring detaching during patient use. 

Although not required, internal inspection facilitated by a borescope is currently a recommended practice. Despite this, many facilities have yet to acquire a borescope. Owning a borescope is the first challenge given financial limits imposed following COVID-19. The next challenge is knowing how to use the borescope and interpret what you see. Even with initial install training, it is subjective as to when a scratched channel warrants pulling for repair, and small channel restrictions are often overlooked if there is no perceived difficulty passing instruments or cleaning brushes.   

The importance of leak testing every endoscope with each use is generally understood. It is the small mistakes within the process that lead to large consequences related to repair and equipment malfunction. The most common mistake we see is depressurizing a scope while submerged. This allows fluid to slip past the O ring within the leak tester connector and enter the electrical connector. Similarly, allow ample time to displace the pressurized air to ambient levels for endoscope models with self-venting valves. Failure to follow venting requirements, may allow fluid to enter the electrical connector after leak test. Both scenarios result in fluid invasion, even though the endoscope has no existing defect to the airtight integrity. Often the effects of these seemingly minor mistakes are not realized until the equipment fails during procedural use, affecting case completion, extending anesthesia as well as increasing the risk of injury to the patient.  

  • Manual versus automated cleaning (including cleaning verification testing) 

Meticulous manual cleaning is supported by industry standards and guidelines. Manual cleaning steps are complex, especially for duodenoscope and EUS models. As a result, steps are skipped or partially completed. Competencies need to be detailed. True return demonstration specifically geared towards each required step, especially the location and brush position for elevator cleaning, would shine a light on weak areas and needed individual employee training support. Too often, even model-specific competencies merely state that the act of brushing was completed – not that each individual action was demonstrated.  

Automated pump units for flushing and rinsing endoscopes provide much needed standardization. Flushing units allow for the delivery of larger fluid volumes than those achieved with syringes and injurious repetitive motion. 

The elimination of specific manual cleaning steps, due to enhanced cleaning claims by the AER manufacturer, is commonly not clearly understood. Often the utilization of these claims is not reflected in the written procedure, facility policy or the overall health system policy. Most policies simply state that all steps of the manufacturer’s IFU will be completed. The automation of these steps, while validated, are commonly not supported by organizational and regulatory recommendations. Justification and policy alignment will remove this gap.   

Verification tests are helpful at identifying reprocessing gaps, but they do not assure a scope is clean. The test is only as good as the area sampled and does not provide insight as to what kind of microorganisms are residually present, just that the number of detected organisms is within the passing or failing range designated by the test manufacturer. Improvement can be realized by implementing a plan to move away from high-level disinfection. Sterilization allows for greater log reduction and the destruction of spores which is clearly more desirable than high-level disinfection.  At this point, high-level disinfection remains the norm mostly due to convenience. Sterilization units and their associated chemicals require controls that are housed in Sterile Processing, adding transportation time and cleaning competition with surgical cases.  Fast-paced Gastrointestinal and Urological settings thrive on expedient turnover times.  Current approved sterilization methods may present additional challenges or limitations, such as load capacity associated with multi-lumened endoscopes as well as the comprehensive validation of all current models in use. While these challenges are slowing down the process, this direction will continue to gain preference.    

  • Aeration, drying, storage and handling (transportation) 

There are transport delays moving scopes out of the OR to decontamination. It is not uncommon for an airway endoscope to be used prior to intubation, then sit for the remainder of the surgery. This often happens with gastroscopes utilized in bariatric surgeries as well. Addressing expedient removal of endoscopes is a common challenge.  

Endoscopes should be secured within their sterilization trays after use. Failure to place the endoscope properly increases the risk of damage while affixing the lid prior to transport. This is one of the most common causations of damaged endoscopes. The stacking of trays or placing other objects on top of the endoscope should also be avoided.  

Proper drying has been the most overlooked step since the dawn of flexible endoscopy. Many reprocessing departments do not have access to viable air options in the clean area or existing storage cabinets. 

  • Maintenance and repair 

Few facilities have formal flexible endoscope preventative maintenance programs. Consulting AAMI EQ56:2013 and AAMI EQ89:2015 can offer great insight as to the requirements for establishing a true preventive program and optimal utilization of different maintenance strategies. Annual formal inspection is still necessary even when daily per-use inspections are performed and documented. Partnering with your repair provider for assistance in this area can be beneficial for controlling repair cost, repair frequency, inventory shortages and increased risk to the patient for injury or cross-patient contamination related to existing damage. Trained inspectors can identify underlying issues that help avoid costly repairs or adverse outcomes associated with failure during use. 

Carolyn Klimas, Executive Director, Specialty Products Marketing, Olympus America Inc.
  • Pre-cleaning and treating 

Pre-cleaning scopes as soon as possible after the procedure – ideally, as soon as the endoscope is removed from the patient. The longer pre-cleaning is delayed, the greater the opportunity for soils and bioburden to dry on endoscope surfaces, which may make soils more difficult to remove and the endoscope more difficult to thoroughly clean 

Perform pre-cleaning exactly as indicated in the endoscope OEM’s IFU. Do not skip steps and ensure that any required accessories/adapters are used correctly. Use the correct accessories/adapters (per endoscope OEM’s IFU) to perform pre-cleaning. Cleaning accessories are designed specifically to loosen soils and bioburden from internal channels/surfaces of the endoscope. 

  • Visual inspections and leak testing 

Ensure reprocessing technicians follow the endoscope OEM’s IFUs on how to visually inspect the endoscope for damage and/or debris 

Staff training:

  • Any deviation from the Leak Testing process or missing any of the OEM-specified Leak Testing steps subjects the device to the potential of fluid invasion and costly repair.
  • Repairs can negatively affect your facility’s up-time, which is the use of the device to perform life-saving procedures.
  • Reduced up-time reduces your facility’s ability to create revenue from the use of the device that is out for repair.   
  • Manual versus automated cleaning (including cleaning verification testing) 

Manual cleaning:

  • Adherence to IFUs in manual cleaning is critical as manual cleaning steps in the IFUs have been tested and validated for reprocessing efficacy as part of the 510(k) process.
  • Ensure appropriate detergent concentration, contact time and temperature for maximum efficacy
  • Use the correct brush for each scope
  • Take the time to do it right
  • Ensure each channel is adequately brushed
  • There is no maximum time specified
  • Brush until no further debris observed
  • Manage and measure the process
  • Document each technician’s results
  • Identify outliers to provide consistency
  • Use a flushing pump according to manufacturer IFUs when you replace pumping with syringes. 

Automated cleaning:

  • Automated Endoscope Reprocessors (AER) may automate some cleaning steps, ensuring consistency and bolstering the cleaning process. 

Cleaning verification:

  • Conducting periodic, internal review of competency and inservicing with the endoscope manufacturer can help ensure steps are completed properly.
  • Olympus does not require cleaning verification testing as we have validated the cleaning process described in our IFUs. However, we support customers who choose to perform this optional step.
  • Consider use of newer tools such as visual reprocessing guides to ensure the process is completed in full. 
  • HLD and rinsing versus sterilization 

HLD using compatible disinfection methods for your endoscope is the recommended method for decontamination for semi-critical medical devices, including most endoscopes. 

Sterilizing flexible endoscopes must be done using a method that is compatible with the device, otherwise sterilization may cause physical damage to the device or the process may not have proven microbiological effectiveness.

  •  Aeration, drying, storage and handling (transportation) 

Aeration:

  • For endoscopes compatible with ethylene oxide gas sterilization, always refer to the endoscope reprocessing manual for minimum aeration parameters. 

