INSTRUCTIONS FOR CLEANING AND STERILIZATION OF ALL B.BRAUN AESCULAP HAND HELD SURGICAL INSTRUMENTS AND POWER PRODUCTS (UNITED KINGDOM REQUIREMENTS) 1 INTRODUCTION This paper is intended to give general guidance on how medical devices supplied by B.Braun Aesculap may be processed to prepare them for use. Equipment, operators, cleaning agents and procedures all have a contribution to the efficacy of the processing and the healthcare facility should ensure that the combination actually in use results in a medical device that is safe for use. Alternative methods of processing may be equally suitable. Devices labelled for single use only must not be reprocessed for re-use. When single use devices are supplied non-sterile, and require sterilization before use, then the appropriate sections of these instructions may be applied unless other specific instructions are provided in the package insert. 2 Cleaning Two methods of cleaning B.Braun Aesculap medical devices are provided in this paper, a manual method and a method using an automated washer/disinfector. Whenever possible the automated method should be used. The automated cleaning process is more reproducible and therefore more reliable, and staff are exposed less to the contaminated devices and the cleaning agents used. Whichever method is used, staff should use suitable protective clothing and equipment (PPE) at all times. Take careful note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the product. 1
For cleaning medical devices, only specifically formulated cleaning agents (detergents) should be used. For manual cleaning, enzymatic agents with both bactericidal and fungicidal properties are to be preferred. For cleaning instruments manufactured from aluminium alloys a ph neutral agent should be used. Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided since the aluminium can be chemically attacked and the instrument may be damaged. For automatic (washer/disinfector) cleaning, neutral to mild alkaline agents (up to ph 10.5) may be preferred. Use only agents recommended for use in these machines. In all cases respect the indications, instructions and warnings provided by the supplier of the cleaning agent. Pay particular attention to the concentration used and the total dispersion of the detergent. A list of cleaning agents is included in Appendix 1 of this document. These have been used to support these processing instructions. B.Braun Aesculap does not recommend any one of these in preference to the others. Other cleaning agents not included in the list may be equally suitable. The quality of the water used for diluting cleaning agents and for rinsing medical devices should be carefully considered. Mineral residues from hard water can result in staining of the device or prevent effective cleaning and decontamination. Descaling agents may be needed and will not harm the devices. 2.1 Point Of Use Remove gross soil using absorbent wipes. 2.2 Transport to Processing Area Avoid mechanical damage. (e.g. don t mix heavy devices with delicate ones). Pay particular attention to cutting edges, both to avoid injury and damage to the medical device. Get the medical devices to the point where cleaning is to be performed as soon as practical (if transfer to the processing area is likely to take time, consider covering the instruments with a damp cloth to avoid drying out of the soil). 2.3 Preparation for Cleaning Disassemble the device where possible. See instructions provided in operation technique or separate information available from your B.Braun Aesculap representative. Most heavy-duty powered instrumentation cannot be further disassembled beyond removing attachments. Please refer to the product instructions for these procedures. Cases should be loaded immediately following washing and prior to sterilization. 2
2.4 Manual Cleaning 2.4.1 Pre-Cleaning & Cleaning Equipment required: Brushes soft and firm, bottle brushes for cannulations etc. Personal Protective Equipment (PPE) as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield) Absorbent wipes Procedure: Remove gross soil using absorbent wipes moistened with cleaning agent Ensure that all surfaces are thoroughly wetted Using suitable brushes clean the medical device thoroughly paying particular attention to rough surfaces and features where soil may be shielded from the brushing Use a soft bristle brush of appropriate diameter for cannulations. Ensure that the brush passes the whole length of the cannulation Operate articulating devices and those with moving parts Rinse in running water until all traces of cleaning solution are removed Pay particular attention to cannulations, hinges, blind holes and joints between mating parts. Activate any blade/bur/bit holding or clamping apparatus to clear away any remaining cleaning solution Visually inspect for any remaining soil and repeat the steps above if necessary Allow to drain on absorbent wipes or transfer immediately to inspection step 2.5 Automated Cleaning Using Washer-Disinfector (Recommended) 2.5.1 Pre-Cleaning Equipment Required: PPE as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield) Absorbent wipes Procedure: Remove gross soil using absorbent wipes moistened with cleaning agent Ensure that all surfaces are thoroughly wetted Visually inspect for any remaining soil and repeat the steps above if necessary Allow to drain on absorbent wipes or transfer immediately to cleaning step 3
