Support, Biotek (A Division Of Chetan Meditech Private Limited)

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SURGICAL INSTRUMENTS-CARE & HANDLING

Recommendations for the Care and Handling of BIOTEK® Surgical Instruments and Instrument Cases

DESCRIPTION

BIOTEK® instruments and instrument cases are generally composed of aluminum, stainless steel, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing sterilization and drying cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap to maintain sterility.

Materials
Aluminum
Stainless Steel
Polymeric Materials

DISCLAIMER

BIOTEK® instrument cases are intended to protect instrumentation and facilitate the sterilization process by allowing steam penetration and drying. BIOTEK has verified through laboratory testing that its instrument cases are suitable for the specific sterilization methods and cycles for which they have been tested. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. Testing should be conducted in the health care facility to ensure that conditions essential to sterilization can be achieved. BIOTEK does not accept responsibility or liability arising from a lack of cleanliness or sterility of any medical devices supplied by BIOTEK that should have been properly cleaned and/or sterilized by the end user prior to use.

1. General. Surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling. Care must be taken to avoid compromising their exacting performance. To minimize damage and risk of injury, the following should be done:
• Inspect the instrument case and instruments for damage upon receipt and after each use and cleaning. Incompletely cleaned instruments should be re-cleaned. Instruments in need of repair should be set aside for repair service or returned to BIOTEK (Instruments returned to BIOTEK or its distributors should be cleaned and sterilized prior to shipment.)
• Only use an instrument for its intended purpose.
• When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.

2. General Cleaning. Clean instruments prior to initial sterilization and as soon as possible after use. Do not allow blood or 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. Wash all instruments whether or not they were used or inadvertently came into contact with blood or saline solution.

3. Ultrasonic Cleaners can be used with hot water as per manufacturer’s recommended temperature (usually 90º-140ºF or 32º-60ºC) and specially formulated detergents. Follow manufacturer’s recommendations for proper cleaning solution formulated specifically for ultrasonic cleaners. Be aware that loading patterns, instrument cassettes, water temperature, and other external factors may change the effectiveness of the equipment.

4. Washer-Decontamination Equipment will wash and decontaminate instruments. Complete removal of soil from crevices and serrations depends on instrument construction, exposure time, pressure of delivered solution, and pH of the detergent solution, and thus may require prior brushing. Be familiar with equipment manufacturers’ use and operation instructions. Be aware that loading, detergent, water temperature, and other external factors may change the effectiveness of the equipment.

1. Removal of Gross Contamination-The effectiveness of subsequent decontamination processes depends on prior removal of gross soil as it may be impaired by dried or coagulated protein. Gross soil should be removed under running water using a mechanical aid such as a brush with rigid nylon bristles. Care should be taken to avoid splashing and generating aerosols by holding instruments below the surface of the water in a sink into which water is running and continuously draining. Instruments should not be held under a running tap, as this is likely to result in splashing. Operatives should wear protective equipment including gloves and goggles. Care should be taken to avoid penetrating or cutting injuries. Particular attention should be taken to remove all debris from all cannulations and obscure holes in the instruments.

2. Disassembly-The majority of surgical instruments and trial prostheses are constructed in such a way that they will not require disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to decontamination. In most cases the method of disassembly is self-evident. Loosen and/or disassemble instruments with removable parts. Screws or bolts on some instruments can be loosened for cleaning but are self-retaining to prevent loss.

3. Washing/Disinfecting- It is recommended that the instruments, disassembled as required, be decontaminated using an automatic washerdisinfection unit utilizing thermal disinfection. This should preferably be of the ultrasonic or continuous tunnel process type. The cabinet type is an acceptable alternative if a continuous process machine is not available. (Typical initial cleaning temperature is at or below 95° F (35°C), followed by a hot water disinfectant rinse where the surface temperature of the instruments should reach a minimum temperature of 160°F (71°C) for a minimum of 3 minutes, 176°F (80°C) for a minimum of 1 minute, or 194°F (90°C) for 1 second.) Compatible detergents and rinse aids may be used as recommended by the manufacturer of the washer-disinfection unit. These detergents and/or rinse aids, however, should be of neutral or near neutral pH. Excessively acidic or alkaline solutions may corrode aluminum instruments or instrument cases.

PREPARATION AND ASSEMBLY

After cleaning/disinfecting, the disassembled instruments should be reassembled and placed in their proper locations in the instrument cases.

RESPONSIBILITIES OF THE USER

General. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance.
Cleaning/Decontamination. The health care facility is responsible to ensure that conditions essential to safe handling and decontamination can be achieved.
Sterility. Users should conduct testing in the health care facility to ensure that conditions essential to sterilization can be achieved and that specific configuration of the container contents is acceptable for the sterilization process and for the requirements at the point of use.

WARNINGS AND PRECAUTIONS

Unless otherwise indicated, instrument sets are NOT sterile and must be thoroughly cleaned and sterilized prior to use. Instruments should NOT be flash-autoclaved inside the instrument case. Flash-autoclaving of individual instruments should be avoided. Unwrapped instrument cases DO NOT maintain sterility. A cannula set needs to be repaired and/or replaced when the fluid flow through the cannula around the scope is decreased.

STORAGE AND SHELF LIFE

Instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be exercised in handling of wrapped cases to prevent damage to the sterile barrier. The health care facility should establish a shelf life for wrapped instrument cases based upon the type of sterile wrap used and the recommendations of the sterile wrap manufacturer. The user must be aware that maintenance of sterility is event-related and that the probability of occurrence of a contaminating event increases over time, with handling, and whether woven or non-woven materials, pouches, or container systems are used as the packaging method.

