Monitoring & QAQuestion 64 of 100
A supervisor asks a technician to assemble a process challenge device for the daily biological indicator test. What is a process challenge device?
a.A device that measures chamber pressure independently of the sterilizer gauges
b.A test assembly that presents a challenge to the sterilization process equal to or greater than the most difficult item routinely processed, containing a biological or chemical indicator
c.A tray of instruments used only for training new technicians
d.A software module that records cycle data for traceability
Explanation
A PCD, such as a commercial test pack or a homemade AAMI test pack, places the indicator in the hardest-to-sterilize location so that a passing result gives confidence that easier items were also processed. The design must challenge the process at least as much as the routine load. Pressure verification, training, and electronic record keeping are separate functions unrelated to the definition of a PCD.
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