Drying:

  • Wiping down external surfaces before hanging
  • Following manufacturer’s IFU for drying time, volume, pressure through channels
  • Drying the endoscope lumens with filtered pressurized air for an extended period of time after high-level disinfection and before storage in a conventional endoscope storage cabinet
  • Placing the reprocessed endoscopes directly into a drying cabinet vs a standard storage cabinet where gravity is used to facilitate the drying process 

Storage and handling

  • Use covered, rigid protection for transportation
  • During transport, use color-coded liners with indicators to identify scope status
  • Use a HEPA filtered cabinet, at minimum, to help prevent environmental contamination
  • Consider use of drying cabinets during endoscope storage
  • Consider additional protection for the distal end of the endoscope during transport and storage.  Distal Tip Protectors should be made of materials that do not retain any moisture or harbor bacteria. 
  • Maintenance and repair 
  • Inspect the endoscope prior to a procedure according to manufacturers’ IFUs
  • Ensure the repair company you partner with follows the FDA’s quality systems regulations for repairs
  • Understand that products repaired by companies other than the original equipment manufacturer may mean that the reprocessing instructions in the Instructions for Use are no longer validated since the parts and process used by the third party to repair the product do not undergo testing by the original equipment manufacturer
  • If you choose to use third-party repair services, you are strongly advised to get validated reprocessing instructions from the third party.  You are also recommended to check with your AER company to confirm the third-party repair service has validated their repaired scope in the AER. 
Alison Sonstelie, CHL, CRCST, oneSOURCE consultant & Sterile Processing Coordinator at Sanford Health, Fargo, ND
  • Pre-cleaning and treating

 I believe pre-cleaning and treatment is a key area for process improvement. For areas outside of endoscopy, many of the caregivers using endoscopes have very little training or awareness of the importance of this step in reprocessing. Departments should work with end users to develop a robust education plan, checklists, visual cues, etc., to help implement best practices. A crucial part of process improvement is tracking compliance to the new process. Feedback forms and communication plans should be established before implementation. This can help identify parts of the process that need more education, like pre-treatment, handling and containment. If you're in a medical center that sends scopes to inpatient areas, tools like feedback forms can also help identify departments that need additional assistance. During the stressors of COVID-19, many employees struggle with remembering or having time to perform critical tasks. If you notice a decrease in compliance during this time, work with end users to identify gaps and develop solutions. 

  • Visual inspections and leak testing

Steps in processes that rely on judgment and visual inspection are vulnerable to mistakes. If you can automate these steps, like leak testing, you will get consistent and reliable results. Automated leak testing can identify leaks that are too small or difficult to see with the human eye. Spotting these early may avoid more costly damage, impacting the cost of repair. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Again, automating processes will deliver a more consistent product. Automated endoscope reprocessors perform uniformly during each cycle, and can monitor that parameters were met for each phase. Indicators can ensure that the minimum recommended concentration (MRC) of disinfectant was met. Manual cleaning needs consistent education, training, and competency checks.  With so many steps in the process, it is crucial that we continuously verify that staff are performing each step correctly.

  • HLD and rinsing versus sterilization 

The information about remaining microbial load after HLD is staggering. Sterilization is the best reprocessing method for patient safety, with the caveats that other reprocessing steps must be performed correctly and the sterilization method is feasible for the facility. When sterilization is not possible, it is of the utmost importance to ensure pre-treatment and cleaning are performed correctly.  

  • Maintenance and repair 

The cost of maintenance and repair is a barometer for how well you are performing all the tasks in a use and reprocessing cycle of an endoscope. If one area is neglected, there is a greater potential for damage to endoscopes. You should leverage your repair company to provide information about repair trends and provide education for departments that handle the endoscopes.   

Ron Banach, Director, Clinical Training, Ruhof Corp.
  • Pre-cleaning and treating  

These are the most critical time sensitive step in the cleaning process. It is most effective to pre-clean an endoscope at bedside before bioburden dries. All Best Practice recommendations from the various Professional Medical Society groups support this step. The Ruhof CleanStart pre-cleaning bedside kit offers a premixed Endozime SLR solution, which is an exclusive advanced chemistry formulation, with pre saturated contoured sponge to assist in timely and effective pre-cleaning at beside. The product removes gross contaminants and synthetic lipids and is available in a user friendly pouch.  

  • Visual inspections and leak testing 

All  Endoscopy manufacturers’ IFUs state that it’s mandatory to leak test after every Endoscopy procedure. This is vital to the safety of the patient and success of the procedure. Documentation of this step is also stressed by the Professional Medical Societies and Joint Commission Inspectors. 

The recently added recommendations to visually inspect the scope – both the external scope components and the internal lumen/channel – have added a tremendous benefit, confirming both the cleanliness and working integrity of the endoscpe. The extra time added to the cleaning process is outweighed by the safety and validation of a clean endoscope. Ruhof’s VIB, Visual Inspection Borescope, allows for instant visual detection of internal debris and damage and offers robust software allowing for still image capture, video clips, email sharing, archiving and reporting. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Adding the assistance and documentation of an automated cleaning /flushing pump to the cleaning process is vital. The staff responsible for the cleaning at the sink benefits greatly from the automation as it reduces the physical effort of manual cleaning. In addition, techs can document the leakage test, chemistry dosing, flushing and rinsing of the lumens/channel and air purge – all in minutes. Most importantly, this process offers standardization in the cleaning process, enables one to follow the IFU requirements and will document and identify the endoscope and staff user. 

Once all cleaning and visual inspection is complete a final step is to implement a reliable method of Microbial Contamination Verification. The critical importance of this step is to verify the effectiveness of the cleaning process. A monitoring system that detects Adenosine Triphosphate (ATP), the universal energy molecule found in all animal, plant, bacterial, yeast and mold cells is the best option. This measured numeric result will provide the assurance of a clean device prior to HLD or sterilization. Ruhof’s ATP Complete Contamination Monitoring System is a quick and reliable verification method for testing surgical instruments, flexible endoscopes and surfaces with results in as little as 15 seconds. 

  • HLD and rinsing versus sterilization 

The Spaulding Classification scheme is the instrument classification system used for medical instrumentation reprocessing decisions. The Classification System indicates three categories of ascending risk: Critical, semi-critical and non- critical. The endoscope falls into the category of semi-Critical, as these devices contact mucous membranes. Semi-critical items require only high-level disinfection (HLD) as the terminal reprocessing step. With recent reports of drug-resistant organisms, super bug outbreaks and new viruses it may be time to challenge this classification system in respect to the reprocessing of certain more challenging endoscopes, i.e., duodenoscopes, bronchoscopes and endoscopic ultrasound endoscopes.  

Aeration, drying, storage and handling (transportation) 

The key importance of proper handling (transporting) an endoscope is to assure patient and staff safety. Too often the staff is unduly relaxed about the importance of preventing a costly repair which can result from a careless preventable mistake. There are guideline recommendations and best practice examples of how to avoid damage to an endoscope. 

Recent laboratory studies have presented the importance of using aeration or a drying device to reduce the possibility of bacterial growth in lumens and channels. However, following this recommendation can add additional turnaround time and cost to endoscope reprocessing.  

  • Maintenance and repair 

Every endoscope user has the option to use either the OEM or third-party services for repairs. The responsibility to maintain the original manufacturer’s performance standards should be regulated by the FDA, The Joint Commission, CMS and other federal agencies to assure steps are in place to follow safety and quality repair practices. 

Bryan Lord, CEO, Pristine Surgical

Single-use devices obviate the need for all six of these steps. Importantly, they also dramatically change the economics of SPD departments, where maintenance and upkeep expenses are roughly three times the cost of the endoscope itself. Pristine’s single-use design eliminates this expensive, labor-intensive process and delivers a brand-new, crystal clear image every time. And the Pristine Surgical platform’s automated inventory management tools remove bottlenecks created by the unavailability or poor quality of reused endoscopes.

Outside of healthcare, and arguably independent of the Sterile Processing & Distribution (SPD) department, few comprehend the complexity, demands, intensity and pressure of SPD, along with SPD’s nascent desire to be accurate, effective, efficient and understanding of their essential contribution to high-quality patient care. 

Sterile processing duties extend well beyond the tasks of a restaurant scullery, for example. SPD professionals – both management and technicians – must grasp the science (microbiology, for one) and the technology (how to disassemble and reassemble complex devices and follow detailed instructions for use (IFUs)). Any deviation from those norms can lead to dangerous – if not fatal – patient outcomes and a barrage of negative media exposure. 

As part of its 16-year exhaustive coverage of endoscope reprocessing, Healthcare Purchasing News has explored the ins and outs, ups and downs of a foundational and fundamental service within the healthcare community. In fact, last year HPN detailed the broad spectrum of steps required to reprocess endoscopes. You can revisit that content here on HPN Online: https://www.hpnonline.com/sterile-processing/article/21110528/the-full-scope-of-reprocessing-introspection-and-intervention. 

