NO STAINLESS STEEL IS TRULY “STAINLESS”
With decades of experience in the manufacture and sale of medical instruments, we realize fully well that corrosion is the most common cause of concern to any user. In any such event, the quality of material is immediately blamed to be inferior and the manufacturer unreliable. We feel this reaction is not fair in most cases. The objective of the following discussion is to make users aware, address misconceptions and answer most frequently asked questions regarding stainless steel and corrosion problems.
The term “stainless” is often taken too literally. The fact is that even under normal clinical conditions the finest stainless steel instruments can become rusted, spotted or stained. Stainless steel, a British invention of the 50s, has proved to be the most suitable material for surgical and dental instruments. It is economically viable, acquires attractive and durable finish, can be honed to an extremely sharp edge or fine point, remains tough even in small dimensions and can be hardened. Harden-able stainless steel is called Martensitic. It contains carbon that causes hardness. But it is also carbon that reacts with water and oxygen in air to cause oxidation (corrosion). Bulks of instruments are made with this type of stainless steel. The next important content is chromium. It resists corrosion. The more the chromium the less are the chances of corrosion. It also gives it a shine. High chromium steel is called Austenitic, non-magnetic or 18-8 stainless. It is also commonly used in kitchen appliances and cutlery. However, it is not harden-able hence cannot be used for cutting instruments. Rough surface is more vulnerable to corrosion. This is why corrosion mostly occurs in serrations, knurling, ratchets, joints, cracks or cavities. But the most common cause of corrosion is improper care of instruments during use, cleaning and sterilization process.
Just contact us. We are constantly introducing new styles and developing products to meet the specific, changing needs of our customers.
We usually do not set any limit for minimum quantity for placing an order for our running items. However, we suggest you to contact us about minimum order limit for any new requirements or new product development.
The product samples are offered free of charge on the condition that they will be returned to us in same condition within 30 days if they are no longer required but we have to ask for the freight charge. We would require your FedEx, DHL, UPS, TNT or international courier account number to enable us to send you the samples by collected air freight to the customer’s account.
THE MATERIALS USED BY FIDA INTERNATIONAL IN MANUFACTURING OF VARIOUS TYPES OF INSTRUMENTATION.
AISI These are the initials for the American Iron and Steel Institute. AISI has identified the various formulations of steel and catalogued using a number system. Many of the materials used in surgical instrumentation have AISI numbers, i.e. AISI 304 or AISI 410.
ASTM These are the initials for the American Society of Testing and Materials. They establish standards and specifications for many materials, both metallic and non-metallic. Some materials will have an AISI number as well as an ASTM number.
Austenitic Series 300 Stainless Steels are Austenitic or non-harden able or non-magnetic. The carbon content is as low as 0.08 percent that means these metals cannot be heat hardened and will not hold a strong cutting edge. However, it may be \’work hardened\’ through machining or forming. The presence of almost 18 percent chromium and 8 percent nickel makes these metals highly corrosion resistant and guarantee a brilliant shine. The term 18-8 stainless is sometime used to describe this series.
Martensitic Series 400 Stainless Steel alloys are magnetic type and heat harden able. These have relatively high carbon and low chromium percentages, along with traces of manganese (Mn), silicon (Si), sulphur (S), phosphorous (P), nickel (Ni) Molybdenum (Mo) etc endowing the metal with specific properties. Their use is a necessity wherever strength and temper are required. The degree of hardness depends largely on the carbon level. This series is used in most O.R quality instruments, cutting and non-cutting, because it has a high tensile strength, can hold edge for a long time and is corrosion resistant. However, as there is little or no nickel in this series it is susceptible to corrosion if not looked after properly.
BS 5194: Part 1
This is a relatively modern British innovation that has become in universal use for steel instruments. It reaches the factories in the form of bars and sheets. Looking at these lengths of rough and dark gray material, one wonders how it will be fashioned into beautifully finished instruments. Such a transformation reveals craftsmanship at its best.
