3rtert.pdf

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 pati...

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 disposab les, convenience kits, stainless 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 are: 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 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. 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 (“Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 140 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 141 Chapter II 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 142 illustrations of surgical instruments and his book was widely translated into European 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-Roman 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 stain 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 143 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. 144