Qualification - ANSTesting that assesses the performance of a steam sterilizer in the
environment in which it will be used before the equipment is approved for routine use in the
healthcare facility.
Validation - ANSDocumented procedures performed by a medical device manufacturer to
establish that a process consistently yields a product complying with predetermined
specifications.
Verification - ANSDocumented procedures performed in the users environment to establish that
predetermined specifications have been met.
Lot (load) control number - ANSNumber and /or letters by which a specific group of products
can be traced to a particular manufacturing or sterilization operation.
Extended cycle - ANSSterilization cycles that fall outside of the traditional cycles used in the
Central Service department because exposure times exceed standard steam sterilization times.
Wet pack - ANSTrays/containers containing moisture after the sterilization process is complete
Biobarrier - ANSA package system that allows a sterilant to enter a pack and after sterilization,
creates a barrier to contamination.
Extending sterilization cycles - ANSWhile some sterilization failures result from mechanical
failures over which the technician has no control, many failures can be avoided by:
False - ANSA steam sterilizer can successfully sterilize anything placed in it.
Steam traps - ANSThese are installed on the steam distribution line to help remove
condensation.
False - ANSWell-managed departments are not impacted by the grapevine.
Master budget - ANSThis budget predicts the healthcare facility's total revenue and expenses
for a specified period of time.
Six Sigma - ANSA quality process that focuses on developing near-perfect products and
services.
Prions - ANSCause for special concern in CS because routine reprocessing processes are not
enough to protect patients.
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