This year HPN focuses in on the six primary priorities that SPD must learn, master and execute with as much precision, integrity and devotion as possible … on a daily basis, 24/7/365. HPN recruited 15 sterile processing executives, regarded as experts in their class and field and asked them to comment on the key areas for continued improvement that need to be monitored consistently for process breakdowns and challenges, particularly against the backdrop of the ongoing pandemic. 

These are the six: 

  • Pre-cleaning and treating
  • Visual inspections and leak testing
  • Manual versus automated cleaning (including cleaning verification testing)
  • HLD and rinsing versus sterilization
  • Aeration, drying, storage and handling (transportation)
  • Maintenance and repair 

Jean Sargent, CMRP, FAHRMM, FCS, President and Principal, Sargent Healthcare Strategies, and long-time HPN Editorial Advisory Board Member is a veteran in sterile processing circles with extensive experience in SPD and Supply Chain in hospitals, hospital systems, integrated delivery networks (IDNs) and consulting. She also serves as a frequent speaker at conferences and trade shows, including IAHCSMM and AHRMM. 

Sargent encapsulates the sterile processing’s Sturm und Drang in six ways of her own. 

Tools. “The fact that many have developed niche tools to support the cleaning process is amazing. What is disheartening is that all facilities that use scopes do not provide these tools, including the basics, to ensure patient safety.” 

Training. “The training of staff to learn over 100 steps to provide a scope that is safe for use on the next patient is daunting. Maintaining that diligence is also daunting, but necessary. With the outbreaks of infections passed from one patient to another, there has been a further understanding of this necessity.” 

Technique. “Competencies in this process are imperative to demonstrate the techs processing the scopes are indeed performing to the highest standard and are recognized for this type of attention to detail.” 

Time. “Allowing proper staffing to complete each and every step, without interruption, must be considered to ensure the patient will be safe and free from transmission of bioburden from the previous patient.” 

Teamwork. “There is now a team that includes SPD, GI, IP, SC, physicians and administration to ensure this process is afforded the tools, training, and time to ensure the process is effective, and there are enough scopes to allow for comprehensive processing.” 

Compassion. “As a patient I ask about tools, training, technique and time to ensure I am not putting myself at risk. It is not easy to question your physician, but it is necessary to protect your health. Do you ask?” 

Bryan Lord, CEO, Pristine Surgical, recognizes the burdens and pressures driving SPD professionals, which is why his company manufactures disposable/single-use scopes. 

“Our customer research shows that today’s SPD department is pulled in multiple directions, and that staying current on training is a constant challenge,” Lord said. “That’s because newer, more complex and larger devices often require more complex cleaning and sterilization protocols, increasing the strain on SPD departments that now need to clean, sterilize and house the new devices. Single-use devices reduce the workload burden on the SPD department and minimize the potential of exposure of patients and staff alike. 

“Most importantly, we believe single-use devices improve safety in two important areas,” Lord continued. “1. [They] eliminate the need to clean and sterilize endoscopes, which also eliminates the risk of cross-contamination or bioburden. 2. Regarding the COVID-19 pandemic, single-use devices expose fewer healthcare providers to equipment that may have been contaminated with the novel coronavirus or other infectious microbes.” 

HPN asked sterile processing executives to expound on each or as many of the six as he or she felt comfortable, based on their organization’s specialty. 

Nancy Fellows, MSN, MPA, RN, CNOR, Senior Clinical Education Consultant, Advanced Sterilization Products (ASP) 

Challenges with endoscope reprocessing are not new, pandemic or not, and were recently addressed by Cori Ofstead, MSPH, in the article, “Challenges in Achieving Effective High-Level Disinfection in Endoscope Reprocessing,” published in the American Journal of Infection Control 2019.1 According to Ofstead’s article, concerning evidence exists that endoscope reprocessing may frequently be error-prone, ineffective and potentially represent danger of contamination exposure to patients.  

When one looks to key areas of continued improvement in the area of endoscope reprocessing, human factors need to be considered. Ofstead’s article identified several factors that contributed to reprocessing failures including the human factor; non-adherence with guidelines, standards, policy and procedures, and manufacturer’s written instructions for use (IFU). 1

  1. Human factors contributing to non-adherence with guidelines, standards, and manufacturer instructions for use (IFU)
  2. Clinical use of endoscopes with visible damage
  3. Use of products that may interfere with reprocessing (simethicone, lubricants, and tissue glue)
  4. Presence of residual soil after manual cleaning
  5. Rinse-water quality issues
  6. Retained moisture in fully reprocessed endoscopes 
  • Manual versus automated cleaning (including cleaning verification testing) 

Per SGNA, endoscope reprocessing includes the following:

  1. Pre-cleaning
  2. Leak testing
  3. Manual cleaning
  4. Rinse after cleaning
  5. Visual inspection
  6. High-level disinfection (manual or automated)
  7. Rinse after high-level disinfection
  8. Drying (alcohol and forced air)
  9. Storage2

One point of failure we want to address and that may contribute to ineffective endoscope reprocessing is the presence of residual soil after manual clean. Pre-cleaning removes organic material (e.g., blood, body fluids, body soil) and decreases the bioburden, making it much more likely that subsequent reprocessing steps will be successful. Pre-cleaning should be performed at point of use, before bioburden has an opportunity to dry and before complete decontamination. Per many manufacturers’ Instructions For Use (IFU), it is recommended that endoscopes remain moist and ideally reprocessed within an hour post-procedure. If more than an hour lapses, additional instructions and recommendations for processing are typically discussed. 

Another important step in the process is cleaning verification. AAMI ST 91 12.4.2 states that the cleaning verification of flexible and semi-rigid endoscopes should include: Visual inspection combined with other verification methods that allows the assessment of both external surfaces and internal housing and channels.3

  • HLD and rinsing versus sterilization

The automation of high-level disinfection can eliminate the multiple points of failure associated with improper high-level disinfection practices such as the use of expired products, improper HLD temperature, inadequate testing for the minimum effective concentration of HLDs and improper storage of MEC test strips.

While high-level disinfection is an acceptable reprocessing modality of semi-critical endoscopes, published articles and discussion have surfaced raising the topic for the consideration of a paradigm shift from high-level disinfection to sterilization.

  • Aeration, drying, storage and handling (transportation)

There has been a growing number of articles and discussions around the importance of drying, transport and storage of endoscopes, and the failure to do so properly can be a leading cause for microorganism proliferation and biofilm formation. As stated in a study by J Kovalena – Endoscope drying and its pitfalls, “inadequate drying and storage procedures, together with inadequate cleaning and disinfection, are the most important sources of endoscope contamination and post-endoscopic infection.” 4

Further, current professional guidelines and standards around transportation indicate that each endoscope should be isolated and transported  with its components in its own closed system to  the next stage of processing, as it is considered  contaminated.

  • The system should be marked with a biohazard label and must meet OSHA requirements for transporting hazardous items.5
  • “The system should be large enough to accommodate a single endoscope without the need to over-coil the  insertion or light guide tubes.”6
  • “Transport the soiled endoscope to the reprocessing area in a closed, puncture-resistant container that  prevents exposing staff, patients or the environment  to potentially infectious organisms.”7
  • Storage is another important factor to consider and as HICPAC states in their document “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC.”8
  • After reprocessing is complete, store endoscopes and accessories in a manner that prevents recontamination, protects the equipment from damage, and promotes drying.
    • Store processed flexible endoscopes in a cabinet that is either:
    • o   of sufficient height, width, and depth to allow flexible endoscopes to hang vertically without coiling and without touching the bottom of the cabinet
    • o   or designed and intended by the manufacturer for horizontal storage of flexible endoscopes.

