PARCUS MEDICAL
Parcus Cleaning and Sterilisation
55 Pages
Preview
Page 1
Parcus Cleaning & Sterilization (English) 1. Purpose These instructions are recommended for the care, cleaning, maintenance and sterilization of single use and reusable Parcus orthopaedic surgical instruments. The Instructions for Use (IFU) is intended to assist health care personnel in safe handling practices, effective reprocessing and maintenance of Parcus instruments. Hospital personnel, including those in Receiving and Central Sterile Supply Departments (CSSD), as well as in the Operating Room (OR) may be directly involved in handling instruments purchased from Parcus or on a loan basis as consignment instruments. Hospital directors and other management in each of these departments should be informed of these instructions and recommendations to ensure safe and effective reprocessing and to prevent damage or misuse of Parcus instruments. 2. Scope This IFU provides information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments and is applicable to all reusable medical devices manufactured and/or distributed by Parcus. This information is also applicable to single-use medical devices manufactured by Parcus that are supplied nonsterile but are intended to be used in a sterile state. Devices that cannot be reused may be labeled with the following symbol: Do not reuse This IFU is not applicable to air driven or electrically powered equipment. However, it is applicable to functional attachments (e.g. reamers and drill bits) that are connected to powered equipment for use. 3. Considerations The user/processor should comply with local laws and ordinances in countries where reprocessing requirements are more stringent than those detailed in this manual. New and used instruments must be thoroughly processed according to these instructions prior to use. During musculoskeletal surgery, instruments become contaminated from blood, tissue, bone chips and marrow. The instruments may also become contaminated with body fluids containing hepatitis virus, HIV or other etiological agents and pathogens. All health care workers should become familiar with the necessary Universal Precautions for preventing injuries caused by sharp instruments when handling these devices during and after surgical procedures and during reprocessing. It should be noted that saline and other irrigation fluids are often used in copious amounts during surgical procedures and will exert a corroding effect on instruments. Orthopaedic surgery requires instruments which are heavy and have multiple components, articulating or rotating parts, removable handles, plastic replacement parts, and series of gauges or other measuring devices in graduated sizes. Devices are usually supplied in sets and subdivided into trays in which the devices may be arranged by size or in the order needed for a specific surgical procedure. The materials used in the manufacture of surgical instruments that are intended to be used inside the body are radio-opaque and can, therefore, be detected with conventional X-Ray or fluoroscopy. Other parts of instruments that are not used inside the body may be manufactured from metallic alloys or plastic. No part of this device is intended to be implanted in the body. Hospitals must assume responsibility for cleaning, disinfection, packaging and sterilization of all loaner instrument sets before returning them to Parcus. However, the next user must also inspect the set upon receipt to verify that instruments have, in fact, been adequately cleaned and decontaminated before repeating reprocessing procedures to prepare the loaner set for subsequent reuse. Parcus cannot guarantee that sterility was attained by the previous user and has been maintained during transit. Parcus representatives often open and inspect instrument sets between users, which will, of course, compromise sterility and require complete reprocessing prior to subsequent use. To maintain instruments properly it is important to consider the following information and processing instructions: • • • • • • • • • •
Warnings and precautions Instrument set completeness and functionality Reprocessing limitations and/or restrictions Preparation for reprocessing at the point of use Preparation for cleaning (including assembly/disassembly as necessary) Cleaning, disinfection and drying Maintenance, inspection, testing and lubrication Sterile packaging Sterilization Storage
4. Processing Instructions These processing instructions are intended to assist the hospital and central supply management in developing procedures to attain the above goals, both for hospital owned and for loaned instrument sets. This information is based on Parcus testing and experience, material science, as well as widely accepted recommendations of a number of organizations including: American National Standards Institute (ANSI); American Society for Testing and Materials (ASTM); Association for the Advancement of Medical Instrumentation (AAMI); Association of Operating Room Nurses (AORN); and International Standards Organization (ISO) Note: These instructions describe the necessary processing steps that new and used instruments must undergo to attain sterility. A.
B.
Warnings and Precautions •
Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges.
•
Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers.
•
Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and pipe cleaners should be used.
•
Cleaning agents with low foaming surfactants should be used during manual cleaning procedures to ensure that instruments are visible in the cleaning solution. Manual scrubbing with brushes should always be performed with the instrument below the surface of the cleaning solution to prevent formation of aerosols and splashing which may spread contaminants. Cleaning agents must be easily and completely rinsed from device surfaces to prevent accumulation of detergent residue.
