The No. 1 responsibility of everyone involved in reusable medical device processing is to minimize the risk of patient harm caused by a device that remains contaminated with organic debris after processing. This responsibility begins with pre-cleaning the device at point-of-use and it continues through all of the processing steps prior to its eventual use with a patient. The responsibility to minimize patient risk from a contaminated device is especially critical when it comes to processing surgical instruments.
Surgical instruments that remain contaminated after cleaning, “visual” inspection and sterilization continue to be a significant cause of surgical site infections (SSIs). SSIs are the most common and most expensive of all hospital-acquired infections (HAIs). SSIs are responsible for 20 percent of all HAIs, and SSIs occur in 2 to 5 percent of all surgeries. On average, an SSI increases the hospital length of stay by 9.7 days.1
Sadly, far too many people mistakenly believe that if a device has been sterilized, even though the device remains contaminated with organic debris after cleaning, it is safe to use on a patient. Nothing could be further from the truth. Any device that remains contaminated with residual organic debris is not safe to use, even after complete and thorough sterilization.
So what steps can you and your facility take to reduce the risk of a reusable medical device, including scopes, which remains contaminated with organic debris after processing from being returned to use and causing patient harm?
Spot the challengers
The first step that you can take is to recognize that certain types/categories of reusable medical devices create the greatest decontamination, cleaning and sterilization challenges for everyone involved with device processing. Once you’ve identified those specific types/categories of devices that pose the greatest processing challenges, you and your facility can implement steps, including your demanding validated IFUs for those devices to ensure that the devices are clean, sterile, moisture-free and safe on every processing cycle.
The good news is that you and your staff don’t have to try and identify those devices that cause the greatest processing challenges and represent the greatest infection risk to your patients. That is because “The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient infections reported in the literature or media; reports provided by the Centers for Disease Control (CDC), the Veterans Administration (VA), and other health care settings; and manufacturer-initiated surveillance studies.”2
The FDA first published its list of “High Risk” reusable medical devices on June 9, 2017. This list was compiled by the FDA “As required under Section 3059 of the 21st Century Cures Act, a list of these reusable devices (see Table 1 below), categorized specifically by regulation and product code or by design features for certain device types, which will require validated instructions for use (IFUs) and validation data in their premarket notifications.”3
Table 1: Reusable Devices that Require Validation Data and Validated Reprocessing Instructions
Bronchoscopes (flexible or rigid) and accessories; Ear, Nose, and Throat (ENT) Endoscopes and accessories; Gastroenterology and Urology Endoscopes that have elevator channels; Neurological Endoscopes; Arthroscopes and accessories; Laparoscopic Instruments and accessories; Electrosurgical Instruments and their Respective Accessories; Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, lumens with internal surfaces that are not smooth); Hinges, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise “roughened” surfaces (e.g., jaws); Interior device channels (e.g., the “I” beam and channel inside of a Kerrison Rongeur); Sleeves surrounding rods, blades, activators, inserters, etc; Shafts within lumens (e.g., the operating shaft inside of a laparoscopic instrument); Adjacent device surfaces between which debris can be forced or caught during use; O-rings; Stopcocks/Valves; Crevices; Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments that are insulated with plastic ‘shrink-type’ insulation); Instruments that have dead-ended chambers (e.g., the distal end of a laparoscopic instrument); Devices with these or other design features that cannot be disassembled for reprocessing. In the future this list may be updated by the FDA as additional information regarding reprocessing medical devices becomes available.”4
Given the documented patient harm caused by these “High Risk” devices, the FDA demands that the manufacturers of these devices validate their IFUs to prove that they can be thoroughly cleaned prior to sterilization. This demand for IFU validation by the FDA is because of the greater risks to the public health posed by these devices. Additionally “510(k) submissions for these types of devices should include protocols and complete test reports of the validation of the reprocessing instructions. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions.”5Demand validated IFUs
So how does the FDA’s list of “High Risk” medical devices apply to you, to your healthcare facility and to your patients? You and your facility must start to demand validated IFUs from all of your “High Risk” device manufacturers. Unless the device manufacturer has validated its cleaning IFU through independent laboratory testing to prove that its cleaning process removes all of the organic debris from the device prior to sterilization, you have no assurance that you are returning a clean, sterile, moisture-free, safe device back for use on your patients.