STAINLESS STEEL TYPE AISI 304 This material is easy to machine and form. Instruments or components that do not need to be hardened, such as speculums, retractor blades, hollow handles, hospital hollow wares, nuts, screws and pins etc, are usually made from this grade.
STAINLESS STEEL TYPE AISI 316L It is a very high purity alloy. \’L\’ stands for low carbon. It is also called SMO. It is a preferred material for making most orthopedic implants, such as plates and screws, nails, staples, prostheses and aneurysm clips etc. Certain instruments that have prolonged contact with implants also utilize this material to avoid transfer of dissimilar metal particles which could cause galvanic corrosion reaction on the implants. It is however important to know that metal implants and prostheses can sooner or later fail since no metal has yet been developed that will equal the revitalizing durability of living bone.
STAINLESS STEEL TYPE AISI 410 This is a most commonly used grade for the manufacture of non-cutting instruments. Typical examples are hemostats, assorted forceps, and retractors and so on. It is easy to work with and has Rockwell Hardness in the range of C-40 to C-45. It is a misconception that this grade is inferior in any way as it clearly complies with the British, German and International Standards for application in surgical instruments.
STAINLESS STEEL TYPE AISI 420 & 440 These are useful grades for cutting instruments such as scissors, knives, chisels, rongeurs, bone cutters, bone drills and taps etc. AISI 420 can get Rockwell Hardness in the range of C-48 to C-50 but if hardness around C-55 is required then grade AISI 440 with more carbon is appropriate.
Type ASTM F67 – Commercially Pure grades 1,2 and 4. It has the same strength as steel but weighs only 60 percent of the steel. It is highly corrosion resistant but very difficult to work with. Some microsurgery instruments, mandibular implants and weight bearing hip prostheses are made from it. Its biocompatibility is far more superior than any other currently employed implant material. It can be finished in a distinct blue colour but repeated autoclaving may give it a reddish tinge.
GRADE GC20 This is the hardest man made material, sometime also referred to as diamond. It has a Rockwell of C-86. Cemented carbide is often called hard metal. Its inserts are sintered in the jaws of high wearing instruments such as needle holders, scissors and wire cutters. Traditionally these instruments are partly gold-plated for recognition.
OTHER MATELS: There are also many non-ferrous materials that are used in instruments for their specific properties. They may be easier to machine or form and more suitable for procedures or budget.
STERLING SILVER It is 92.5 percent pure silver (Ag). Current uses include trachea tubes, probes for eyes and haemostatic clips. Silver will turn black with oxide. This does not interfere with the function of the instrument. A bit of rub with or without silver polish or elbow grease will bring the original shine back. These instruments should be handled carefully as they are expensive as well as delicate.
GERMAN SILVER An alloy of silver and nickel that is less expensive and is used as an alternative to Sterling Silver. It is also more durable and does not turn black after autoclaving.
BRASS AND COPPER Free cutting brass type 360 and nickel-copper Class A or B are easily formed, molded and welded therefore useful for making instruments that are otherwise hard to make from steel or require malleable features. Certain instruments made traditionally in these soft metals are Proctoscope, malleable uterine sounds and retractor blades, catheters and cannulas. In order to enhance surface wear these are usually plated.
ALUMINUM There are many hard and soft grades. With its excellent heat dissipation capacity along with durability and lightweight it is employed for making the container system for sterilization and storage. FIDA International offer a durable yet economical system, please see our catalogue. Aluminum requires a protective layer by hard anodizing that can also be in different colors for identification. Some instrument handles, mallet heads and splints are also made of aluminum.
