HSPA Regulations and Standards Compliance 2

Question 1

Which organization publishes the ST79 guide for steam sterilization?

Accepted Answer

AAMI

Answer

AAMI publishes ST79, the definitive guide for steam sterilization in healthcare facilities.

Question 2

What is the FDA's role in regulating sterile processing?

Accepted Answer

FDA regulates medical devices and sterilization equipment and requires manufacturers to provide validated IFU

Answer

The FDA regulates devices through 510(k) clearance and requires validated reprocessing IFU from manufacturers.

Question 3

What does OSHA's Bloodborne Pathogens Standard require of SPDs?

Accepted Answer

Exposure control plan, PPE, Hepatitis B vaccination offer, and post-exposure procedures

Answer

OSHA requires a comprehensive exposure control plan including PPE, vaccination, sharps safety, and post-exposure protocols.

Question 4

What does Joint Commission expect for SPD quality monitoring?

Accepted Answer

Ongoing quality programs including cleaning verification, sterilization monitoring, and documented compliance

Answer

Joint Commission expects ongoing quality monitoring including cleaning verification, sterilization monitoring, and documented compliance.

Question 5

What are the legal implications of not following manufacturer reprocessing IFU?

Accepted Answer

May void warranty, create liability, result in citations, and breach standard of care

Answer

Non-compliance can void warranties, trigger regulatory citations, create malpractice liability, and breach the standard of care.

(HSPA) Healthcare Sterile Processing Association Certification Practice Test