VMMC
Health Care Waste Management Tool
Standard Operating Procedure
Section: / Number: / Title: / Revision:QAU-HCWM / 007 / Sterilization of Reusable Metal Instruments / 1
Name / Title / Date
Lead author: / Sameer Sakallah / Senior laboratory advisor / 2011.12.22
Lead author: / Britta Runbeck / Quality assurance (QA) specialist / 2012.03.01
Review and approval: / Tom Layloff / Senior QA advisor / 2012.03.15
Effective date:
1. Purpose
The purpose of this guidance is to provide instruction on recommended best practices for steam sterilization of reusable male circumcision (MC) kits in health care settings. These instructions are intended to promote sterility assurance and to guide health care personnel working with reusable MC kits in the proper use of processing equipment.
2. Scope
The scope of this document is to provide instruction on sterilization processing with a gravity-displacement or dynamic-air-removal steam sterilizer (decontamination, preparation, sterilization and sterile storage areas), personnel considerations, processing procedures and quality control testing.
3. Responsibilities
Title / ResponsibilitySite manager / · Advocate for health worker safety.
· Ensure that all staff, including management, implementation and transport teams, have obtained and are familiar with:
o National HCWM policies and regulatory framework
o VMMC campaign-specific HCWM policies and procedures.
· Enforce site health care waste management plan (goal, budget, staff, roles and responsibilities, supervision, training and reporting).
· Ensure that all relevant products required for sound HCWM are adequately supplied prior to commencement of operations, and meet a minimum standard of quality - i.e.
o Waste containers (color-coded bags, boxes, etc.)
o Labeling tools and signage
o Decontamination products and equipment
o Temporary storage space
o Visual aids
o Control documents
· Ensure that all levels of site staff, including the transport team, are adequately trained in all the proper HCWM procedures relevant to their scope of work prior to commencement of duty.
· Identify waste container supply needs and report stockouts.
· Ensure that a designated on-site route plan and collection schedule is designed and implemented for HCW.
· Ensure that the waste is weighed correctly and control documents are correctly filled in and signed off upon collection for off-site transport.
· Conduct quality audits and verify compliance with HCWM SOPs.
Infection control officer / · Ensure that all staff, including management, implementation and transport teams, have obtained and are familiar with:
o National HCWM policies and regulatory framework
o VMMC campaign-specific HCWM policies and procedures.
· Enforce site health care waste management plan (goal, budget, staff, roles and responsibilities, supervision, training and reporting).
· Ensure that all levels of site staff, including the transport team, are adequately trained in all HCWM procedures relevant to their scope of work prior to commencement of duty.
· Train and ensure staff is properly following hand hygiene and surgical scrub procedures where applicable.
· Advocate for health care worker safety.
· Ensure that all relevant products required for sound HCWM are adequately supplied prior to commencement of operations, and meet a minimum standard of quality - i.e.
o Waste containers (color-coded bags, boxes, etc.)
o Labeling tools and signage
o Decontamination products and equipment
o Temporary storage space
o Visual aids
o Control documents
· Ensure a clean and orderly environment at the site (supervisory).
· Identify waste container supply needs and report stockouts.
· Ensure that reporting systems (incident, injury-on-duty, needle stick injury, waste movement, etc.) are adopted and in place.
· Ensure that all waste generated at source (point of origin) is correctly segregated and packaged, and that the packaging is safely closed off before collection for on-site transport (supervisory).
· Ensure all aspects of sterile processing of reusable metal instruments and decontamination of disposable instruments) are competently performed by the Orderlies, including:
o Decontamination
o Preparation
o Packaging
o Sterilization
o Sterile storage
o Distribution of re-sterilized reusable metal instruments
· Ensure decontaminated disposable metal instruments are securely stored (supervisory).
· Ensure that the waste is weighed correctly and control documents are correctly filled in and signed off upon collection for off-site transport.
· Ensure that a designated on-site route plan and collection schedule is carefully designed and implemented for HCW.
· Conduct quality audits and verify compliance with HCWM SOPs.
