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By Kris Ellis
The processing, wrapping, and handlingof surgical trays are daily activities in every sterile processing department(SPD). In order to establish and maintain sterile instruments and trays, SPDpersonnel must be consistent in adhering to recommended practices and ensuringthe proper functionality of vital equipment. These efforts require continuousmonitoring of procedures and standards, as well as equipment specifications andcapabilities.
Becki Jenkins, CST, RCST, CRCST, FEL, director and medicalcoordinator of Missionary Connection, suggests that an intimate familiarity withsterilizer manufacturers recommendations is essential. Right inside ofevery sterilization manual, theres a section for recommended loadconfiguration, she says. There is a formula used for package density andthere are also several recommendations for how you would assemble a set on theinside. For example, some instruments are denser than others and they would beplaced more in the middle of the tray rather than on the ends of the tray.
Jenkins explains that putting denser instruments in the middleof the tray makes the most sense because the indicator will also be placed inthe middle. So if the indicator changes in the middle of they tray, thatmeans that the parameters of the machine, of the sterilizer youre using, weremaintained in the middle of that tray, so you can be reasonably assured that itssterile.
Jenkins notes that sterility assurance is frequentlymisinterpreted, and that a thorough understanding of this concept can be highlybeneficial. What it means is that the parameters of the sterilizer that youused were met, she explains. Youre going to sterilize your tray and youregoing to use indicators that are provided by the manufacturer that measure thecriteria that they say will make the set or the instrument sterile at the end ofthe cycle. If at the end of the cycle the indicator changed, it means that allparameters for that sterilizer were met, thereby you can be reasonably assuredthat its sterile.
The concept of reasonable assurance, in terms of sterility, isbased on 10-log-six, or one part per million. That means that theres onebug in a million that could actually create disease, says Jenkins. How weget the sterility assurance is theyre validating at half cycles, and even thesterilizer manufacturers are validating their cycles in their sterilizers at ahalf cycles, and then its doubled when we get it (through use of a fullcycle). Theyre going to sterilize it at two minutes. If it gets to a terminal kill at two minutes, were going tobe sterilizing it for four minutes, so its reasonable to think that wereactually going to get greater than a 106 kill, because were doubling thesterilization time. Thats sterility assurance. So our sterility assurancelevels are really pretty high when you look at it like that.
At Jenkins facility, a large Midwestern hospital,Association for the Advancement of Medical Instrumentation (AAMI) standardsserve as guiding principles in the SPD. Generally speaking, we make sure everything is properlyclassified if its going in a sterilizer, it needs to be a Class 2 andvalidated for a commonly available sterilization cycle, she says. And thatwould be true of rigid sterilization containers as well as those that getwrapped in a sterile wrap. For instrumentation as well as the trays, whetherthey be rigid or wrapped, we make sure we have the manufacturers instructionsfor both.
According to Jenkins, ensuring that sterilizers have beenvalidated for a cycle commonly available in healthcare is key. I think a bigproblem everywhere right now is getting manufacturers to understand that we donthave these unusual cycles that they present to us, she says. Thats amajor point of contention within even the standards committees is that peoplesay, I dont understand, were validating them according to theguidelines, well were leaving out that part commonly available inhealthcare.
Jenkins explains that the specified amount of weight per traythat a sterilizer can hold is another area of concern in sterile processingcircles. Manufacturers sometimes want to hold it to an Occupational Safetyand Health Administration (OSHA) recommendation, which is 35 pounds, ignoringthe fact that the autoclave makers themselves have validated their system for nomore than 16 pounds to 20 pounds, depending on the manufacturer. Theyre kindof focusing on the weight only from an ergonomic point of view rather than froma sterilization and an ergonomic point of view, which would mean we need toadhere to the 16-pound to 20- pound weight limit prescribed by the manufacturerof the sterilizer. Interestingly enough, if they did that, then the ergonomicconcern would go away. Theyre not lifting 35 pounds, which is what theergonomic OSHA regulation is; youre lifting no more than 16 pounds to 20pounds.
Packaging materials that go inside trays are also a source ofconcern for Jenkins. Those materials can directly affect the sterilizationprocess, she says. Theyre classified as a Class 1, so theyre notactually required to produce any validation information, but most of thecompanies, I would say a greater number of them do produce that information thannot. But because its classified as Class 1, theyre really not required to.
The argument is, its a towel, well, a towel ismade of cotton and thats approved science; thats 240 woven muslin and thatsapproved science we know that that works. If you start throwing in differenttypes of papers and different types of polyurethane to throw on the trays, thatsthe same thing that peel pouches are made of, and they had to validate those.
The Association of periOperative Registered Nurses (AORN)sRecommended Practices for Selection and Use of Packaging Systems specifies thatpackaging systems should:
In terms of compatibility with the sterilization process,packaging systems AORN also recommends that packaging systems should:
In maintaining the sterility of items that have gone throughthe sterilization process, care must be taken in the manner in which they arehandled and moved. Jenkins says limiting the number of times items are moved isan important consideration. Every time its moved, there are hands touchingit, she notes. I wouldnt recommend harsh handling of anykind of sterilization container, because they all have filters or wraps. Butmore specifically, theres a danger with wrapped items because sometimespeople almost haphazardly throw them down. Thats true of peel pouches, and even closed containersbecause they just have filters on the top.
Protocol calls for trays to be carried away from the body witharms outstretched. Jenkins points out that for those facilities that use traysweighing up to 35 pounds, instead of the 16 to 20 recommended by manufacturers,this can be extremely difficult.
Event-related sterility is a concept that could use somemodification, in Jenkins opinion. We have event-related sterility now, andwhat that means is as long as theres no damage and nothing that can be seenthat was done to the package, it can be considered sterile, she says. Iwish they would also include handling of the package, because if it gets slammedinto the cabinet or dropped on the floor, just because theres no visiblemarkings on the outside of the package, I assure you that unsterile air wentinto that package, and now we have an area where we dont have a sterilepackage anymore, so theres a little more education that needs to happen onthat. Trays should also be carried one at a time; we have people that arestacking four or five trays on top of each other and carrying them down thehall, and theres no way for them to have that away from their body.
In summary, Jenkins advocates diligent education for SPDprofessionals, as well as manufacturers. If those of us who are end users donteducate ourselves, if we dont stay up on standards and procedures andprotocols, the patient suffers, because were not going to ask the rightquestions and if the manufacturers arent doing the same thing, then theyrenot going to be able to get us the answers if we have the questions to ask,she says. We all have to work together, and thats what my soapbox has beenfor the last nine or 10 years now lets start working together. Whateverwe do or dont do can have repercussions on our patients, who might be ussomeday. Patients or physicians should never have to ask if something is sterile thats our job and thats the manufacturers job.
1. Recommended practices for selection and use of packagingsystems. Association of periOperative Registered Nurses. AORN J. 2000 Dec;72(6):1052-6, 1058-9.