References:

  1. C.L. Ofstead et al. / American Journal of Infection Control (2019), Accessed 12/12/2019 www.ajicjournal.org/article/S0196-6553(19)30849-1/fulltext. This study was funded in full or in part by an educational grant from ADVANCED STERILIZATION PRODUCTS (ASP).
  2. Alfa, 2013; AAMI, 2015; Petersen et al., 2011; Gastroenterological Society of Australia [GESA] & Gastroenterological Nurses College of Australia [GENCA], 2010
  3. ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities, p 39
  4. Kovalena, 2017; Journal of Hospital Infection, Vol 97, Issue 4  – Endoscope drying and its pitfalls, p. 1, Summary
  5. OSHA 29 CFR 1910.1030 -Bloodborne Pathogens
  6. ANSI/AAMI ST91: [2015] Flexible and semi-rigid endoscope processing in Health Care Facilities. 12.4.2; 12.4.3; 12.4.4; p. 39-40
  7. SGNA:2018 Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes; pp. 16-17
  8. HICPAC: 2018 Essential Elements of a Reprocessing Program for Flexible Endoscopes; pp.2-3
Christian Escobar, Director of Marketing – Visualization, Ambu
  • Pre-cleaning and treating

Bedside pre-cleaning and manual cleaning continue to be the most important aspects of reprocessing as they physically remove soil and other bioburden from the device. Bedside pre-cleaning and manual cleaning are aspects of post-use that need a lot of attention on protocol building and verifications as the efficacy of disinfection/sterilization depends upon these processes being performed correctly and consistently, according to the manufacturer’s instructions for use. According to recent data from the FDA 522 studies, these processes are not adhered to consistently, which creates a significant patient safety risk. Consistency in reprocessing reusable endoscopes and oversight is crucial to rendering the devices safe and appropriate for clinical use.  

  • Visual inspections and leak testing

Again, depending on the systems and processes, visual inspections and leak testing can be highly variable. They are also dependent on human factors aspects such as adequate training and personnel competency, consistent performance, properly functioning reprocessing equipment, and protocols and processes that inhibit inadvertent corner-cutting for expediency. Hospitals should evaluate ways to reduce variability in reprocessing practices – or eliminate reprocessing altogether by switching to sterile, single-use devices.    

  • Manual versus automated cleaning (including cleaning verification testing)

What is most critical is that cleaning is correctly and consistently performed effectively on these devices. Verifying that devices have been cleaned effectively, not just “properly,” should be an area for improvement. Investing in reprocessing automation, verification checks, and other areas of validation should be considered.

  • ·          HLD and rinsing versus sterilization

Having sterile devices confirmed and ready for patients is increasingly desired both by patients and healthcare providers. Due to the complexity of reusable flexible scopes, moving to sterile devices should be a primary patient safety goal to reduce risks. One prime opportunity is to simply move to single-use, sterile endoscopes where possible and available.    

  • Aeration, drying, storage and handling (transportation)

Managing high endoscopic procedure volume in various departments makes managing scope inventory following reprocessing a challenge. This challenge can potentially be alleviated by shifting to single-use endoscopes where possible. That would reduce the burden for many of the logistics of handling endoscopes from point-of-care, through reprocessing, into storage, and transportation.             

  • Maintenance and repair

The service and maintenance of reusable endoscopes is a long-standing area in need of improvement. Often the primary solution is more significant and expensive service agreements. However, given endoscope design and inherent wear and tear during use from other devices and accessories, such as stents, reprocessing, transport, etc., there is an excellent opportunity to reduce or eliminate service/repair/logistics demands with single-use, sterile endoscopes. In addition, when devices are sent out to the device manufacturer, facilities are often provided with loaner endoscopes that can have an unknown service, maintenance, and cleaning history. That can create patient safety risk. 

Betty McGinty, RN, CGRN, CER, Fellow, Clinical Education Services, Boston Scientific Corp.
  • Pre-cleaning and treating 

Focus upon timeliness of initiation and follow through. The process should begin within the procedure room as soon as the endoscope is removed from the patient in an attempt to remove bioburden and to decrease the opportunity for biofilm formation.  Notation of times that the procedure ended and pre-cleaning was performed can allow the reprocessing staff to coordinate the manual cleaning that follows and may prevent the need to follow delayed reprocessing pre-soaking steps. 

  • Visual inspections and leak testing 

Employment of tools to aid visual inspection. Visualization of the endoscope for cleanliness as well as for damage is recommended to be performed at all stages of handling and reprocessing. Inspection via the naked eye has limitations. Tools that enhance visualization such as adequate lighting, magnification, and borescopic channel inspection offer opportunity to improve decontamination efforts and to detect endoscope defects that could interfere with cleaning. 

Thorough attention to detection of leaks. Leak testing of endoscopes precedes manual cleaning. A leak can allow fluid invasion that may be the cause of internal endoscope damage as well as a source of contamination with a risk for patient infection. Testing involves time dedicated to manipulation of endoscope controls, buttons and elevator mechanism with additional time to observe for a continuous stream of bubbles that signal a leak. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Ensuring an endoscope is clean prior to manual/automated high-level disinfection or sterilization. Manual cleaning of a soiled endoscope is a critical step that requires focused and deliberate attention. Its success (or failure) contributes to the outcome of the remaining reprocessing steps. Visual inspection of the cleaned endoscope is not a guarantee that the performed decontamination is complete, particularly within the internal channels. Use of a rapid audit tool for residual organic soil following manual cleaning serves to ascertain the need for additional manual cleaning prior to high-level disinfection or sterilization. Automated cleaning following manual cleaning can offer an additional level of safety. 

  • HLD and rinsing versus sterilization 

Allowance of enough rinsing of disinfectant/sterilant from internal and external endoscope components. Rinsing serves to prevent exposure and potential skin and mucous membrane injury due to chemical residue. Specific rinsing instructions (volume, number of rinses, type of water) are provided by the specific chemical manufacturer. Automated Endoscope Reprocessors (AERs) that provide rinse cycles require settings that support the prescribed rinsing as well as correctly attached connectors that enable all channels to be flushed and rinsed. 

  • Aeration, drying, storage and handling (transportation) 

Ensuring a dry endoscope, internally and externally, for each patient. Moisture supports survival and multiplication of microorganisms as well as the promotion of biofilm development. Endoscope external drying post reprocessing is accomplished with a clean, lint-free cloth, and the long, narrow internal channels require drying with forced instrument air. Literature suggests an infusion of air for a minimum of 10 minutes to dry the internal channels. Various mechanical devices for air infusion that include storage cabinets with air control filters and/or continuous endoscope channel air flow hook ups can be employed to help achieve a dry endoscope. Prevention of re-contamination of a reprocessed endoscope is the rationale behind handling the scope with clean gloves, protecting it with a covering during transport, and storing it in a cabinet that is clean, well-ventilated, and dust-free. 

  • Maintenance and repair 

Ensuring endoscope/accessory fleet is functional and free of defects. Visual inspection of endoscopes and accessories ideally occurs during all phases of handling. Damaged endoscopes and accessories not only fail to perform the procedure but also offer reprocessing hindrances and can contribute to microbial survival. Damaged devices upon discovery signal a need for repair or disposal. Manufacturers’ preventive maintenance schedules for equipment (i.e., endoscopes, flushing pumps and automated endoscope reprocessors) are designed to support intended functions. A challenge offered by the COVID-19 pandemic involved decreased/lack of use of endoscopic equipment due to canceled elective procedures. Resumption of procedures signaled a need for preparatory re-start practices (disinfection cycles, filter changes). Another challenge realized was the potential delay of handling repairs and routine equipment maintenance schedules due to staffing limitations of the manufacturer. 

References

  • Society of Gastroenterology Nurses and Associates. Standards of Infection Prevention in the Gastroenterology Setting. 2019.
  • Society of Gastroenterology Nurses and Associates.  Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes.  2018. 
Marcia Frieze, CEO, Case Medical
  • Pre-cleaning and treating 

All facilities face the challenge of ensuring consistent and effective decontamination of devices from one degree to another. However, flexible endoscopes provide additional challenges. From misalignment over “whose job it is,” to unclear procedures with numerous steps, to evolving evidence and best practices, pre-cleaning and treatment remains a critical procedure prone to missteps and breakdowns. If your facility has not done so, convene a multidisciplinary team to review best practices and instructions for use to establish policies and procedures and to define endoscope reprocessing roles and responsibilities, including pre-cleaning immediately following the procedure while the endoscope is still attached to the video processor and light source. 

There are many solutions and methods on the market that include enzymatic detergents for treatment.  Some require diluting a concentrated solution. Others provide a sponge for wiping the surface of endoscopes, which can be messy and can spread soil across the device surface. A ready-to-use kit, like the Case Solutions Endoscope Bedside Kit, stocked in each procedure room will ensure that the proper supplies are close at hand when needed. The Case Solutions endoscopy kit includes a package of three lint free wipes treated with Safer Choice awarded PentaZyme detergent and a 250ml ready-to-use bottle of PentaZyme detergent. With a single pass, wipe from the clean end (posterior) to the soiled end (distal tip) to remove the gross soil on the surface of the endoscope. Repeat with each of the two remaining wipes. Follow by flushing the interior channel(s) using the bottle of PentaZyme. 