Rubber, Plastic, Silicon and Teflon are increasingly used in a wide variety of application, both reusable and disposable. Some of the useful characteristics are toughness, flexibility, resilient, resistant to chemicals, insulating, no moisture absorption, heat deformation, high impact strength, easy fabrication and low cost etc. In fact the possibilities are endless. Plastic items are gradually enabling a new wave of convenience and cost reduction in the operating room, a trend that will undoubtedly continue to grow with the passage of time. The use of latex rubber, however, has been discouraged because it contains certain protein that is said to cause skin allergy to some patients and hospital staff. No significant hazards are expected from silicon products under normal conditions of handling and use.
Carbon steel and non-ferrous metals instruments are protected from staining or discoloring by plating of various types. Until the advent of stainless steel most surgical instruments were plated. However many instruments are still more economical or effective to make plated. Mixing of plated instruments with stainless steel instruments in the reprocessing cycle should be avoided as it may result in transference of chrome to stainless that will look like stains. All plated instruments should be routinely checked to ensure there are no cracks or worn areas in the surface. In recent years the use of ultrasonic cleaning has hastened the demise of plated instruments as it tends to strip the plating from the base metal.
SILVER PLATING – Instruments or components made of copper or brass can be plated with silver by electrodeposited coating. To enable the final silver deposit to adhere it will follow a primary coating of silver strike solution, nickel or copper plating. The silver plating shall not be less than 0.0010 inch in thickness. It is especially suitable on malleable instruments because the layer of silver plating is so thin it does not crack or chip when instrument is bent. Silver plating may turn black with silver oxide and may be given a good rub to get the shine back.
NICKLE PLATING Nickel adheres very well to carbon steel and is not removed easily. The surface is made free from all flaws or defects which will be detrimental to the final finish. Cutting edges are ground to remove all plating. There are not many instruments made with carbon steel these days, except perhaps for veterinary use or some general-purpose scissors. Moisture will act rather quickly to first stain and then corrode these instruments.
CHROME PLATING Carbon steel, copper and brass are all base metals that can be chrome plated. Finish on all edges and surfaces shall be uniform and free from burrs, sharp edges (except where required), crevices, grind marks, rough areas, cracks and overlaps. Chrome plating often has a layer of copper or nickel underneath and therefore protects instruments longer from corrosion and discoloration.
BLACK CHROME PLATING Black finish makes work easier under microscope or extra lighting because of lack of glare. Until recently, the black or ebonized finish was achieved by dipping in a sodium salt solution and then baking in oven. These salts, however, have now been reclassified as very toxic and therefore unsafe to use. There are also some very strong disinfectants also now available that can strip this type of black finish completely. We have therefore abandoned this process and may only be able to offer instruments ebonized in Europe if necessary.
A single-use medical device is intended for use on a single patient during a single medical procedure and then it must be discarded.
With the birth of new diseases, like BSE and CJD or increase of hepatitis, in the last decade, decontamination of medical devices has become a prominent issue. Increasing fears were realized in 1997, by which some 23 deaths from CJD had been recorded in Britain. By 2004, this number had arisen to 143. It is not known how many more people may be incubating the disease.
A study published in Sep 2004 by US FDA has confirmed that the infectious agents (prions) found in these diseases are very difficult to destroy by conventional methods even at elevated temperatures. This study was designed to examine the effects of the rigorous decontamination protocols, recommended by the World Health Organization (WHO), on various types of instruments. The most important conclusions were that such chemical procedures can cause (1) darkening of some instruments (2) damage carbon contents in metal and (3) corrode gold plating, welded and soldered joints.
Another recent research published in \’New Science\’ has revealed that even routine sterilization above 138C does not inactivate CJD. Infection may therefore spread through surgical instruments, endoscopes and laryngoscopes used previously in infected patients. A report published by the DWG identified that most of the sterilization sites assessed in the British hospitals were deficient in a number of key areas.
On a wider note, all kind of hospital-acquired infection (HAI) is a major concern for all healthcare providers. Recent estimate from the Public Account Committee, covering England have suggested that there are over 100,000 cases of HAI a year in England at a cost of Pounds 1 billion and causing 5,000 deaths. HAI can be caused by a variety of transmission routes, which includes inadequate reprocessing of reusable medical devices.
