Sterilization第 57 / 100 题

An instrument manufacturer's instructions for use specify a prevacuum cycle at 270 degrees F for 4 minutes with an 8-minute dry time, but department policy uses a 30-minute dry time for all trays. Which should be followed?

a.Follow the longer validated department cycle only if it is also within what the device manufacturer permits; the device manufacturer instructions for use set the required minimum parameters and must be reconciled with sterilizer capability
b.Always follow department policy, because it is approved by the infection prevention committee
c.Always use the shortest parameters listed anywhere, to protect the instruments
d.Choose whichever parameters the operating room requests for turnaround

解析

Reprocessing must follow the device manufacturer written instructions for use, validated against what the facility sterilizer can actually deliver, and any conflict is resolved before the device is put into service rather than by local preference. Longer drying is generally acceptable, but exposure parameters cannot be shortened below the validated minimum. Turnaround pressure and blanket policy never override validated instructions.

法律依据: AAMI ST79

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