Instrument Design and Human Factors Part 1 Mod 6

Instrument Design and Reprocessing

• The instrument industry is urged to develop easier-to-reprocess devices.
• Human factors should be considered in instrument reprocessing, ensuring feasibility in daily work environments.

Disposable Instruments

• Offer a practical alternative to reusable instruments, reducing time, cost, and liability in care and cleaning.
• Advantages of single-use instruments:
  • Streamline reprocessing tasks.
  • Minimize cross-contamination risks.
  • Eliminate complex reprocessing instructions.
  • Reduce human error in sterilization processes.
  • Enhance patient safety.
  • Lower both tangible and intangible costs of reprocessing.

Stainless Steel Types

• Austenitic Stainless Steel (300 Series):

  • Softer and more malleable.
  • High corrosion resistance and non-magnetic properties.
  • Contains high levels of chromium and nickel.
  • Commonly used for probes, dilators, retractors, and basins.

• Martensitic Stainless Steel (400 Series):

  • Hardened steel, typically used for hemostats, needle holders, scissors, clamps, and forceps.

Regulatory Standards

• CDC Guidance: Instrument end-users must adhere to manufacturers' instructions for usage and reprocessing.
• IAHCSMM Recommendation: Care and cleaning processes should involve the original equipment manufacturer.
• FDA Stance: Reusable medical device manufacturers need to validate instructions for use and reprocessing to ensure patient safety.

Instrument Grades

• OR Grade: High-quality surgical instruments made from U.S. and German grade stainless steel for surgical settings.
• Mid Grade: High-quality instruments made from Pakistani stainless steel, suitable for clinics and physician's offices.
• Physician Grade: Forged from surgical-grade Pakistani stainless steel for routine surgical or diagnostic use.
• Floor Grade: Cost-effective, sterile disposable instruments made from Pakistani steel for various surgical settings.

Reprocessing Guidelines

• FDA issued guidance for reprocessing, focusing on validation methods and labeling for medical devices.
• Characteristics of general metal types:
  • Good corrosion resistance.
  • Heat-treated for hardness and sharpness.
  • High carbon content for strength but is more brittle.

Gold Plating

• Gold plating involves layering tungsten carbide on stainless steel to enhance sharpness, strength, and durability.

Instrument Use

• 12-inch Scissors: Utilized in cardio, thoracic, and gynecological procedures.
• 4-inch Scissors: Designed for delicate tasks in pediatric, ophthalmic, and plastic surgeries.

Instrument Functions

• Scissors: Cut tissue and other materials.
• Forceps: Grasp tissue using interlocking teeth or serrated jaws.
• Sponge and Towel Clamps: Hold gauze and isolate surgical areas.
• Needle Holders: Drive suture needles through tissue.
• Retractors: Access and expose wounds.
• Hooks: Grasp bone, tissue, or suture strands.
• Curettes: Cut or scrape bones.
• Bone Files and Rasps: Smooth out bone and cartilage surfaces.
• Bone Chisels: Cut or mark bones.

Instrument Design Features

• Include various components like tips, jaws/blades, spring joints, screw joints or box locks, ratchets, shanks, and finger rings.

This quiz focuses on the critical aspects of instrument design and the human factors that influence the reprocessing of medical devices. It highlights the need for the instrument industry to develop devices that are easier to reprocess and emphasizes the importance of clear technical instructions for users.