With the NHS spending more money each year for litigation settlement it\’s no wonder that there is currently a major government focus on cleaning up hospitals. Additionally, patients are placing increasing demands upon health care sector, much of which is driven by the media, to use more and more single-use devices.
A French public study undertaken in 1996 showed that:
- 92% would prefer to have single-use products used on them or their relatives.
- 60% were in fear of contracting disease by the use of reusable products.
- 62% were prepared to pay for single-use products.
Hospital infections are now the fourth leading cause of death in the United States, behind heart disease, cancer and strokes. (Reference: “The Hospital-Acquired Bloodstream Infections” Vol. 7 No.2)
With the statistics as serious as these it\’s no wonder that single-use medical devices are seen as a more effective measure for minimizing the risks involved.
As an alternative to disinfecting and sterilizing, more and more medical devices are being developed that are suitable for use only once. That means they have not touched any patient before and therefore pose no risk of cross-infection whatsoever.
Single-use products, after use, are contaminated hazardous waste that must be removed from hospitals as soon as possible and incinerated. In Britain guidance on disposal of clinical waste can be found in Safe Disposal \ of clinical waste, issued by the Health Advisory Committee, HSC ISBN 07176 26927. The World Health Organization (WHO) has also recommended such instruments be incinerated.
The overall environmental burden of recycling single-use clinical waste, when compared with reusable, is unclear. In a report by Bell in 1998, it was noted that when considering the effect on the environment it should be remembered that the cleaning and sterilizing of reusable products and equipment have significant environmental implications and as such should not automatically be assumed \’environmentally more friendly\’.
It may also be noted that after constant use, there are doubts about the quality of reusable instruments. Also key is the reliable monitoring and recording of the frequency of reprocessing and reuse for each individual medical device. Even if this problem is somehow brought under control, it will be at a huge capital investment, personnel costs and overheads.
If the reprocessing is contracted out, it may cost even more and also entail additional issues like, accountability, accessibility, repair/replacement, capacity, convenience, waiting time, transportation, audit trails and so on. Such a change may even result disruption, including task re-allocation or even redundancy of staff.
Converting to a single-use system may also entail an immediate budget increase due to bulk purchase, need for more storage space, specialist staff and incineration cost. However, the subsequent savings and convenience will effectively offset these constraints. The cost effectiveness of eliminating the risk of fatal diseases might alone justify the use of single- use devices. Single-use may not be a viable option for all surgical procedures due to instrument availability, but should be adopted where such alternatives are available and effective.
Single use medical devices are often associated with convenience, improved reliability, time and cost saving. Because of their high volume, they often cost much less than the reusable. They are Ready-to-use; therefore, there is no waiting time, no cost for reprocessing, maintenance or post-operation tracking. Because they are new every time, there is no risk of infection. The attributes of single-use devices are multiple. These are the real key to success and peace of mind for the suppliers and users alike.
Reprocessing Single-use Medical Instruments considered being a threat to patient safety
Single-use medical devices are not designed with cleaning in mind. These must not be reprocessed and reused as stated in the MRHA document DB 2000 (04).
Reprocessing a single-use medical device is contrary to manufacturer\’s design may cause breakage of parts or impairment of performance.
The residues left by surgical procedure or sterilization agents during reprocessing have the potential to cause toxic effects in patients.
Even if reprocessing kills bacteria, it will not necessarily destroy or remove the bacterial endotoxins on devices that were not designed to be re-cleaned.
Reprocessing may alter the biocompatibility of a single use device, causing physical or chemical changes which may pose a threat to the patients.
The original manufacturer ensures that the packaging containing a single use device is protective and sufficient. Reprocessing may compromise this.
Anyone considering re-using these devices should be aware that this action will pass the legal liability from the manufacturer to the reprocessor.
Infections acquired in hospitals are an increasingly serious problem adding sizeable costs to the health service in financial claims on this behalf.
