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November 2013The self-study lesson on this central service topic was developed by STERIS. The lessons are administered by KSR Publishing, Inc.

Earn CEUsThe series can assist readers in maintaining their CS certifi cation. After careful study of the lesson, com-plete the examination at the end of this section. Mail the complete examination and scoring fee to Health-care Purchasing News for grading. We will notify you if you have a passing score of 70 percent or higher, and you will receive a certifi cate of completion within 30 days. Previous lessons are available on the Internet at www.hpnonline.com.

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Learning Objectives• Explain how the evolution of

endoscopes has affected their care and handling

• Identify common types of endoscope damage

• Explain what to expect when switching to oxidative chemistries for endoscope use

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The number of new endoscopic pro-cedures being developed by physi-cians continues to climb. It has been

estimated that approximately 15-20 million endoscopy procedures are performed annu-ally1; including 14.2 million colonoscopies and 2.8 million fl exible sigmoidoscopies.2

As procedures are developed, so are the endoscopes required to perform them. Ad-vancements in design and technology have led to endoscopes that provide better image quality through high-defi nition technology, are intricate in design and capabilities, and can collect many types of detailed informa-tion. These are highly advanced and deli-cate reusable medical devices that require thoughtful handling and detailed, thorough reprocessing, to ensure their safe and effec-tive use for each patient.

Care and handling in a more complex environmentThe increasing complexity of endoscope design has added to the complexity of the cleaning and disinfecting/sterilizing pro-cesses for each type and model of scope. This creates an ongoing challenge for repro-cessing professionals to stay up-to-date on reprocessing training and protocols. In fact, it has recently been reported that at least 3 out of 15 scopes are being improperly cleaned.3

Recent epidemiology estimates suggest that the risk associated with endoscopes have been signifi cantly underestimated.

Typically, endoscopes are considered semi-critical devices for which sterilization is preferred but high level disinfection is ap-propriate; however depending on the proce-dure being performed, the same endoscopes are now considered critical and require ster-ilization. Proper care and handling of these delicate instruments during reprocessing is critical for patient safety and to optimize the instrument’s useful life. There are a variety of resources that provide guidelines for proper care and handling of devices.

First, there are the manufacturer’s instruc-tions for use (IFU), which includes details on proper care and handling. For example, with fl exible endoscopes, instructions may in-clude detailed bedside pre-cleaning instruc-tions, leak testing instructions, and details of

Endoscope care watch-outsby Inga Magiday and Jim Rygiel

what to do in case of a failed leak test. They may also include the recommended bend radius, to prevent a device from being too tightly coiled.

Original equipment manufacturer (OEM) instructions also recommend the type of chemistries that may be used for scope re-processing. For example, many OEMs will recommend a neutral pH detergent cleaning chemistry. Any chemical used during the clinical procedure or during reprocessing can impact the integrity of the scope, so all chemicals should be labeled for use on endoscopes, and should be used according to the chemistry’s instructions for use (such as contact time, temperature, and proper dilution ratio). Many general chemicals used to clean sinks and other surfaces may leave residues, and therefore should also be taken into consideration. All chemicals should be thoroughly rinsed off to avoid adverse reactions. Water quality is also an important factor to consider; poor water quality can lead to device damage over time.

Manufacturers also encourage owners to follow a regular preventative maintenance schedule for their devices. Just like preventa-tive maintenance on a car, planned mainte-nance will optimize the useful life of devices and may prevent any major scope damage.

Other excellent resources for care and stan-dards guidelines include but are not limited to, the Society of Gastroenterology Nurses and Associates (SGNA) and the American Society for Gastrointestinal Endoscopy (ASGE). These organizations provide recom-mendations on proper reprocessing protocols to ensure that each scope is processed in a manner that renders it safe for use on patients and maintains the integrity of the endoscope.

