Monitoring & QA第 70 / 100 题

A recall requires the department to trace every package from a suspect cycle. What information must the load record contain?

a.Only the date and the technician initials
b.Only the sterilizer number and the cycle type
c.Only a list of the departments the items were sent to
d.Sterilizer identification, cycle or load number, date and time, contents of the load, cycle parameters, operator identification, and the results of physical, chemical, and biological monitoring

解析

Complete load documentation permits a targeted recall, links a specific package to a specific cycle, and demonstrates that monitoring was performed and reviewed. Each package also carries a lot control label with the sterilizer, cycle, and date so it can be matched back to the record. Partial records leave gaps that force a much broader and more disruptive recall.

法律依据: AAMI ST79

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