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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



November 2013

2013 Endoscope Care Guide

SPD performance honed under fire, pressure

Nursing, O.R. demands make or break patient care quality

Photo courtesy Medivators
Ask any Sterile Processing and Distribution staff member about the rigors of their job and he or she likely will inundate you with the perils of balancing reprocessing products for the nursing floors and serving as a dedicated “wet works” team for the Operating Room and its more complex and costly devices and equipment.

So what are some of the traits of a high-reliability SPD team involving endoscopic equipment? Terry

 Mistalski, Vice President, Global Marketing and Business Development, Medivators Inc., shares this impressions:

·         Thorough understanding of the architecture, care, use and handling of endoscopes.

·         Thorough knowledge if the endoscopic equipment is a Class II or Class II device as defined by the Spaulding Classification. The classification will dictate if the device must be high-level disinfected (Class II) or sterilized (Class III).

·         Quick turnaround of endoscopes (after proper cleaning and reprocessing, of course) for use in high volume procedures, such as colonoscopies.

·         Accurate tracking of the endoscope in the facility and in reprocessing because SPD is likely remote to the area where the endoscope is used procedurally.

·         Thorough cross-training of all SPD team members to ensure everyone is competent in all aspects of SPD. 

Photo courtesy Medivators

Yet a host of pressing endoscopic issues regularly challenge any SPD team. They encompass the following:

·         Tracking endoscopes throughout the facility. When centralized SPD reprocesses endsocopes that come from remote locations (different floors/buildings), it can be difficult to keep track of their location, and availability status. There are new RFID/bar-code technology software and hardware that can track scope utilization and location.

·         Determining if an endoscope is “patient ready.” That means that it has been pre-cleaned immediately post-procedure, leak-tested, brushed and flushed, and high-level disinfected. This also applies to all removable parts, such as air/water/suction valves. New endoscope tracking technology enables a facility to follow and document an endoscope throughout the day, and monitor if and when each step was successfully completed, and by whom. Single-use removable parts, such as air/water/suction valves are now available, eliminating the reusable ones as potential sources of microbial or chemical contamination.

·         Meeting the demand of getting the “patient-ready” scopes back into service as quickly as possible, so that the doctor and endoscopy team can effectively perform all scheduled procedures.

·         Ensuring that in-house best practices by the staff reflect, and do not contradict, the content provided in the “policies and procedures” manuals related to reprocessing endoscopes. Deviation from established practices will be noticed by any credentialing agencies.

·         Understanding what the reprocessing requirements of peripheral devices that may be used in endoscopic procedures are, and what automated equipment can be used to reprocess them. A couple of examples are transesophageal (TEE) probes and laryngoscope blades.

– Terry Mistalski, Vice President, Global Marketing and Business Development, Medivators Inc.

Photo Courtesy Richard Wolf

·         One universal issue not limited to endoscopic but any instrument is do I have the equipment and supplies needed to effectively clean? Are the brushes the right size to fit into the channel without bending and compromising the brush’s ability to clean the walls of the channels? Will the flushing mechanism be effective to push debris from the channels during the cleaning process? Can the staff use the correct ratio of detergent to water so the solution is contributing to cleaning? Are the machines in working order and did the staff report malfunctions so it can be fixed immediately? 

·         Do I have the budget to buy the equipment and supplies I need to effectively clean endoscopic instruments? 

·         Is the physical plant conducive to effectively cleaning instruments, as in does the layout impede the process or is it constructed for the end user to move through each cleaning step efficiently and effectively clean the instrument? 

·         Do I have the budget to impact a poor layout?

·         How can the staff be trained and how can I maintain their reprocessing integrity? 

·         How can the manager get the reprocessing information to the staff when they need it during reprocessing (decontamination, inspection and assembly, sterilization)? Most times, this information is online with no immediate computer access or is stored in a book in the manager’s office. 

·         How do I measure the quality of reprocessing? Do the staff have the right equipment and time to effectively inspect the instrument to measure cleaning, measure quality? 

– Sydney Nye, R.N., Senior Product Manager - Customer Education and Reprocessing, Richard Wolf Medical Instruments Corp.

Routinely dogging SPD departments are the content and quality of device manufacturer instructions for cleaning, disinfecting and sterilizing products, along with justifications. Too frequently, these instructions may be misunderstood or overlooked.

·         Device manufacturers are not consistent with the template they use to publish their instructions for reprocessing instruments. This adds to the difficulty for the end user being able to use the information – the layout and location of the information is different from company to company and they way it is written may be difficult to interpret.

·         Many times the end user only has a few minutes to locate the specific information they need and wading through a manual is a daunting task. In some cases, the instrument inspection instructions may be in the section for the Operating Room staff, which is important for them to ensure the instrument is in working order. But it may not be repeated in the reprocessing section of the instructions, which can often be overlooked.

