A few years ago, we conducted a study with the V.P. of The Musculoskeletal Infection Society, Dr. Antonia Chen, and Noreen Hickok, a PhD Chemist. The doctors designed the protocol and conducted the study at the Rothman Orthopedic Institute. The study compared the sterility of orthopedic drill bits in their reprocessed consigned trays to prepackaged sterile drill bits.
In each of 4 separate test events, 25% of the drill bits pulled from consigned trays had living fungus and bacteria on them.
What does this tell us? Does it mean that steam sterilization doesn’t work or that blue wrap and sterilization containers don’t work? Does it mean the manufacturers’ IFU’s are incorrect? Or perhaps the life of a sterilized instrument is just unpredictable once it leaves the sterilizer and sterility is not guaranteed?
Who knows? But data is data, and the quality of our data cannot be disputed. Maybe there should be more testing like the one in our study. Not just looking at a sterilization indicator to verify sterility but testing random lots of instruments post cycle. Until the mystery is solved, we must do everything we can to protect an instrument during and after sterilization so that it arrives to the surgeon’s hands sterile.
When using peel packs, I suggest adding instrument protectors. Adding structure to the pack helps maintain the integrity of the sterile barrier. They help protect the seals by keeping an instrument immobile. They prevent crushing/creasing during storage, handling and transport. Well-designed instrument protectors allow for more sterilant contact and facilitates heat transfer, giving the instrument a better chance at getting (and staying) sterile in the first place.
(A summary of the study results can be found at www.sterilebits.com)