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BeyondCleaningReprocessingflexible GIendoscopessuccessfully

• Is there really“sterile dirt”?

• A look insidea flexibleendoscope

• Working withyour AERmanufacturer

• Water quality-a criticalcomponent

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November 2005 • Vol. 29 No. 11

Straight Dope onScope Care

Inaugural guide shows you the ropes

Straight Dope onScope Care

Inaugural guide shows you the ropes

Scope Cleaning Guide

Beyond cleaningReprocessing flexible GI endoscopes successfullyby Bradley Catalone, Ph.D. and George Koos

Today, it is hard to imagine that anyone remotelyassociated with the gastrointestinal (GI) depart-ment has not heard of the risks and problemsassociated with improper or inadequate repro-cessing of flexible endoscopy equipment.

A flexible endoscope, as with any medicalinstrumentation, cannot be high-level disinfectedor sterilized without first being meticulouslycleaned. Taking shortcuts in cleaning with theidea that high-level disinfection or sterilizationwill still render the scope safe for patients is anapproach guaranteed to put patients at risk. The“Sterile Dirt” theory just doesn’t cut it. Thereare several published examples of patient infec-tions resulting from failure to properly clean anendoscope1,2. Manufacturer’s guidelines for thecleaning of flexible endoscopes are well docu-mented and should always be followed. Althoughcleaning is a major factor in rendering flexibleendoscopes safe for reuse, there are other factorsthat could affect the successful disinfection orsterilization throughout the rest of the process.These factors are easy to maintain and monitorwithout further time constraints, but can be det-rimental to the process if overlooked.

First, it is critically important to understandyour equipment and how it is designed to func-tion. This will allow your facility to best utilizethe technology and be the most productive, whilealso minimizing damage, costly handling mis-takes and the risk of cross contamination. Therehave been a number of reprocessing errors pub-licized in the popular press that have been at-tributed solely to not knowing specific functions,attributes or designs of endoscopes and associ-ated equipment3,4. It is important that the staff istrained thoroughly by the manufacturer of eachspecific piece of equipment. More times thannot, staff will ask questions of sales representa-tives regarding processes involving other com-panies’ equipment. Only the manufacturer ofthe equipment should answer questions aboutits equipment.

Although flexible scope sales representativesare knowledgeable about the entire process ofusing the scope in the procedure through suc-cessful reprocessing, they are unable to answerquestions regarding other manufacturer’s auto-mated endoscope reprocessors (AERs). EachAER manufacturer is required to validate itsequipment and connections for use with each

compatible endoscope. These AER manufac-turers will have specific instructions for use,which may vary with each endoscope model.Not all flexible endoscopes may be compatibleor validated for use in all AERs. Ask the manu-facturer of your AER for an in-service to under-stand your equipment.

Secondly, only use validated connectors sup-plied by the AER manufacturer for each modelof endoscope. Connections are vital to the dis-infection or sterilization process in AERs. EachAER works with different pressures and designs,which in turn require specific connectors forspecific scopes. Flexible endoscopes are com-plex devices comprising long, narrow lumensand bifurcations. The slightest difference in thesechannels may require different connections asdetermined and validated by the AER manu-facturer. Endoscopes in the same series from thesame manufacturer may have different chan-nels and options that also require different con-nectors. When purchasing a new scope alwayscontact your AER manufacturer for the rightconnectors and training. Once you have theright connectors, they must be maintained andcannot be modified. Do not allow staff to repairor replace parts of these connectors without spe-cific authorization and instructions from theAER manufacturer. Contact your AER manu-facturer with a list of your scopes to ensure youare using the proper connectors.

Next, have your equipment serviced regu-larly. If the endoscope has been thoroughlycleaned and properly connected with the AERmanufacturer’s validated connector, but the AERitself is not working according to specification,there again is a risk to the process. Flexibleendoscopy equipment and AERs should be ser-viced and maintained according to themanufacturer’s specifications. Many facilitiesmaintain equipment with internal personnel, andthese resources should be trained and have theproper instructions for the preventive mainte-nance and service of the equipment. Equipmentmay appear to be in working order, but onlythe proper upkeep can ensure the systems areworking as intended. The repair and service ofassociated equipment is vital to ensuring theproper functionality of the scope. Proper main-tenance also helps ensure patient safety by iden-tifying physical damage that may reduce the

effectiveness of reprocessing. Make sure yourequipment and scopes are in good working or-der and contact the manufacturer for informa-tion as needed.

Water quality, specifically the AER incomingfeed water and final rinse water, is a critical com-ponent of any successful endoscope reprocess-ing program. Numerous reports of nosocomialinfections and pseudoinfections linked to AERrinse water clearly demonstrate the importanceof water quality2,5.