•
Do not place heavy instruments on top of delicate devices.
•
Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris, saline, or disinfectants to dry on used instruments.
•
Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringers Solution.
•
Mineral oil or silicone lubricants should not be used because they: 1) coat microorganisms; 2) prevent direct contact of the surface with steam; and 3) are difficult to remove.
•
These validated reprocessing instructions are not applicable to Parcus trays that include devices other than those for which the trays have been specifically designed. This includes instruments that are not manufactured and/or distributed by Parcus as well as placing excessive Parcus instrumentation in the set restricting air flow and reducing efficacy of the sterilization cycle.
•
Descaling agents that include morpholine should not be used in steam sterilizers. These agents leave residue which can damage polymer instruments over time.
Receiving Inspection – Instrument set content and functionality verification •
Upon receipt in the hospital, instrument sets should be inspected for completeness. Inspect for thumb, wing, set, or other types of screws; screw-in or other detachable handles; and auxiliary exchangeable parts such as drill bits. Many organizing trays have graphics, outlines, catalog numbers, and instrument names or sizes silk-screened or otherwise marked on tray.
•
Orthopedic surgical procedures follow a precise order in which the instruments are used. Also, many instruments have dimensional features which govern bone resections and determine implant sizes, depth and angle of drill holes, etc. Therefore it is very important that all components comprising the set are available. Contact your Parcus Representative if you have questions or concerns.
•
Markings on instruments used for measuring anatomical dimensions must be legible. These may include gauge markings, angles, inner or outer diameters, length or depth calibrations, and right/left indications. Notify your Parcus representative if scales and other markings are not legible.
C.
Limitations and Restrictions •
Neutral pH enzymatic and cleaning agents are recommended and preferred for cleaning Parcus reusable devices. Alkaline agents with pH of 12 or less may be used to clean stainless steel and polymer instruments in countries where required by law or local ordinance; or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeldt-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents are completely and thoroughly neutralized and rinsed from devices. Note: Drill bits, reamers, rasps and other cutting devices should be carefully inspected after processing with alkaline detergents to ensure that cutting edges are fit for use. Note: It is important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues. Some enzymatic solutions are specifically for breakdown of fecal matter or other organic contaminants and may not be suitable for use with orthopaedic instruments.
D.
•
Repeated processing, according to the instructions in this manual has minimal affect on Parcus reusable manual instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is normally determined by wear and damage due to the intended surgical use and not to reprocessing.
•
Automated cleaning using a washer/disinfector alone may not be effective for orthopaedic instruments with lumens, cannulations, blind holes, mated surfaces and other complex features. A thorough, manual or combination manual/automated cleaning process is recommended.
•
Where applicable, multi-component instruments should be disassembled for cleaning. Disassembly, where necessary, is generally self evident. Care must be taken to avoid losing small parts. If a part is lost, notify your Parcus representative when the instrument set is returned.
•
Instruments must be removed from metal or polymer trays for manual and/or automated cleaning procedures. Do not clean instruments while in polymer or metal trays. Instrument trays must be cleaned separately from instruments.
•
Polymers used in Parcus instrument sets can be sterilized using steam/moist heat. Polymer materials have a limited useful life. If polymer surfaces turn “chalky,” show excessive surface damage (e.g. crazing or delamination), or if polymer devices show excessive distortion or are visibly warped, they should be replaced. Notify your Parcus representative if polymer devices need to be replaced.
•
Most currently available polymers will not withstand conditions in washer/sterilizers that operate at temperatures equal to or greater than 141°C/285°F, and use live-steam jets as cleaning features. Severe surface damage to polymer devices will occur under these conditions.
•
Soaking in disinfectants may be a necessary step to control certain viruses. However, these agents may discolor or corrode instruments (household bleach contains or forms chlorine and chloride in solution and has a corrosive effect similar to saline). Disinfectants containing glutaraldehyde, or other aldehydes, may denature protein based contaminants, causing them to harden and making them difficult to remove. Where possible, soaking in disinfectants should be avoided.
•
Steam/moist heat is the recommended sterilization method for Parcus instruments.
•
Ethylene Oxide (EO), Gas Plasma Sterilization and dry heat sterilization methods are not recommended for sterilization of Parcus reusable instruments.
