Your first-line-of-defense against Corrosion the "passive oxide layer" of Surgical Instruments
Stainless steel surgical instruments are made of corrosion resistant high-grade specialty steels. The key word here is “resistant”. Corrosion resistant does not mean corrosion proof. One of the special characteristics of these steels is that the manufacturer forms a "passive oxide layer" on the surface, which protects them against corrosion. This makes surgical instruments as corrosion resistant as possible. It is imperative that you maintain the passive oxide layer to prevent corrosion and maintain your surgery instruments in optimal condition. If this is not done the stainless steel will corrode or stain more readily which will reduce the life of the surgical instrument and/or render it useless. Initially, all “stainless steel” surgical instruments have the same corrosion resistance. When strength and hardness requirements are important factors for instrument function, corrosion resistance is generally lower. Increasing the corrosion resistance would soften the stainless steel. Manufacturers of surgical instruments and surgical instrument containers recommend the use of neutral pH cleaning concentrates. Newly developed neutral pH all-in-one or "combination" cleaning concentrates have been shown to be effective in optimizing the efficacy of the "passive oxide layer". This will provide a longer life for stainless steel surgical instruments. More information and studies regarding the "passive oxide layer" of Surgical Instruments is below.
Interpreting "Rust" - Yellow-brown to Dark-brown Stains or Spots
Yellow-brown to dark-brown stains or spots on surgical stainless steel instruments are frequently mistaken for "rust". These residue deposits (stains or spots arranged in groups or along edges or in crevices) are usually the instrument being exposed to result of high chloride content. They will lead to pitting of the surgical instrument surface if not removed. (see Avoiding High Levels of Chloride below) Excessively hard water can contain high levels of salt sufficient to cause stains or spots that appear as rust. Boilers used to generate the steam for steam sterilizers, if not cleaned properly, will produce contaminated steam which can deposit minerals onto instruments during the sterilization process.
Neutral pH Cleaning Concentrates recommended by Device Manufacturers
Virtually all manufacturers of surgical instruments, rigid scopes, flexible scopes, and instrument containers recommend the use of neutral pH cleaning concentrates. Generic Example of this recommendation: Do not use high acidic (pH <4) or high alkaline (pH >10) products for disinfection or cleaning, since these can corrode metal, cause discoloration or stress fractures.
Do not use abrasive pads or cleansers, which will scratch the surface allowing dirt and water deposits to collect. Abrasive cleaning will remove the protective passive layer.
Do not use high concentrations of chlorine bleach to clean or disinfect stainless steel instruments, as pitting will occur. Never use bleach to clean any surgical instruments. The high pH of bleach causes surface deposits of brown stains and might even corrode the instrument. Even high quality stainless steel is not impervious to an acidic bleach solution.
Sort instruments by similar metal for subsequent processing so that electrolytic deposition (galvanic corrosion) due to contact between dissimilar metals will not occur.
Rinsing Instruments - Tap or "Source" Water
Tap water can contain many minerals, which may discolor and stain surgical instruments. It is recommended that de-ionized water be used for the final rinsing to prevent spotting. all-in-one or "combination" cleaning concentrates can be effective in treating unacceptably hard source water and removing hard water encrustation from surgical instruments and equipment. If untreated tap water is used for final rinsing, then the instruments must be dried immediately to avoid staining.
Clean instruments, or apply treatment to prevent the drying and encrustation of debris, as quickly as possible after use. Do not allow blood and debris to dry on the instruments. If cleaning must be delayed, place groups of instruments in a covered container with appropriate detergent or enzymatic solution to delay drying. The use of pre-soaking enzyme foam sprays has been shown to reduce the time expended for manual cleaning and render higher quality outcomes. After surgery, open all box locks and disassemble instruments with removable parts. This will limit blood drying on instruments that may cause them to corrode. The "all-in-one" cleaners and the enzyme-detergent foam sprays deliver a chemical complex to: maintain hydration of bioburden, prevent corrosion, clean the surface, and condition the surface of instruments & scopes. This can significantly reduce manual cleaning and facilitate cleaning the surface of surgical instruments, scopes, and the lumens of cannulated instruments inside-and-one. If used properly, all-in-one enzyme detergent foam sprays and/or all-in-one "combination" cleaning concentrates can render excellent outcomes and facilitate cleaning instruments and scopes inside-and-out. They effectively cleaning the surface while cleaning lumens and working channels. This can eliminate or reduce the manual labor expended, rendering lower reprocessing costs while improving turnaround.
