Surgical Instrument Quality and Classification
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Questions and Answers

What is the primary focus of the CDC mandate regarding medical device reprocessing?

  • Compliance with FDA regulations
  • Disposal of medical waste
  • Adherence to manufacturer's instructions (correct)
  • Sterilization of medical devices
  • What does the IAHCSMM recommend involving the 'original equipment manufacturer'?

  • Care and cleaning of medical devices (correct)
  • Recycling of medical devices
  • Purchasing of medical devices
  • Quality control of medical devices
  • What is the primary concern of the U.S. FDA regarding reusable medical devices?

  • Manufacturing quality
  • Patient safety (correct)
  • Cost-effectiveness
  • Environmental impact
  • Which grade of instrument is made from U.S. and German grade stainless steel?

    <p>OR Grade</p> Signup and view all the answers

    What is the primary characteristic of Sterile disposable Floor Grade instruments?

    <p>Low cost and reliable performance</p> Signup and view all the answers

    When did the FDA issue final guidance on reprocessing RMD?

    <p>March 24, 2015</p> Signup and view all the answers

    What is the primary focus of the FDA's guidance on reprocessing RMD?

    <p>Validation methods and labeling</p> Signup and view all the answers

    What is the primary characteristic of Physician Grade instruments?

    <p>Forged from surgical grade Pakistani stainless steel</p> Signup and view all the answers

    What is the primary concern of the document regarding instrument design?

    <p>Creating devices that are less challenging to reprocess</p> Signup and view all the answers

    What is the advantage of single-use instruments?

    <p>Reducing the time cost and liability associated with the care and cleaning of reusable instruments</p> Signup and view all the answers

    What is the characteristic of Austenitic stainless steel?

    <p>Softer, more malleable type within the 300 Series</p> Signup and view all the answers

    What is the characteristic of 300 Series stainless steel?

    <p>Extreme corrosion resistance, non-magnetic, and contains high chromium content and nickel</p> Signup and view all the answers

    What is the characteristic of 400 Series stainless steel?

    <p>Good corrosion resistance, heat treated to varying degrees of hardness, and magnetic</p> Signup and view all the answers

    What is the use of 12” scissors and forceps?

    <p>Cardio, thoracic, and gynecology</p> Signup and view all the answers

    What is the use of 4” delicate scissors and forceps?

    <p>Pediatric, ophthalmic, and plastic surgeries</p> Signup and view all the answers

    What is the purpose of a curette?

    <p>To cut or scrape bones or sockets</p> Signup and view all the answers

    What is the purpose of a needle holder?

    <p>To drive suture needles through tissue</p> Signup and view all the answers

    What is the purpose of gold plating on an instrument?

    <p>To introduce tungsten carbide to increase and maintain sharpness, strength, and gripping capability</p> Signup and view all the answers

    Study Notes

    Instrument Quality and Classification

    • OR Grade: highest quality surgical instruments made from US and German grade stainless steel for surgical settings.
    • Mid Grade: high-quality instruments made of Pakistani stainless steel for clinics, physician's offices, and surgical settings.
    • Physician Grade: forged from surgical grade Pakistani stainless steel for routine surgical or diagnostic use in office settings.
    • Sterile Disposable Floor Grade: ready-to-use, sterile disposables made of Pakistani steel for surgical settings, combining low cost with reliable performance.
    • Floor Grade: made of Pakistani steel, combining convenience with reliable function at an affordable cost for non-critical applications.

    Regulatory Guidelines

    • CDC: instrument end-users must comply with all steps as directed by the device manufacturer.
    • IAHCSMM: recommends involving the original equipment manufacturer in processes such as care and cleaning, and instrument asset management.
    • US FDA: emphasizes the need for manufacturers to validate instructions for usage, labeling, and reprocessing for device user community, prioritizing patient safety.

    Instrument Materials

    • Austenitic Stainless Steel: softer, more malleable type within the 300 Series, used for probes, dilators, retractors, and basins.
    • Martensitic Stainless Steel: hardened steel within the 400 Series, used for hemostats, needle holders, scissors, clamps, forceps, etc.
    • 300 Series Steel: has extreme corrosion resistance, is non-magnetic, contains high chromium content and nickel, and is workable and malleable.
    • 400 Series Steel: has good corrosion resistance, can be heat-treated to varying degrees of hardness and sharpness, and has high carbon content.

    Instrument Uses and Characteristics

    • 410 Series Steel: used for gripping instruments like forceps, tweezers, retractors, and dressing forceps.
    • 420 Series Steel: used for cutting instruments such as bone rongeurs, chisels, gouges, and scissors.
    • Gold Plating: introduces tungsten carbide, an extremely hard metal that increases and maintains sharpness, strength, and gripping capability.
    • 12" Scissors: used for cardio, thoracic, and gynecology.
    • 4" Scissors: used for pediatric, ophthalmic, and plastic surgeries.

    Instrument Designs and Functions

    • Scissors: used to cut tissue or other materials.
    • Forceps: have interlocking teeth or serrated jaws used to grasp tissue.
    • Sponge and Towel Clamps: hold gauze or wall-off surgical areas.
    • Needle Holders: drive suture needles through tissue.
    • Retractors: access and expose wounds.
    • Hooks: grasp bone, tissue, and suture strands during procedures.
    • Curettes: cut or scrape bones or sockets.
    • Bone Files and Rasp: smooth bone and cartilage.
    • Bone Chisels and Osteotomies: cut or mark a bone.
    • Instrument designs include tips, jaws or blades, spring joints, screw joints or box locks, ratchets, shanks, and finger rings.

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    Description

    This quiz covers the different grades of surgical instruments, including OR Grade, Mid Grade, Physician Grade, and Sterile Disposable Floor Grade, and their uses in various medical settings.

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