When producing the tool or instrument, it’s important to select and use materials that match the design specifications. This generally requires a combination of metals, plastics, rubber, and, of course, adhesives. Additionally, our production team must also consider any costs associated with the manufacturing process when aiming for an economically optimal balance between quality assurance, timeliness, and cost. We make sure to follow exacting protocols in order to meet or exceed client requirements so that the end result can be unsurpassed in quality.
To support this, we employ quality assurance measures throughout the entire process, starting with our raw material procurement and encompassing tool design, production guidance, and ongoing quality control reviews. After producing each instrument, the team performs a detailed inspection before packaging. We use only proven methods of manufacturing, including CNC machining, MIG/TIG welding, flame working, lapping, and grinding, to ensure each instrument is produced in accordance with client expectations. Our commitment to excellence demands that our products are not just of the highest quality but also reasonably priced, allowing us to guarantee their long-term performance.
Raw Material/Steel:
The first step in making surgical instruments is to source high-quality raw materials, such as stainless steel. Ameri Surgical Instruments ensures that the raw material used for the instruments is of high quality and meets the required standards. We make all surgical instruments and tools from high-quality stainless steel due to its durability, corrosion resistance, and biocompatibility. Some surgical instruments may also be made from other materials such as titanium, cobalt-chromium alloys, or ceramics, depending on the specific instrument’s intended use and requirements.
Resins Surgikal uses austenitic stainless steel grades 316L and 304L for surgical instruments and tools. 316L stainless steel is a low-carbon version of 316 stainless steel and has higher corrosion resistance, while 304L stainless steel is a low-carbon version of 304 stainless steel and It is commonly used in situations in which welding is needed.
Other types of stainless steel, such as martensitic stainless steel and precipitation-hardening stainless steel, may also be used for some surgical instruments and tools that require higher strength or hardness. But these types of stainless steel tend to be less compatible with living things and may be harder to sterilize. Following is the step-by-step process of how Ameri Surgical Instruments® make surgical instruments and tools after selecting raw material.
Forging Process
The raw material is heated to a high temperature and then forged into the desired shape using specialized equipment such as a forging hammer or press. This step helps creating the basic shape of the instrument.
The forging process involves shaping a metal by applying pressure and heat to deform it into the desired shape.
Here are the general steps involved in the forging process of a surgical instrument:
- Heating: The raw material, usually a stainless steel billet, is heated to a specific temperature to make it malleable and easy to shape.
- Forming: The heated billet is placed on a forging press, where it is subjected to compressive force to deform it into the desired shape. This can be done using various forging techniques, including open-die forging, closed-die forging, and impression-die forging.
- Trimming: Once the forged shape is achieved, excess material is trimmed away to give the final shape.
- Heat Treatment: The forged instrument is then heat-treated to improve its strength, hardness, and other physical properties. This process may involve quenching, tempering, or annealing, depending on the instrument’s specific requirements.
- Inspection: The forged instrument is inspected to ensure that it meets the required specifications, dimensions, and quality standards.
The forging process is an important step in the manufacturing of surgical instruments, as it can impart specific mechanical properties to the instrument that make it suitable for its intended use. Forged instruments are generally stronger, more durable, and have better performance characteristics than those made by other manufacturing methods.
Machining
Once the basic shape of the instrument is created, it is then machined using specialized equipment such as CNC machines. This step helps to create the fine details of the instrument.
Milling
Milling is another process that is used to create complex shapes and patterns on the instruments. Ameri Surgical Instruments uses advanced milling machines to create intricate designs on the instruments.
Inspection
After machining and milling, the instruments are inspected again to ensure that they meet the required specifications.
Filling
Some surgical instruments require filling or welding to create a smooth surface or to join two parts together. Ameri Surgical Instruments has specialized equipment to fill or weld the instruments as required.
Filling Inspection
After filling, the instruments are inspected again to ensure that the filling has been done correctly and that there are no defects.
Binding and Temper
Binding and tempering are processes used to harden the instruments and make them more durable. Following is the Standard Operating Procedure of Ameri Surgical Instruments for binding and tempering Surgical Tools:
- Heat Treatment:
The forged instrument is heated to a specific temperature to improve its strength, hardness, and other physical properties. This process may involve quenching, tempering, or annealing, depending on the instrument’s specific requirements.
- Quenching:
The heated instrument is rapidly cooled by immersing it in a quenching medium such as oil or water. This process hardens the instrument by “freezing” the metal’s microstructure in a high-energy state.
- Tempering:
The hardened instrument is then reheated at a lower temperature to soften and relieve some of the internal stresses that were created during the quenching process. This process also helps to improve the instrument’s toughness and ductility.
- Inspection:
The instrument is inspected to ensure that it meets the required specifications, dimensions, and quality standards.
The binding and temper process is critical in the manufacturing of surgical instruments, as it can impart specific mechanical properties to the instrument that make it suitable for its intended use. The specific heat treatment and quenching process used will depend on the instrument’s material, shape, and intended use.
Snaffling Fitting
Snaffling is a process used to remove any burrs or rough edges from the instruments. Once snaffling is completed, the instruments are fitted together to ensure that they function properly.
Plant or Heat Treatment
After snaffling fitting, the instruments are subjected to heat treatment or a specific plant process to make them more durable.
Polishing / Instrument Finish
Once the instruments are heat-treated, they are polished to create a smooth and shiny finish. Ameri Surgical Instruments uses specialized polishing equipment and techniques to create a consistent finish on all their instruments.
Q. A Inspection 2%
After polishing, 2% of the instruments are randomly selected and inspected to ensure that they meet the required standards.
Ultrasonic Cleaning
The instruments are then cleaned using ultrasonic cleaning machines that use high-frequency sound waves to remove any dirt, oil or debris.
Lubrication
After cleaning, the instruments are lubricated to ensure smooth movement and prevent corrosion.
Tuck Checking
Tuck checking is a process used to ensure that the instruments are properly assembled and that there are no loose parts.
Etching
Etching is a process used to mark the instruments with a unique identification number or brand name. Ameri Surgical Instruments uses specialized equipment to etch their instruments.