If a single-use device is to be reused on any patient, that patient must be clearly informed about the risks involved and he must consciously agree to this form of treatment.
To claim quality is one thing, to deliver it another. Our product quality is maintained in our multi-step quality control procedures. Our products are made according to preset product spec sheets or tech packs of each product which contains all the details and criteria about the product manufacturing from the start till the completion of order – from the selection and purchase of raw material to the shipment of consignment. These tech packs are developed after receiving customer order along with product specifications by our quality assurance department with the coordination of research and development and production departments. The customer\’s feedback always holds important place in this process as well as in house developed, FIDA International consistent quality control procedures. These tech packs are distributed to the entire setup involved in product manufacturing directly and indirectly and these are kept as standing instructions and reference guides. This helps us in achieving desired results and coordinating the operations of purchasing, production, packing and quality control departments as well as export and accounts departments. With this effective control over ‘information preparation, distribution and implementation’, a consistent and homogeneous quality product is made and a timely and preplanned order execution takes place, each and every step is recorded and after the completion of every order whole process is evaluated in order to check any lapse that could have occurred or could be occurred in future. The end result of this effort is topnotch quality of our products, on time delivery of orders, superb customer services and flourishing business of our customer’s giving them edge over their competitors. If you have another question please contact us. We\’ll provide prompt & accurate answers.
FIDA International implement a number of procedures and tests to make instruments more resistant to corrosion, these are:
Procedure during Manufacturing:
(1) Selection of high quality Stainless Steel:
FIDA International source and use stainless steel from approved suppliers, according to BS 5194: Part 1: 1991 / ISO 7153-1 and ASTM: F899-95. Mill test certificate confirming the chemical composition of material is obtained with every batch.
(2) Use of Austenitic Stainless Steel:
As far as possible and where hardness is not required, FIDA International makes instruments or their components, such as hollow handles, pins, screws or springs etc. with non-carbon material.
(3) Electro polishing:
A process in which the instrument is made an anode in a drum containing suitable electrolyte, and a minute amount of metal is removed from its surface as the current flows. This technique helps polish areas inaccessible by the \’Polishing mops\’ i.e. jaws, ratchets, box joints etc
It is bathing of finished instruments in acid to burn out foreign particles imbedded on its surface during manufacturing process. It leaves a protective film on the surface.
Procedures during Testing:
At certain stages of the manufacture the following tests are applied to check the corrosion resistance of FIDA International Instruments.
(1) Copper Sulphate Test: A chemical test prescribed and recommended in ISO 13402: 1995 (E)
(2) Boiling Water Test: This is not at random, 1 or 2 percent, as with most of our competitors. At FIDA International it is 100 percent.
Yes, we are An ISO 9001:2000 and ISO 13485 Certified Company. We have CE Marking for many of our products.
A. We export all over the world, some major countries like Australia, USA, UK, UAE, Germany, Japan, France, Italy, Denmark, UAE and India.
A. All payment should be made in US dollars, unless otherwise specified in the quotation sent to you. We give the following options for payment.
* Full Advance Payment: This method is most convenient for small orders as it minimizes the bank charges involved in other methods of payment. You may send payment by Check or Bank Draft favoring FIDA International Instruments Co to our postal address, or, you may send Telegraphic Transfer (TT) or Wire Transfer to our Bankers under intimation to us.
* Part Payment in Advance: For larger orders, we expect that you send 50% value in advance. Balance payment is payable against delivery of documents through your bank. This method involves Bank Charges which are payable by the customer.
* Letter of Credit: We expect Sight Letter of Credit against bulk orders. This method involves considerable Bank charges. All Bank Changes as per the terms of Letter of Credit, must be to the account of the buyer.
Please us our email or contact us form for banking details.
- Normal mode of shipment is \”Air Freight\”. However we also use Air Post Parcel, Sea Post Parcel, Courier, etc. upon special requests from customers.