Clinical staff / · Follow health care waste management policies and procedures.
· Practice safe operating procedures and wear appropriate PPE.
· Follow general hand hygiene and surgical scrub procedures where applicable.
· Ensure a clean and orderly environment at the site.
· Apply Sharps Safety Best Practice.
· Place sharps containers properly at designated locations.
· Ensure that all waste generated at source (point of origin) is correctly segregated and packaged into appropriate color-coded containers, and that the packaging is safely closed off before collection for on-site transport.
· Notify Orderly when waste container is ¾ full and is ready for collection and replacement.
· Place contaminated metal instruments into presoak bath after use.
· Notify Orderly if instrument presoak bath needs replacing.
· Notify Orderly if there is a spill that requires cleaning and supervise and assist accordingly.
Orderly / · Know the health care waste management policies and procedures.
· Practice safe operating procedures and wear appropriate PPE.
· Follow general hand hygiene procedures.
· Ensure a clean and orderly environment at the site.
· Place sharps containers at designated locations.
· Properly prepare sodium hypochlorite solutions as needed.
· Collect sharps containers and other waste containers once they have reached their maximum capacity (no more than ¾ full) and take them to the temporary storage site.
· Competently perform all aspects of sterile processing of reusable or disposable metal instruments, including:
o Decontamination
o Preparation
o Packaging
o Sterilization
o Sterile storage
o Distribution of re-sterilized reusable metal instruments
· Store infectious and sharps waste in a secure location.
· Ensure decontaminated disposable metal instruments are securely stored.
· Properly clean up spills where needed.
Transport team manager / · Obtain and enforce relevant HCWM management policies and procedures and wearing of appropriate personal protective equipment (PPE).
· Advocate for health worker safety.
· Ensure that all levels of staff are adequately trained in all the proper HCWM procedures relevant to prior to commencement of duty.
· Ensure supply of appropriate scale(s) dedicated solely to the purpose of weighing waste, as well as a budget for periodic calibration by an accredited third party to ensure that it is consistently accurate in operation.
· Ensure staff is adequately trained on how to use and calibrate scale(s) for the purpose of weighing HCRW.
· Ensure an adequate supply of required tools and first aid kits and spill containment kits to be kept on board the vehicle(s).
· Conduct quality audits and verify compliance with relevant HCWM SOPs.
Transport Team / · Obtain and apply relevant HCWM management policies and procedures and wear appropriate personal protective equipment (PPE).
· Follow general hand hygiene where applicable.
· Ensure that a designated route plan and collection schedule is carefully designed and implemented.
· Ensure that all tools and first aid kits and spill containment kits on board vehicles are well-stocked.
4. Definitions
Term / DefinitionAbsorbent surgical towel / Typically, a low-lint 100% cotton surgical towel women with a plain weave
Asepsis / Prevention of contact with microorganisms
Bacterial count / Method of estimating the number of bacteria per unit sample, usually expressed as number of colony-forming units
Bioburden / Population of viable microorganisms on a product and/or a sterile barrier system
Biological indicators (BIs) / Test systems containing viable microorganisms providing a defined resistance to a specified sterilization process
Biological indicator control, positive / Biological indicator, from the same lot as a test biological indicator, which is left unexposed to the sterilization cycle and then incubated to verify the viability of the test BI
Bowie-Dick test / Diagnostic test of a dynamic-air-removal steam sterilizer’s ability to remove air from the chamber and prevent air re-entrainment
Challenge test pack / Pack used in qualification, installation and routine quality assurance testing of hospital sterilizers
Chemical indicators (CIs) / Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or specific tests of sterilization equipment
Cleaning / Removal of contamination from an item to the extent necessary for further processing or for the intended use
Container system, rigid sterilization / Sterilization containment device designed to hold medical devices for sterilization, storage, transportation and aseptic presentation of contents
Containment device / Reusable rigid sterilization container, instrument case or organizing tray intended for use in health care facilities for containing reusable medical devices for sterilization
Contaminated / State of having been actually or potentially in contact with infectious agents
Decontamination / The process by which medical devices, instruments and equipment are rendered safe for personnel to handle
Decontamination area / Area of a health care facility designated for collecting, retaining and cleaning soiled and/or contaminated items