·         A company may choose to use an illustration and no words for a reprocessing action, which may miss some nuances of that action and the reprocessing step be done incorrectly. 

·         Disinfecting steps may be confusing because this can be written for safe handling of the instrument in the assembly area immediately following decontamination or the same disinfecting steps are used to high-level disinfect the instrument immediately prior to patient care.

·         Many device manufacturers that have been standardizing their reprocessing instructions use the ST-81 layout for writing reprocessing instructions. It provides a consistent framework for a device manufacturer to write the instructions, which in turn, allows the end user to quickly find the information they are seeking.

– Sydney Nye, R.N., Senior Product Manager - Customer Education and Reprocessing, Richard Wolf Medical Instruments Corp.

·         Checking the Minimum Effective Concentration (MRC) of a reusable high-level disinfectant (HLD) before each use (the term Minimum Recommended Concentration may also be used). Every legally marketed HLD states this requirement on the label. Management must ensure that the staff is familiar with and trained on the use of the HLD.

·         Performing a “wipe and flush” of an endoscope with a detergent solution immediately upon completion of the endoscopy procedure. If this step is not completed, biological matter remaining on and in the scope, enabling the possible development of biofilm, and compromising the disinfection step of reprocessing.

·         Ensuring that a leak test is performed on every endoscope post-procedure and before reprocessing.

·         Meticulous cleaning of all removable parts (air/water/suction valves) prior to disinfection.

·         “Brush and flush” of endoscopes in detergent solution and fresh water rinse prior to disinfection (unless the facility is using an automated endoscope reprocessor that has been cleared by the FDA to eliminate manual pre-cleaning at the sink).

– Terry Mistalski, Vice President, Global Marketing and Business Development, Medivators Inc.

Automation and a consistent sense of urgency drastically affect the perception and performance of many of the manually performed steps needed for comprehensive endoscope care. Two top examples are improper leak testing and the ineffective use of cleaning chemicals.

Improper Leak Testing: When a leak test is performed by rote and the observer is rushed and/or not mindful of the intricacies of each step of the process, small holes are often missed. Fluid intrusion is the triple crown of destruction, because it can:

1.    Damage internal components of the endoscope

2.    Shorten the endoscope’s useful lifespan, and

3.    Serve as a portal for contaminants that can lead to cross contamination issues  

To avoid fluid invasion during leak testing, make sure your leak testing process includes the following: 

·         Have an adequate, well lighted work space.

·         Pressurize the scope before putting it in the water. Failure to do so can allow water to creep in before a hole is discovered.

·         Remove function valves and biopsy port covers. This step enables personnel to identify holes in the suction, biopsy, and/or air/water channels.

·         Use a large sink that allows for a large, looping configuration of the endoscope and permits quicker, easier flow.

·         Massage the video switches with a circular motion, allowing for an evaluation of the soft material. Fluid that seeps in here can cause the switches to take pictures on their own or to fire unintentionally.

·         Observe the control body area while turning the control knobs, thereby allowing for inspection of the “O” ring seals supporting the knobs.

·         Remove the scope from the sink prior to releasing pressure. If a hole has been missed water can enter the scope and be sucked into the leakage tester. The next scope that is pressurized using the leak tester will have that water blown into its interstitial spaces.

Photo courtesy of
Integrated Medical Systems International, Inc. (IMS).

When repairing bending rubber on a flexible endoscope, verify that all materials have been tested to withstand all accepted sterilization methods, including the Sterrad NX.

It is a painful (and expensive) fact that fluid damage to an endoscope in most cases is caused by a hole that was not discovered during leak testing. Underestimating the importance of this process can wreak havoc on your endoscope inventory and operational budget.

Ineffective Use of Cleaning Chemicals:

The improper use of cleaning chemicals is another recurrent problem. All of the label’s instructions for use must be followed as they relate to reconstitution ratio, temperature, minimal exposure to internal and external surfaces, and/or effective rinsing practices, which are critical to preventing biofilm development and bioburden retention.  

– Lynne A. Thomas, R.N., CGRN, CFER, Vice President, Regulation and Compliance, Integrated Medical Systems International Inc.

SPDs also struggle with justifying immediate-use sterilization procedures, so Richard Wolf’s Sydney Nye offers the following tips.

“In order for any facility to utilize immediate-use sterilization, they first need to determine if they can adhere to these steps:

·         Can the instrument be cleaned and inspected according the manufacturer’s instructions prior to sterilization?

·         Can the sterilizers in the O.R. be set to the manufacturer’s specific sterilization instructions (gravity displacement or pre-vac)?

·         Can the instrument be transferred in an aseptic manner to the point of use? 

·         Does the manufacturer recommend this particular instrument be sterilized using immediate-use sterilization? 

“All of these key points have been documented in AORN July 2013, and must be considered before a facility utilizes immediate-use sterilization. And this process is only used in the event the patient’s care is going to be compromised without the instrument, such as in the event the instrument is contaminated during a procedure.”


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