The average sterile processing department has a number of similarities with a wedding cake: lots of expensive ingredients mixed together and every step and ingredient have to be perfect, or it has the potential to ruin someone’s big day. And just like a wedding cake, there are certain things that should not be included in the final product. No one wants to accidentally take a bite of a decorative flower or chip a tooth on a plastic bride-and-groom figurine. Likewise, surgeons and surveyors don’t want to open a surgical tray to find something in there that really shouldn’t belong. Wedding cake surprises may ruin a day, but sterilization surprises can impact lives.
What are these surprising additions to surgical trays that don’t deserve to be there? What items most often show up without an IFU invite? Let’s take a look at seven sterile processing ingredients that you should leave out of your trays and out in the cold.
Nonsurgical spoons Believe it or not, there is such a thing as a surgical-grade spoon. Used in everything from OB/GYN procedures to cardiothoracic surgeries to lift the sternum while stitching, these surgical-grade medical devices really do serve a clinical purpose. The problem comes in when nonsurgical spoons make their way into our surgical trays. There are many surgical inventories around the country that are actually using cafeteria spoons for these purposes, putting themselves at genuine risk of regulatory findings and potential lawsuits for using non-FDA-approved devices in the medical setting. As basic as it may sound, these nonsurgical spoons can often be identified by decorative designs on their handles or silverware company names on the back of the handle. Without sterilization validations or instructions for use, these nonsurgical spoons should be replaced immediately with appropriate surgical devices.
Wooden toothpicks It is not uncommon to find sterile processing departments today that are packaging and processing wooden toothpicks for particular surgeons who, among other reasons, use the toothpicks to remove specimens from a biopsy site. Even though these objects are not reused, as with the other items on this list, they have not been through sterilization validation testing in a laboratory setting to develop reliable sterilization parameters for hospitals to safely and compliantly sterilize them onsite. Because they have no validation and no IFUs, they have no place in our sterilizers or on our sterile storage shelves, and definitely have no place touching our patients. If requested, departments should supply industrially sterile options that come packaged from the manufacturer.
Rubber bands Similar to the wooden toothpicks mentioned above, rubber bands can sometimes make their way into an SPD inventory as an item themselves, or used as a means to hold cords or other multipiece instruments together inside a package. These also lack instructions for use for proper sterilization in a hospital setting, so any manner in which they are processed, packaged, and distributed by the SPD would only be a best guess, not a validated form of device processing and sterilization. Even if the rubber bands themselves are not being used for anything more than holding a cord, if you can’t prove with manufacturer documentation that the band itself can be made sterile, then you can’t ensure the sterility of the device it is holding together. Industrially sterilized rubber bands are available if your facility requires them for some reason.
Safety pins Safety pins are another example of surgical wedding-cake crashers if they are being processed through the SPD without documented validations and IFUs. Used for various purposes, such as pinning sterile drapes and attaching drapes to drains, safety pins have a valid use in the operating room and are available sterilized from the manufacturer. These items typically do not come with instructions for sterilizing onsite, and are definitely not approved as reusable medical devices. They are most commonly packaged for use with particular circumcision clamps and, if required at your facility, should be purchased sterilized for single use.
#2 pencils Not just for elementary school pop quizzes, the classic wooden graphite pencil has also written itself into an inventory list or two in various hospitals across the U.S. Used to mark osteotomy cuts in craniofacial and maxillofacial surgery, among other things, these items (yep, you guessed it) typically don’t come with validated sterilization parameters, and thus, should not be flowing through your sterile processing department into the operating room. Again, even if the argument is posed as, “The pencil never leaves the back table and is just used to take notes,” the proper response should be, “If we can’t validate the sterility of the pencil, we can’t ensure the entire back table is not at risk of contamination.” Hey! Ho! Pencils have to go!
Paper No conversation of pencils would be complete without their partner in surgical crime, printer paper. Out of all these uninvited surgical guests, paper is by far the most used and most controversial. In keeping with the theme of this post, the fundamental question that must be answered is whether Staples, Office Max, or Dunder Mifflin has done sterilization validation studies on their paper and supplied your sterile processing department with instructions for proper packaging and validated sterilization parameters for it? If not, what evidence-based best practice or regulatory-compliant process are you operating under when your SPD team places paper count sheets or inventory lists in your sterilized trays? Why should printer paper get a pass when every other aspect of the surgical field must pass rigorous infection control and regulatory standards? The answer is it shouldn’t.
Rope Finally, there is no better item to tie up this entire conversation with than rope. Needed for particular traction scenarios, the case can easily be made for a clinical use of sterile rope. The problems arise, again, when sterile processing is asked to process particular rope products without an associated IFU and validated parameters. If your traction rope arrives at your department in a Walmart bag, that is a tell-tale sign that it should go back out the same door through which it came. If you cannot locate manufacturer parameters for sterilization, the rope cannot and should not continue on through your department workflow. As with many of the other items on this list, industrially sterilized rope is available for single-use.
The parameter prenup If you find yourself at the end of this article surprised at how one of these items ended up uninvited in your surgical trays, you are not alone. But now that you have identified the culprit, it’s time to cut it out of your reprocessing party, and clarify your department policies to guard against any items going into your sterilizers unless they have validated parameters backing them up. Your surgical guests are depending on you to get their surgical ingredients right.
To make sure that happens, you shouldn’t say “I do” without an IFU.
(Originally published through the Ultra Clean NewSplash series)