The reprocessing decontamination process, whether done manually or automatically in a washer-decontaminator- disinfector, can only be effective if cleaning is adequate. Effective disinfection or sterilization: (Generic Sterilization with a Pre-Vacuum Sterilizer (HI-VAC): 270-272° F (132-134° C), 16-minute exposure time, with 4 pulses and a 30-minute dry time. Generic Sterilization with a Gravity Displacement Sterilizer: 270-272° F (132-134° C), 30-minute exposure time, with a 30-minute dry time.) Sterilization of an inadequately cleaned instrument is not possible. Cleaning is the prerequisite for sterilization.
To maintain moving parts and protect instruments from staining and rusting during sterilization and storage, they should be lubricated with a water-soluble, preserved lubricant after each cleaning. Most automated washer decontaminators provide the option for lubrication at the end of the final rinse treatment. Since effective ultrasonic cleaning removes all lubricant, re-lubrication is important. A complete "all-in-one" cleaner will provide lubrication. The lubricant should contain a chemical preservative to prevent bacterial growth in the lubricant bath. The bath solution should be made with de-mineralized water. A lubricant containing a rust inhibitor helps prevent electrolytic corrosion of points and edges. Immediately after cleaning, instruments should be immersed or rinsed for 30 seconds and allowed to drain off, not wiped off. A lubricant film will remain through the sterilization to protect them during storage.
Staining and spotting may result if residual chemicals are not completely rinsed from instruments that are subjected to steam sterilization. Following the manufacturer’s recommendations for the proper sequence of treatments (cold water pre-wash, enzyme/detergent wash, purified water rinse/lubrication, and drying) is critical in preventing staining and spotting. A Cleaning concentrate that will avoid spotting should be "free-rinsing" or state "rinse clean".
Studies regarding the "passive oxide layer" of Surgical Instruments
(Guidelines on metals and alloys in contact with food; Council of Europe; published 11.10.2000. Systemic nickel: the contribution made by stainless steel cooking utensils; Contact Dermatitis, Volume 32:2, 1994) of the stainless steel passive layer to prevent corrosion have revealed a reduction in corrosion prevention with the use of cleaning concentrates that are not neutral pH. The use of cleaning agents that deliver an acid rinse will release nickel from the stainless steel and decrease the efficacy of the passive layer. This is most critical on initial reprocessing events of stainless steel surgical instruments. Measurable levels of nickel have been detected. It was also shown that, as the number of subsequent uses increased, the level of nickel release diminished and reached a steady state (measured in the order of μg/l). These observations reflect the changes that occur in the passive oxide layer on first immersion of stainless steels in aqueous media.
Stainless steel is essentially a low carbon steel which contains chromium at 10% or more by weight. It is this addition of chromium that gives the steel its unique stainless, corrosion resisting properties. The chromium content of the steel allows the formation of a rough, adherent, invisible, corrosion-resisting chromium oxide film on the steel surface. If damaged mechanically or chemically, this film is self-healing, providing that oxygen, even in very small amounts, is present. The corrosion resistance and other useful properties of the steel are enhanced by increased chromium content and the addition of other elements such as molybdenum, nickel and nitrogen. Stainless steel has a passive film created by the presence of chromium (and often other alloying elements, nickel, molybdenum) that resists this process. When exposed in air, stainless steels passivate naturally (due to the presence of chromium). But the time required can vary. In order to ensure that the passive layer reforms rapidly after pickling, a passivation treatment is performed using a solution of nitric acid and water.
How is the "passive oxide layer" Manufactured and Maintained ?
The passive layer or stainless steel is intended to prevent or resist corrosion. The process is called “Passivation”. “Passivation” and Polishing eliminate the carbon molecules form the instrument surface. This forms a layer which acts as a corrosive resistant seal. Passivation is a chemical process that removes carbon molecules from the surface of the instrument. This chemical process can also occur through repeated exposure to oxidizing agents in chemicals, soaps, and the atmosphere. Polishing, by the manufacturer, is a process used to achieve a smooth surface on the instrument. It is extremely important to polish an instrument because the passivation process leaves microscopic pits where the carbon molecules were removed. Polishing also builds a layer of chromium oxide on the surface of the instrument. With proper cleaning, handling, and sterilization the layer of chromium oxide will build up and protect the instrument from corrosion and /or pitting. In some circumstances older instruments are less corrosive than new ones. The newer instruments have not had the time to build up the chromium oxide layer. However, improper cleaning and sterilization can cause the layer of chromium oxide to disappear or become damaged thus increasing the possibility of corrosion and/or pitting. Proper cleaning and sterilization can cause the layer of chromium oxide to improve over time thus decreasing the possibility of corrosion and/or pitting. Second only to the financial asset value of the working staff, the surgical instrument and scope inventory is the single most financially valuable asset of the healthcare facility. That is a why it is so important to properly clean, sterilize, handle, and store your instruments.
John Temple
Product Development
Surgical Instrument cleaners and conditioners
Neutral pH and "free-rinsing" for residue free Eye Surgical Instruments
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