Reprocessing glossary

A

Accredited external reprocessing provider: An organisation or facility outside the practice that is officially recognised for meeting standards in cleaning, sterilising, and reprocessing reusable medical devices.

ACSQHC: The Australian Commission on Safety and Quality in Health Care.

ARTG (Australian Register of Therapeutic Goods): A register maintained by the Therapeutic Goods Administration (TGA) that lists all approved medical devices, medicines, and accessories that can be legally supplied in Australia.

Asepsis: The absence of pathogenic microorganisms; a state of cleanliness required to prevent infection during clinical procedures.

Aseptic presentation: The technique of opening sterile packaging and presenting instruments in a way that maintains their sterility.

Aseptic removal: The process of taking items out of their sterile packaging without contaminating them.

B

Barcode labelling (sterilisation): Use of barcode adhesive labels for efficient tracking and identification of sterilised packs.

Benchtop steam steriliser (autoclave): A compact steriliser that uses pressurised steam to kill microorganisms by coagulating proteins; standard in general practice.

Bioburden: The amount and type of organic and inorganic material (such as blood, tissue, body fluids, dirt) present on a reusable medical device before cleaning.

Biodegradable (cleaning agents): A product that breaks down naturally in the environment without causing harm, making it more environmentally friendly.

Biofilm: A layer of microorganisms that can develop on the surface of medical devices, making them more resistant to cleaning and disinfection.

Biological Indicator (BI): A test system containing viable microorganisms used to assess whether sterilisation conditions were sufficient to kill known resistant microbes.

Biological/Enzymatic Indicator: A test system containing live microorganisms used during validation or troubleshooting to confirm sterilisation effectiveness.

Bowie-Dick Test: A specific test performed on vacuum steam sterilisers to check for effective air removal and steam penetration in the steriliser chamber.

C

Calibration: The process of verifying and adjusting the accuracy of measuring instruments to ensure they provide correct readings.

Cavitation: The process by which microscopic bubbles formed by ultrasonic waves implode, creating energy that removes debris from surfaces.

Certification number (of calibration device): A unique ID that verifies the calibration equipment used is itself traceable to recognised measurement standards.

Challenge load: The entire load configured to represent the most difficult-to-sterilise scenario – the worst-case load – used during validation of steriliser performance.

Challenge pack: A specially prepared pack used in validation or routine testing to represent the most difficult-to-sterilise part of a load (eg a tray of instruments with complex lumens).

Chemical indicator: A device or material that changes colour when exposed to specific sterilisation parameters (eg temperature, steam), providing a visual indication that the sterilisation process has occurred. It does not confirm sterility.

Class 1 chemical indicator: A visual marker incorporated into sterile packaging that changes color to show the package has been exposed to sterilisation conditions (like correct temperature), but does not guarantee the item inside is sterile.

Class 1 chemical indicator: A process indicator used on every pack or load to show that the item has been exposed to the sterilisation process (eg steriliser tape).

Class 2 chemical indicator: A specialised test indicator (eg Bowie-Dick test) used to assess air removal and steam penetration in pre-vacuum (Class B) sterilisers.

Class 6 chemical indicator: An emulating indicator designed to react to all critical parameters of a specific sterilisation cycle, providing a high level of assurance of process completion.

Class B steriliser cycles: Advanced steriliser cycles capable of sterilising all packaged items, including single and double wrapped, narrow lumen, solid, and porous items. Use fractionated vacuum stages to remove air, allowing steam penetration under pressure.

Class S steriliser cycles: Steriliser cycles capable of sterilising unwrapped solid goods and some limited porous or hollow items, with active drying; suitable for most general practices.

Clean zone: Comprises: Pre-sterile zone: Area where reusable medical devices are cleaned, dried, and packaged, but not yet sterilised. Sterile zone: Area where sterilised devices are stored, protected from contamination, and ready for use.

Co-located reprocessing facility: A reprocessing facility located within the same premises or building as a general practice, responsible for cleaning, disinfection, or sterilisation of medical devices on behalf of that practice.

Competent person: A staff member with the necessary knowledge, training, and skills to perform a specific task safely and correctly.

Consequence (risk matrix): The potential severity of harm or impact that could result if a threat or hazard occurs (insignificant, minor, moderate, major, catastrophic).

Consumable item: An item intended to be used once or for a limited number of uses before being discarded or replaced. This includes single-use items and items that wear out with repeated use, such as indicator strips, wraps, brushes, and cleaning cloths.

Contamination: The presence of infectious agents or other unwanted materials on a surface or within a substance.

Control measure: An action or procedure implemented to reduce or eliminate a risk or hazard (eg staff training, policy change).

Control point: A point in a process where monitoring can be applied to reduce a risk, but which is not critical to preventing unacceptable outcomes.

Controlling and monitoring software: Software systems that operate or track reprocessing equipment. These systems need to be verified after updates or changes to ensure they function correctly.

Corrective action: A step taken to fix or address a problem or deviation identified during monitoring or validation (eg repeating sterilisation after a failed cycle).

Critical control point: A step in a process at which control is essential to prevent or eliminate a risk to patient safety.