A major limitation of far too many manufacturers’ non-validated IFUs is that they require processing personnel to “visually inspect” the device for bioburden and biofilm after cleaning and prior to sterilization. The problem with this “visual inspection” requirement in their IFU is that microscopic bioburden and biofilm are invisible to the human eye, which makes the task physically impossible.
Look for copycats
Another significant problem with non-validated IFUs is that “Most companies create an IFU for a new product by plagiarism. They merely copy a competitor’s IFU and change the name. If the IFU is created by a regulatory expert, the IFU will be nearly identical to the competitor’s IFU. However, if the IFU is created by a marketing person, the IFU will explain how their product is totally different from the competitor’s product.”6 Regardless of which approach a manufacturer uses to create their IFU, the tragic fact is that the IFU was never validated to see if those instructions actually work to provide a clean, sterile, moisture-free, safe device after processing.
You and your staff can follow every step of a manufacturer’s non-validated set of IFUs perfectly and still be returning a contaminated device back to surgery where it can cause patient harm. You must insist that your reusable device manufacturers provide your facility with validated cleaning and sterilization IFUs. In order for the IFUs to have actually been “validated” and not just labeled as such, the validation testing must have been conducted by an independent biologic testing laboratory using AAMI and FDA IFU validation testing protocols.
When asking a device manufacturer for a copy of their validated IFUs, you need to be sure the manufacturer understands you are asking for more than just cleaning and sterilization instructions. The manufacturer must provide you with the independent laboratory validation test report that proves that their IFUs actually work for cleaning and sterilizing the device. If a device manufacturer can’t – or won’t – provide you with cleaning and sterilization IFUs that have been independently validated using AAMI and FDA IFU testing protocols, then you need to look for another device manufacturer who can and will.
In light of the FDA’s list of “High Risk” medical devices, and as recent lawsuits against endoscope manufacturers whose IFUs had never been validated have shown, healthcare facilities have an ethical, moral, financial and legal responsibility to demand validated IFUs from all of their reusable medical device manufacturers. Your patients are counting on you.
References
1 Journal of the American College of Surgeons “Surgical Site Infection Guidelines, 2016 Update” January 2017 Volume 224, Issue 1, Pages 59–74
2 FDA publication “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” June 9, 2017 Appendix E
3 Op. cit.
4 Op. cit.
5 Op. cit.
6 Medical Device Academy blog, https://medicaldeviceacademy.com/ifu-validation/ Rob Packard, April 12, 2017
Surgical instrument manufacturers’ Instructions For Use (IFUs) examples
Editor’s Note: The following IFUs are actual examples provided by James Schneiter as collected from device manufacturers. The content has not been altered, save for removing the company names and other identifying factors, and replacing the names with Company A, Company B and Company C, respectively. The motivation for and point of this exercise is purely educational – not compensatory or punitive – to help readers understand, recognize and compare and contrast content.
“ANSI/AAMI ST79 standards recommend that sterilizer manufacture’s written instructions for cycle parameters should also be followed. Medical device manufacturer’s exposure time to sterilization temperature may need to be longer than indicated by sterilizer manufacturer but must never be shorter. It is the responsibility of the user to establish whether sterilizer meets these minimum recommendations.”
Company A Instruments IFUs
INDICATIONS FOR USE
Company A surgical instruments are designed to perform a specific function, such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating, suturing, or ligating. For use by, or as directed by, a surgeon. Instruments should be used only for the purpose for which they are designed. The proper surgical technique for the use of instruments is the responsibility of the surgeon.
