- Education and Science»
- Medicine & Health Science
Surgical Instruments, Were you cheated if they are not marked 'German Steel'?
How important is it that your instruments are made of German Steel?
Are surgical instruments made of German steel better?
It is fairly well known that Germany produces top quality steel, and have great craftsmen. When it comes to manufacturing precision instruments, they enjoy a stellar reputation. So does the Rolls Royce manufacturer! Where am I going with that? Well, we can't all afford a Rolls Royce, but that doesn't mean that we can't drive a Quality vehicle. The same applies to surgical instruments, and, for that matter, just about about anything else.
Here is the real question: (For example) How important is it to spend what it costs to purchase an instrument made of German steel in Germany, by German Craftsmen?
There are two answers. The first one only you can answer. If it makes you feel better, and you can afford it, you should probably go for it. I expect that you will get a high quality surgical instrument, possibly accompanied with a lifetime warranty. But the price tag will likely be very high. The reason for that is partially quality and reputation, but also the high cost of labor and general manufacturing costs in that country.
The other answer is, that it is not important where your instrument is made, as long as a high steel quality is used, and the finish and functionality of the instrument is high grade. But to make sure you get the quality you are paying for, as well as the savings you should expect, you need some important questions answered. Knowledge is power, and you will be surprised what you learn when you dig below the surface.
How to dig below the surface
- When buying Surgical Instruments, Knowledge equals Savings
Not all Surgical Instruments are created equal, but you don't have to pay high prices to get great quality. You do however need to know how to find great quality while enjoying huge savings.
'German quality' stainless steel
Is The Manufacturer of your instruments the ORIGINAL Manufacturer?
It is not unusual that manufacturers outsource all or part of the manufacturing process of surgical instruments. This is generally done to speed up the process, or to save money, or both. That, in itself is not a problem, as long as the customer benefits. But you should know that just because a manufacturers name is on an instrument, it does not necessarily mean that the full manufacturing process occurred in their factory. In fact, it is possible that the instrument was made entirely by a different manufacturer. Such a practice is called 'BRANDING' and the company you are purchasing the instrument from, and whose name is on the instrument is considered a 'PRIVATE LABEL MANUFACTURER'. This is perfectly legal, but still something that you should be aware of.
For example: If I bought an instrument entirely manufactured in Germany, I would expect to pay the full price, but if they sent the steel to a manufacturing unit in China, Pakistan or India, they would save a lot on the manpower and general manufacturing process, and even though they would use properly trained craftsmen, I would still expect to see a reduction on the pricetag. A company could have the majority of the instrument production outsourced, and then do the final adjustments and finishing in house. However, as long as the manufacturer has a good reputation and stands by his warranty claims, I would not be concerned.
Japanese steel ophthalmic instrument
German Steel or German Quality Steel? That is the question.
Here is a tit-bit of information worth having.
In my experience as a buyer of surgical instruments, I have learned to question whether an instrument (originating from Pakistan, India or China for example), marked 'German Steel' is actually made of German manufactured steel, or 'German Quality' steel, which could have been manufactured in any country other than Germany. Having said that, It does not mean that the instrument is of inferior quality, as steel used to manufacture surgical instruments and many other steel products are generally subject to approval of organizations such as ASTM, (an International Standardization organization) and AISI (and organization that has classified and numbered the various steel grades, and is a leader of this technology in North America. More is available on these organizations in the links below, and I have included a link to the Rockwell scale, (the most used method for measuring steel hardness).
Is it possible to get Instruments from Asian manufacturers made with imported German steel?
Certainly. But take for instance Pakistan. Today, there are some 2900 surgical instrument manufacturers according to Sialkot Export. The sectoral analyses of surgical instruments of Pakistan in 2009-2010, has Pakistan's total export in this sector at $225 million USD. The sector, at that time, was made up of over 2300 companies of which approximately 30 was considered large, 150 medium sized and the remainder small. Most of these companies purchase forgings from forgers who manufacture and or imports steel. Some companies will import German-made Steel, but both the steel price, the import taxes and shipping charges greatly increases the cost of producing the instruments. Manufacturers I have dealt with consider such a request a 'special order' and it would have to be large. I would insist on copies of the steel purchase records, material data sheets and an independent lab analysis of the shipment. I would ask the same certification of the large companies that keep imported German steel in stock. My company's buyers are totally satisfied with Japanese steel (with Tungsten Carbide working surfaces where necessary). If you have to purchase from a suppliers, you can still question them on all those points. They should have documents on file. The link 'How to dig below the Surface has detailed information'
Sector analysis of Surgical Instrument industry in Pakistan
- Pakistan Institute of Trade And Development
The info is found in Publications/27
American Society for Testing and Materials
- ASTM International - Standards Worldwide - News Releases
ASTM International is one of the largest standards development and delivery systems in the world. For over a century, ASTM has met the technical needs of commerce.
AISI The American Iron and Steel Institute
- About AISI: AISI Mission | AISI - American Iron & Steel Institute
AISI the American Iron and Steel Institute has established standards for steel compositions.
The Rockwell Scale
- Rockwell Hardness Test Method | Newage Testing Instruments
The Rockwell hardness test method, as defined in ASTM E-18, is the most commonly used hardness test method.
Processes used in making Surgical Instruments
Retractor with light and suction
What you should know about the steel used in manufacturing surgical instruments
Grades of steel
Different grades of steel are used depending on the instrument manufactured. Cutting edges for example needs to be of harder grade steel than a retractor. Another reason why, in my opinion, it is not necessary to purchase a needle holder entirely manufactured with the most expensive and very hard steel, is that the only place you will benefit from such a hard surface on that instrument is the working tip. You could, for example, find yourself the very satisfied owner of a needle holder made of a good quality Japanese steel with Tungsten Carbide tips. Here I would add that I prefer the TC tips that are imported from Germany. The result is an excellent instrument, where unnecessary expense has not been wasted on areas where it is of no benefit to the user. Cutting costs where it is not necessary is important for institutions where budget restraints are a reality, so a chance to obtain quality instruments without excess 'bells and whistles' is of importance.
Application Of Stainless-Steel Grades In different Types Of Surgical Instruments
There are different benefits to the different steel grades, and the composition of each is made to best suit its need. You will see the AISI numbers for each category
Knives (302, 303, 420, 440)
Osteotomes (410, 440)
Reamers (410, 630)
Rongeurs (410, 420)
Scalpels (420, 440)
Scissors (410, 420)
Dissectors (410, 416, 420)
Cannulae, Needle Vents (302, 303, 304)
Forceps (302, 303, 304, 410)
Retractors (302, 303, 304, 410, 416, 420, 431, 440)
Specula (302, 303, 304, 316)
Spreaders (302, 303, 304, 410, 416, 440)
Clamps (303, 304, 410, 416, 420)
Drills (303, 440)
Handles (303, 304)
Hammers, Mallets, Rulers, Screws, Tunnelers (303)
Punches (303, 410, 416, 420)
Skin Hooks (303, 410, 416, 420)
Suction Tubes (303, 304)
Probes, Tongs (303, 440)
Holders (304, 410)
Clip Applicators, Dilators (410)
Elevators (410, 420)
Orthopedic Instruments (430