Sterilization, Instrument Tracking, Compliance, and Safety in Healthcare (Lecture Notes)

This set covers access to documentation (OneSource), FDA/AAMI/OSHA requirements, device identification and tracking (lot vs log numbers, SPM), sterilization indicators and indicators, biological indicators, loaner instrumentation, hazard classifications, safety practices (PPE, latex allergies, double gloving), fire safety (PASS), and the role of Joint Commission and CSP/SPD in hospital operations.

What digital platform is commonly used to access instrument documentation and product information?

OneSource.

What document is typically available for a product on OneSource?

The IMP/document (Instructions for Use) right there.

What does FDA require manufacturers to validate?

Their product labels.

What does AAMI provide with respect to sterilization standards?

Minimum standards for sterilization and medical instruments.

Who regulates products used in healthcare and their labeling?

The FDA (Food and Drug Administration).

What does OSHA regulate in the workplace?

Workplace safety, including exposure to airborne contaminants and handling hazardous chemicals.

What do Safety Data Sheets (SDS) provide?

Safety information on chemicals: hazards, storage, handling, and first aid.

What are the three device classifications discussed for sterility risk?

Critical, semi-critical, and non-critical items.

What is the difference between a lot number and a log number?

Lot number = production batch; log number = the individual item.

What organization accredits hospitals and conducts inspections?

The Joint Commission.

What is the purpose of count sheets?

To list contents of a tray and ensure all items are present.

What software tracks instrumentation in the facility?

SPM — Sterile Processing Microsystem.

What is the purpose of biological indicators in sterilization?

To verify that sterilization killed biological organisms (e.g., Bacillus stearothermophilus) on every load.

Approximately how long does a typical steam sterilization cycle take?

About two and a half hours from start to finish.

Name four chemicals mentioned for sterilization or high-level disinfection.

Glutaraldehyde, formaldehyde, ethylene oxide, hydrogen peroxide.

What does IFU stand for?

Instructions For Use.

What is the purpose of chemical indicators in sterilization?

To indicate that a sterilization cycle has occurred.

Why is on-site training conducted regularly?

To reinforce procedures and safety, especially for new staff and recurring issues.

What does the NFPA hazard rating system include?

A 0–4 scale with color-coded diamonds; blue for health, red for flammability, etc.

What should you do if you have a latex allergy in this setting?

Inform staff and use non-latex gloves (e.g., nitrile).

What is double gloving and why is it used?

Wearing two pairs of gloves to reduce infection risk.

What is the role of Biomed in hospitals?

Biomedical engineering checks and calibrates equipment (e.g., PCA pumps) and ensures safety; may tag equipment.

What should be done with damaged or missing items in a tray?

Deficiencies noted; do not use; escalate to leadership.

What is the maximum allowed weight for a tray?

25 pounds.

What is the typical process for loaner instrumentation?

Receive in advance, inspect for damage, ensure proper cleaning, process through CSP; do not use if damaged.

What is the difference between chemical indicators and biological indicators?

Chemical indicators show a cycle occurred; biological indicators verify lethality with living organisms.

What should you do during a fire safety drill to remember PASS?

PASS stands for Pull, Aim, Squeeze, Sweep.

What is the typical role of Central Sterile Processing (CSP/SPD) in surgery preparation?

Decontamination, cleaning, inspection, packaging, and tray assembly to prepare for the OR.