2.5.2 Cleaning Equipment Required: Washer/disinfector (see note below) Cleaning/rinsing agents as required by washer disinfector Procedure: Load the medical devices into the washer disinfector: Avoid contact between devices (movement during washing could cause damage, and washing action could be obstructed) Arrange medical devices so that cannulas are not horizontal and battery openings are oriented downwards (to assist drainage) DO NOT USE STERILIZATION TRAYS THAT ORIENT THE EQUIPMENT VERTICALLY IN THE WASHER. Damage to the handpiece can occur if this is done Operate the washer disinfector cycle. (See note below) On completion unload the washer disinfector. Visually inspect each device for remaining soil and dryness. If soil remains repeat the cleaning process. Remaining wetness may be removed with medical grade compressed air or by heating in an oven below 110 C Note: Washer/disinfectors should comply with the requirements of HTM 2030 and ISO 15883 (in preparation). They should be properly installed and be regularly tested in accordance with ISO 15883. The washing cycle should include: Pre Rinse with neutral or mild alkaline ph enzymatic detergent (2-4 minutes at 15-16ºC) Detergent can be omitted at the pre-rinse stage if washer/disinfector equipment does not have this ability Wash with neutral or mild alkaline ph enzymatic detergent (2-4 minutes at a minimum of 60ºC) Drain Cold Water Rinse for at least 2 minutes Final Rinse (at least 2 minutes at a minimum of 60ºC) Drain Dry Phase for 15 minutes (with max. temperature of 137ºC) 4
2.6 Inspection Before preparing for sterilization all medical devices should be inspected Generally un-magnified visual inspection under good light conditions is sufficient. All parts of the devices should be checked for visible soil, damage and/or corrosion. Particular attention should be paid to: Soil traps such as mating surfaces, hinges, shafts etc. Recessed features (holes, cannulations). Features where soil may be pressed into contact with the device For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves Functional checks should be performed where possible: Mating devices should be checked for proper assembly Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required and only in accordance with instructions for use) 3 Sterilization After completion of the washing and disinfection process, the instruments must be checked for functionality. Directly afterwards they must be immediately sterilised for a minimum of three minutes at a temperature of 134 to 137 degrees C. The three minute time is for exposure, it does not include ramp up times or dry cycle times needed. B.Braun Medical Limited confirm that all handheld Instruments and Power Tools can be decontaminated in accordance with HTM 2030 and sterilised in accordance with HTM 2010. However, based on different process parameters, sterility has to be proven by each sterilisation site. Healthcare facilities should validate the process that they use, employing the actual equipment and operators that routinely process the devices. Steam autoclave (moist heat) sterilization using a pre-vacuum (forced air removal) cycle is required. Autoclaves should comply with the requirements of, and be validated in accordance with, ISO 13683. Sterilization cases can be used and should be loaded just prior to the sterilization step. 5
Sterilization Parameters Listed In This Report Must Follow A Washer/Disinfector Process. If A washer/disinfector is not available, sterilization parameters listed in the instructions for use of the involved product must be followed. Note: The final responsibility for validation of sterilization techniques and equipment lies directly with the hospital. To ensure optimal processing all cycles and methods should be validated for different sterilization chambers, wrapping methods and/or various load configurations. 4 Storage Before Use The shelf life is depending on sterile barrier employed, storage, environmental and handling conditions. A maximum shelf life for sterilized medical devices before use should be defined by each health care facility. 5 References ISO 11134: Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization ISO 13683: Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities. 6
Appendix 1 Cleaning Agents Used To Support These Processing Instructions. A cleaning agent (detergent) specifically formulated for cleaning medical devices should be used. For manual cleaning enzymatic agents with both bactericidal and fungicidal properties are to be preferred. For cleaning instruments manufactured from aluminium alloys, a ph neutral or an enzymatic cleaner known to be suitable for aluminium should be used. Contact with strong alkaline detergents or solutions containing iodine or chlorine should be avoided. For automatic (washer/disinfector) cleaning mild alkaline agents (up to ph 10.5) may be preferred, however use only agents recommended for use in these machines. In all cases respect the indications, instructions and warnings provided by the supplier of the cleaning agent. Notes: 1. Below are listed the cleaning agents used by B.Braun Aesculap to support the instructions for processing hand held surgical instruments and power products provided in this document. 2. B.Braun Aesculap does not recommend these products in preference to others that are available. Other products may perform equally or better in conjunction with the equipment being used. 3. The instructions provided by the supplier of the cleaning agent should be followed. 4. Cleaning agent use must not contain chemicals that are not suitable for aluminium instruments. 5. Personal protection for operators should be provided in accordance with the suppliers instructions and safety data sheets 6. Suitability of alternative agents should be checked by reference to the supplier s information and/or physical testing. Cleaning agents used for manual and automated (washer/disinfector cleaning) B.Braun Contact Joanne Clegg for details. Helimatic Cleaner Enzymatic for aluminium automatic washers Helizyme for manual or ultrasonic cleaning Supplier Designation Comment Alkapharm Alkazym Suitable for aluminium instruments Johnson and Johnson Enzol Suitable for aluminium instruments 7