Autoclave Pack With a Failed Internal Indicator Before Elective Surgery
It is 9:10 am on a Tuesday. Three elective surgeries are booked: two cat neuters and one dog ovariohysterectomy. At 8:50 am you open the autoclave and find that the external chemical indicator tape on the ovariohysterectomy pack has turned from beige to dark brown, but the internal chemical indicator strip inside the pack is still beige. The autoclave log shows a cycle at 132 C for 4 minutes with a pressure of 27 psi; the daily Bowie-Dick test was not run because the practice's steam generator was serviced yesterday and the first cycle of the day was this pack. The pack wrapper is intact and dry, and the pack was assembled on Friday. The surgeon is ready and the owner has already paid a deposit. A second, smaller pack containing only a laparotomy drape and gowns is available with a passing internal indicator, but it does not contain the instruments needed for the ovariohysterectomy.
1. Can this pack be used? What immediate actions would you take, and what would you say to the surgeon?
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The pack should not be used. The external tape only shows that the pack was exposed to the sterilization process; it does not prove that steam penetrated to the center of the pack. The internal indicator is the meaningful check for this pack, and it is still beige, so sterilization is not confirmed. The fact that the wrapper is intact and dry, or that the pack was assembled on Friday, does not override a failed internal indicator. The pack should be quarantined, not opened onto the surgical field.
I would tell the surgeon immediately and clearly: the internal indicator failed, the pack is not usable, and the case needs to be delayed or rescheduled. I would pull every pack from that load and quarantine them, label the autoclave as out of service until it is checked, and run a Bowie-Dick test before any further processing. I would look for another source of the needed instruments, such as a loaner pack from a nearby practice, but I would not substitute the smaller drape-and-gown pack because it lacks the instruments. I would document the failure, the time, the load contents, and the actions taken, and I would not let the deposit pressure me into using an unverified pack.
2. What are the likely causes of this failure, and what changes would you make to prevent it from recurring?
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The most likely cause is an air-removal or steam-quality problem: the generator was just serviced, the first cycle of the day was this pack, and the Bowie-Dick test was skipped. Residual air in the chamber prevents steam from reaching the center of a wrapped pack, so the outside tape changes while the inside strip does not. Other possibilities include overloading the chamber, placing packs too tightly, using the wrong cycle parameters for the pack type, or a faulty internal indicator, but the timing and the skipped Bowie-Dick test point first to air removal or steam quality.
Prevention is procedural. The Bowie-Dick test should be run at the start of every day the autoclave is used and after major service, before any load is released. Every pack should be checked for an internal indicator before it is put on the shelf, and the result should be logged. Biological indicators should be run on the schedule the practice has set, and the autoclave should be serviced and validated after the repair. Staff should be trained that external tape is not proof of sterility. I would also review loading patterns and cycle selection for wrapped instrument packs versus flash cycles, and I would make sure the log includes the Bowie-Dick result, not just the time and temperature.
3. How would you handle the client and the schedule, and what would you document?
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I would ask the surgeon to speak with the owner, or I would speak with the owner if the surgeon delegated it, and explain that the surgery is being delayed because a sterilization check did not pass. I would avoid technical blame and avoid saying the pack was sterile when it was not. I would give a realistic new time or date, explain that the dog is not in pain or at immediate risk from waiting, and offer to call when the instruments are verified. If the owner cannot return, I would discuss transfer to another practice rather than proceed with unverified instruments.
For the schedule, I would proceed with the two cat neuters only if I had verified packs for them, and I would not use any pack from the failed load. I would document the failed indicator, the load contents, the quarantine, the autoclave being taken out of service, the Bowie-Dick result after the repair, the owner conversation, and the rescheduled date. I would also complete an incident report if the practice uses one. The record should show that the decision was made for patient safety, not that the team was careless.