•
Use of hard water should be avoided. Softened tap water may be used for initial rinsing. Purified water should be used for final rinsing to eliminate mineral deposits on instruments. One or more of the following processes may be used to purify water: ultra-filter (UF), reverse-osmosis (RO), deionized (DI), or equivalent.
Point of Use Preparation for Reprocessing •
Remove excess body fluids and tissue from instruments with a disposable, non-shedding wipe. Place instruments in a basin of distilled water or in a tray covered with damp towels. Do not allow saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on instruments prior to cleaning. Note: Soaking in proteolytic enzyme solutions facilitates cleaning, especially in instruments with complex features and hard-to-reach areas (e.g. cannulated and tubular designs, etc.). These enzymatic solutions break down protein matter and prevent blood and protein based materials from drying on instruments. Manufacturer’s instructions for preparation and use of these solutions should be explicitly followed.
•
Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.
•
E.
F.
G.
Used instruments must be transported to the central supply in closed or covered containers to prevent unnecessary contamination risk.
Preparation Before Cleaning •
Where applicable, multi-component instruments should be disassembled for appropriate cleaning. Care should be exercised to avoid losing small screws and components. If a part is lost, notify your Parcus representative when the instrument set is returned.
•
Published instructions for use and surgical techniques and/or procedures may provide a supplemental source to illustrate assembly/disassembly instructions for specific Parcus instruments.
Preparation of Cleaning Agents •
Neutral pH enzymatic and cleaning agents with low foaming surfactants are preferred and recommended by Parcus. Alkaline agents with pH of 12 or less may be used in countries where required by law or local ordinance. Alkaline agents should be followed with a neutralizer and thorough rinsing.
•
All cleaning agents should be prepared at the use-dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of recommended temperatures is important for optimal performance of cleaning agents.
•
Dry powdered cleaning agents should be completely dissolved prior to use to avoid staining or corrosion of instruments.
•
Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (bloody and/or turbid).
Manual Cleaning/Disinfection Instructions Step
Description
1
Completely submerge instruments in pH neutral enzyme solution and allow to soak for 20 minutes. Use a soft-bristled, nylon brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft-bristled brush (i.e. pipe cleaner brush).
2
Remove the device from the enzyme solution and rinse in softened tap water for a minimum of 3 minutes. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.
3
Place prepared pH neutral cleaning solution in a sonication unit. Completely submerge device in cleaning solution and sonicate for 10 minutes at 45-50kHz.
4
Rinse instrument in purified water for at least 3 minutes or until there is no sign of blood or soil on the device or in the rinse stream. Thoroughly and aggressively flush lumens, holes and other difficult-to-reach areas.
5
Repeat steps 1-4.
6
Remove excess moisture from the instrument with a clean, absorbent and non-shedding wipe.
Note: If stainless steel instruments are stained or corroded, an acidic, anti-corrosion agent in an ultrasonic cleaner may be sufficient to remove surface deposits. Care must be taken to thoroughly rinse acid from devices. Acidic, anti-corrosionagents should only be used on an as needed basis. H.
Combination Manual/Automated Cleaning and Disinfection Instructions 1.
Completely submerge the instruments in enzyme solution and allow to soak for 10 minutes. Use a soft nylon-bristled brush to gently scrub the device until all visible soil has been removed. Particular attention must be given to crevices, lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens should be cleaned with a long, narrow, soft nylon-bristled brush (i.e. pipe cleaner).
Note: Use of a sonicator at 45-50kHz will aid in thorough cleaning of devices. Note: Use of a syringe or water jet will improve flushing of difficult to reach areas and closely mated surfaces. 2.
Remove devices from the enzyme solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, blind holes and other difficult-to-reach areas.
3.
I.
J.
Place instruments in a suitable washer/disinfector basket and process through a standard instrument washer/disinfector cleaning cycle. The washer/disinfector manufacturer’s instructions should be strictly adhered to.
Automated Cleaning/ Disinfection Instructions 1.
Automated washer/disinfector systems are not recommended as the sole cleaning method for surgical instruments. Orthopaedic instruments should be cleaned following the manual or combination manual/automated cleaning procedure outlined in this manual except where specifically indicated.
2.
An automated washer/disinfector may be used as follow-up to the manual cleaning procedure above but is not required.
3.
Simple instruments without multiple components, lumens/cannulations, blind holes, mated surfaces, connectors and internal mechanisms or other complex features may be successfully cleaned and disinfected using a typical washer/disinfector cycle for surgical instruments. Devices should be thoroughly inspected prior to sterilization to ensure effective cleaning.