CONTRAINDICATION
Instruments should not be used for anything other than their intended use.
WARNING
Consult individual national infection control/prevention protocols for specific guidance regarding processing medical devices with suspected exposure to Creutzfeldt-Jakob Disease (CJD).
CAUTION
After cleaning, especially ultrasonic cleaning, check screws on instruments because the vibration from the ultrasonic cleaning may cause them to loosen or fall out.
For electrosurgical instruments, use the least amount of power appropriate for the application. For electrosurgical cables, disconnect from the generator or instrument by grasping the connector only. Do not pull the cable by the cord. Do not use instrument or cable if insulation is not fully intact.
Company A surgical instruments are supplied non-sterile and must be cleaned, lubricated and sterilized prior to use according to hospital protocol and the procedures outlined in this document. Failure to follow these procedures will invalidate the instrument’s warranty and can cause the instrument to fail.
Inappropriate use of instruments will lead to damage that is usually not repairable; for example, a hemostat that is used to clamp tubing can become misaligned and quickly break.
INSPECTION OF ALL INSTRUMENTS
All instruments are carefully inspected before shipment. Because damage may occur during transit, the instruments should be thoroughly inspected upon receipt. All instruments must be inspected prior to use.
Handling and Operating Instruments: Instruments should be handled and operated by personnel completely familiar with their use, assembly and disassembly. Before a new instrument is used and prior to each surgical procedure, the instrument must be decontaminated, lubricated and sterilized as described below. Handle the instrument with care. The instrument must be inspected to assure proper functioning prior to each use with particular attention paid to the condition of all moving parts, tips, box locks, ratchets and cutting edges. Each instrument with a screw must be inspected before and after use to ensure that the screws do not move when operating the instrument. Screws can loosen and back out of an instrument as a result of normal operation and/or the vibration during ultrasonic cleaning. Failure to make a complete inspection to assure the proper operation and function of the instrument may result in unsatisfactory performance, perhaps because a part is missing. Do not use if the instrument does not appear to be functioning properly. Use of an instrument for a task other than that for which it is intended could result in a damaged or broken instrument, or one which provides an unsatisfactory performance. In order to insure warranties and guarantees, instruments in need of repair should be sent to Company A.
DECONTAMINATION AND STERILIZATION PROCEDURES
As with any decontamination procedure, personnel should follow accepted guidelines for hand washing, the use of protective attire, etc. as recommended by A.A.M.I. Standards and Recommended Practice, “Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Non-Clinical Settings”, ANSI/AAMI ST35:2003.
Decontamination is a two-step process:
1) Thorough cleaning and rinsing.
2) Sterilization or disinfection.
A. MANUAL DECONTAMINATION
PRECLEANING: Remove gross debris from surgical instruments with a lap sponge and sterile water routinely during the procedure to prevent drying on of blood and body fluids, etc. It is important to rinse instruments that have been exposed to blood and saline solution before these substances dry. Blood and body fluids as well as saline solutions are highly corrosive. In addition, blood can produce a stain that is difficult to remove.
CLEANING: To prevent the formation of biofilm, cleaning should occur as soon as possible after instrumentation is used. Biofilm is an accumulation of a biomass of bacteria and extracellular material that tightly adheres itself to the surface of the instruments. It cannot be easily removed, and protects microorganisms from being easily removed by ordinary cleaning/decontamination methods used in hospitals. It is particularly problematic in lumened medical devices.
Step 1. Maintain moisture: Immediately after the surgical procedure, place the instruments in an instrument tray/container and cover with a towel moistened with sterile distilled water. Foam, spray or gel products, specifically intended for use with surgical instruments, are available to keep the soil moist. Transport tray of soiled instruments in an impervious plastic bag or container with a tight lid to the decontamination environment (keep the outside of the containment clean).
