Combining similar instruments with different IFUs; lining sterilizer racks; mixing sterilization containers
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Q How should we handle sets that have instruments from multiple manufacturers? The problem concerns the manufacturers’ IFUs, as they generally are not in agreement about sterilization parameters. I suggested using the most stringent parameters, but my staff does not agree with me. Have you dealt with this issue before? Is it OK to go above and beyond what the IFU instructs? I greatly appreciate any advice you can give. Thank you!
A As you know, CS/SPD staff are expected to follow all manufacturers’ IFUs for reprocessing medical devices. Regarding sterilization parameters, such as method, exposure, temperature and time, the manufacturer’s IFU provides the validated effective conditions that will render the device sterile without damaging it. Deviation from the IFU could therefore result in sterilization failure and instrument damage, which could pose a very serious risk to patient safety and welfare. In the event you are dealing with all similar general surgery instrumentation, such as handheld stainless steel, hemostats, forceps, scissors, retractors and the like, where the IFU may have given a minimum temperature and exposure time but fail to provide a maximum or acceptable range, it is important that you obtain clarification in writing prior to deviating from the IFU. Most family groupings of such instrumentation can most likely be sterilized within the same parameters.
Q We have always used linen materials, such as wrappers, drapes and sheets, to line our sterilizer racks in an effort to help prevent tears and wetness. This always did the job quite well. I went to an OR nursing conference awhile back and a speaker said that linens should not be used as they are inappropriate for this purpose from both a technique and economic perspective. As a result, we decided to discontinue this practice. Since then we have tried using single-use foam shelf liners which are quite expensive. They seemed to work well as far as preventing excessive tearing, but we were experiencing a great deal of wet packs and other moisture issues which has created delivery problems with the OR. We have had to delay some cases and increase IUSS to re-sterilize the contaminated instrument sets. We have not changed anything in the packaging or instrument processing and have investigated all the common causes for wet packs, including the sterilizer’s performance. Everything seemed to check out. I believe that for some reason the foam liners are the cause of the wetness. The vendor rep says he has not heard of any other hospitals having this problem, so it must be an internal issue. We have temporarily gone back to using linens as liners and all is good. I know that we shouldn’t use the linen and I am looking for another alternative. Do you have any suggestions?
A I have worked with many hospitals to help resolve the issue of wet packs. In most cases, sterilizer issues relating to steam quality and/or processing was the problem. Once the issues were identified, the staff implemented corrective actions. I have also worked with several hospitals where after a thorough analysis; we concluded that the foam liners were causing an increase in moisture retention. Foam does have its benefits but it also has major disadvantages. Its inferior wicking and absorption impedes drying and results in wet packs and contamination. Foam liners, as you noted, are also expensive. Many of my clients have converted to cellulose, autoclave cart-shelf liners. (see Figure 1). The liners can be reused and some facilities routinely change the liners daily, while others are changing them weekly or when they get water-stained. Those who use cellulose liners report that they provide superior tear and moisture prevention with savings well over 50 percent compared to what foam liners cost.
Q We have a new nurse manager in our sterile processing department and she is requiring that we do not mix instrument containers in loads with other items. She says the containers can create excessive metal mass which can cause excessive moisture and contamination to the other wrapped or packaged items. I have never heard of this before. We have been mixing our loads this way for years and very seldom do we encounter wetness with packaging. Is there some standard that states loads cannot contain items with different packaging materials?
AThere is no standard or recommendation that states that containers cannot be sterilized in the same sterilizer load with items packaged in different materials. As a matter of fact AAMI ST79 clearly states that “rigid sterilization containers can be sterilized safely and economically in the same load as other supplies that require a common exposure cycle.” As is in the all sterilizer loads attention must be given to the proper loading and configuration of all items that are placed in the sterilizer. In the case of a mixed load which includes sterilization containers, wrapped and peel pouch items, the sterilization containers should be placed on shelves below items which are packaged in absorbent materials such as linens, synthetics, disposable flat wraps and peel pouches. Unless specified differently in the manufacturers IFU containers should be placed with the container bottom flat on the shelf. Proper placement of the container is important as it will facilitate air evacuation providing for full sterilant permeation and efficient drying. The stacking of sterilization containers should not exceed the number stated in the manufacturer’s IFU. If instructions and validation for the stacking of the containers during the sterilization process is not clearly documented in the IFU it should not be done.
Ray Taurasi
Ray Taurasi is Principal, Healthcare CS Solutions. His healthcare career spans over five decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, SGNA, AAMI and a past president of IAHCSMM. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration, nursing, and health sciences. He is the author of numerous articles and textbook chapters; he is a frequent speaker at national and international healthcare conferences.
Note to readers from Ray Taurasi - In 2021, my life’s career path will transition to one of new opportunities and adventures. As a result, after nearly 19 years and 225 CS Solution columns, this edition will be my last.
“All changes, even the most longed for, have their melancholy; for what we leave behind us is a part of ourselves; we must die to one life before we can enter another.”– Anatole France
I wish you and your loved ones a healthy and joyful holiday season and a beautiful New Year! God Speed, Ray
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