Part_1_mod_6.pdf

🌿 Part 1 mod 6 what is the CDC mandates ? that instrument end-users “comply with all steps as directed by the device manufacturer” what IAHCSMM recommends ? The International Association...

🌿 Part 1 mod 6 what is the CDC mandates ? that instrument end-users “comply with all steps as directed by the device manufacturer” what IAHCSMM recommends ? The International Association of Healthcare Central Service Materiel Management (IAHCSMM) recommends that processes such as care and cleaning; and the management of instrument assets; involve the “original equipment manufacturer” what US FDA point ? The U.S. Food and Drug Administration (FDA) points to “a need for manufacturers of reusable medical devices to validate instructions for usage, labeling and reprocessing for the device user community, in the name of patient safety.” List 5 grade of instrument Part 1 mod 6 1  OR Grade The highest quality surgical instruments made from U.S and German grade stainless steel designed to meet the exacting standards required in a surgical setting. Mid Grade High quality, Mid-Grade OR instruments made of Pakistani stainless steel, deliver significant value and performance in the 1. clinics, 2. physician’s offices, 3. and other surgical settings. Physician Grade Forged from surgical grade Pakistani stainless steel and designed for 1. routine surgical or 2. diagnostic use 3. in the office setting. Sterile disposable Floor Grade Ready to use, and suitable in a number of surgical settings, sterile disposables, made of Pakistani steel, combine low cost with reliable performance. Floor Grade Made of Pakistani steel and combining convenience with reliable function at an affordable cost; these disposable instruments are ideal for non-critical applications. when FDA issued final guidance on reprocessing RMD “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance – March 24, 2015”). The document emphasizes the importance of instrument design – calling on the instrument industry to create devices that are less challenging to reprocess than some of those on the market presently. Part 1 mod 6 2  It also singles out the “human factors” affecting instrument reprocessing, saying reprocessing instructions should be “technically feasible” in the intended, everyday work environment. what is Disposable instruments reduce reducing the time cost and liability associated with the care and cleaning of reusable instruments has begun. Disposable instruments are often a viable alternative to their multi- use counterparts. what is advantage of Single use instruments Single-use instruments: 1. Provide a solution to reprocessing instruments day to day. 2. Reduce cross contamination. 3. Eliminate the need for comprehensive reprocessing instructions and follow-through. 4. Reduce human error in cleaning and sterilizing. 5. Improve patient safety. 6. Reduce tangible and intangible instrument reprocessing costs. what is Austenitic and Martensitic Stainless steel Austenitic stainless steel is the softer, more malleable type within the 300 Series; Martensitic is the hardened steel within the 400 Series. 300 series steel The 300 Series is used for 1. probes, 2. dilators, 3. retractors 4. and basins. It has the following characteristics: 1. Extreme corrosion resistance 2. Non-magnetic. Part 1 mod 6 3  3. Contains high chromium content and nickel. 4. Workable and malleable. 5. Cannot be heat treated to differing degrees of hardness. 400 series steel The 400 Series is used for hemostats, needle holders, scissors, clamps, forceps, etc. It has the following characteristics: Good corrosion resistance Heat treated to varying degrees of hardness and sharpness High carbon content Strong but more brittle Resistant to breakage, used for precise cutting edges Magnetic. 410 series steel The highest quality, 410 grades stainless is used for 1. gripping instruments like 2. forceps, 3. tweezers, 4. retractors, 5. dressing forceps, etc. 420 series steel The highest quality, 420 grades stainless is used for cutting instruments such as 1. bone rongeur , 2. chisels, 3. gouges, 4. scissors. what is Gold plating mean Part 1 mod 6 4  Gold plating on an instrument means that tungsten carbide has been introduced – tungsten carbide is an extremely hard metal that is used to laminate high grade stainless steel to increase and maintain sharpness, strength and gripping capability and shelf life. 12” scissors use for what 12” scissors and forceps are used for cardio, thoracic and gynecology 4” scissors use for what 4”delicate scissors and forceps are used for pediatric, ophthalmic and plastic surgeries. Scissors are 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 rasps smooth bone and cartilage. Bone chisels and osteotomies cut or mark a bone. Part 1 mod 6 5  Instrument designs include: tips; jaws or blades; spring joints; screw joints or box locks; ratchets; shanks; and finger rings. Part 1 mod 6 6