Dynamic-air-removal steam sterilization / One of two types of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions (prevacuum cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure
Gravity-displacement steam sterilization / Type of sterilization cycle in which incoming steam displaces residual air through a port or drain in or near the bottom of the sterilizer chamber
Hypochlorite solutions / Widely used for decontaminating surgical instruments, laboratory equipment and spot disinfection of countertops and floors in health care facilities
Incubator / Apparatus for maintaining a constant and suitable temperature for the growth and cultivation of microorganisms
Infectious microorganisms / Microorganisms capable of producing disease in the appropriate hosts
Installation qualification / Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with specifications
Microorganism / Entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
Operational qualification / Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures
Performance qualification / Process of obtaining and documenting evidence that the equipment is installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification
Personnel protective equipment (PPE) / Specialized clothing or equipment worn by an employee for protection against a hazard
Process challenge device (PCD) / Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process
Processing area / Area of a health care facility in which decontaminated, clean instruments, and other medical and surgical supplies are inspected, assembled into sets and trays, and wrapped, packaged or placed into rigid sterilization container systems for subsequent sterilization
Shelf life / When the term is used with respect to a sterilized medical device, the period of time during which the item is considered safe for use
Steam sterilization / Sterilization process that uses saturated steam under pressure, for a specified exposure time and at a specified temperature, as the sterilizing agent
Sterile storage area / Area of a health care facility designed to store clean and sterile items and protect them from contamination
Sterilization / Validated process used to render a product free from viable microorganisms
5. References
1. American National Standards Institute/Association for the Advancement of Medical Instrumentation ST79: 2010 & A1:2010 & A2:2011, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
2. SOP-QAU00-006, Decontamination of Non-sharp Metal Instruments
3. SOP-PQAU001-005, Decontamination of General Surfaces
6. Procedures
6.1. Care and handling of contaminated reusable items
6.1.1 Personal protective equipment
When handling contaminated items, personnel should wear appropriate PPE, including gloves, rubber boots, aprons, long pants and long sleeves, and either a face shield or goggles and a procedure mask to protect the eyes, nose and mouth from accidental splashes.
6.1.2 Contaminated reusable items
Contaminated items should be contained during their transport from the point of use to the decontamination area. Containers, devices or carts must be marked with a biohazard label or other means of identifying contaminated contents. Red bags, bins with lids, enclosed or covered carts, rigid sterilization container systems, and impermeable bags are among the types of containers that may be used alone or in combination to transport contaminated items.
For guidance on safe handling and transport of contaminated reusable items, see Guidance on Proper Decontamination, Storage, Transport and Disposal of Disposable Non-Sharp Metal Instruments.
6.2. Cleaning, decontamination and inspection
6.2.1 Cleaning and decontamination
Cleaning and decontamination should begin as soon as possible after the reusable medical instruments have been used. The first and most important step in the decontamination process is thorough cleaning and rinsing. Cleaning primarily removes rather than kills microorganisms. Because the cleaning process is not microbicidal, a subsequent disinfection or sterilization process might be necessary to ensure an item is safe for handling. After cleaning, instruments should be thoroughly rinsed to ensure loosened debris and detergents are adequately removed.
For specific information on the cleaning and decontamination processes, see SOP 006, Decontamination of Non-sharp Metal Instruments. For guidance on creating a diluted sodium hypochlorite solution for cleaning and disinfecting medical instruments, see also SOP 005. Refer to Annexes 3 and 4 for visual aids.
Note: Cleaning and decontamination procedures should also be applied to the rigid sterilization container holding the medical instruments.
6.2.2 Inspection
Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging. If instruments reveal rust or damage, they should be disposed of appropriately and replaced with new instruments.
The rigid sterilization container should be inspected for any sharp edges or nicks that will puncture or tear the wrapper(s). The latching mechanism or closure on the rigid sterilization container should be checked to ensure it will remain secure.