Step 2. Enzymatic Soak: Immerse fully opened and/or disassembled instruments in an enzymatic solution, specific for use with surgical instruments. Prepare the solution and use per enzyme manufacturer’s recommendations, paying special attention to instructions for correct dilution, temperature and soak time. Flush air from lumens and fill them with enzymatic solution for full contact with this inner surface during the soak time.
Step 3. Rinse: Remove from enzymatic soak after the time period recommended by the enzymatic manufacturer and rinse thoroughly with tap water. Flush lumens until rinse water runs clear.
Step 4. Cleaning Instruments: Choose a cleaning solution appropriate for surgical instruments and follow the manufacturer’s instructions for use. The use of neutral pH detergents is vital to the maintenance of surgical instruments. Contact with acidic or alkaline solution will remove the instruments’ protective barrier of chromium oxide, often leading to corrosion, pitting, and breakage. You may find that depending on the type of soil, a detergent that is a little more or less acid or alkaline may be more appropriate. The ideal cleaning agent is nonabrasive, low-foaming and free-rinsing. Using a small clean hand-held brush, remove soil from all surfaces of the instrument while fully immersed in the solution. During manual cleaning, never use steel wool, wire brushes, scalpel blades or highly abrasive detergent or cleansers to remove soil from surgical instruments. These will damage the instruments’ protective surface and lead to corrosion. Use a clean soft bristled brush to clean instruments with an accessible channel. Remove the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument must be thoroughly cleaned after each use. A build-up of soil, debris, lubricants, etc. in these areas, will make it difficult to use the instrument and eventually irreparably damage it. Vigorously flush channels with the cleaning solution. Deionized water is recommended and preferred because it is free of the many compounds which exist in ordinary tap water. These substances, alone, cause stains and when tap water is combined with some detergents it will form insoluble deposits on the instruments. Manual cleaning should remove all visible residue. It is essential to keep the box locks and hinges open during any manual or automated cleaning process.
Step 5. Rinse: Thoroughly rinse instruments by immersing in tap water and wiping with a clean, soft cloth. Flush lumens until water runs clear.
Step 6. Ultrasonic Cleaning and Rinsing: Follow the recommendations of the ultrasonic manufacturer regarding cycle times, detergents, proper placement of the instrument tray, and conditioning (“degassing”) of the cleaning solution, etc. Use an ultrasonic cleaner to remove soil from hard to reach surfaces such as grooves, crevices, lumens, instruments with moving parts, etc., after gross soil has been removed. Open or disassemble instruments as appropriate. Place instruments in a mesh bottom stainless steel instrument tray. Place the tray into the ultrasonic cleaner. Flush air out of lumens and fill them with the ultrasonic cleaning solution (under the solution level in the chamber) for effective removal of soil from that inner surface by the ultrasonic activity.
Step 7. FINAL RINSE should be with “treated water.” Softened or deionized water should be used for the final rinse to better removeions that cause water to be hard. Iron ions may also be removed by this treatment. Deionization removes ionized salts and particles from the water. Excessively hard water can spot or stain instruments and excessive chlorine in water can cause pitting of the instrument. Deionized water is preferred for the final rinse.
Step 8. Decontaminate Clean Instruments: Once instruments have been cleaned they must be rendered safe for handling, inspection and assembly. They may be steam sterilized without a wrapper or disinfected following the instructions from the instrument, sterilizer and disinfectant manufacturers.
Step 9. Visual Inspection and Instrument Set Assembly: Visually inspect the instrument for cleanliness and to ensure all parts are in proper working order, as the set is assembled. Inspection is a vital part of proper care and maintenance. Instruments in need of repair will not perform accurately in surgery and breakage is likely to occur. DO NOT USE damaged instruments. Worn ratchets, loose box locks and misaligned jaws can be repaired at a fraction of the cost of new instruments. Contact your local representative for information regarding a cost-effective instrument repair program.