Per AORN, “The collective evidence supports pre-cleaning of flexible endoscopes at the point of use as a mechanism for moistening, diluting, softening and removing organic soils (e.g., blood, feces, respiratory secretions) and reducing the formation of biofilm. If organic soil and biofilm are not removed completely, the subsequent HLD or sterilization process might not be effective.” 

  • Visual inspections and leak testing 

Damage to the interior of an endoscope provides crevices where microorganisms can hide and collaborate to develop a biofilm sanctuary. Once biofilm is established, it’s nearly impossible to remove. Visual inspection with a borescope and leak testing provide opportunities to identify endoscope damage before biofilm can take hold. Not only does early intervention allow for an endoscope to be sent for repair and maintenance, but it prevents another risk associated with biofilm—the swapping of genetic material allowing antibiotic resistance to be shared between different types of microorganisms. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Most endoscopes require numerous reprocessing steps, starting with point of use treatment, continuing to manual and automated cleaning. In some cases, over a hundred individual steps must be followed before an endoscope is considered fully decontaminated and safe for use on the next patient. A tracking program that identifies those steps; provides instructions for cleaning and post processing; and tracks the repair, maintenance and monitoring history of each individual scope is very beneficial as a training tool and for record keeping. Case Medical offers a software program specifically designed for endoscope care. The CaseTrak360 Endo module can be purchased as a stand-alone program or as part of the comprehensive CaseTrak360 software system. 

  • HLD and rinsing versus sterilization 

Both HLD and sterilization are dependent on effective cleaning, so cleaning is always paramount. When you consider the complexity of flexible endoscopes, the dozens of steps in the reprocessing cycle, the potential for human error, and the blurring of lines between semi-critical and critical uses of modern endoscopes, the risk of depending exclusively on high-level disinfection is just too high. Some manufacturers have introduced single-use scopes or replaceable components, such as elevator channels, that are a particularly challenging to clean and disinfect. 

With its greater margin of safety, sterilization should be considered as part of a thorough risk analysis that also considers proper cleaning tools, quality checks, likelihood of interventional use and even storage and processing requirements. Sterilized endoscopes in sealed containers can be stored without the limited hang time and reprocessing required when HLD is performed. 

However, not all sterilization containers are compatible with low-temperature sterilization nor have validated clearance for the lumen size and length of a specific flexible endoscope. As a result, it is important to review the IFU for the container system you are considering and check for compatibility.  Since the introduction of the SteriTite universal container system in 1997, Case Medical has validated its container system to be compatible with sterilizer manufacturers’ claims. 

  • Aeration, drying, storage and handling (transportation) 

Guidance documents include standards for aeration, storage and transport of endoscopes. A sealed sterilization container, properly labeled, has an advantage over wrapped sets, and certainly when compared to HLD scopes, as the same container provides reusable packaging for processing, handling, storage and sealed transport. A tamper-evident seal can be applied to differentiate containers with soiled endoscopes from those with processed endoscopes. One further advantage is the shelf life of an endoscope in a sealed sterilization container system compared to a disinfected endoscope. Case Medical’s SteriTite container has a validated one-year shelf life versus perhaps a seven-day shelf life or hang time when scopes are disinfected. 

  • Maintenance and repair 

The need for maintenance and repair of flexible endoscopes if often reactive, following the discovery of damage that may have existed for weeks, months or even years. Flexible endoscopes have a defined useful life, provided by the manufacturer; however, factors such as frequency of use, the effects of chemical agents on the device surface, and water quality for rinsing can contribute to wear and accelerate the need for repair and replacement. Disinfected but unused endoscopes must be reprocessed after a defined hang time, adding processing cycles (and wear and tear) even when not used on patients. The porous surface of flexible endoscopes is subject to damage and, when compromised over time, can contribute to aborted cycles in some low temperature sterilization cycles. 

Minerva Loran, President, Clinical Choice LLC 

  • Pre-cleaning and treating 

Determine fluid volume for flushing of the endoscope required by the IFU. OEM IFU volume requirements vary by model. For example, the Olympus TJF-Q180V IFU requires 1,000 ml of fluid. Larger fluid volumes help prepare the endoscope for manual cleaning. Standardizing to a volume sufficient to meet all OEM requirements is an opportunity to improve cleaning. 

Pre-clean as soon as possible post-procedure. Endoscope withdrawal time to pre-cleaning is an area that should be monitored. When multiple scopes are used in a procedure, it can be difficult to meet maximum 60-minute timeframes between endoscope withdrawal and manual cleaning. Endoscopes that exceed maximum may require soaking, which prohibits the scope from being turned around for the next patient.  

  • Visual inspections and leak testing           

Leak testing is paramount to maintaining the integrity of your endoscopes and reducing maintenance costs. Dry leak testing technology has improved to the point where it can replace wet leak testing on some manufacturer’s scopes but not all scopes. Ensure your staff is educated on both dry and wet leak testing. 

Visual Inspections of the exterior surfaces should be performed every reprocessing cycle.  Pulling endoscopes with minor scratches or chips increase patient safety and decreases overall maintenance costs. Catching endoscopes requiring minor repair verses major repairs decreases endoscope downtime.      

  • Manual versus automated cleaning (including cleaning verification testing) 

Some AERs have automated cleaning claims to replace manual cleaning. Check out their cleaning claims before eliminating manual cleaning. AER cleaning claims of residual protein may be much higher than your current post manual clean requirements. For example, your manual clean requirements may be one microgram of residual protein or less. The AER claims may be 6.4 micrograms of residual protein.    

  • Aeration, drying, storage and handling (transportation)           

Aeration/Drying, storage and handling all play important roles in effective infection control. Properly drying the endoscope, prior to or during storage, helps prevent microbial growth.  Proper storage should include sufficient HEPA-filtered airflow to keep contaminated air out when the cabinet is closed or open, removable drip trays that can be removed without touching the endoscope tips, cradle systems to keep all endoscopes including Enteroscopes and Double Balloon endoscopes from coiling or touching the floor and support of the endoscope to prevent damage to the insertion and light guide tube and applicable internal channels.   

Kevin Anderson, Clinical Education Coordinator, Healthmark Industries Co. 

  • Pre-cleaning and treating 

As long as we are using reusable endoscopes, the pre-cleaning and treatment steps will be critically important to the safe processing of endoscopes. As we know, it only takes minutes to develop biofilms that can cause challenges to the cleaning process. Another layer to this is communication or documentation. Processing staff need to know when bedside cleaning of endoscopes took place due to the time constraints mentioned in the endoscope manufacturer’s IFUs. In order to implement a delayed processing procedure, staff at the point-of-use need to communicate and document their bedside cleaning procedure. 

  • Visual inspections and leak testing 

Visual inspection and leak testing are critically important for endoscope processing. Leak testing needs to be done correctly every time. Therefore, competency of the staff to perform this task is imperative. Another component to be conscientious about is whether your leak tester is functioning properly. The leak testers need to provide a specific amount of psi to detect leaks, so this should be checked regularly. Visual inspection is another competency that needs to be taught and encouraged. This is a step that can get skipped when turnover times are the priority. Secondly, everyone’s vision is not the same. We need to implement enhanced visual inspection tools like lighted magnification and borescope examinations in order to catch all the potential defects with the endoscope. 

  • Manual versus automated cleaning (including cleaning verification testing) 

With the complexity of flexible endoscope devices, it is important that we have effective manual and automated cleaning procedures in place. We know that there are now AERs on the market that claim to alleviate the need for a manual cleaning process. However, this manual cleaning process is where inspections are done, gross soils are removed, and the processing tech can identify potential problems. Secondly, following manual cleaning, cleaning verification tests may be performed to give another level of assurance that our manual process is working. 

  • HLD and rinsing versus sterilization 

HLD should be enough to safely process flexible endoscopes according to our current Spaulding classification. However, between the increasing complexity of the endoscopes themselves and the complexity of the interventional procedures being done with flexible endoscopes, consideration should be given to moving from HLD cleaning to sterilization modalities whenever possible. While moving to sterilization would be preferable, we need to be sure to get our cleaning process down because sterilization will not be effective on dirty endoscopes. 

