M1 Infection Prevention - Module 3

Infection Control Exam 1

How does the FDA classify medical devices?

The FDA classifies medical devices into 3 categories based on the risk of injury or harm:

• Class I: Lowest risk

• Class II: Moderate risk

• Class III: Highest risk

What are Class I medical devices?

• Lowest risk devices with minimal chance of harm.

• Safety is ensured through general regulatory controls:

  • Registration

  • Proper labeling/branding

  • Manufacturing standards

• Examples:

  • Tongue depressors

  • Dental instruments

  • Dental floss

  • Gloves and eye protection

What are Class II medical devices?

• Devices where general controls alone are not enough to ensure safety.

• Require:

  • Special labeling requirements

  • Performance standards

  • FDA pre-market notification

  • Post-market monitoring

• Examples:

  • X-ray machines

  • Infusion pumps

  • Surgical needles

  • Masks and respirators

What are Class III medical devices?

• Highest risk devices that may cause serious harm.

• Require:

  • Scientific review by expert panels

  • FDA pre-market approval

• Examples:

  • Pacemakers

  • Heart valves

  • Automated external defibrillators (AEDs)

  • Dental implants

What factors should be considered when selecting and using PPE?

• CDC: Provides recommendations for when, what, and how PPE should be used to prevent infection.

• OSHA: Requires employers to provide, maintain, clean, repair, and properly dispose of PPE.

• PPE selection should consider:

  • Type of exposure (blood, OPIM, splashes, sprays, or airborne microorganisms)

  • Barrier effectiveness and durability for the task

  • Proper fit to ensure protection and comfort for the user.

What are the requirements for surgical gowns in oral healthcare settings?

• Worn when splash, spatter, spray, or aerosols of blood/OPIM are expected.

• Must provide coverage:

  • Long sleeves (protect wrists and forearms)

  • Cover neck to knees

  • Wrap around the back to protect clothing

• Scrubs and lab coats are not PPE and do not provide hazard protection.

• Gowns must resist liquid and microbial penetration and be available in multiple sizes.

• Change gowns:

  • Between patients

  • When contaminated with blood/OPIM

  • Before leaving patient-care areas

• Remove carefully to prevent contamination of people and surfaces.

When should surgical masks be worn in healthcare settings?

• Worn by OHCP during procedures that may produce:

  • Splash

  • Spatter

  • Spray

  • Aerosols of blood or OPIM

• Protects OHCP from exposure and protects patients from microorganisms carried in the nose/mouth of providers.

• Coughing patients should wear masks as part of Respiratory Hygiene/Cough Etiquette.

How are surgical masks classified and tested?

• Surgical masks are Class II medical devices.

• ASTM testing evaluates:

  • Fluid resistance

  • Bacterial filtration efficiency (BFE)

  • Particulate filtration efficiency (PFE)

  • Breathability

  • Flammability

• Higher ASTM levels provide greater protection against splash, spatter, and aerosols.

What are the ASTM levels for surgical mask protection?

• Level 1: Low barrier protection

• Level 2: Moderate barrier protection

• Level 3: High barrier protection (used for aerosol-generating procedures)

• N95 respirators: Provide protection for airborne precautions and are not the same as surgical masks.

What factors affect surgical mask effectiveness?

• Fluid resistance: Protects against penetration by blood and fluids.

• BFE/PFE: Measure how well the mask filters bacteria and particles.

• Fit and edge leakage: Poor fit decreases protection.

• Breathability: Greater protection can increase airflow resistance.

What are the proper practices for using surgical masks?

• Use a new mask for each patient.

• Replace masks when they become wet or contaminated.

• Masks should fit properly and come in different sizes/styles to meet user needs.

• Do not confuse surgical masks with N95 respirators.

When are particulate respirators required?

• Required when Airborne Precautions are needed for airborne pathogens.

• Must use a NIOSH-certified, fit-checked particulate respirator.

• Particulate respirators are Class II medical devices.

What are OSHA requirements for healthcare personnel using respirators?

Healthcare personnel must receive:

• Medical clearance before wearing a respirator

• Training and education on proper use

• Periodic evaluation of the respiratory protection program

What are the different types of NIOSH-certified particulate respirators?

• N95: Filters ≥95% of particles

• N99: Filters ≥99% of particles

• N100: Filters ≥99.8% of particles

• Must filter particles approximately 0.1–1.0 microns in size.

What is required when putting on a particulate respirator?

• Perform a user seal-check (fit-check) every time the respirator is worn.

• Ensures there is no air leakage around the facepiece.

• Proper fit is necessary for protection.

When does the CDC recommend N95 or higher-level respirators for OHCP?

• Recommended when caring for patients with:

  • Suspected or confirmed tuberculosis (TB)

  • Suspected or confirmed SARS-CoV-2 (COVID-19)

• Airborne precautions may also apply to influenza, measles, varicella-zoster, and SARS viruses.

Why is protective eyewear important in healthcare settings?

• Prevents pathogen transmission through the conjunctival mucosa (eyes).

• Protects against:

  • Splash

  • Spatter

  • Spray

  • Aerosols

• Prevents contamination from touching eyes with infected hands or objects.

What are the requirements for protective goggles?

• Goggles are Class I medical devices.

• Must:

  • Fit snugly around eyes and brow

  • Have solid side shields

  • Preferably be indirectly vented with anti-fog coating

• Regular eyeglasses and contact lenses do not replace eye protection.

What are the requirements for face shields?

• Protects areas of the face not covered by goggles.

• Should have:

  • High crown and chin protection

  • Wrap-around coverage to the ears

  • Comfortable, snug fit

• Must be worn with a surgical mask because face shields are open from below.

How should goggles and face shields be handled after use?

• Front and sides are considered contaminated.

• Headbands, ties, and ear loops are considered clean.

• After use:

  • Place in designated container

  • Wear gloves while cleaning

  • Wash with soap and water

  • Disinfect with hospital-level disinfectant

  • Rinse and air dry before reuse.

When should gloves be worn by OHCP?

• Gloves prevent hand contamination during patient care activities.

• Wear gloves when anticipating contact with:

  • Blood, OPIM, mucous membranes, or nonintact skin

  • Patients with contact-transmitted infections

  • Contaminated patient-care items or environmental surfaces

• Gloves should be task-specific and selected based on the procedure.