SPD - Sterile Processing Department Technician Regulations and Standards Questions and Answers

Question 1

The U.S.
Food and Drug Administration (FDA) classifies medical devices based on risk.
In which classification would a steam sterilizer, biological indicator, and chemical indicator most likely be placed?

Accepted Answer

Class II

Answer

Class I

Answer

Class III

Answer

Class IV

Question 2

A technician is updating the department's chemical inventory list. According to OSHA's Hazard Communication Standard, which of the following documents must be readily accessible for every hazardous chemical used in the SPD?

Accepted Answer

The Safety Data Sheet (SDS)

Answer

The manufacturer's annual financial report

Answer

A peer-reviewed article on the chemical's efficacy

Answer

The original shipping manifest for the chemical

Question 3

A hospital is preparing for an unannounced survey from an accrediting body that focuses on patient safety and quality of care. The surveyor is observed asking a technician to explain the process for a sterilization load recall. Which organization is most likely conducting this survey?

Accepted Answer

The Joint Commission (TJC)

Answer

Environmental Protection Agency (EPA)

Answer

Occupational Safety and Health Administration (OSHA)

Answer

Association for the Advancement of Medical Instrumentation (AAMI)

Question 4

Which AAMI standard is considered the comprehensive guide for steam sterilization and sterility assurance, covering topics from decontamination and packaging to sterilizer maintenance and quality control?

Accepted Answer

ST79

Answer

ST58

Answer

ST91

Answer

ST108

Question 5

A sterile processing department uses ethylene oxide (EtO) for sterilizing heat-sensitive devices. Regulations concerning the permissible exposure limits for workers and the allowable emissions of EtO gas into the atmosphere are primarily established and enforced by which agency?

Accepted Answer

Environmental Protection Agency (EPA)

Answer

The Joint Commission (TJC)

Answer

Food and Drug Administration (FDA)

Answer

Centers for Disease Control and Prevention (CDC)

Question 6

Which of the following provides evidence-based guidelines and recommendations for infection prevention but does NOT have regulatory authority to enforce them?

Accepted Answer

Centers for Disease Control and Prevention (CDC)

Answer

Occupational Safety and Health Administration (OSHA)

Answer

Environmental Protection Agency (EPA)

Answer

Food and Drug Administration (FDA)

The U.S.Food and Drug Administration (FDA) classifies medical devices based on risk.In which classification would a steam sterilizer, biological indicator, and chemical indicator most likely be placed?

The U.S.
Food and Drug Administration (FDA) classifies medical devices based on risk.
In which classification would a steam sterilizer, biological indicator, and chemical indicator most likely be placed?