Step 10. Lubricate: The use of an instrument lubricant, that is compatible with the method of sterilization to be used, is recommended before instruments are sterilized. Be certain that the instrument lubricant is diluted and maintained properly, according to the manufacturer’s instructions. This type of lubricant is referred to as “instrument milk” and is usually applied by spraying into the box locks and moving parts or by dipping the opened instruments into a solution. Lubricants that are too concentrated or too heavily applied will result in slippery instruments that will also be mistaken as wet after sterilization. After thoroughly cleaning instruments, proper application of lubricants to joints will keep them moving freely and aid in protecting the surface from mineral deposits. Note that ultrasonic cleaners remove all lubrication; therefore this maintenance procedure should be done routinely after ultrasonic cleaning and before sterilization. Proper lubrication is an integral step in maintaining the long-life of the surgical instrument. Lubrication will prevent the friction of metal on metal and preserve the smooth function of the instrument thus avoiding corrosion by friction. Furthermore, routine use of lubricating agents, on thoroughly clean instruments, will prevent hinged and other movable parts from sticking. Lubrication will aid in protecting the entire instrument surface from mineral deposits.
Step 11. Drying: Before instruments are wrapped for sterilization or storage, they must be thoroughly dry. If a set of instruments is wet when wrapped for sterilization it is likely to come out of the sterilizer wet. “Wet Packs” are not suitable for use after sterilization because they may be easily contaminated when handled. In addition, remaining moisture, particularly in box locks and hinges may result in corrosion that will weaken the instrument and lead to breakage during use. Prepare instrument sets for sterilization using a wrapper, pouch or rigid sterilization container that is appropriate for the method of sterilization to be used.
B. MECHANICAL DECONTAMINATION
General surgical instrumentation may be processed in a washer sterilizer or washer decontaminator/disinfector. Some of these processes include an enzyme application phase and a lubrication phase that is designed into the cycle.
Follow the manufacturer’s specifications when using automatic washer-sterilizers or washer decontaminators/disinfectors. They usually require the use of a low foaming, free rinsing detergent with a neutral pH (7.0). A high-foaming detergent may clean effectively but will often leave residual deposits on the instruments and do harm to mechanical washers. Automated washer sterilizers and washer decontaminator/disinfectors usually have adjustable wash and rinse times. Some washers enable the user to customize extra cycles to process heavily soiled surgical instruments more effectively. Check with a Technical Service representative at 1-800-431-1123 for questions regarding processing delicate, complex and/or multipart instruments by this method.
C. TERMINAL STERILIZATION
After following the decontamination recommendations, reusable instruments are ready for sterilization. Independent laboratory testing, conducted according to the F.D.A. (21 CFR PART 58) and Good Laboratory Practice Regulations (G.L.P.), has validated steam sterilization as an effective process for reusable instruments. See also, AAMI Standards and Recommended Practices, “Steam Sterilization and Sterility Assurance in Health Care Facilities”, ANSI/AAMI ST46:2002; “Flash Sterilization Steam Sterilization of Patient Care Items for Immediate Use, ANSI/AAMI ST37:3ed. AAMI standards recommend that the sterilizer manufacturer’s written instructions for cycle parameters should also be followed. Steam sterilization of lumened instruments requires that they be flushed with sterile water just prior to wrapping and sterilization. The water generates steam within the lumen to move air out. Air is the greatest enemy to steam sterilization, preventing steam contact if not eliminated. Medical device manufacturer’s exposure times to sterilization temperature may need to be longer than the minimum indicated by the sterilizer manufacturer but must never be shorter.
Company B IFUs
3.3 Validated cleaning and disinfecting procedure Note See the instructions for use pertaining to the instrument in question for product-specific information about appropriate equipment.
3.4 Preparations at the place of use
► If applicable, rinse non-visible surfaces (preferably with deionized water), using a disposable syringe, for example.
► Remove any visible surgical residues as much as possible with a damp, lint-free cloth.
► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.
