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 oide t is an effectie low tem- perature method of steriliation for heat and moisture sensitie deices including eible endoscopes. ccording to the .. ood and rug dministration about fty percent of all sterile medical deices in the .. are sterilied with ethylene oide.1
ut the proper-
ties that mae t such a great method of steriliation its ability to ill also present potential safety riss with its use. Recent media reports hae highlighted forced
t steriliation plant shut downs in eorgia and llinois because of eleated carcinogenic gas emissions in surrounding communities. llinois ouse ill sees to phase out eth- ylene oide emissions in the state preenting any steriliation company within e miles of a region with a population density of at least 1 residents per suare mile or within the same distance from a school or day care. ospitals would need to meet the same reuirement by anuary and critical access hospitals by . t has been around for a long time and has
gotten a bad rap oer the years said amien erg Regional anager of terile rocessing at ealth and mmediate ast resident of and oting member and co- chair for seeral committees. he lethality is amaing and its compatibility with materials is great. t does its ob ery well. he downside
is its toicity but that is what maes it a good sterilier. ecause of the toicity the hospitals hae to comply with regulatory reuirements 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 hospitals worow and the products you need to sterilie. nna R. utierre R
R terile rocessing ducator/docate terile rocessing rogram irector at ortis ollege describes her recent isit to a manu- facturing endor that supplies basin sets and R pacs using inactie t. he says trained sterile processing technicians rst assembled trays its and pacs 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 inactie t were drawn into the bag maing the sealing process safe for the technician to handle. he pacages were then placed onto a cart and rolled into a warm incubating chamber where the t was actiated inside of the bag. he pacages remained there for a certain amount of time to fully sterilie all items inside of the specially designed bags and were then uarantined until biological and chemical indicators read negatie.
32 December 2019 • HEALTHCARE PURCHASING NEWS •
hpnonline.com was impressed said utierre. here were
so many uestions during my isit but hae to say it was one of my most interesting eperi- ences had eperienced. he manufacturer did undergo a premaret approal clearing with the and of course there is so much more to learn of this process. thylene oide is not the only option for
steriliing heat or moisture sensitie semi-critical deices of concern said r. ancy Robinson istinguished cientist R. aporied hydrogen peroide steriliers such as the - R ow emperature teriliation ystems are used to sterilie hysteroscopes epidu- roscopes neuroscopes choledochoscopes ureteroscopes bronchoscopes ureteroscopes naso-pharyngo-laryngoscopes and ultrasound transducers in less than minutes. he sterilied deices can be used imme-
diately or may be stored prior to their net use Robinson added. he approimately minute cycle time is much closer to that of a system as compared to the ery long cycle time for ethylene oide steriliers.
1. thylene ide teriliation for edical eices https:// www.fda.go/medical-deices/general-hospital-deices-and- supplies/ethylene-oide-steriliation-medical-deices
. egislators uneil bill to eep ethylene oide emissions away from densely populated regions he tate ournal-Register eptember 1 1. https://www.s
-r.com/news/11/ legislators-uneil-bill-to-eep-ethylene-oide-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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