Inspection, Maintenance, Testing and Lubrication 1.
Carefully inspect each device to ensure that all visible contamination has been removed. If contamination is noted repeat the cleaning/disinfection process.
2.
Visually inspect for completeness, damage and/or excessive wear.
Note: If damage or wear is noted that may compromise the function of the instrument, contact your Parcus representative for a replacement. 3.
Check the action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to ensure smooth operation throughout the intended range of motion.
4.
Hinged, rotating, or articulating instruments should be lubricated with a water soluble product intended for surgical instruments that must be sterilized. Some water-based instrument lubricants contain bacteriostatic agents which are beneficial. To remain effective, the expiration date specified by the manufacturer should be adhered to for both stock and use-dilution concentrations.
Note: Mineral oil or silicone lubricants should not be used because they 1) coat microorganisms; 2) prevent direct contact of the surface with steam; and 3) are difficult to remove.
K.
5.
Check instruments with long slender features (particularly rotating instruments) for distortion.
6.
Where instruments form part of a larger assembly, check that the devices assemble readily with mating components.
Sterile Packaging Note: Any instrument capable of being opened/loosened and closed/tightened shall be sterilized in the open/loose state. Packaging individual instruments •
Commercially available, medical grade steam sterilization wraps of the appropriate sizes may be used to package individual instruments. The package should be prepared using the AAMI double wrap or equivalent method.
Note: Sterilization wraps must be free of detergent residues. Reusable wraps are not recommended.
Packaging instrument sets in rigid trays or instrument trays with defined, preconfigured layouts •
Trays may be wrapped in standard medical grade, steam sterilization wrap using the AAMI double wrap method or equivalent.
•
Areas designated for specific devices shall contain only devices specifically intended for these areas. These validated reprocessing instructions are not applicable to Parcus trays that include devices that are not manufactured and/or distributed by Parcus.
Safety Precaution: The total weight of a wrapped instrument tray should not exceed 11.4kg/25lbs.
L.
Sterilization Instructions
•
See following table for recommended minimum sterilization parameters that have been validated by Parcus to provide a 10-6 sterility assurance level (SAL).
•
The hospital is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Provisions for protection of any sharp or potentially dangerous areas of the instruments should also be recommended by the hospital.
•
Moist heat/steam sterilization is the preferred and recommended method for Parcus instruments and trays.
1.
Cycle Type
Min Temperature
Prevacuum
132oC / 270oF
Min Exposure Time (Wrapped) 4 minutes
Min Dry Time 30 minutes1
Drying times vary according to load size and should be increased for larger loads
Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly.
M.
•
Sterilizer manufacturer recommendations should always be followed. When sterilizing multiple instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not exceeded.
•
Instrument sets should be properly prepared and packaged in trays that will allow steam to penetrate and make direct contract with all surfaces.
•
Ethylene oxide or gas plasma sterilization methods should not be used unless package inserts for the applicable product specifically provide instructions for sterilization using these methods.
Storage Instructions •
Sterile, packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin, and temperature/humidity extremes.
•
Sterile instrument packages should be carefully examined prior to opening to ensure that package integrity has not been compromised.
Note: Maintenance of sterile package integrity is generally event related. If a sterile wrap is torn, perforated, shows any evidence of tampering or has been exposed to moisture, the instrument set must be repackaged and sterilized.
5. Hospital Responsibilities for Parcus Loaner Sets •
Orthopaedic surgical instruments generally have a long service life; however, mishandling or inadequate protection can quickly diminish their life expectancy. Instruments which no longer perform properly because of long use, mishandling, or improper care should be returned to Parcus to be discarded. Notify your Parcus representative of any instrument problems.
•
Loaner sets should undergo all steps of decontamination, cleaning, disinfection, inspection, and terminal sterilization before being returned to Parcus. Documentation of decontamination should be provided with instruments being returned to Parcus.
•
Missing or damaged instruments from loaner sets should be brought to the attention of the Operating Room supervisor, to the director of the Central Sterile Supply Department, and to your Parcus representative to ensure that the next hospital will receive a complete set of instruments in working condition.
•
The instructions provided in this manual have been validated by Parcus in the laboratory and are capable of preparing orthopaedic devices for use. It is the responsibility of the Hospital to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained in order to achieve the desired result. Equipment and processes should be validated and routinely monitored. Any deviation by the processor from these instructions should be properly evaluated for effectiveness to avoid potential adverse consequences.