Quality surgical instrument manufacturing procedures are unique and vary from one manufacturer to the next. These procedures, when coupled with the knowledge and skill of the craftworkers, result in instruments that are exceptionally accurate, true to the design, and of consistently high quality. Peak Surgicals, a manufacturer of surgical instruments, rigorously inspects raw materials before making instruments to guarantee a high-quality end output.
Examination of Raw Material
- Verifying the form and size of the raw material stock to verify quality
- Analyzing the chemical composition using carbon, x-ray fluorescence, and emission spectrometry;
- Examining the mechanical qualities (e.g., hardness) using ductility and hardness studies
- Examining the metal structure for determining its acceptability
Grades of Stainless Steel used for Surgical Instrument Manufacturing
Surgical instruments are now composed of a range of materials such as composites, polymers, titanium, and stainless steel. Typically, two kinds of stainless steel series are utilized in the manufacture of surgical instruments.
- Stainless steel in the 300 series (Austenitic)
- Stainless steel in 400 series (Martensitic)
Heat treatment cannot be used to harden Austenitic steel. The 304 grade is the most common grade used for surgical equipment and is best suited for objects that need some malleability, meaning they can be pushed or molded into a different shape without breaking the metal. Cannulas, retractors, probes, mallets, and spreaders are among the surgical instruments usually created using this steel series.
Martensitic steel is a low-carbon steel that can be toughened and tempered by heat treatment. This kind of steel is ideal for surgical instrument manufacturing that demands strength and harsh cutting edges due to the strength achieved via the hardening process. Instruments such as bone cutters, clamps, forceps, needle holders, and chisels are usually made from the 410/420 grade of this steel series.
Corrosion Resistance
Though stainless steel is typically corrosion-resistant, however, it is not immune to rust and corrosion. Perhaps a more accurate word would be stain-resistant,’ rather than stainless or stain-free. This is due to the fact that there are several factors that might produce corrosion on stainless steel.
These include strong acid or alkaline concentrated detergent, friction with other non-corrosion resistant metals (during or after production), steel flaws, lubricating electrolytes, high chloride conditions, and other variables.
However, corrosion can be avoided with good material and tool selection, manufacturing care and procedures such as passivation, and careful medical care and handling before and after each use.
Determination of Melting Point and Processing Quality
The melting point and processing quality of synthetic material are determined by thermo-differential analysis; for molecular analysis, infrared spectrometry is employed. Peak Surgicals complete its trial processing for the manufacturing of surgical instruments. The following factors influence the ultimate quality of instrument manufacturing:
- The raw product quality,
- The master designs for each instrument pattern,
- The specific unique instrument pattern forms for quality comparison testing,
- The die (i.e., the first forging pattern) used to forge instrument components
- Craftworker skills and training, monitoring of all heating and cooling throughout manufacture, and quality control at each stage of the process
- Each step of the processing must be monitored for quality assurance. Peak Surgicals adheres to 13485 to ensure the consistency and quality of each surgical tool.
Forging of Surgical Instruments
Forging is a vital operation that is carried out at a high temperature (about 800° C [1,472° F]) and with great force to construct the first shape of an instrument. Hardening and annealing (heating the item to remove hardness for handling and machining) also need heating the instrument components to high temperatures (about 800° C [1,472° F] and more).
