Instrument Design and Human Factors Part 1 Mod 6

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Questions and Answers

What is one of the main advantages of single-use instruments?

They can be reused multiple times with no complications.

They are made from higher quality materials than reusable instruments.

They are always less expensive than reusable instruments.

They eliminate the need for comprehensive reprocessing instructions. (correct)

Which characteristic is NOT associated with austenitic stainless steel?

Extreme corrosion resistance

Non-magnetic nature

High chromium content and nickel

Heat treatable to different degrees of hardness (correct)

The 400 Series stainless steel is primarily used for which types of instruments?

Hemostats and needle holders (correct)

Probes and dilators

Clamps and basins

Basin and retractors

What does the document suggest is an important factor for the reprocessing instructions of instruments?

They must be technically feasible in everyday work environments. Signup and view all the answers

Which of the following is a disadvantage of reusable instruments compared to single-use instruments?

They require thorough cleaning and reprocessing. Signup and view all the answers

What is a key characteristic of martensitic stainless steel?

It belongs to the 400 Series and is heat treatable. Signup and view all the answers

What is NOT listed as a benefit of using disposable instruments?

Increased instrument lifespan Signup and view all the answers

Which statement about the 300 Series stainless steel is false?

It contains no nickel and has poor malleability. Signup and view all the answers

What does the CDC mandate regarding instrument end-users?

End-users should adhere to all manufacturer directives. Signup and view all the answers

Which organization recommends involving the original equipment manufacturer in care and cleaning processes?

International Association of Healthcare Central Service Materiel Management (IAHCSMM) Signup and view all the answers

What grade of instrument is made from U.S. and German grade stainless steel?

OR Grade Signup and view all the answers

For what type of use are Physician Grade instruments primarily designed?

Routine surgical or diagnostic use in office settings Signup and view all the answers

What defines Sterile Disposable instruments in terms of material and application?

Ready to use, made of Pakistani steel for various surgical settings Signup and view all the answers

What does the FDA emphasize regarding reusable medical devices?

Manufacturers should validate usage instructions for patient safety. Signup and view all the answers

What is the primary advantage of using Floor Grade instruments?

Combines convenience with reliable function at an affordable cost. Signup and view all the answers

What characterizes Mid Grade surgical instruments?

They are made of Pakistani stainless steel providing significant value. Signup and view all the answers

What is the significance of tungsten carbide in gold plating on surgical instruments?

It enhances the sharpness, strength, and shelf life. Signup and view all the answers

Which type of steel is primarily used for cutting instruments such as scissors?

420 series steel Signup and view all the answers

In what types of surgeries are 4” delicate scissors and forceps predominantly used?

Pediatric, ophthalmic, and plastic surgeries Signup and view all the answers

Which of the following is NOT a characteristic of the 410 series steel?

Highly malleable Signup and view all the answers

What is the primary function of needle holders in surgical procedures?

To drive suture needles through tissue Signup and view all the answers

Which instrument is specifically designed to smooth bone and cartilage?

Rasp Signup and view all the answers

What characteristic is associated with the gripping instruments like forceps in the 410 series steel?

Brittleness Signup and view all the answers

What is the primary purpose of retractor instruments in surgery?

To access and expose wounds Signup and view all the answers

Study Notes

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.

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Description

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.