Podcast
Questions and Answers
What is the primary recommendation made by IAHCSMM regarding the management of instrument assets?
What is the primary recommendation made by IAHCSMM regarding the management of instrument assets?
- Focus solely on cost-effectiveness in instrument selection.
- Engage with the original equipment manufacturer in the processes. (correct)
- Utilize only sterile disposable instruments from local manufacturers.
- Follow the guidelines of the CDC without any modifications.
Which statement aligns with the FDA's guidelines for reusable medical devices?
Which statement aligns with the FDA's guidelines for reusable medical devices?
- Device users should be encouraged to create their own reprocessing protocols.
- Manufacturers must rely on non-validated expert opinions for safe device usage.
- User community should solely depend on the device's marketing for safety guidelines.
- Manufacturers are required to validate instructions for usage and reprocessing. (correct)
What defines OR Grade instruments?
What defines OR Grade instruments?
- Instruments manufactured with U.S. and German grade stainless steel meeting surgical standards. (correct)
- Instruments primarily made for diagnostic use in a clinical setting.
- Instruments that are designed exclusively for non-critical applications.
- Instruments made from low-cost materials for routine use.
What is a characteristic of Physician Grade instruments?
What is a characteristic of Physician Grade instruments?
What is the main advantage of using sterile disposable Floor Grade instruments?
What is the main advantage of using sterile disposable Floor Grade instruments?
What aspect of instrument design does FDA's final guidance emphasize?
What aspect of instrument design does FDA's final guidance emphasize?
In what type of settings are mid-grade surgical instruments primarily used?
In what type of settings are mid-grade surgical instruments primarily used?
Which grade of instruments is most suitable for non-critical applications?
Which grade of instruments is most suitable for non-critical applications?
What type of steel is typically used in Mid Grade surgical instruments?
What type of steel is typically used in Mid Grade surgical instruments?
What is emphasized about human factors in instrument reprocessing?
What is emphasized about human factors in instrument reprocessing?
What is one significant advantage of single-use instruments compared to reusable instruments?
What is one significant advantage of single-use instruments compared to reusable instruments?
Which of the following statements about Austenitic stainless steel is correct?
Which of the following statements about Austenitic stainless steel is correct?
What is a characteristic of Martensitic stainless steel compared to Austenitic stainless steel?
What is a characteristic of Martensitic stainless steel compared to Austenitic stainless steel?
What distinguishes the 400 Series stainless steel from the 300 Series?
What distinguishes the 400 Series stainless steel from the 300 Series?
Which usage is correct for 4” delicate scissors and forceps?
Which usage is correct for 4” delicate scissors and forceps?
Gold plating on surgical instruments primarily serves to improve what feature?
Gold plating on surgical instruments primarily serves to improve what feature?
Which of the following is NOT a characteristic of the 300 Series stainless steel?
Which of the following is NOT a characteristic of the 300 Series stainless steel?
What is a primary characteristic of 410 series stainless steel?
What is a primary characteristic of 410 series stainless steel?
What is NOT a benefit of using disposable instruments in surgical settings?
What is NOT a benefit of using disposable instruments in surgical settings?
Which of the following surgical instruments is primarily intended for cardio, thoracic, and gynecology procedures?
Which of the following surgical instruments is primarily intended for cardio, thoracic, and gynecology procedures?
Flashcards are hidden until you start studying
Study Notes
CDC Mandates
- End-users must follow all manufacturer directives related to medical devices.
IAHCSMM Recommendations
- Processes for caring and cleaning instruments should involve the original equipment manufacturer.
- Emphasizes the importance of thorough asset management in medical settings.
FDA Points
- Manufacturers of reusable medical devices are required to validate usage and reprocessing instructions for safety.
- Focus on ensuring instructions are practical for everyday use by device users.
Instrument Grades
- OR Grade: Highest quality, made from U.S. and German grade stainless steel, designed for surgical settings.
- Mid Grade: High-quality instruments made of Pakistani stainless steel, suitable for clinics and physician's offices.
- Physician Grade: Forged from surgical grade Pakistani stainless steel, designed for routine surgical or diagnostic use in offices.
- Sterile Disposable Floor Grade: Ready-to-use, low-cost sterile disposables suitable for various surgical settings.
- Floor Grade: Affordable disposable instruments made from Pakistani steel, ideal for non-critical applications.
FDA Guidance on Reprocessing
- Issued guidance emphasizes the need for easier-to-reprocess device designs.
- Highlights the impact of "human factors" on instrument reprocessing, calling for feasible reprocessing instructions.
Disposable Instruments
- Reduce time, cost, and liability related to cleaning reusable instruments.
- Considered a viable alternative to multi-use instruments.
Advantages of Single-Use Instruments
- Offer solutions for daily reprocessing challenges.
- Minimize cross-contamination and the need for complex reprocessing instructions.
- Decrease human error during cleaning and sterilization.
- Enhance patient safety and reduce associated reprocessing costs.
Stainless Steel Types
- Austenitic Stainless Steel: Softer, malleable, found in the 300 Series with extreme corrosion resistance. Non-magnetic.
- Martensitic Stainless Steel: Harder, found in the 400 Series, suitable for tools requiring higher strength and precise cutting.
Characteristics of Stainless Steel Series
- 300 Series: Used for probes and retractors; noted for high chromium and nickel content; non-heat-treatable.
- 400 Series: Used for hemostats and scissors; heat treated for hardness, strong yet more brittle.
- 410 Series: Highest quality for gripping instruments like forceps.
- 420 Series: Highest quality for cutting instruments such as bone chisels and scissors.
Gold Plating
- Indicates tungsten carbide is introduced to high-grade stainless steel, enhancing sharpness, strength, and longevity.
Instrument Sizes and Usage
- 12” Scissors & Forceps: Utilized in cardio, thoracic, and gynecology procedures.
- 4” Scissors & Forceps: Designed for pediatric, ophthalmic, and plastic surgeries.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