3.5 Preparations before cleaning
► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
► During disassembly, take note of the product-specific characteristics described in the corresponding instructions for use.
3.6 Cleaning/Disinfection
► Observe the product-specific safety notes relating to the reprocessing procedure contained in the corresponding instructions for use.
► Check visible surfaces for residues after mechanical cleaning/disinfecting.
► Repeat the cleaning/disinfecting process if necessary
3.11 Steam sterilization
► Take note of the product-specific characteristics relating to sterilization described in the corresponding instructions for use, such as whether or not the product needs to be disassembled.
► To prevent breakage due to stress corrosion, sterilize the instruments with the locking mechanism open, or locked on the first ratchet tooth.
► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g., by opening any valves and faucets).
► Validated sterilization process – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.
3.12 Sterilization for the US market
■ Company B advises against sterilizing the device by flash sterilization or chemical sterilization.
■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Company B recommends the following parameters:
Company B Tray/Sterile container (perforated bottom) Minimum cycle parameters*
Sterilization method Temp. Time Minimum drying time
Prevacuum 270 °F/ 275 °F 4 min 20 min
*Company B has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Company B sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA-cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc.
Company C Products and Services General Surgical Instrument Cleaning and Sterilization Guide (IFUs)
Reusable Devices Instructions For Use
These instructions for use are intended for reusable surgical instruments labeled with the Company C name. This cleaning and sterilization guide does not replace device-specific instructions for use already included with the device.
How Supplied
Company C devices are packaged as non-sterile. Cleaning and sterilization must occur prior to use.
Limitations on Reprocessing
Repeated reprocessing has minimal effect on these devices. End of life is normally determined by wear and damage due to use.
Warnings
Devices shall be used in accordance with these instructions for use. Read all sections of this insert prior to use. Improper use of this device may cause serious injury. In addition, improper care and maintenance of the device may render the device non-sterile prior to patient use and cause a serious injury to the patient or health care provider.
Cautions
If there are any variations between these instructions and either your facility’s policies and/or your cleaning/sterilization equipment manufacturer’s instructions, those variations should be brought to the attention of the appropriate responsible hospital personnel for resolution before proceeding with cleaning and sterilizing your devices.
Use of device for a task other than that for which it is intended will usually result in a damaged or broken device.
Prior to use, inspect device to ensure proper function and condition. Do not use devices if they do not satisfactorily perform their intended function or have physical damage.
Avoid mechanical shock or overstressing the devices. Close distal ends prior to insertion or removal through cannulas.
Always use caution when inserting or removing devices through cannula. Lateral pressure on the device during removal can damage the working tip, shaft of the device. Be sure the tips are closed and the device is pulled straight out until completely clear of cannula to avoid catching the valve assemblies in cannulas or dislodging the cannula.
Only the cleaning and sterilization processes which are defined within these instructions for use have been validated.
Use only neutral pH (6-8) detergent solutions.
Pre-processing Instructions
Initiate cleaning of device within 2 hours of use.
Transport devices via the institution’s established transport procedure.
Remove excess gross soil as soon as possible after use by rinsing or wiping the device.
All devices must be processed in the completely open position (i.e., flushports, jaws, etc.) to allow solution contact of all surfaces.
Manual Cleaning: (Steps 5, 6, 7, 9 and 11 are required for lumen devices only.)
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Prepare the enzymatic / neutral pH detergent solution, utilizing tap water with a temperature range of 27°C to 44°C (81°F to 111°F), per manufacturer’s instructions.
3. Place device in the open/relaxed position, with flush port open, and completely immerse in the detergent solution and allow device to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time.
4. Using a soft bristled brush, remove all visible soil from the device. Actuate device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent solution is changed when it becomes grossly contaminated (bloody and/or turbid).
5. For lumen devices, use a soft bristled brush with a brush diameter and length that is equivalent to lumen diameter and length. Scrub the lumen (i.e., angulated/nonangulated positions) until no visible soil is detected in the lumen rinsing step below.
