The Autoclave Spore Test Comes Back Positive on Friday Afternoon
Friday, 4:40 p.m. The office manager reads the weekly biological spore test for the office autoclave: positive, with growth in both the test vial and the control vial. The last negative test was the prior Friday. During the week, 12 instrument packs were processed and used on 31 patients. Four packs sit unwrapped in the clean supply cabinet, and two loads are still in the sterilizer. The backup autoclave was serviced two weeks ago but has not had a spore test since service. Three procedures are booked Monday at 8:00 a.m., and no one has been assigned to call patients.
1. What happens in the first hour?
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Stop and quarantine. Take the affected sterilizer out of service and label it. Growth in the control vial means the test is valid - this is a true failure, not a test error, so do not rationalize it away.
- Remove all four packs from the clean cabinet and hold them; do not open or use.
- Do not unload and use the two loads still inside; treat them as contaminated.
- Do not assume the backup is usable. It has had no biological indicator since service, so it is unverified. Run a spore test with a control and hold Monday scheduling until results are in.
- Pull the sterilization log and match load numbers, dates, and indicators to the packs used, so you can identify which patients received instruments from which load.
- Notify the provider and the person responsible for infection control, and open an incident record with times and actions.
Do not throw anything away - packs, vials, and logs are the evidence trail.
2. What is the reasoning behind patient notification here, and who decides?
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The MA does not decide this alone; the provider and infection-control lead make the clinical call, with the practice manager handling communication logistics. The MA's job is to supply accurate data: which loads were released, which packs went to which patients, and when.
Reasoning: 31 patients were exposed to instruments that may not have been sterile. Actual transmission risk from a failed cycle is low, but the practice cannot assume zero and cannot silently wait for infections to appear. The decision turns on whether packs from released loads were used on patients, which organisms are plausible, and what the practice's exposure policy and state requirements say. The standard sequence is: identify exposed patients, notify them with clear instructions on signs of infection and whom to call, notify the provider so any presenting infection is evaluated with this history in mind, and document all of it.
Blaming or hiding is not an option; a documented, prompt response is what protects patients and the practice.
3. What has to happen before the sterilizer is used again, and what do you do about Monday?
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Return to service criteria (per manufacturer instructions and practice policy): repair or service as indicated, then revalidate - biological indicator with a control, plus mechanical and chemical monitoring, repeated for a defined number of consecutive negative cycles (commonly three) before any load is released. Log every cycle. Until then, the unit is not in service regardless of the Monday schedule.
Monday: assume no in-house sterilization unless the backup completes and passes verification. Options, in order of preference: shift the three procedures to a later date; refer to a colleague or surgery center with verified sterilization; use only pre-sterilized single-use or vendor-sterilized instruments if the practice stocks them. Do not run a cycle on an unverified unit to save the schedule.
Call the affected patients Friday or first thing Monday, document the reason and the options offered, and notify the provider so clinical urgency is weighed for each case.