STERILITY

Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use. BIOTEK® instruments can be steam autoclaved and repeated autoclaving will not adversely affect them, unless otherwise indicated in the labeling. If you have any problems when using BIOTEK® instruments or instrument cases, please bring this to BIOTEK’s or BIOTEK’s distributor’s attention when you return them. (Instruments returned to BIOTEK or its distributors should be cleaned and sterilized prior to shipment. Unless supplied sterile, instruments must be thoroughly cleaned and sterilized prior to surgical use. Individual users must validate the cleaning and autoclaving procedures used on-site, including the on-site validation of the recommended minimum cycle parameters described below. Surgical instruments may be autoclaved using a full cycle. Instruments that have been used in a surgical environment should be thoroughly cleaned prior to autoclaving.
Since BIOTEK is not familiar with individual hospital handling procedures, cleaning methods, bioburden levels, and other conditions, BIOTEK assumes no responsibility for sterilization of product by a hospital even if the above guidelines are followed.

Processing Steps-Suggested Method

Removal of gross contamination & disassembly

By hand submerged in water with continuous flow with mechanical aid (e.g. brush) wearing protective gloves & goggles, disassemble instruments into individual parts

Washing & Disinfecting

Automatic washer-disinfection unit utilizing thermal disinfection (ultrasonic or continuous tunnel process preferable) – Temperatures, cycles & disinfectant type used as instructed by manufacturer of washer-disinfection unit

Sterilization

Steam Autoclave
Cycle Parameters*
Gravity Displacement Sterilizer (Full Cycle)
270º-275º F (132º-135º C) Wrapped or unwrapped 12 minutes exposure time – 8 minutes drying time
Pre-Vacuumed Sterilizer (HI-VAC)
270º-275º F (132º - 135º C) – Wrapped or unwrapped 5 minutes exposure time – 8 minutes drying time
*Validated by BIOTEK under laboratory conditions;
However, these cycles must be re-validated by the end user to ensure that sterility can be achieved on site.

Precautions

When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact. Unless otherwise indicated, instrument sets are NOT Sterile and must be thoroughly cleaned and sterilized prior to use. Instruments should NOT be flash-autoclaved inside the instrument case. Flash-autoclaving of individual instruments should be avoided, whenever possible. Unwrapped instrument cases DO NOT maintain sterility.

Magnetic Resonance Imaging (MRI) is a commonly accepted and widely used medical procedure. It is often safe to perform MRI on an individual that has an orthopaedic implant device. However, it may be contraindicated in certain situations because the magnetic field present in the MRI environment may, under certain circumstances, result in movement or heating of a metallic orthopaedic implant device. Metals that exhibit magnetic attraction in the MRI setting may be subject to movement (deflection) during the procedure. Both magnetic and non-magnetic metallic devices of certain geometries may also be subjected to heating caused by interactions with the magnetic field. Of secondary concern, is the possibility of image artifacts that can compromise the procedure and image quality.
Implant Materials
Orthopaedic devices are manufactured from metals and polymeric materials. BIOTEK metallic implants are produced from titanium in either the alloy or pure form and stainless steel. With the exception of stainless steel, these materials have no magnetic attraction in the MRI environment and implant movement / deflection is not expected. Stainless steels used in some BIOTEK devices may exhibit small magnetic interaction in the MRI environment.
Implant Movement
There are currently several researchers as well as an ASTM committee exploring methods for accurately assessing the MRI compatibility of implant devices. The primary focus of the research has been the measurement of implant movement in response to a magnetic field. Several studies have been conducted in which the movement/deflection of various orthopaedic implants are measured in the high magnetic field (0.3-1.5 Tesla) region of MRI units. The results of these studies show no measurable movement of implants fabricated from titanium alloys.
In an effort to improve imaging capabilities, MRI units employing larger magnetic fields (3.0 Tesla) are also being used. It is possible that implants exhibiting weak interactions in a 1.5 Tesla magnetic field may show a stronger interaction with the 3.0 Tesla field. It has also been examined and found that the movement/deflection of selected orthopaedic implants fabricated from titanium and stainless steel in a 3.0 Tesla MRI unit exhibited little or no movement/deflection.
Implant Heating
Whereas several studies examining the movement/deflection of metallic implants have been performed, comparatively little information has been developed for the potential heating of implants caused by MRI induced electrical currents. MRI induced heating of an implant is important in that it has the potential to damage both the implant and the tissues surrounding the implant.
MRI induced heating of implanted devices is caused by the absorption of magnetic energy during the procedure. The rate of energy absorption is referred to as the specific absorption rate (SAR). In general, only minor heating of passive (non electrified) metallic implants has been found in the MRI setting. However, significant heating is possible for implants that have an elongated shape (e.g. pacemaker lead) or those that provide a conductive loop (large all metallic external fixators). Polymers and composites do not conduct electric current and this minimizes the chance of significant heating of these devices.
Recommendations
Although studies indicate that the MRI procedure has minimal effects on most BIOTEK orthopaedic implant devices, there are certain devices, like external fixation devices that may have magnetic components and should not be used in an MRI environment. BIOTEK cannot make claims regarding the compatibility of BIOTEK implants with any MRI unit. It is recommended that the patient contact the surgeon or the manufacturer of the MRI equipment to discuss the compatibility of BIOTEK implants with the MRI equipment before undergoing any test.