By John Roark
Scopes are delicate instruments that must be handled with care but cleaned and disinfected with vigilance.
The infection risks associated with both flexible and rigidscopes is a serious issue. Proper cleaning, disinfection and sterilization of theseinstruments must be continually monitored and consistently maintained. Association of periOperative Registered Nurses (AORN)recommended practices effective Jan. 1, 2003 state:
Rigid and flexible scopes have different cleaning andsterilization needs and can pose different threats when it comes to infectioncontrol.
The rigid scopes are much easier to clean, but pose agreater risk, says Lawrence Muscarella, PhD, chief of infection control atCustom Ultrasonics, Inc. The flexible scopes are harder to clean, but pose a lowerrisk.
It is important to bear in mind that scopes are made up ofmany different components, each requiring special attention. Each valve, channel and surface of the endoscope in and ofitself is a unique medical instrument, says Muscarella. An endoscope isarguably comprised of seven or eight separate sub-instruments. Each of thoseinstruments needs to be addressed during reprocessing. Once you understand thatits a multi-instrument, you know that theres a different set of rules thatwould apply than if it were a scalpel, which you would consider one instrument.
Whenever a scope is processed, all channels must be cleaned,even if they werent used during the procedure.
Problems can occur when someone is not educated, saysMuscarella. You cant train your personnel how to clean the easiestendoscope and expect them to do the job flawlessly. You need to train thatperson on the most complex type of instrument to reprocess, which is probablythe GI colonoscope or GI side-viewing duodenoscope. There has to be attention toevery single channel of the endoscope, whether that channel was or was not usedduring the procedure. If you have knowledge of all of the endoscopes and youunderstand that different models have different designs and therefore differentneeds, the steps will be the same, but the adaptations may be different. Youre going to have a problem if you dont adaptproperly.
A basic framework can be followed to help ensure that scopesare receiving optimal care. Each step is as important as the others, and no stepshould be compromised.
Step One: Pre-Cleaning
The first essential step in the cleaning process for bothflexible and rigid scopes is pre-cleaning wiping down the scope andimmersing it in enzymatic detergent mixed with water immediately after theprocedure to remove any bioburden or debris. Only a detergent that has beenshown by its manufacturer to be effective should be used during endoscopereprocessing. Do not use a detergent for which data are not available.
Some common mistakes made at this critical juncture, says LeeAnn Purtell, product manager of rigid scope repair for Mobile Instrument Service& Repair Inc., is that often, scopes are soaked for too long.
The general rule of thumb is that no scope should remainimmersed in any solution even distilled water for more than 60 minutes.Follow the manufacturers recommended soaking time. When it comes toenzymatic cleaners, people will think more is better. Theyll put moreenzymatic detergent than is necessary in the mix of water. High concentrationsof detergents can leave surfactants on the glass, which are very hard to remove. They can discolor parts of the scope, and can pit the glass.Dont use too high of a mix, and dont soak too long.
A lot of times, scopes will sit in a bin of glutaraldehyde,says Rob Purtell, product manager, also with Mobile Instrument Service &Repair, Inc. Its very important not to leave them in longer than thepublished time. If a scope is supposed to be in a cold soak for 20 minutes andyou forget about it and leave it in there for several hours, it can begin to eataway at some of the components. Ive seen scopes that have been left overnight. It will do atremendous amount of damage follow the published soaking guidelines from themanufacturers that make that fluid.
Flexible scopes have an appearance that belies theirfragility, continues Rob. A lot of times nurses or techs will have the scopes coiledup almost in knots. The scope naturally flows a certain way if you begin to coilit up into a sink full of water. There are some weaker points on the tubes thatcan be damaged if looped improperly.
Lee Ann also cautions against soaking scopes beneath otherinstruments. Its best to keep them separate, and you never want toput anything heavy on top of the scopes.
Step Two: Leak Testing
An essential step for flexible scopes is the leak test,designed to gauge the integrity of the scope, and that no fluids have leakedinto the internal channels. You need to make sure that the scope is holdingair when you put it through the cleaning process, says Rob. If a scope hasa breach that will allow fluid to get inside, it can cause damage to theinternal components. Once the fluid gets in, theres no way for it to get out repair companies have to open up the entire scope and put it in an oven to dryit out. Inside the scope there are stainless steel components thatwill rust, there are also video components and wires that can get corroded.