  • Aeration, drying, storage, and handling 

Moving as much as possible to automated ways of drying flexible endoscopes external and internal surfaces is an important step that needs to be a point of focus going forward. We know that the AERs do not get our endoscopes dry. The best things that we have available are either forced air dryers that dry inside the scope, or a drying cabinet that dries both external and internal surfaces. No matter what methods we use to dry our endoscopes, we need to have a quality check in place to ensure that the endoscope that is ready for use, or in storage, is in fact dry as a bone. 

  • Maintenance and repair 

Flexible endoscopes are expensive hospital assets that also present a mode for transmitting infections to the patients, or even causing trauma to the patients. Maintenance and repair are critical components for any endoscope program to mitigate these risks. Partnering with OEMs or repair vendors is a great way to educate and identify ways to isolate potential hazardous endoscopes before they go back into rotation for use on a patient. You would not drive your car for 100,000 miles and never do preventive maintenance on it. You should not presume that endoscopes can take the kind of beating that we put them through and think that they will perform without proper maintenance and repairs. 

Jahan Azizi, Special Projects Manager, Healthmark Industries Co.
  • Visual inspections and leak testing 

You cannot clean what you cannot see with naked eyes. The most basic verification of the performance of a cleaning process is by carefully inspecting the cleanliness of instruments and materials with your eyes. Many standards and guidance’s recommend for enhanced visual inspection.  

[You] need to assure that all leak testers are in good working condition and have sufficient output pressure (> 2 PSI). This can be achieved by performance and preventive maintenance at regular intervals. 

  • Maintenance and repair 

Reasoning: There is a need to perform enhanced visual inspection (both external and inside lumens using a borescope) on regular intervals (i.e., monthly) as a quality approach. This will help to identify problems that missed during busy schedule [and] during the cleaning/disinfection process.  

Natalie Reece, Endoscopy Clinical Educator, Key Surgical
  • Pre-cleaning and treating 

Point-of-use cleaning is important for all surgical instruments, but due to the increased risk for biofilm growth inside of flexible endoscopes, the emphasis on pre-cleaning of endoscopes immediately following use cannot be overstated. Dangerous biofilms can start to grow in a matter of hours, and sometimes quicker, but if cleaning is done quickly the risk of biofilm formation is minimal. (See Charles G. Roberts, “The role of biofilms in reprocessing medical devices’ published in AJIC in 2013.) A lot of attention has been paid to the areas that come in direct contact with patient fluids, such as the suction channel and biopsy port valve, but the air and water channels could pose an equal threat for contamination. 

Unfortunately, many facilities are overlooking the importance of using an air/water cleaning adapter during point-of-use cleaning. As we have seen, the air/water valve is not a sufficient “back-flow-prevention valve,” and contamination from blood, stool or other patient fluids can travel through endoscope tubing and channels. (See FDA guidance, “Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes,” Nov 29, 2016.) You should always use an air/water channel cleaning adapter during point-of-use cleaning to ensure that you are adequately flushing both the water and air channels of potential contamination. Ignoring the air and water channels of your endoscope could leave you vulnerable to biofilm growth and potential patient transmission or infection. 

  • Visual inspections and leak testing 

Visually inspecting for damage, loss of function, and gross soil (paying close attention to the distal tip) is important at every step of the endoscope reprocessing cycle. Though the human eye cannot detect microbial contamination, inspecting for gross soil and damage that may harbor microbes could prevent biofilm formation. In addition to the human eye, “tools such as video borescopes of an appropriate dimension (length and diameter) may be used to visually inspect the internal channels of some medical devices,” states ANSI/AAMI ST91:2015 12.4.2. 

In addition to the endoscopes themselves, don’t forget to inspect the water bottle and tubing, biopsy forceps, cytology brushes, cleaning brushes or any other devices used during the procedure. If damage has occurred, the scope must be immediately removed from use and should be sent for repairs. Alert your manager and contact your repair team right away to ensure that no additional damage is incurred during reprocessing. Failure to communicate when damage is found can present an enormous risk to patient safety. According to the 2013 Kovaleva et Al. study, “Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy,” the use of damaged endoscopes is one of the most common factors associated with microbial transmission. In a study published in 2017 by Ofstead & Associates, they tested 20 different scopes at three different facilities and found that all of the scopes had visible irregularities such as discoloration, scratches gouges, non-intact channel lining, debris and damaged distal ends. With this information, we can assume that visual inspection is lacking in many facilities and therefore is an opportunity for improvement. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Manual cleaning is hands-down the most important step in endoscope reprocessing. If this process is not performed correctly, no other efforts will matter. As we often say in the sterile processing world, “if it cannot be cleaned, it cannot be sterile.” A good rule of thumb during manual cleaning is to clean the least dirty part of the endoscope first, moving toward the distal tip/most dirty part, cleaning that last. This way, you are not contaminating an otherwise clean part of the instrument. An easy way to remember this is the phrase, “tail to tip.” If your scope has open channels, the IFU may require you brush it during manual cleaning. Cleaning brushes should be single-use, and of the correct size for the endoscope channel or port. (See the 2008 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities.) 

If your scope has an elevator, move any elevator cables up and down several times and water pick this area with the help of a syringe and/or brush it with a specially designed elevator brush. Do not attempt to brush the scope backwards by starting at the distal tip as this may cause the brush to get stuck. So start at the port nearest to the control head. It is important brushing occurs under the water at all times to avoid creating aerosols or spraying contaminated water. Always inspect your brush and manipulate the bristles under water once it extends out of a channel to ensure that all bioburden, saliva, lubrication, etc. is removed before reintroducing brush into the channel. You will want to pass the brush through as many times as needed until it comes out visibly clean. Keep in mind, however, you won’t always be able to see bioburden or residual residue. If the instruments are not properly manually cleaned, the disinfection/sterilization and drying procedures can fail, which increases the possibility of transmission of infection from one patient to another. Even if your AER has a mechanical cleaning step, you should always perform manual cleaning before putting your scope into the AER. 

  • HLD and rinsing versus sterilization 

You should always check your scope manufacturer’s IFU to know whether your scope needs to be high-level disinfected or sterilized. According to the Spaulding Classification System, many flexible endoscopes fall into the “semi-critical” category and only require high-level disinfection. In 2016, however, AORN adopted a modification of the Spaulding Classification System that separates flexible endoscopes into two groups: The original designation of semi-critical and a critical designation for flexible endoscopes that enter directly or secondarily (i.e., via a mucous membrane) into sterile tissue and the vascular system. Bronchoscopes, cystoscopes and duodenoscopes fall into this modified designation as they increase the risk of infection if they are contaminated with microorganisms when used. Therefore, they should be considered critical devices, meaning they should be sterilized. 

Additionally, most rigid endoscopes are classified as critical items and must be sterilized. An important part that is often missed, however, is that the requirements are set for the bare-minimum. According to ANSI/AAMI ST91:2015, At a minimum, it is recommended that devices are subjected to high-level disinfection after each use. When possible and practical, flexible and semi-rigid endoscopes should be sterilized due to the greater margin of safety built into sterilization.” 

Another important area of concern is the residual diluted HLD chemistries that can be left behind if rinsing is inadequate. For example, AAMI states, “Water bottles may not drain completely, resulting in diluted HLD solution.” OPA causes discoloration of the skin and mucous membranes, irritation, anaphylaxis and other allergic reactions. Gluteraldehyde is known to cause hereditary virulence and is carcinogenic. PAA can cause chemical burns. One study investigated the use of GA in endoscopy and found that it can cause colitis (inflammation of the bowel) with necrosis and ulcerations. Patients afflicted with this experience severe abdominal cramps, rectal bleeding, a high temperature and chills. Studies have shown that these chemicals can be absorbed into the medical devices themselves, especially if they’re PVC or silicone or polyurethane and can be released later. Their uptake is thought to be cumulative, meaning the more repetitions of the disinfection process the water bottle has seen, the more toxicity is later released during procedures. (See Ryu, et. Al. “Cytotoxicity Assessment of Residual High-Level Disinfectants,” May 8, 2013.) 

