The selection and use of quality surgical instruments are key components in providing safe, efficient and cost effective patient care in the operating room (OR). Quality instrument manufacturing involves standards for various aspects of the manufacturing process, including the basic requirements for the quality of stainless steel used, as well as quality control inspections used at every step in the process. Despite the existence of these standards, perioperative professionals are still confronted with surgical instruments of varying quality levels, depending on the individual quality standards of the instrument manufacturer. Therefore, it is important that members of the Sterile Processing and perioperative teams involved in the selection and use of surgical instrumentation understand the variations in instrument manufacturing processes, in order to provide the best possible instruments for patient care. This continuing education activity will provide a review of the key considerations in the quality manufacturing process for premier OR grade surgical instruments.
A brief overview of the historical evolution of surgical instruments will be presented. The key components of premier quality stainless steel used in the manufacture of surgical instruments will be discussed. The United States requirements for stainless steel surgical instrument package labeling will be outlined, including the definition of country of origin. The steps in the manufacturing process of high quality surgical instruments will be described in detail. The clinical considerations related to the selection and use of quality premier OR grade instruments, and the importance of the facility’s water quality in maintaining quality surgical instruments, will be presented.
The key thing in the production is quality of Steel. The best steel produce the best instruments. SurgiRange use German Steel as require by our valued customers. And this is all to ensure the finest quality Steel.
Austenitic 316 (AISI 316L) steel is a type of stainless steel. In the forging process, our expert craftsman give life to the metal and give it the basic shape that will go through sequence of complex process.
At the stage of forging, every forged tool comes for inspection to certify no piece comprises any cracks or is reformed outside the acceptable limits. There are more steps for inspection the quality of raw instruments.
In this procedure forging is cut or shaped by machine i.e. the tool gets cutting sharp edge and raw material in the exact demand shape. Here instruments are taking their exact shape through grinding and hammers.
In this process, drilling of holes in the instruments where essential for screw. Different Kinds of Screwing machines are used here and instruments are made pairs.
Inspected not only for machining and milling, but for every process they have been go through for inspection. At this stage, all instruments are examined not only for machining and milling, but for every procedure they have been go through for inspection. At this stage only best instruments are designated and instruments with little holes and manufacturing faults are again fixed.
At this stage, all instruments are examined not only for machining and milling, but for every procedure they have been go through for inspection.
At this stage the steel is not too hard yet so the process of filling is used to shape the instruments in the expect shape they are need to be.
At the filling inspection, filling the inspection is made. The measurement and shape are checked according to sample.
Group of 12 pieces in the temper machine with a particular material. Then instruments are tempered and gets equal heat and treatment so a reliable quality would be accomplished.
Pieces are combined with screw. Heat treatment instruments are dipped in a material. Instruments get there finish polish, satin or gold. Snaffling Fitting is for scissors and forceps they are in two pieces are combined in this process with screw. Heat treatment instruments are dipped in a material to toughen the material by hanging for five minutes. Then Instruments get there finish here, for example if instruments have to polish or satin and gold finish.
Snaffling Fitting is for scissors and forceps they are in two pieces are combined in this process with screw.
At the plant and heat treatment instruments are dipped in a material to toughen the material by hanging for five minutes.
Instruments get there finish here, i.e. if instruments have to polish or satin and gold finish.
QA designated person performs the 4% inspection to assure product quality. After that instruments are packed in pouches and ready to ship.