Manufacturer’s Instructions & Device Classification

What type of information is typically found in a manufacturer's guide for medical devices?

• Only the price

• Cleaning instructions and characteristics

• Hospital cleaning schedules

• Employee duties

Which material is NOT commonly used in reusable medical devices?

• Rubber

• Textile

• Glass

• Wood

Why is it important to update the manufacturer’s instructions regularly?

• To comply with hospital dress codes

• To ensure accurate and safe reprocessing

• To reduce workload

• To avoid patient interaction

What is a Cardex used for?

• Sterilizing instruments

• Documenting patient symptoms

• Recording information about each instrument

• Accessing Wi-Fi in MDRA

What does the term "MIFU" stand for?

• Medical Instrument Function Unit

• Manufacturer's Instructions for Use

• Mandatory Internal Function Use

• Multi-Instrument Function Utility

Which step is often included in the manufacturer's cleaning instructions?

• Lubrication

• Ironing

• X-ray scanning

• Burning

What type of sterilization may be used for heat-sensitive devices?

What is the purpose of a unidirectional workflow in MDRA?

• Reduce staff workload

• Promote faster sterilization

• Avoid cross-contamination

• Improve ventilation

How many zones must be clearly identified in an MDRA?

• 1

• 2

• 3

• 4

What PPE must be worn before entering the contaminated area?

• Only gloves

• Hat, gloves, gown, visor or goggles

• Shoes and jewelry

• Nothing specific is required