Identifying types of damageEndoscopes are inherently fragile: they contain electrical, plumbing and mechani-cal components requiring constant atten-tion. Internal components including high defi nition electronics and extremely fragile fi ber-optic bundles create challenges. Even a normal ‘day in the life’ of an endoscope can pose numerous obstacles to remaining fully functional. Every step of use, from storing the scope, to operating the device,

www.hpnonline.com • HEALTHCARE PuRCHAsing nEWs • November 2013 49

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to performing a procedure, to transporting and reprocessing the soiled scope, can lead to accidental breakage.

Understanding the root cause of endo-scope failures or damage helps users reduce downtime and maximize the endoscope’s performance. Many endoscope failures can be eliminated or prevented by identifying the early warning signs. damage during transport:Typical transportation breakage identifiers are things such as dents, dings, chips and cosmetic cracks from exterior trauma. The internal workings of flexible endoscopes are particularly prone to damage and this dam-age may not be obvious. Faulty containment systems, used for transportation, can lead to mishandling or accidental drops. In ad-dition, transportation begins and ends with the scopes on some sort of hanging system, so scopes are at high risk for unintentional impact damage as they are removed and replaced on the hanging systems. Examples:• Bent light guide prongs (hitting a hard

surface during transport)• Cracked control body/housing (from

dropping)• Broken fibers (observed when the scope is

subsequently used)damage during clinical use:Even handling practices during normal pro-cedural use carries risks of damage. Typical operator errors can be as simple as trigger-ing the cauterizing forceps prematurely, resulting in internal component perforation and potentially distal tip c-cover damage. Forceps and other instrumentation designed to be passed through the biopsy channel can actually cause severe internal damage if not advanced properly. Most OEM instructions require the bending section to be straight while advancing any instrument or fiber through the working channel. Occasionally surgeons want to advance fibers while the scope is articulated, which causes unneces-sary pressure to the internal components resulting in image guide fiber damage. Using the scope for leverage or over flexing insertion tubes can lead to buckling and pro-duce resistance with deflection. Wriggling and buckling noticed in the outer tubes can easily collapse internal work-ing channels. Insertion tubes exhibiting defec-

tive areas can also compromise patient safety by creating irregular or limited flexibility. Examples:• Loose/broken angulation wires (misuse/

forcing angulation knobs)• Cracked light guide lens (hitting distal tip

on a hard surface)• Punctures/holes in internal lumens due to

sharp instruments, biopsy forceps, lasers, or improper use of cleaning brushes

• Broken fibers/cracked lenses — normally due to handling or dropping

reprocessing-related damage:During reprocessing, endoscopes are in-troduced to numerous potential hazards. Something as simple as the exposure to wa-ter, harsh chemicals, chemicals not meant for device use, or the improper use of the chemi-cals can raise the risk for a required repair. Fluid invasion into the internal endoscope parts is one the most common endoscope failures leading to expensive repairs.

Strict adherence to OEM recommenda-tions for cleaning, and disinfecting and/or sterilizing can help minimize the need for repair. Even the cosmetic appearance of an endoscope can be compromised by deviating from recommended reprocessing protocols. Discoloration, blistering, peeling, cracking, or pitting of the endoscope’s external compo-nents can appear as a result of overexposure to chemistries. Examples:• Cracking and spotting from poor water

quality• Clogged biopsy channel (not using clean-

ing brushes/instrument used is incorrect diameter and/or failing to flush lumens)

• Clogged air/water channel (failing to utilize cleaning brushes and/or failing to flush lumens)

• Buckling — possibly caused by over coil-ing the device or over inflation (normal wear can also cause stretching or looseness of the bending rubber material)

• Fluid invasion — due to the presence of a leak within the device. This can usually be detected during leak testing

Storage risks: Appropriate storage cabinets are essen-tial for safely main-taining endoscopes when not in use. In addition, if scopes are not dry when stored, moisture left inside the endoscope can oc-clude the air/water channels, or even leave residue on distal tip lens assemblies, which will compromise video image acuity. Examples:• Crushed/dented insertion tube (improper

transport, storage, usage)

• Cracked light guide lens (hitting distal tip on a hard surface)

Introducing oxidative chemistries: what to watch out forIn recent years, an important trend in endoscope reprocessing has been the re-placement of aldehyde chemistries with oxidative formulations for disinfection. There are significant differences between these two types of products; in the way they work and the effects they have on en-doscopes. Users need to be aware of what to expect when switching chemistries. Hidden damage may be exposedAldehyde-based disinfectants are widely used for high level disinfection of semi-critical flexible endoscopes. However, alde-hydes are known to be protein cross-linking agents. This means that any residual soils, including microorganisms that remain on the device after cleaning, may become fixed onto the surface of the device. Over time this fixed protein layer builds up; it can result in cosmetic changes to devices and can hide damage.