6. For lumen devices, place the device into the open/relaxed position with the distal tip pointed down. Flush the device with a minimum of 50 ml of detergent solution utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e. total of 3 times), ensuring all fluid exiting the lumen is
clear of soil.
7. For lumen devices, if visible soil is detected during the final lumen flush, re-perform brushing and flushing of the lumen.
8. Rinse the device by completely immersing in tap water with a temperature range of 27°C to 44°C (81°F to 111°F), for a minimum of 30 seconds to remove any residual detergent or debris.
9. For lumen devices, following the rinsing step, place the device into the open/relaxed position with the distal tip pointed down.
Flush the device with a minimum of 50 ml of tap water utilizing a temperature range of 27°C to 44°C (81°F to 111°F), by using the flushing port located on the handle/shaft. Repeat the flush process a minimum of 2 times (i.e., total of 3 times).
10. Dry the device with a clean, lint-free towel.
11. For lumen devices, manipulate the device to allow rinse water to drain from the lumen.
12. Visually examine each device for cleanliness.
13. If visible soil remains, repeat cleaning procedure.ning and Sterilization Guide
USA Rx Only
Automatic Cleaning
1. Ensure all pre-processing instructions are followed prior to cleaning.
2. Clean the devices via the Automatic cleaning parameters below.
3. For lumen devices, manipulate the device to allow rinse water to drain from the lumen.
4. If visible moisture is present dry the instrument with a clean, lint-free towel.
5. Visually examine each instrument for cleanliness.
6. If visible soil remains, repeat cleaning procedure.
Inspection/Maintenance
Proper care and handling is essential for satisfactory performance of any surgical device. The previous cautions should be taken to ensure long and trouble-free service from all your surgical devices. Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts. If any of these conditions appear, do not use the device. Return devices to an authorized repair service center for repair or replacement.
Before sterilizing, lubricate the device with instrument milk or a steam-permeable/ water-soluble lubricant, following the lubricant manufacturer’s instructions.
Let devices drip dry for three (3) minutes before packaging for sterilization.
Packaging
Devices can be loaded into dedicated packaging systems. Sterilization wrap material must be cleared for the applicable sterilization modality by your country’s regulatory body. Use in accordance with packaging manufacturer’s sterilization instructions being sure to protect jaws and cutting edges from damage.
Sterilization
All devices must be processed in the completely open position (i.e., flushports, jaws, etc.) to allow sterilant contact of all surfaces.
All devices with concave surfaces shall be configured so that water pooling does not occur.
Prevacuum Steam Sterilization Parameters
Minimum Preconditioning Pulses: 3
Minimum Temperature: 132°C (270°F)
Minimum Exposure Time: 3 minutes
Minimum Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization Parameters
Minimum Temperature: 132°C (270°F)
Minimum Exposure Time: 15 minutes
Minimum Dry Time (lumens): 45 minutes
Minimum Dry Time (non-lumens): 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Gravity Steam Sterilization Parameters – Non-lumen devices only
Minimum Temperature: 121°C (250°F)
Minimum Exposure Time: 30 minutes
Minimum Dry Time: 30 minutes
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
EO Sterilization Parameters
Sterilizer Cycle: 100% Ethylene Oxide (EO)
Minimum Preconditioning Time: 30 minutes
Minimum EO Gas Concentration: 700 mg/L
Minimum Temperature: 54°C (130°F)
Minimum Humidity: 65%
Minimum Exposure Time: 120 minutes
Minimum Aeration: 8 hours @ 43°C (110°F)
Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply)
Storage
After sterilization, devices must remain in sterilization packaging and be stored in a clean, dry environment.
Other Resources: To learn more about sterilization practices and what is required of manufacturers and end users, visit www.aami.org, www.aorn.org or www.iso.org
Products and Services
General Surgical Instrument Cleaning and Sterilization Guide
