SPD Regulations and Standards 2

Question 1

What is the role of AAMI in sterile processing?

Accepted Answer

AAMI develops consensus standards and recommended practices that define how medical devices should be reprocessed

Answer

AAMI manufactures sterilization equipment

Answer

AAMI inspects and accredits hospitals

Answer

AAMI provides funding for SPD departments

Question 2

How does the FDA regulate the reprocessing of medical devices?

Accepted Answer

The FDA requires device manufacturers to provide validated reprocessing instructions and clears sterilization equipment and chemical agents

Answer

The FDA has no authority over reprocessing

Answer

The FDA only regulates pharmaceutical drugs

Answer

The FDA directly oversees daily SPD operations

Question 3

What does OSHA require specifically related to SPD workplace safety?

Accepted Answer

OSHA mandates bloodborne pathogen protection, hazard communication, PPE provision, ergonomic safety, and exposure monitoring for SPD staff

Answer

OSHA only covers construction workers

Answer

OSHA recommends but does not require safety measures

Answer

OSHA only applies to the operating room

Question 4

What is the significance of Joint Commission standards for SPD operations?

Accepted Answer

Joint Commission accreditation standards include specific requirements for infection control and environment of care that directly govern SPD operations

Answer

Joint Commission only inspects emergency departments

Answer

Joint Commission standards are suggestions only

Answer

Joint Commission does not evaluate reprocessing practices

Question 5

What are CMS Conditions of Participation and how do they relate to SPD?

Accepted Answer

CMS Conditions of Participation are federal requirements for Medicare/Medicaid participation that include infection control standards governing instrument reprocessing

Answer

CMS conditions only apply to physician offices

Answer

CMS does not regulate sterilization

Answer

CMS conditions are identical to Joint Commission standards

Question 6

What is the significance of IEC/ISO 17665 for steam sterilization?

Accepted Answer

It is the international standard specifying requirements for the development, validation, and routine control of steam sterilization processes

Answer

It is a building code for SPD facilities

Answer

It only applies to manufacturers, not hospitals

Answer

It is an outdated standard no longer in use