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CS CONNECTION


devices should have a cleaning effective- ness test performed each time they are processed before proceed- ing to HLD or steriliza- tion. We continually use the golden rule of ‘if it’s not clean you cannot disinfect or sterilize the device’ then why would we proceed to HLD or sterilization with- out ensuring the device was clean?” “The FDA has done studies of trained individuals processing devices following the manufacturers IFUs to the letter, and after that cleaning they culture the scopes and still get some positive results for contamination,” said Berg. “I don’t want to see people using the science of sterilization to say ‘I have a safe product.’ We need to ensure the clean- ing is effective and it can be successfully reproduced before we have the sterilization conversation.” “Sterilization reduces risk but does not remove the risk,” said Bassi. “If the scope is not clean it cannot be sterilized, and some studies have shown the scope to still have bacteria after sterilization – therefore we need to closely look at what our solution is going to be as the problem stems from the complexity around cleaning the device. If in- tricate devices with robotics and mechanical


Nancy Chobin EtO pros and cons


thylene oide t is an effectie low tem- perature method of steriliation for heat and moisture sensitie deices including eible endoscopes. ccording to the .. ood and rug dministration  about fty percent of all sterile medical deices in the .. are sterilied with ethylene oide.1


ut the proper-


ties that mae t such a great method of steriliation  its ability to ill  also present potential safety riss with its use. Recent media reports hae highlighted forced


t steriliation plant shut downs in eorgia and llinois because of eleated carcinogenic gas emissions in surrounding communities. llinois ouse ill  sees to phase out eth- ylene oide emissions in the state preenting any steriliation company within e miles of a region with a population density of at least 1 residents per suare mile or within the same distance from a school or day care. ospitals would need to meet the same reuirement by anuary  and critical access hospitals by . t has been around for a long time and has


gotten a bad rap oer the years said amien erg Regional anager of terile rocessing at ealth and mmediate ast resident of  and  oting member and co- chair for seeral committees. he lethality is amaing and its compatibility with materials is great. t does its ob ery well. he downside


is its toicity but that is what maes it a good sterilier. ecause of the toicity the hospitals hae to comply with regulatory reuirements to eep their employees safe. nother downside is its long aeration time


erg added. t is not bad but do your due diligence and determine if it ts your needs based off your hospitals worow and the products you need to sterilie. nna R. utierre  R  


R terile rocessing ducator/docate terile rocessing rogram irector at ortis ollege describes her recent isit to a manu- facturing endor that supplies basin sets and R pacs using inactie t. he says trained sterile processing technicians rst assembled trays its and pacs bagged them and then too them to a separate room where they were sealed similar to a peel pouch. uring the sealing process most of the air


was acuumed out and minute amounts of inactie t were drawn into the bag maing the sealing process safe for the technician to handle. he pacages were then placed onto a cart and rolled into a warm incubating chamber where the t was actiated inside of the bag. he pacages remained there for a certain amount of time to fully sterilie all items inside of the specially designed bags and were then uarantined until biological and chemical indicators read negatie.


32 December 2019 • HEALTHCARE PURCHASING NEWS • hpnonline.com  was impressed said utierre. here were


so many uestions during my isit but  hae to say it was one of my most interesting eperi- ences  had eperienced. he manufacturer did undergo a premaret approal  clearing with the  and of course there is so much more to learn of this process. thylene oide is not the only option for


steriliing heat or moisture sensitie semi-critical deices of concern said r. ancy Robinson istinguished cientist R. aporied hydrogen peroide steriliers such as the - R ow emperature teriliation ystems are used to sterilie hysteroscopes epidu- roscopes neuroscopes choledochoscopes ureteroscopes bronchoscopes ureteroscopes naso-pharyngo-laryngoscopes and ultrasound transducers in less than  minutes. he sterilied deices can be used imme-


diately or may be stored prior to their net use Robinson added. he approimately  minute cycle time is much closer to that of a  system as compared to the ery long cycle time for ethylene oide steriliers.


1. thylene ide teriliation for edical eices  https:// www.fda.go/medical-deices/general-hospital-deices-and- supplies/ethylene-oide-steriliation-medical-deices


. egislators uneil bill to eep ethylene oide emissions away from densely populated regions he tate ournal-Register eptember 1 1. https://www.s-r.com/news/11/ legislators-uneil-bill-to-eep-ethylene-oide-emissions-away- from-densely-populated-regions


mechanisms cannot be cleaned effectively by the cleaning equipment we have today then perhaps we need to strike a balance between reusable and disposable.”


Manufacturer support of the CS/SPD According to Anna R. Gutierrez, AA, CRCST, CSPDT, CIS, CFER, Sterile Process- ing Educator/Advocate, Sterile Processing Program Director at Fortis College, putting greater control into the hands of CS/SPD professionals as to which mechanisms they use for HLD and sterilization would help improve device safety. She believes manu- facturers should test their devices with a variety of chemistries so that the CS/SPD has a choice as to which one they will use. “As a sterile processing technician I believe every technician should know about all the options they have when disinfect- ing or sterilizing a medical device,” said Gutierrez. “One can never know what can happen in the operating room that can warrant the use of a HLD rather than


Anna R. Gutierrez


sterilization. For awhile now HLD and some forms of sterilization such as EtO have received such a bad rap and thus some hos-


pitals have gone away from certain chemical processes not realizing if used properly can be more effective in killing microorganisms or can even save reprocessing time. In fact, I have noticed most manufacturers don’t even include EtO instructions in their IFUs any longer.” utierre says the Spaulding Classifica- tion system should be used as a guide, and CS/SPD professionals should take other factors into consideration when determining whether a device requires HLD or steriliza- tion, such as what types of microorganisms may be present on the device and whether or not the chemistry will kill a certain type of microorganism. “As technicians we all have received heav- ily soiled instruments that have undergone ‘mucous membrane’ procedures that arrive into decontamination in pretty question- able circumstances,” said Gutierrez. “There are times when the manufacturers’ IFUs for these devices will specify HLD, such as some older generation sigmoidoscopes and exible endoscopes. Sometimes the manu- facturer will approve EtO sterilization for the scope but the hospital may not have access to that process and thus use HLD as their only option. At the end of the day, having more options in the form of sterilization is always a better solution than HLD in my opinion.”


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