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

Question 1

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

Accepted Answer

The Joint Commission (TJC)

Answer

OSHA

Answer

CDC

Answer

FDA

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

Only a manufacturer's letter of approval

Answer

A verbal agreement from the hospital chief of surgery

Answer

Annual renewal of the reprocessing contract

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 ST58

Answer

AAMI TIR30

Answer

AAMI ST41

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

6 months

Answer

1 year

Answer

30 days

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

Chemical burns from sterilants

Answer

Ergonomic injuries from heavy instrument sets

Answer

Radiation exposure from sterilization equipment

Question 6

What written document must employers provide to CSSD workers describing the hazardous chemicals used in the department?

Accepted Answer

Safety Data Sheet (SDS)

Answer

Material Compliance Report (MCR)

Answer

Sterilant Usage Log (SUL)

Answer

Chemical Exposure Index (CEI)