- The shipping charges vary according to the size of shipment, destination and Mode of dispatch. C.I.F. rates are quoted if you inform us the exact quantity, destination and mode of dispatch preferred by you.
If you have any technical questions please feel use our contact us form.
Price/Price changes: Our prices are on FOB, C&F, or CIF basis depending upon our customer preference. Prices are likely to remain firm in future. However, we retain the right to alter prices on account of buyer without prior notice. All quoted prices have certain validity period and therefore subject to our final confirmation. Any changes in the shipping costs or insurance rates are on account of the buyer. Better price options are offered for FCL shipments.
Payment Terms: For small order valued less than 10,000 USD, half deposit required with the order, balance to be paid on completion when goods are ready to ship. For order valued more than 10,000 USD, the payment could be made by irrevocable letter of credit (L/C) at SITE. From new customers, bank and trade references are required with the order.
Delivery Periods: We can provide the best lead time depending upon the type of the product. Irrespective of the volume of our customers’ orders, we consign the stock items within a week and repetitive products is 30 days and for new products is 45-60 days from the date of receipt of confirmed orders or from the date of confirmations of our quotations depending on the nature of the order.
Delivery Terms: The terms of delivery are quoted FOB, CFR or CIF for cargo required to be shipped by sea and FCA, CPT or CIP for by air mode of shipment (Incoterms 2000 developed by ICC).
Better way to quicken the delivery time:
The production proceeds on after approval of samples. For sample approval, we need to get customer’s logo, if required, specific raw material input and complete product detail from customer. If design, logo or product material is changed by the customer, the new samples will take more time. So we emphasis there is no misunderstanding for the samples and other details of the order. Things get fast and easier by detailed and quick communication between us and our customer regarding the product and order. Secondly, our production planning and coordination department arranges all orders in strict schedule after arrival of advance T/T deposit or L/C. The earlier the information and payment reach us, the sooner the delivery time will be.
Mode of Shipments: Primarily, our shipments are made via air-freight. However, we can also ship by sea if requested by customer.
Stamps: We stamp our products as per client requirements as decided during the ordering process. The logo or name can be printed, embossed or embroidered depending on the nature of product. Please note that you must be the lawful owner of that logo, design and brand name. We would like to see the evidence of your lawful ownership in this regard.
All instruments are initially packed in poly bags and 12 pieces are packed in cardboard box finally packed in export worthy cartons. Weight of each carton comes around 20 to 25 kg.
- Size of export worthy cartoon is
- 12 inches x 12 inches x 9 inches
- 12 inches x 12 inches x 12 inches
- 14 inches x 14 inches x 16 inches
Feel free to forward your questions to us through our 24-hour functional customer support center.
Yes, we adhere to strict environment friendly production process and continuously try to improve our production operations with latest techniques to minimize the impact on environment. Yes. We adhere to strict environment friendly production process and continuously try to improve our production operations with latest techniques to minimize the impact on environment.
Gold handle on scissors, forceps, or needle holders means they have Tungsten Carbide (TC) inserts on the working surfaces. TC is one of the hardest alloys used for surgical instruments. They are approximately twice as expensive as standard instruments, but can last five times longer, cutting the same tissue. This can be very cost effective in the long run.
Please email us at firstname.lastname@example.org, for pricing and catalogue.
You can Contact ASL by E-mail, Cell, Fax, Phone or Post.
If you wish to have a quotation of any particular item, please use Request of Quotation Form.
For all other reasons, use any of the following methods:
Fax: +92 523 301034
Phone: +92 3456 774411
Post Address: Amir Street, Ali-ul-Haq Road, Model Town, Sialkot – 51310, Pakistan.
We consider our work force as our asset and our wings. Like all high flying objects, we take great care of our wings in all situations. All our products are free from child labor and from any other form of exploitation of the employees. We make sure that at all levels of our operations no employee below the prohibited age limit or under bad working conditions has to work on our products.