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If sterilizing an implantable device, should users perform biological monitoring (spore testing) more frequently?

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If sterilizing an implantable device, should users perform biological monitoring (spore testing) more frequently?

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10

Any load containing implantable devices should be monitored. Ideally, implantable items should not be used until the results of tests are known to be negative. As previously noted, the manufacturer’s directions concerning the appropriate placement of the biologic indicator (BI) in the sterilizer must be followed. A control BI (not processed through the sterilizer) from the same lot as the test indicator should be incubated in the same manner as the test BI. The control biological indicator should yield positive results for bacterial growth.

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