Differential diagnosis:
(1) false positive biological indicator (BI)
(2) bad run due to improper settings (run-specific problems)
(3) intermittent autoclave failure
(4) definite ("hard") autoclave failure
Response:
(1) Take the autoclave out of service pending an investigation.
(2) Identify the items that were involved in the implicated run and any subsequent runs.
(3) Review the records of the affected run for run-specific procedural problems.
(4) Review recent results of biological indicators for the autoclave.
(5) Review the results of the positive indicator to make sure results are valid, looking for evidence of improper handle or contamination (based on Gram stain and culture of the indicator).
(6) Perform 3 runs of the autoclave, each with a biological indicator. Consider using paired indicators from different manufacturers.
If an implantable device is involved, it should be resterilized just to make sure it is sterile.
If (a) review of the records shows no problems with the autoclave, (b) a possible false positive indicator and (c) all 3 test indicators are negative:
(1) Do not recall and resterilize items.
(2) Closely monitor the autoclave for any signs of failure
(3) Perform daily indicator tests for 1 week.
If run-specific problems are identified:
(1) Recall and resterilize items in that run.
(2) Closely monitor the autoclave for any signs of failure
(3) Perform daily indicator tests for 1 week.
If there is evidence of (a) equipment failure, (b) problem with utilities or (c) one or more indicators are positive:
(1) Recall and resterilize all items since the last negative biological indicator in a working autoclave.
(2) Troubleshoot the affected autoclave.
(3) Monitor patients who may have been exposed to items in the implicated autoclave runs.