Here are some suggestions on how to main-tain acceptable water quality:• Check with the AER manufacturer to deter-mine the specific requirements for the quality ofthe incoming feed water. Oftentimes, prefiltrationsystems are required to reduce the bioburden ofthe incoming feed water. Prefiltration will im-prove the quality of the water used to reprocessthe endoscope, and also reduce contaminates thatenter the AER internal tubing and reservoirs.• Understand that the quality of the incomingfeed water, especially for those facilities that donot centrally treat their incoming water, maychange seasonally. As a result, the useful life ofwater filters may vary throughout the year.• Maintain acceptable water quality by usingthe AER manufacturer’s recommended filtersand replacement frequency. Not all filters aremanufactured to the same specification nor arethey appropriate for use with an AER watertreatment system.• Implement a quality control program to rou-tinely sample the final rinse water. Althoughroutine sampling currently is not endorsed byany of the major professional societies or gov-ernment agencies, documented patient infectionsand pseudoinfections due to contaminated wa-ter provide a strong rationale for this recom-mendation5. The wrong time to discover thereis a water quality issue is after a patient infection.

Finally, proper drying and storage of flexibleendoscopes reduces the risk of nosocomial in-fections. The multi-society guideline for repro-cessing flexible GI endoscopes categorizes thefinal drying steps, including a flush with 70percent to 90 percent ethyl or isopropyl alcoholfollowed by forced air, according to theguideline’s strongest recommendation (Cat-egory IA: strongly recommended for implemen-tation and strongly supported by well-designed

Because of a growing number of patient infections and injuriesthat have been linked to poorly, if not improperly, cleaned andcared for endoscopes, Healthcare Purchasing News decided tolaunch an annual guide to educate and reinforce proper cleaning,care and handling of these expensive devices. HPN enlisted ex-perts in the manufacturing and reprocessing communities to offeradvice and wisdom that should prove useful and valuable to ourreaders who are dedicated to delivering high-quality healthcare.

Scope Cleaning Guide

experimental, clinical or epidemiologic stud-ies)6. In contrast, there currently is no recom-mendation for maximum storage time ofproperly reprocessed endoscopes. Some pro-fessional societies, including the Association ofperiOperative Registered Nurses (AORN), rec-ommend that endoscopes be reprocessed im-mediately before use7. However, many facilitiesdo not adhere to this recommended practicebecause the clinical benefits are not well estab-lished and the resources required are signifi-cant. In addition, very few studies have beenpublished evaluating the safety of storingendoscopes for prolonged periods.

A primary reason for the lack of a consensusrecommendation regarding endoscope storageis that the ability to maintain an endoscope in apatient-ready state during storage is highly de-pendent upon environmental factors that areunique to each facility. For example, the ambi-ent air temperature and humidity, the numberof air room changes per hour, and the generalcleanliness of the endoscope storage area andcabinet are important variables that are related

to the risk of endoscope contamination duringstorage.

Everyone understands the importance of thor-ough cleaning, and hopefully the need to un-derstand all the factors that contribute to safeand effective reprocessing. Healthcare facilitiesmake great investments in areas like the GI de-partment to create medical miracles every dayutilizing advanced technologies and innovativeprocedures…don’t risk patient safety by nothaving all the information. Utilize your equip-ment manufacturer’s resources to train staff andoptimize the performance and safety of yourequipment. HPNHPNHPNHPNHPN

1.Alvarado CJ, and Reichelderfer M. APIC guideline for infec-tion prevention and control in flexible endoscopy. Am JInfect Control 2000, 28: 138-55.

2.Mehta, AC, Prakash, UBS, Garland R, Haponik E, Moses L,Schaffner W, and G Silvestri. American College of ChestPhysicians and American Association for Bronchoscopyconsensus statement: prevention of flexible bronchoscopy-associated infections. Chest 2005; 128: 1742-1755.

3.Glionna, JM. Unsterile devices prompt warnings: use of dirtyendoscopes in colon and throat exams can pass along in-fections activists say. The Los Angeles Times, Los Ange-les, CA, Feb 13, 2003, p B1.

4.Fahy, J, and Spice B. Monroeville hospital urges 200colonoscopy patients to get checked for hepatitis, HIV. ThePittsburgh Post-Gazette, Pittsburgh, PA, March 31, 2005.

5.Muscarella, LF. Application of environmental sampling toflexible endoscope reprocessing: the importance of moni-toring the rinse water. Infect Control Hosp Epidemiol. 2002;23(5): 285-289.

6.Multi-society guideline for reprocessing flexible gastrointes-tinal endoscopes. Gastrointest Endosc 2003; 58(1): 1-8.

7.Recommended practices for cleaning and processingendoscopes and endoscope accessories. 2005. Standards,Recommended Practices, and Guidelines. Denver: Asso-ciation of periOperative Registered Nurses, 2005: 341-346.

Bradley Catalone, Ph.D., MBA, is senior manager ofinfection control for the Medical Systems Group ofOlympus America. Prior to joining Olympus, Cataloneworked in the pharmaceutical industry. You can reachCatalone via e-mail at bradley.catalone@olympus.com.

George Koos is the senior product manager for clean-ing, disinfection and sterilization for the Medical Sys-tems Group of Olympus America. He has specialized ininfection prevention product lines for the last nine years,serving in various medical sales and marketing roles.You can reach Koos via e-mail at george.koos@olympus.com.

Reprinted from Healthcare Purchasing News