Melissa Kubach, Clinical Education and Training Manager, Mobile Instrument Service & Repair 

  • Pre-cleaning and treating 

Despite improvements in pre-cleaning proficiency within the GI setting, compliance within the operating room remains a challenge. Small diameter flexible endoscopes of all types often receive little to no pre-cleaning in the OR. Unlike GI where training can be focused on dedicated reprocessing staff members, the number of applicable staff for the OR is much higher. Furthermore, the complexity of the required steps varies greatly between different manufacturers and models increasing the likelihood of insufficient cleaning. The operating room environment is inherently challenging from a pre-cleaning perspective. Case tear down often requires point-of-use cleaning for additional items such as instrumentation and video cameras. OR turnover minutes are closely monitored; not to mention the greater need for post patient care.   

  • Visual inspections and leak testing 

Visual inspection under magnification is required after manual cleaning and prior to high-level disinfection or sterilization. This step is often rushed or overlooked, which increases the risk of debris remaining in recesses of damaged epoxy or components. If documentation for each overall inspection were required, the increased attention would improve compliance and reduce the risk of cross-patient contamination as well as incidents such as an aged or chemically damaged glue ring detaching during patient use. 

Although not required, internal inspection facilitated by a borescope is currently a recommended practice. Despite this, many facilities have yet to acquire a borescope. Owning a borescope is the first challenge given financial limits imposed following COVID-19. The next challenge is knowing how to use the borescope and interpret what you see. Even with initial install training, it is subjective as to when a scratched channel warrants pulling for repair, and small channel restrictions are often overlooked if there is no perceived difficulty passing instruments or cleaning brushes.   

The importance of leak testing every endoscope with each use is generally understood. It is the small mistakes within the process that lead to large consequences related to repair and equipment malfunction. The most common mistake we see is depressurizing a scope while submerged. This allows fluid to slip past the O ring within the leak tester connector and enter the electrical connector. Similarly, allow ample time to displace the pressurized air to ambient levels for endoscope models with self-venting valves. Failure to follow venting requirements, may allow fluid to enter the electrical connector after leak test. Both scenarios result in fluid invasion, even though the endoscope has no existing defect to the airtight integrity. Often the effects of these seemingly minor mistakes are not realized until the equipment fails during procedural use, affecting case completion, extending anesthesia as well as increasing the risk of injury to the patient.  

  • Manual versus automated cleaning (including cleaning verification testing) 

Meticulous manual cleaning is supported by industry standards and guidelines. Manual cleaning steps are complex, especially for duodenoscope and EUS models. As a result, steps are skipped or partially completed. Competencies need to be detailed. True return demonstration specifically geared towards each required step, especially the location and brush position for elevator cleaning, would shine a light on weak areas and needed individual employee training support. Too often, even model-specific competencies merely state that the act of brushing was completed – not that each individual action was demonstrated.  

Automated pump units for flushing and rinsing endoscopes provide much needed standardization. Flushing units allow for the delivery of larger fluid volumes than those achieved with syringes and injurious repetitive motion. 

The elimination of specific manual cleaning steps, due to enhanced cleaning claims by the AER manufacturer, is commonly not clearly understood. Often the utilization of these claims is not reflected in the written procedure, facility policy or the overall health system policy. Most policies simply state that all steps of the manufacturer’s IFU will be completed. The automation of these steps, while validated, are commonly not supported by organizational and regulatory recommendations. Justification and policy alignment will remove this gap.   

Verification tests are helpful at identifying reprocessing gaps, but they do not assure a scope is clean. The test is only as good as the area sampled and does not provide insight as to what kind of microorganisms are residually present, just that the number of detected organisms is within the passing or failing range designated by the test manufacturer. Improvement can be realized by implementing a plan to move away from high-level disinfection. Sterilization allows for greater log reduction and the destruction of spores which is clearly more desirable than high-level disinfection.  At this point, high-level disinfection remains the norm mostly due to convenience. Sterilization units and their associated chemicals require controls that are housed in Sterile Processing, adding transportation time and cleaning competition with surgical cases.  Fast-paced Gastrointestinal and Urological settings thrive on expedient turnover times.  Current approved sterilization methods may present additional challenges or limitations, such as load capacity associated with multi-lumened endoscopes as well as the comprehensive validation of all current models in use. While these challenges are slowing down the process, this direction will continue to gain preference.    

  • Aeration, drying, storage and handling (transportation) 

There are transport delays moving scopes out of the OR to decontamination. It is not uncommon for an airway endoscope to be used prior to intubation, then sit for the remainder of the surgery. This often happens with gastroscopes utilized in bariatric surgeries as well. Addressing expedient removal of endoscopes is a common challenge.  

Endoscopes should be secured within their sterilization trays after use. Failure to place the endoscope properly increases the risk of damage while affixing the lid prior to transport. This is one of the most common causations of damaged endoscopes. The stacking of trays or placing other objects on top of the endoscope should also be avoided.  

Proper drying has been the most overlooked step since the dawn of flexible endoscopy. Many reprocessing departments do not have access to viable air options in the clean area or existing storage cabinets. 

  • Maintenance and repair 

Few facilities have formal flexible endoscope preventative maintenance programs. Consulting AAMI EQ56:2013 and AAMI EQ89:2015 can offer great insight as to the requirements for establishing a true preventive program and optimal utilization of different maintenance strategies. Annual formal inspection is still necessary even when daily per-use inspections are performed and documented. Partnering with your repair provider for assistance in this area can be beneficial for controlling repair cost, repair frequency, inventory shortages and increased risk to the patient for injury or cross-patient contamination related to existing damage. Trained inspectors can identify underlying issues that help avoid costly repairs or adverse outcomes associated with failure during use. 

Carolyn Klimas, Executive Director, Specialty Products Marketing, Olympus America Inc.
  • Pre-cleaning and treating 

Pre-cleaning scopes as soon as possible after the procedure – ideally, as soon as the endoscope is removed from the patient. The longer pre-cleaning is delayed, the greater the opportunity for soils and bioburden to dry on endoscope surfaces, which may make soils more difficult to remove and the endoscope more difficult to thoroughly clean 

Perform pre-cleaning exactly as indicated in the endoscope OEM’s IFU. Do not skip steps and ensure that any required accessories/adapters are used correctly. Use the correct accessories/adapters (per endoscope OEM’s IFU) to perform pre-cleaning. Cleaning accessories are designed specifically to loosen soils and bioburden from internal channels/surfaces of the endoscope. 

  • Visual inspections and leak testing 

Ensure reprocessing technicians follow the endoscope OEM’s IFUs on how to visually inspect the endoscope for damage and/or debris 

Staff training:

  • Any deviation from the Leak Testing process or missing any of the OEM-specified Leak Testing steps subjects the device to the potential of fluid invasion and costly repair.
  • Repairs can negatively affect your facility’s up-time, which is the use of the device to perform life-saving procedures.
  • Reduced up-time reduces your facility’s ability to create revenue from the use of the device that is out for repair.   
  • Manual versus automated cleaning (including cleaning verification testing) 

Manual cleaning:

  • Adherence to IFUs in manual cleaning is critical as manual cleaning steps in the IFUs have been tested and validated for reprocessing efficacy as part of the 510(k) process.
  • Ensure appropriate detergent concentration, contact time and temperature for maximum efficacy
  • Use the correct brush for each scope
  • Take the time to do it right
  • Ensure each channel is adequately brushed
  • There is no maximum time specified
  • Brush until no further debris observed
  • Manage and measure the process
  • Document each technician’s results
  • Identify outliers to provide consistency
  • Use a flushing pump according to manufacturer IFUs when you replace pumping with syringes. 

Automated cleaning:

  • Automated Endoscope Reprocessors (AER) may automate some cleaning steps, ensuring consistency and bolstering the cleaning process. 

Cleaning verification:

  • Conducting periodic, internal review of competency and inservicing with the endoscope manufacturer can help ensure steps are completed properly.
  • Olympus does not require cleaning verification testing as we have validated the cleaning process described in our IFUs. However, we support customers who choose to perform this optional step.
  • Consider use of newer tools such as visual reprocessing guides to ensure the process is completed in full. 
  • HLD and rinsing versus sterilization 

HLD using compatible disinfection methods for your endoscope is the recommended method for decontamination for semi-critical medical devices, including most endoscopes. 

Sterilizing flexible endoscopes must be done using a method that is compatible with the device, otherwise sterilization may cause physical damage to the device or the process may not have proven microbiological effectiveness.

  •  Aeration, drying, storage and handling (transportation) 

Aeration:

  • For endoscopes compatible with ethylene oxide gas sterilization, always refer to the endoscope reprocessing manual for minimum aeration parameters. 