Muscarella cites a report of a damaged bronchoscope infectinga patient. The hospital failed to perform the leak test, and as aresult, they were transmitting disease from patient to patient, he says. Hadthey done the leak test, they would have determined that there was damage to theinstrument. It isnt just fluid invasion that you get you can getmicrobial invasion into any kind of a tear, pit or laceration on the internalchannel. You cant see down the internal channel you have no way ofknowing if it was damaged. Leak testing is important not just for the functioning of theendoscope, but for raising a flag that your instrument may be a potentialcarrier of a disease.
Step Three: Manual Cleaning
Manually brush all channels that can be brushed, saysMuscarella. What you cant brush, flush with enzymatic detergent (or otherdetergent for which efficacy data are available), and soak according to thedetergents labeling paying strict attention to recommended time, dilutionand temperature. Some of these detergents can cause problems to the scope orthe automated reprocessor, he says. You dont want to immerse theendoscope in the detergent or the disinfectant for longer than recommended.The concept of, if the label says 15 minutes, 30 minutes is twice as good,does not apply.
Rigid scopes should be carefully cleaned by hand with a softcloth, using care and caution. Lenses can be scratched by an abrasive agent.Rigid scopes should only be put through instrument washers or used in anyultrasonic device labeled to be compatible with rigid endoscopes.
Step Four: Rinsing to Remove Detergent and Soil
Lee Ann recommends rinsing scopes two or three times withdistilled water to remove all residual cleaning solutions. That is a commonmistake, she says. People dont rinse them, and the cleaningsolutions can build up on the lenses. They look hazy or fuzzy, and you cantsee through them. Use an alcohol wipe to gently remove the surfactants, orgently use a pencil eraser to erase the film. If it doesnt come off, itsprobably pitted the glass, and it will have to be repaired.
We also suggest at this point prior to sterilization thatthe scope be inspected to make sure that all parts are intact, that theres nodamage to any of the components, continues Lee Ann. Use a jewelersmagnifying glass to look at the lenses to make sure they are not damaged,chipped or scratched. Using a scope that has potential damage can weaken theparts, which can fall out into the patient. Its important not to be puttingsomething back into service that is damaged.
The cleaning step becomes a real saving grace if thedisinfectant is approaching its minimum effective concentration, or if someshortcut is taken in the disinfection step, says Muscarella. It reducesthe bioburden considerably, so when you go to the next step of disinfecting, youhave much less of a challenge, much less of a formidable problem on your hands.
Step Five: Disinfecting/Sterilizing
Sterilizing [rigid scopes] is tricky because there reallyis no perfect option currently out there, says Lee Ann. Every methodavailable has its benefits and limitations. ETO gas is probably the least damaging to the scope, and itwill sterilize the instrument. However, people dont use it because theturnaround time is prohibitive.
Both Sterad and STERIS are quick, readily available chemicalmethods of sterilization. With chemical sterilants you can get discoloration,it can remove any kind of coatings from anodized parts, and depending on thegrade of glass thats used by the manufacturer, you can get some pitting,says Lee Ann, who points out that STERIS is for point-of-use processing only.You can STERIS the scopes between cases, but you cannot STERIS at the end ofthe day, put it on the shelf, and then use it the next day.
Steam sterilization and autoclaving present inexpensivesolutions for newer rigid scopes specifically labeled as autoclavable. Olderscopes will be damaged by the heat employed in these processes.
Lee Ann also cautions that immersing hot instruments in coolwater after sterilization will cause thermal shock, and will fracture thecomponents. For flexible scopes, Muscarella reiterates the importance ofmonitoring the temperature, time and concentration of disinfectants.
Step Six: The Second Rinse
Rinsing flexible scopes after disinfecting is an importantmeans of removing any residual disinfectant. If you dont get rid of thedisinfectant that remains, it can cause patient injury, says Muscarella. Theresidues of that disinfectant or detergent can come in contact with the patient,and cause a reaction by the mucosa of the organ whether its the colon,the lungs or the esophagus youve got to get the disinfectant off toprotect the patient.
