Sklar Surgical Instrumentation PDF

 About Sklar: For 123 years, Sklar has set the standard for surgical instrumentation. In 1892, German born instrument maker John Sklar, founded the company to fill a need for American made surgical instruments and the rest is history. Sklar rose to prominence during World Wars I a...

 About Sklar: For 123 years, Sklar has set the standard for surgical instrumentation. In 1892, German born instrument maker John Sklar, founded the company to fill a need for American made surgical instruments and the rest is history. Sklar rose to prominence during World Wars I and II and was awarded the principal contract as the surgical instrument provider for the United States military. This contract established Sklar as the industry leader and placed it on the forefront of the surgical marketplace, where it went on to receive Certificates of Merit and Achievement from the U.S. Navy and six Army Navy “E” Production Awards. During the 1930s, Sklar’s research department helped to develop a stainless-steelalloy especially suited to the manufacture of surgical instruments. The company’s investment in research was justified long-term; most surgical instruments are still made of long-lasting, rust resistant, stainless steel. Today, Sklar is headquartered in West Chester, Pennsylvania where it remains the authority on the manufacture of high-quality surgical instruments to medical professionals in 75 countries worldwide. Throughout its history, Sklar has collaborated with leading surgeons and medical facilities to develop thousands of unique surgical instrument patterns. In recent years, Sklar has expanded its product line to include more than 19,000 precisions crafted, stainless steel instruments: the largest offering of surgical instruments in the world. Specialty practices include OB/GYN, Orthopedic, ENT, Cardiovascular, Endoscopic, Dermatology, Podiatry, Veterinary, Dental, etc. The prevention and reduction of healthcare associated infection (HAI) is a top priority in medical facilities today. The Centers for Disease Control Prevention (CDC) has cited “a critical gap in patient safety,” calling for increased vigilance toward recommended instrument reprocessing procedures. Many medical practices are converting from reusable to disposable instruments, and Sklar is leading the trend with a full line of high quality, sterile and non-sterile, single-use instruments to complement its trusted and longstanding stainless-steel patterns. All Sklar’s products are offered exclusively through a global network of distributors, providing an additional layer of expertise to its clients worldwide. Introduction The CDC mandates that instrument end-users “comply with all steps as directed by the device manufacturer”. 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”. 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.” With five different grades of instruments, a full line of disposable les, convenience kits, stain- less steel-ware, and care and cleaning solutions to support every stage of the healthcare process, defines proper usage, handling, safe practices and generally accepted requirements for members of the medical community who work with surgical instruments. The five major surgical instrument lines OR Grade: The highest quality surgical instruments made from U.S and German grade stainless steel and 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 clinics, physician’s offices, and other surgical settings. Physician’s Grade: Forged from surgical grade Pakistani stainless steel and designed for routine surgical or diagnostic use in the office setting. Sterile Disposable Floor Grade: Ready to use, and suitable in a number of surgical settings, sterile disposables, made of Paki- stain 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. Reusable vs. Disposable Instruments For anyone who works in the surgical arena, central service supply, instrument manufacturing or the healthcare field in general, improved patient outcome is the ultimate goal. It is the responsibility of the instrument manufacturer to stay abreast of current trends, innovations, and regulations in healthcare, and to develop instrumentation that responds to the real-time needs and concerns of medical professionals. The FDA recently issued its final guidance on reprocessing reusable medical devices (“Repro- cessing Medical Devices in Health Care Settings: Validation Methods and Labelling 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. It also singles out the “human factors” affecting instrument reprocessing, saying reprocessing instructions should be “technically feasible” in the intended, everyday work environment. The movement toward the use of disposable instruments as a means of 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. Single-use instruments Provide a solution to reprocessing instruments day to day. Reduce cross contamination. Eliminate the need for comprehensive reprocessing instructions and follow-through. Reduce human error in cleaning and sterilizing. Improve patient safety. Reduce tangible and intangible instrument reprocessing costs. What to Expect from This Guideline? The Surgical Instruments guidelines are designed to provide a basic overview of the most widely used surgical instruments and a primer to the instrument industry. This guide gives up to date information about: The history of surgical instruments The instrument manufacturing process and metallurgy The parts of a surgical instrument Instrument categorization by function Identification of the top 35 most commonly used instruments Instrument sets Photographs, illustrations, and clear examples The History of Surgical Instruments The history of surgical instruments follows the larger story of humanity’s continued technological advancement. From microscopic bacteria to massive blue whales, creatures great and small instinctively strive to preserve their lives. What sets humankind apart, is our endless capacity to innovate, and to apply those innovations to increase our health and wellbeing. The history of surgical instruments epitomizes this innovation. Prehistory Many uses of