Because oxidative chemistries are effec-tive at removing residue build-up from both the interior and exterior surfaces of devices, device damage that was hidden under aldehdye-fixed residues will be exposed as this residual substance is gradu-ally removed. As a result, there can be a misperception that oxidative chemistries are causing damage, such as pin holes, to a device. However, the fact of the matter is, the oxidative chemistry is removing the residual build-up that clogged up damage that was already present.there may be cosmetic changes to anodized aluminumThere are some flexible devices that may contain plated aluminum, anodized alumi-num or other soft met-als in the construction of the device. Oxidiz-ing agents, depending on their formulation, can remove the color in anodized aluminum over time, depend-ing on the grade and color coating of the

50 November 2013 • HEALTHCARE PuRCHAsing nEWs • www.hpnonline.com

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aluminum. These changes are considered cosmetic and should not affect the use or functionality of the device. It should be noted that chlorine, commonly found in water, is an oxidizing agent and can have these effects.temporary increase in scope repairs Users of oxidative chemistries should be aware that it may take several cycles before the aldehyde build-up is removed and pre-existing damage is exposed. Consequently, a spike in device repair may occur in the fi rst few months.

Do your own investigation As we know, endoscopes are delicate, expensive and prone to damage. For these reasons, it is imperative to investigate the entire reprocessing cycle, in your depart-ment, to ensure optimal care and handling of your devices and to prolong the useful life of your scopes. Above is a checklist of things to observe in your investigation. HPn

Inga Magiday, MBA, is an associate product manager for STERIS Corporation’s Infection Prevention Technologies division. She is re-sponsible for all aspects of Product Marketing, including market analysis, product develop-ment, product launch and ongoing promotion. She holds a Bachelors of Business Administra-

Item QuestionsDuring Clinical Use: How are devices handled and used before, during and after the procedure?

Are insertions and removals performed carefully and correctly?

During all phases of Cleaning:

Pre-cleaning:

What chemicals or materials are used for bedside pre cleaning?

Cleaning:

Is leak testing performed and performed per the IFUs of the scope manufacturer?

How is a failed leak test handled? Are scope manufactures IFUs followed?

Are devices over coiled?

Is the cleaning chemistry compatible (for example, a neutral pH cleaning chemistry is usually recommended)?

Is the chemistry dosed according to label instructions? Is time and temperature fol-lowed accordingly?

Rinsing:

How is this performed? Are lumens fl ushed? What is the quality of the water?

If specifi c instruction for rinsing is provided by the endoscope OEM, is it followed?

Disinfection:

Are OEM instructions followed for proper use (for example, time and temperature exposure)? Exposure for hours or overnight is a potentially damaging practice and not recommended for any device.

HLD Rinsing:

Are good rinsing practices followed?

Are OEM IFUs followed?

What water quality is being used to rinse the device?

During Transport to and from the procedure:

Are scopes over coiled?

Stacked on top of one another?

During Preparationand Storage:

Is alcohol being used for drying?

Is it purged with air?

How is the device hung or stored?

tion and a Master of Business Administration, both with a focus on marketing, from Cleveland State University, Cleveland, Ohio. She is a GI Technical Specialist (GTS) through the Society of Gastroenterology Nurses and Associates program.

Jim Rygiel is the Director of Endoscopy for Spectrum Surgical Instruments, a specialty di-vision with STERIS cooperation. With 20 years of endoscopy experience ranging from OEM training to major third party repair knowledge, he is responsible for overseeing the endoscopy re-pair operation including products, services and educational platforms. Rygiel combines sales and service backgrounds to provide a unique endoscope management program designed around patient safety and scope maintenance. As a proud member of IAHCSMM and SGNA he is able to bridge gaps between Surgery, Sterile Processing and GI departments.