Drying:

  • Wiping down external surfaces before hanging
  • Following manufacturer’s IFU for drying time, volume, pressure through channels
  • Drying the endoscope lumens with filtered pressurized air for an extended period of time after high-level disinfection and before storage in a conventional endoscope storage cabinet
  • Placing the reprocessed endoscopes directly into a drying cabinet vs a standard storage cabinet where gravity is used to facilitate the drying process 

Storage and handling

  • Use covered, rigid protection for transportation
  • During transport, use color-coded liners with indicators to identify scope status
  • Use a HEPA filtered cabinet, at minimum, to help prevent environmental contamination
  • Consider use of drying cabinets during endoscope storage
  • Consider additional protection for the distal end of the endoscope during transport and storage.  Distal Tip Protectors should be made of materials that do not retain any moisture or harbor bacteria. 
  • Maintenance and repair 
  • Inspect the endoscope prior to a procedure according to manufacturers’ IFUs
  • Ensure the repair company you partner with follows the FDA’s quality systems regulations for repairs
  • Understand that products repaired by companies other than the original equipment manufacturer may mean that the reprocessing instructions in the Instructions for Use are no longer validated since the parts and process used by the third party to repair the product do not undergo testing by the original equipment manufacturer
  • If you choose to use third-party repair services, you are strongly advised to get validated reprocessing instructions from the third party.  You are also recommended to check with your AER company to confirm the third-party repair service has validated their repaired scope in the AER. 
Alison Sonstelie, CHL, CRCST, oneSOURCE consultant & Sterile Processing Coordinator at Sanford Health, Fargo, ND
  • Pre-cleaning and treating

 I believe pre-cleaning and treatment is a key area for process improvement. For areas outside of endoscopy, many of the caregivers using endoscopes have very little training or awareness of the importance of this step in reprocessing. Departments should work with end users to develop a robust education plan, checklists, visual cues, etc., to help implement best practices. A crucial part of process improvement is tracking compliance to the new process. Feedback forms and communication plans should be established before implementation. This can help identify parts of the process that need more education, like pre-treatment, handling and containment. If you're in a medical center that sends scopes to inpatient areas, tools like feedback forms can also help identify departments that need additional assistance. During the stressors of COVID-19, many employees struggle with remembering or having time to perform critical tasks. If you notice a decrease in compliance during this time, work with end users to identify gaps and develop solutions. 

  • Visual inspections and leak testing

Steps in processes that rely on judgment and visual inspection are vulnerable to mistakes. If you can automate these steps, like leak testing, you will get consistent and reliable results. Automated leak testing can identify leaks that are too small or difficult to see with the human eye. Spotting these early may avoid more costly damage, impacting the cost of repair. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Again, automating processes will deliver a more consistent product. Automated endoscope reprocessors perform uniformly during each cycle, and can monitor that parameters were met for each phase. Indicators can ensure that the minimum recommended concentration (MRC) of disinfectant was met. Manual cleaning needs consistent education, training, and competency checks.  With so many steps in the process, it is crucial that we continuously verify that staff are performing each step correctly.

  • HLD and rinsing versus sterilization 

The information about remaining microbial load after HLD is staggering. Sterilization is the best reprocessing method for patient safety, with the caveats that other reprocessing steps must be performed correctly and the sterilization method is feasible for the facility. When sterilization is not possible, it is of the utmost importance to ensure pre-treatment and cleaning are performed correctly.  

  • Maintenance and repair 

The cost of maintenance and repair is a barometer for how well you are performing all the tasks in a use and reprocessing cycle of an endoscope. If one area is neglected, there is a greater potential for damage to endoscopes. You should leverage your repair company to provide information about repair trends and provide education for departments that handle the endoscopes.   

Ron Banach, Director, Clinical Training, Ruhof Corp.
  • Pre-cleaning and treating  

These are the most critical time sensitive step in the cleaning process. It is most effective to pre-clean an endoscope at bedside before bioburden dries. All Best Practice recommendations from the various Professional Medical Society groups support this step. The Ruhof CleanStart pre-cleaning bedside kit offers a premixed Endozime SLR solution, which is an exclusive advanced chemistry formulation, with pre saturated contoured sponge to assist in timely and effective pre-cleaning at beside. The product removes gross contaminants and synthetic lipids and is available in a user friendly pouch.  

  • Visual inspections and leak testing 

All  Endoscopy manufacturers’ IFUs state that it’s mandatory to leak test after every Endoscopy procedure. This is vital to the safety of the patient and success of the procedure. Documentation of this step is also stressed by the Professional Medical Societies and Joint Commission Inspectors. 

The recently added recommendations to visually inspect the scope – both the external scope components and the internal lumen/channel – have added a tremendous benefit, confirming both the cleanliness and working integrity of the endoscpe. The extra time added to the cleaning process is outweighed by the safety and validation of a clean endoscope. Ruhof’s VIB, Visual Inspection Borescope, allows for instant visual detection of internal debris and damage and offers robust software allowing for still image capture, video clips, email sharing, archiving and reporting. 

  • Manual versus automated cleaning (including cleaning verification testing) 

Adding the assistance and documentation of an automated cleaning /flushing pump to the cleaning process is vital. The staff responsible for the cleaning at the sink benefits greatly from the automation as it reduces the physical effort of manual cleaning. In addition, techs can document the leakage test, chemistry dosing, flushing and rinsing of the lumens/channel and air purge – all in minutes. Most importantly, this process offers standardization in the cleaning process, enables one to follow the IFU requirements and will document and identify the endoscope and staff user. 

Once all cleaning and visual inspection is complete a final step is to implement a reliable method of Microbial Contamination Verification. The critical importance of this step is to verify the effectiveness of the cleaning process. A monitoring system that detects Adenosine Triphosphate (ATP), the universal energy molecule found in all animal, plant, bacterial, yeast and mold cells is the best option. This measured numeric result will provide the assurance of a clean device prior to HLD or sterilization. Ruhof’s ATP Complete Contamination Monitoring System is a quick and reliable verification method for testing surgical instruments, flexible endoscopes and surfaces with results in as little as 15 seconds. 

  • HLD and rinsing versus sterilization 

The Spaulding Classification scheme is the instrument classification system used for medical instrumentation reprocessing decisions. The Classification System indicates three categories of ascending risk: Critical, semi-critical and non- critical. The endoscope falls into the category of semi-Critical, as these devices contact mucous membranes. Semi-critical items require only high-level disinfection (HLD) as the terminal reprocessing step. With recent reports of drug-resistant organisms, super bug outbreaks and new viruses it may be time to challenge this classification system in respect to the reprocessing of certain more challenging endoscopes, i.e., duodenoscopes, bronchoscopes and endoscopic ultrasound endoscopes.  

Aeration, drying, storage and handling (transportation) 

The key importance of proper handling (transporting) an endoscope is to assure patient and staff safety. Too often the staff is unduly relaxed about the importance of preventing a costly repair which can result from a careless preventable mistake. There are guideline recommendations and best practice examples of how to avoid damage to an endoscope. 

Recent laboratory studies have presented the importance of using aeration or a drying device to reduce the possibility of bacterial growth in lumens and channels. However, following this recommendation can add additional turnaround time and cost to endoscope reprocessing.  

  • Maintenance and repair 

Every endoscope user has the option to use either the OEM or third-party services for repairs. The responsibility to maintain the original manufacturer’s performance standards should be regulated by the FDA, The Joint Commission, CMS and other federal agencies to assure steps are in place to follow safety and quality repair practices. 

Bryan Lord, CEO, Pristine Surgical

Single-use devices obviate the need for all six of these steps. Importantly, they also dramatically change the economics of SPD departments, where maintenance and upkeep expenses are roughly three times the cost of the endoscope itself. Pristine’s single-use design eliminates this expensive, labor-intensive process and delivers a brand-new, crystal clear image every time. And the Pristine Surgical platform’s automated inventory management tools remove bottlenecks created by the unavailability or poor quality of reused endoscopes.

About the Author

Rick Dana Barlow | Senior Editor

Rick Dana Barlow is Senior Editor for Healthcare Purchasing News, an Endeavor Business Media publication. He can be reached at [email protected].

SPD image courtesy Kat Velez, Leesar, HPN’s 2017 SPD of the Year. Elephant: 27671658 © Taalvi | stock.adobe.com
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