Surgical Trays: Ensuring Sterility and Safe Handling
By Kris Ellis
The processing, wrapping, and handling of surgical trays are daily activities in every sterile processing department (SPD). In order to establish and maintain sterile instruments and trays, SPD personnel must be consistent in adhering to recommended practices and ensuring the proper functionality of vital equipment. These efforts require continuous monitoring of procedures and standards, as well as equipment specifications and capabilities.
Becki Jenkins, CST, RCST, CRCST, FEL, director and medical coordinator of Missionary Connection, suggests that an intimate familiarity with sterilizer manufacturers recommendations is essential. Right inside of every sterilization manual, theres a section for recommended load configuration, she says. There is a formula used for package density and there are also several recommendations for how you would assemble a set on the inside. For example, some instruments are denser than others and they would be placed more in the middle of the tray rather than on the ends of the tray.
Jenkins explains that putting denser instruments in the middle of the tray makes the most sense because the indicator will also be placed in the middle. So if the indicator changes in the middle of they tray, that means that the parameters of the machine, of the sterilizer youre using, were maintained in the middle of that tray, so you can be reasonably assured that its sterile.
Jenkins notes that sterility assurance is frequently misinterpreted, and that a thorough understanding of this concept can be highly beneficial. What it means is that the parameters of the sterilizer that you used were met, she explains. Youre going to sterilize your tray and youre going to use indicators that are provided by the manufacturer that measure the criteria that they say will make the set or the instrument sterile at the end of the cycle. If at the end of the cycle the indicator changed, it means that all parameters for that sterilizer were met, thereby you can be reasonably assured that its sterile.
The concept of reasonable assurance, in terms of sterility, is based on 10-log-six, or one part per million. That means that theres one bug in a million that could actually create disease, says Jenkins. How we get the sterility assurance is theyre validating at half cycles, and even the sterilizer manufacturers are validating their cycles in their sterilizers at a half cycles, and then its doubled when we get it (through use of a full cycle). Theyre going to sterilize it at two minutes. If it gets to a terminal kill at two minutes, were going to be sterilizing it for four minutes, so its reasonable to think that were actually going to get greater than a 106 kill, because were doubling the sterilization time. Thats sterility assurance. So our sterility assurance levels 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) standards serve as guiding principles in the SPD. Generally speaking, we make sure everything is properly classified if its going in a sterilizer, it needs to be a Class 2 and validated for a commonly available sterilization cycle, she says. And that would be true of rigid sterilization containers as well as those that get wrapped in a sterile wrap. For instrumentation as well as the trays, whether they be rigid or wrapped, we make sure we have the manufacturers instructions for both.
According to Jenkins, ensuring that sterilizers have been validated for a cycle commonly available in healthcare is key. I think a big problem everywhere right now is getting manufacturers to understand that we dont have these unusual cycles that they present to us, she says. Thats a major point of contention within even the standards committees is that people say, I dont understand, were validating them according to the guidelines, well were leaving out that part commonly available in healthcare.
Jenkins explains that the specified amount of weight per tray that a sterilizer can hold is another area of concern in sterile processing circles. Manufacturers sometimes want to hold it to an Occupational Safety and Health Administration (OSHA) recommendation, which is 35 pounds, ignoring the fact that the autoclave makers themselves have validated their system for no more than 16 pounds to 20 pounds, depending on the manufacturer. Theyre kind of focusing on the weight only from an ergonomic point of view rather than from a sterilization and an ergonomic point of view, which would mean we need to adhere to the 16-pound to 20- pound weight limit prescribed by the manufacturer of the sterilizer. Interestingly enough, if they did that, then the ergonomic concern would go away. Theyre not lifting 35 pounds, which is what the ergonomic OSHA regulation is; youre lifting no more than 16 pounds to 20 pounds.
Packaging materials that go inside trays are also a source of concern for Jenkins. Those materials can directly affect the sterilization process, she says. Theyre classified as a Class 1, so theyre not actually required to produce any validation information, but most of the companies, I would say a greater number of them do produce that information than not. But because its classified as Class 1, theyre really not required to.
The argument is, its a towel, well, a towel is made of cotton and thats approved science; thats 240 woven muslin and thats approved science we know that that works. If you start throwing in different types of papers and different types of polyurethane to throw on the trays, thats the same thing that peel pouches are made of, and they had to validate those.
The Association of periOperative Registered Nurses (AORN)s Recommended Practices for Selection and Use of Packaging Systems specifies that packaging systems should:
- Be appropriate to the items that are being sterilized (i.e., permit identification of contents; permit complete and secured enclosure of the items; protect contents from damage such as tears, punctures, and abrasions; be free of holes; be free of toxic ingredients; be low-linting; permit delivery of contents without contamination; and maintain sterility of package contents until opened)
- Be appropriate to the method of sterilization (i.e., provide adequate seal integrity; be tamperproof and able to seal only once; provide an adequate barrier to particulate matter and fluids; be compatible with and able to withstand physical conditions of the sterilization process; permit adequate air removal; allow penetration and removal of the sterilant);
- Have a favorable cost/benefit ratio; and Be used according to the manufacturers instructions.1
In terms of compatibility with the sterilization process, packaging systems AORN also recommends that packaging systems should:
- Provide adequate air removal
- Permit steam penetration and direct contact with surfaces of items
- Permit adequate drying
- Permit use of material compatible (i.e., non-degradable) with the sterilization process
- Maintain the integrity of the system.
In maintaining the sterility of items that have gone through the sterilization process, care must be taken in the manner in which they are handled and moved. Jenkins says limiting the number of times items are moved is an important consideration. Every time its moved, there are hands touching it, she notes. I wouldnt recommend harsh handling of any kind of sterilization container, because they all have filters or wraps. But more specifically, theres a danger with wrapped items because sometimes people almost haphazardly throw them down. Thats true of peel pouches, and even closed containers because they just have filters on the top.
Protocol calls for trays to be carried away from the body with arms outstretched. Jenkins points out that for those facilities that use trays weighing 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 some modification, in Jenkins opinion. We have event-related sterility now, and what that means is as long as theres no damage and nothing that can be seen that was done to the package, it can be considered sterile, she says. I wish they would also include handling of the package, because if it gets slammed into the cabinet or dropped on the floor, just because theres no visible markings on the outside of the package, I assure you that unsterile air went into that package, and now we have an area where we dont have a sterile package anymore, so theres a little more education that needs to happen on that. Trays should also be carried one at a time; we have people that are stacking four or five trays on top of each other and carrying them down the hall, and theres no way for them to have that away from their body.
In summary, Jenkins advocates diligent education for SPD professionals, as well as manufacturers. If those of us who are end users dont educate ourselves, if we dont stay up on standards and procedures and protocols, the patient suffers, because were not going to ask the right questions and if the manufacturers arent doing the same thing, then theyre not 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 been for the last nine or 10 years now lets start working together. Whatever we do or dont do can have repercussions on our patients, who might be us someday. 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 packaging systems. Association of periOperative Registered Nurses. AORN J. 2000 Dec;72(6):1052-6, 1058-9.