References

1. 2013. Three out of 20 scopes used to examine GI tracts and colons improperly cleaned. APIC. Retrieved from http://www.apic.org/For-Media/News-Releases/Article?id=105610bb-229c-4fbb-bf2b-3870eb159e9e

2. 2004. How many endoscopies are performed for colorectal cancer screening? Results from CDC’s survey of endoscopic capacity. NCBI. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/15578503

3. Three out of 20 scopes used to examine GI tracts and colons improperly cleaned.” APIC Daily News 8 June 2013, Issue 2, Section A: A-6. Print

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Reprocessing fl exible endoscopes - Re-thinking the risk for endoscopy-associated infections

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BIs tell a story Quality management systems for point-of-use

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accreditation process Oxidative chemistries for disinfection and

sterilization Immediate-use steam sterilization (IUSS) facts Water quality systems in sterile processing Reprocessing in the ambulatory surgery

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best practices (Part Two) Steri l ization Recommended Practices:

Checking in on 2012 Washer monitoring: A must-have for today’s

best practices (Part 1) A risky undertaking: Manual cleaning of

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where we’re going Human factors in Central Sterile Services

Department: Human factors engineering and the application of this discipline to a CSSD

Your next steam sterilization moisture event: A systematic approach to wading through it

The right documentation! An examination of sterilization record keeping

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Ethylene oxide sterilization: Regulatory roundup

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Self-Study Archives5 years of Continuing education credit at your fi ngertips - available at: www.hpnonline.com/ce/ce.html

And Much More!

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1. Advancements in the design and technology of endoscopes can provide the physicians with what features.A. Better Image qualityB. More intricate designC. Ability to collect more informationD. Less intricate designE. A, B, C

2. The number of new endoscopic procedures devel-oped by physicians continues to rise.A. TrueB. False

3. Endoscopes are considered__________ in which high level disinfection is appropriate, however depending on the procedure performed may require a more rigorous sterilization process.A. DirtyB. Critical devices C. Semi-critical devicesD. Non-critical devices

4. What are some of the resources that provide guidelines for the proper care and handling of endoscopes?A. Manufacturer’s instructions for useB. Equipment manufacturer’s instructionsC. MSDSD. Professional organizationsE. All the aboveF. A, B, D

5. Any chemical used during the clinical procedure or during reprocessing can impact the integrity of the scope. Which of the below statements are accurate?A. Chemicals used to clean sinks do not leave residueB. All chemicals should be thoroughly rinsed off to

avoid mixingC. Poor water quality can lead to device damage

over timeD. B and CE. A, B, C

6. many endoscope failures can be eliminated or prevented by identifying some early warning signs below.A. Damage to the scope during transportB. Improper storage of an endoscopeC. Clinical use and handlingD. Reprocessing related damageE. All the above

7. If endoscopes are not dry when stored, moisture left inside can occlude the air/water channels and compromise video image acuity.A. TrueB. False

8. Some examples of endoscope damage include which of the following.A. Bent light guide prongsB. Cracked light guide lensC. Intact control body and housingD. A and BE. None of the above

9. ___________ is one of the most common endoscope failures that results in expensive repairs.A. Proper cleaningB. Cosmetic appearanceC. Fluid invasionD. Recommended reprocessing

10. An important trend in endoscope reprocessing in recent years has been the replacement of glutar-aldehyde chemistries with oxidative chemistries. Which of the below statements are accurate when using oxidative chemistries?A. Oxidative chemistries remove residual build-up that

clogged up damage that was already presentB. Oxidizing agents can remove the color in anod-

ized aluminum over time, but is considered a cosmetic change and will not affect the function of the device

C. Users of oxidative chemistries should be aware that it may take several cycles before the aldehyde build-up is removed

D. There may be a temporary increase in scope repairsE. All the above