Muscarella also comments on the rinse water controversy,and the importance of monitoring the quality of the rinse after disinfection. Arguably, the Achilles heel of the entire endoscopereprocessing protocol is the quality of the rinse water, because its the lastthing thats going to contact that instrument before its placed in thepatient, he says. If the water itself is contaminated with chemicals, itcan cause a problem. And if its contaminated with bacteria, its obviouswhat it can do.
Ive taken the position that you cant allow anybacteria in the rinse water because endoscopes and bronchoscopes may sit betweenuses, and that bacteria will proliferate. To someone who is immunosuppressed,introducing just a few bacteria into the lungs can kill them.
Step Seven: Drying
Thorough drying will break the chain of bacterial transmissionfrom possibly contaminated water. You will not get bacteria from the water tothe patient via the endoscope if you dry it, says Muscarella. From ahigh-level disinfectant and liquid sterilization standpoint, itsessential to do, because it stops the transmission of any bacteria in the water.If youre not monitoring the rinse water, its all the more important.
Step Eight: Storing
Flexible scopes must be stored in a low humidity,well-ventilated dry area. You can properly perform all of your cleaning anddisinfection steps, but if you dont properly store the endoscope, you couldrun into a problem, says Muscarella. Lets say you have very, very fewbacteria in your endoscope. If its stored in a wet environment, you now allow thosebacteria to double every 20 minutes. In an eight-hour time period, you can gofrom an instrument that is completely patient-safe to one that is extremelyhazardous for use simply because you didnt store it in a dry environment.
Humidity control is not as much of an issue with the rigidscopes, but moisture penetration, airborne contaminants and handling that wouldcause the package integrity or seals to be broken are factors to be aware of.
Lee Ann stresses the need for carefully handling and storingscopes, which are more fragile than they appear. The components inside areprimarily glass, she says. Any kind of pressure on the insertion tube dropping it, laying something heavy on top, putting any kind of pressure on it can break the parts. All the people in central sterile, anyone who handlesthe scope really has to pay some special attention and handle them carefully.
The Bottom Line
Attention to detail, awareness of manufacturers guidelinesand keeping an eye out for potential problems are the keys to safer scopes. Igo to hospitals to train, and I find more and more that people are just notfollowing the original guidelines by the manufacturer, says Rob. When theybuy the scopes, the manufacturer comes in and does the training. The turnover in facilities can be tremendous new peoplecome in and the information never gets trickled down the way it should. A lot oftimes customers will tell me that the manufacturer last came in six years ago thats the last time they had any formal training on it. The onlyconsistency I ever see is that I almost always find something. Its rare tosee a facility thats really doing things carefully and properly. Theresusually a breakdown in the process someplace.
First and foremost is education and training, says Muscarella.Make sure that reprocessing personnel have access to the internal schematicsof every single endoscope they have in inventory, ideally with some kind ofchart on the wall, so they can reference each of the models and see what makesup each scope. Periodic testing and monitoring by supervisors to make sure thatall those scope models are understood is equally important. If the facility doesnot ensure its staff is well trained and properly performing each reprocessingstep in accordance with published reprocessing guidelines, it is opening itselfup to a lawsuit. Plain and simple.
Because GI endoscopy has a very low reported risk ofinfection, people get complacent, and corners are cut. The problem withendoscopes is that they are unlike most other types of instruments. Its onereusable instrument that is very complex, and may be used on more than a dozenpatients during the course of a single day. If there is a undetected problemwith any one of the reprocessing steps, there is an exponentially high number ofpatients who may have been infected with pathogens. This potential outcomeunderscores the importance of periodic training and routine monitoring of eachthe facilitys reprocessing steps to ensure staff is in compliance withpublished guidelines. Ideally you would like a disposable scenario, but you donthave it. Even though the risk appears to be low, peoples guards are down, andas a result they get a little sloppy. Youre playing with fire when youreinvolved in endoscope reprocessing.