CSSD CSSD - Central Sterile Services Department Documentation and Regulatory Compliance Questions and Answers 1

Question 1

Which organization accredits US hospitals and surveys CSSD departments for compliance with sterile processing standards?

Accepted Answer

The Joint Commission (TJC)

Answer

The Joint Commission surveys US hospitals and evaluates CSSD operations for compliance with infection prevention and sterile processing standards as part of its accreditation process.

Question 2

What does the FDA 510(k) clearance process require for reprocessed single-use devices (SUDs)?

Accepted Answer

Demonstrated equivalence to the original device in safety and effectiveness

Answer

The FDA requires third-party SUD reprocessors to obtain 510(k) clearance by demonstrating that the reprocessed device is substantially equivalent in safety and effectiveness to the original cleared device.

Question 3

Which AAMI standard is the primary comprehensive guideline for steam sterilization and sterility assurance in US healthcare facilities?

Accepted Answer

AAMI ST79

Answer

AAMI ST79 is the comprehensive guide for steam sterilization and sterility assurance in health care facilities, covering everything from decontamination to sterile storage.

Question 4

How long must sterilization records typically be retained according to standard CSSD practice and accreditation requirements?

Accepted Answer

A minimum of 3 years, or longer per state law or institutional policy

Answer

Sterilization records must be retained for a minimum of 3 years under standard guidelines, though state laws or institutional policies may require longer retention periods.

Question 5

What is OSHA's Bloodborne Pathogen Standard (29 CFR 1910.1030) primarily designed to protect CSSD workers from?

Accepted Answer

Exposure to blood and other potentially infectious materials (OPIM)

Answer

OSHA's Bloodborne Pathogen Standard protects workers from occupational exposure to blood and OPIM, requiring engineering controls, PPE, hepatitis B vaccination, and exposure incident protocols.

CSSD - Central Sterile Services Department Practice Test

CSSD - Central Sterile Services Department Practice Test

CSSD CSSD - Central Sterile Services Department Documentation and Regulatory Compliance Questions and Answers 1