Quality Assurance and Safety Flashcards

What is the purpose of a biological indicator (BI) in sterilization monitoring?

Answer: To verify the sterilization process killed a standardized population of highly resistant bacterial spores

Biological indicators contain known quantities of resistant bacterial spores and provide the most definitive proof that sterilization achieved lethal conditions.

What should be done if a biological indicator returns a positive result (growth)?

Answer: Immediately recall all items processed since the last known negative BI, quarantine the sterilizer, and investigate the root cause

A positive BI indicates sterilization failure — all potentially affected items must be recalled and the sterilizer taken out of service until the cause is corrected.

What is the Bowie-Dick test and when should it be performed?

Answer: A daily air removal test performed in the first empty cycle of pre-vacuum steam sterilizers to verify adequate air removal

The Bowie-Dick test verifies that pre-vacuum steam sterilizers effectively remove air from the chamber, as residual air prevents steam contact and sterilization.

What is root cause analysis (RCA) in the context of SPD quality assurance?

Answer: A systematic investigation method used to identify the underlying cause of sterilization failures, contamination events, or near-misses

RCA looks beyond symptoms to identify the fundamental cause of quality failures, enabling effective corrective action to prevent recurrence.

What are the key components of an effective SPD quality management system?

Answer: Comprehensive monitoring including process validation, ongoing testing, competency verification, documentation, corrective actions, and continuous improvement

An effective quality system integrates multiple monitoring approaches to ensure every step of reprocessing consistently produces safe, sterile instruments.

What ergonomic safety concern is most prevalent among SPD technicians?

Answer: Musculoskeletal injuries from repetitive motions, heavy lifting, and prolonged standing during instrument processing

SPD technicians face significant musculoskeletal injury risks from repetitive tasks, heavy tray lifting, and extended periods of standing at workstations.