surgical instruments reflect basic, instinctual acts of self-preservation on which our earliest ancestors relied. The first surgical instruments were teeth and hands, used in conjunction with available natural materials like twigs and thorns. The advent of writing systems ushered in the historical period circa 3,500 BC. The discovery of iron and steel followed, moving surgical instruments into the forefront of modernity. Antiquity In ancient medical history looms as large as Hippocrates, the famous physician of Classical Greece and the father of modern medicine. Hippocrates established medicine as a working discipline, distinct from philosophy and religion. He and his followers also produced a significant body of writings and instruction that included surgical directives, using instruments of bronze and iron. Surviving artifacts and period writings demonstrate the sophistication of Greco-Roman surgical instruments. Many of the fundamental instruments still used today, such as scalpels, forceps, scissors, specula, probes and catheters, were well known to the ancients. Roman surgeons worked with both steel and bronze instruments. Arabic During the Dark Ages, classical Western knowledge was maintained in the Islamic world. Much Greco-Roman philosophy and science survived in Arabic translations that eventually resurfaced in the West. Abu al-Qasim Al-Zahrawi, a surgeon in Islamic Spain, made the greatest advancements in surgical instruments during this period. Known as Albucasis in Europe, he produced a renowned 30-volume medical encyclopedia. The most famous volume contained illustrations of surgical instruments and his book was widely translated into Euro- pean languages and disseminated among medieval surgeons. The Middle Ages Medieval artisans crafted surgical instruments from iron, steel and wood. Metal instruments, including scalpels and saws, often had wooden handles. Unlike the corrosion-resistant bronze favored in Antiquity, these materials easily succumbed to the passage of centuries, which helps explain why fewer medieval instruments have been found than their Greco-Ro-man counterparts. The Renaissance The Renaissance brought a resurgence of learning, creativity and innovation to Europe. The invention of the printing press allowed for faster and more widespread dissemination of ideas, old and new. This enabled a surge of scientific activity that advanced medicine and surgical instruments. The first book featuring surgical instruments drawn to scale, enabling skilled craftsmen to reproduce them, appeared in France in 1594. The Twentieth & Twenty-First Centuries The 20th century of the Common Era saw more scientific and technological progress than any period of recorded history. In this climate of change, surgical instruments completed the millennia- long journey from stone to stainless steel. The practice of sterilization created many new possibilities for internal surgical procedures, increasing demand. It also put an end to the crafting of surgical instruments out of wood or decorative materials, which did not hold up to the heat of steam sterilization. The corrosion of steel instruments was also a challenge. Chrome and nickel plating offered a partial solution to corrosion, at the end of the 1800s, but the advent of stainless steel finally provided an answer. Several engineers on both sides of the Atlantic independently developed variations of stainless steel in the early 20th century. Mayer and Company created the first stainless steel surgical instruments in 1916 for a British otolaryngologist. Improving Manufacturing and Metallurgy Stainless steel is not actually “stainless” or fully stain-proof. It is stained resistant and does not easily spot, corrode or rust with water the way ordinary, carbon steel does. Stainless steel is ideally suited for the surgical suite, because it is rust resistant, it can be honed to an extremely sharp edge or fine point, and it can be hardened to maintain the delicate, yet precise requirements of the surgeon. Proper care and handling will ensure that instruments made of stainless steel will last from two to five years, or longer, depending on the grade of the steel and bonding used. There are over 150 grades of stainless steel, and several grades of stainless steel are used to produce surgical instruments with special requirements for hardness, sharpness or malleability. The primary grades used in the manufacture of instruments are Austenitic and Martensitic steels. Austenitic stainless steel is the softer, more malleable type within the 300 Series; Martensitic is the hardened steel within the 400 Series. The 300 Series is used for probes, dilators, retractors and basins. It has the following characteristics: Extreme corrosion resistance. Non-magnetic. Contains high chromium content and nickel. Workable and malleable.  Cannot be heat treated to differing degrees of hardness. 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 butmore brittle Resistant to breakage, used for precise cutting edges. Magnetic. The highest quality, 410 grades stainless is used for gripping instruments like forceps, tweezers, retractors, dressing forceps, etc. The highest quality, 420 grades stainless is used for cutting instruments such as bone rongeurs, chisels, gouges, and scissors. 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. Parts of the Instrument Surgical instruments are specially designed tools or devices that perform a variety of procedures or operations. The overall design of an instrument is based on the function it will ultimately perform. All instruments have a basic design and are augmented and enhanced (length and curvature of blades, teeth, serrations, etc.) to provide additional functionality or to accommodate physician requirements and preference. The size, length and width of a surgical instrument usually determines the type of surgery intended. For example, 12” scissors and forceps are used for cardio, thoracic and gynecology. 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. Instrument designs include tips; jaws or blades; spring joints; screw joints or box locks; ratchets; shanks; and finger rings.