Material Quality in Single Use Instruments

We all must know that surgical instruments are made from stainless steel. But quality may vary for single-use instruments and reusable instruments. To understand the quality difference between both types of instruments, you must know about:

1. Making Process.

2. Standard of steel quality.

3. Inspection and Testing.

4. Color Identification of Single-Use

5. Re-usability of material.

Let us start to demonstrate all points mentioned above other after other.

1. Making Process

The steel used in crafting single-use instruments is usually a specific grade of stainless steel, commonly consumed for cost-efficiency, durability, and corrosion resistance. For making such material, we use the composition of the following main raw elements:

I. Iron ore

II. Chromium

III. Nickle

IV. Carbon

“Standard of steel quality” will explain the grade and composition ratio.
Hence, the raw material is melted at over 1500°C. After melting, impurities are removed, and the alloy is refined and mixed. The molten composition is then poured into molds and allowed to cool. In this way, we prepare our stainless steel for crafting into single-use instruments.

2. Standard of Steel Quality

AISI (American Iron and Steel Institute) provides standard classifications for different grades of stainless steel used in surgical instruments. Single-use instruments typically fall under lower-grade stainless steel categories, such as AISI 410 or 420, which offer sufficient hardness and corrosion resistance for single-use applications.

These grades are martensite stainless steels, known for their:

· Durability: Capable of withstanding the rigors of single-use applications.

· Corrosion Resistance: Adequate resistance to rust and chemical exposure during sterilization or storage.

· Hardness: Ensures the instruments maintain their structure and sharpness during usage.

In contrast, reusable instruments are often made from higher-grade stainless steels like AISI 316L, which provides superior corrosion resistance and mechanical strength, suitable for repeated sterilization cycles.The choice of steel grade for single-use instruments strikes a balance between cost-effectiveness and performance, ensuring the instrument is fit for its intended purpose while being economically viable for one-time use.

Note:  BEAUTY TECK uses AISI 410 for non-cutting instruments(require less hardening strength) and AISI 420 for cutting instruments(require more hardening strength).The composition of grade AISI 410 stainless steel is as follows:

While on the other hand, AISI 420 stainless steel is harder than AISI 410 ,that is why it is used by BEAUTY TECK to craft single-use cutting instruments for the sake of sharpening the instrument for cutting.The composition of grade AISI 420 stainless steel is given :

Grade 420 stainless steel is generally resistant to attacks from fresh water, mild acids, and food substances, although this resistance is impaired in certain annealed conditions and prolonged contact with unclean food. Widely used for cutlery, it attains very high hardness with heat treatment and is scales-resistant to 650°C. This steel may be annealed, hardened, and tempered.

Here, I would like to mention another grade of stainless steel AISI 304 or simply 304.Its composition of 304 stainless steel is  given below:

As you can see, the composition of 304 steel alloy seems to be stronger than 410 and 420 because 304 steel is excellently resistant to corrosion, making it an ideal material for crafting medical instruments.BEAUTY TECK uses 304 steel in making instruments that require high corrosion resistance, such as hollow-ware and gynaecology instruments etc.

3.  Inspection and Testing

There is a list of standard inspection and testing processes that BEAUTY TECK follow to ensure the stability and functionality of crafted material:

l Passivization/Boiling Test(ASTM 380&F1089).

l Cleaning(G131)

l Hardness(8)

• Bio-compatibility Test

    Ø ISO 10993-10:2021(Irritation and skin sensitization)

     Ø EN ISO 10993-11:2017(Acute Systemic Toxicity Test)

    Ø EN 1SO 10993-5:2009(In Vitro cytotoxicity Text)

4.Identification of Single Use Instruments

To distinguish single-use instruments or disposable instruments from reusable ones, any method is needed. It could prove good for the surgeons or users of medical instruments to know which instruments are disposable and which are not. For this reason, single-use instruments are usually coated with color.An instrument is not coated entirely but a little from its corner just to make it identical.Color options may include cyan blue,red yam,stove green, lemon yellow and sp flame blue. However ,any color can be used for disposable instruments upon the client's request.

For coloring single-use instrument,we do not use normal colors.Only non-toxic colors that are 100% biocompatible and comply ETO sterilization, are used by BEAUTY TECK INTERNATIONAL.

5. Re-usability of Steel

As single-use instruments are used once and then disposed of, where do these disposed instruments go? There should be a proper setup to ensure all that steel is recycled.Yes, stainless steel from single-use instruments can be recycled by melting it down at high temperatures. However, this requires a specialized process, especially since the instruments are considered medical waste and must be properly sterilized before recycling to eliminate biological hazards.

However recycled steel is not typically reused directly to make surgical instruments. Medical-grade stainless steel requires strict quality and purity standards, so recycled steel might be repurposed for industrial applications, not necessarily for crafting new surgical instruments.If recycled steel were to be used for medical instruments, it would be sterilized as part of the manufacturing process. However, most single-use instruments are manufactured from virgin stainless steel to meet medical standards.

"Where Durability Meets Precision – Stainless Steel Redefined"