Critical limit: A specific measurable value (eg sterilisation temperature, cycle time) that needs to be met to ensure a process is effective.

Critical medical device: A medical device that is intended to be introduced directly into or have contact with the vascular system or normally sterile areas of the body.

Cycle record: Documentation of the sterilisation process parameters, including date, steriliser ID, load number, cycle results, and indicators used.

D

Data logger: An electronic device that records sterilisation cycle parameters such as temperature, pressure, and time for later review.

Decontamination: The process of cleaning and disinfecting reusable medical devices before sterilisation.

Degassing: The process of removing dissolved air from the ultrasonic cleaning solution to allow effective cavitation, usually done by running the cleaner without a load after filling.

Demineralised water: Water that has had minerals and impurities removed, usually by distillation or deionisation, to prevent damage to sterilisation equipment and ensure effective sterilisation.

Designated containers (for transport): Rigid, leak-proof, appropriately sized, and labelled containers used to hold and transport used or clean reusable medical devices safely within the practice or externally.

Detergent (high-foaming): A cleaning agent that creates a lot of suds. High foaming is discouraged because it makes items harder to see and rinse, and may create aerosols.

Detergent (low-foaming): A detergent that produces minimal suds, making it safer and easier to rinse—preferred in reprocessing.

Device traceability: The ability to link a specific reusable medical device to the date, sterilisation cycle, staff, and equipment used for its reprocessing.

Directional airflow: Air movement designed to flow from clean areas towards dirty areas, reducing contamination risk by pushing potential contaminants away from sterile zones.

Dirty zone: The area where contaminated reusable medical devices are received and initially cleaned (pre-cleaned) before further processing.

Disinfectant (instrument grade): A disinfectant approved for use on medical instruments, available in different levels based on their efficacy: low-level, intermediate-level, and high-level. Each level corresponds to the type of microorganisms it can inactivate and the intended use of the instrument (eg non-critical, semi-critical, or critical).

Disinfection: A process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects.

Drying cabinet (also Controlled environment drying cabinet): A cabinet designed to dry cleaned medical devices in a controlled, contaminant-minimising environment prior to packaging or storage.

Drying time: The time in the sterilisation cycle allowed for moisture removal from the sterilised load, as validated during commissioning.

E

Environmental risk control (for chemicals): Documented measures to minimise the impact of reprocessing agents on the environment, including correct disposal and avoiding overuse.

Enzymatic detergent: A detergent containing enzymes that break down organic material. Usually used in automated systems for cleaning complex instruments with internal channels.

Enzyme foam: A type of pre-treatment product used to keep instruments moist and begin breaking down organic material before cleaning.

Exposure time: The length of time a device is subjected to a sterilisation or disinfection process necessary to achieve the desired microbial kill.

Extended sterilisation cycle: A sterilisation cycle longer than standard, specified by device manufacturers for certain devices requiring extra time to ensure sterility.

F

Fractionated vacuum: A sterilisation cycle where air is removed in stages by vacuum pulses, improving steam penetration in Class B sterilisers.

G

Gravity displacement steriliser: A type of steam steriliser that removes air by gravity, allowing steam to enter; simple and cost-efficient, common in general practice.

H

Hand basin: A shallow, smooth-surfaced fixture designed solely for hand hygiene. Hand basins are not to be used for cleaning or rinsing reusable medical devices, disposal of fluids, or any purpose other than handwashing.

Hand hygiene stations: Designated areas or equipment (such as sinks or alcohol-based handrub dispensers) specifically for handwashing or hand sanitising within the reprocessing zone.

Hazard: A source of potential harm or a situation that could lead to patient injury or compromised infection control. In reprocessing, hazards are grouped into categories: physical, chemical, biological, and quality.

Heat distribution study: An assessment to confirm uniform heat spread throughout the steriliser chamber, especially important for large-capacity sterilisers.

Heat sealer: A machine used to seal sterile barrier system packaging made from laminate rolls by applying heat to melt and bond the edges.

Heat sealing (packaging): A process using heat to fuse packaging materials; generally out of scope for typical general practice settings.

High-level disinfection system: A process or piece of equipment that uses chemical disinfectants to kill all microorganisms except high levels of bacterial spores, used for semi-critical devices.

Holding time: The time the steriliser maintains the required temperature to achieve effective microbial kill, including a safety margin.

I

Incubator (for BI): A device used to maintain optimal temperature conditions for growing and detecting any surviving microorganisms after a biological indicator test.

Infection prevention and control (IPC) coordinator: A designated individual responsible for overseeing and implementing infection prevention and control measures, including the supervision of reprocessing activities, staff training, and compliance with relevant policies and standards.

Initial treatment at point of use (pre-cleaning): Immediate cleaning or soil removal performed on reusable medical devices right after use, often involving wiping with low-lint cloth or applying a TGA-registered pre-cleaning product to prevent soil drying.

Installation qualification (IQ): The documented process of verifying that a reprocessing unit has been correctly installed according to the manufacturer’s specifications.

Instructions for use: Official guidance provided by the manufacturer detailing how a medical device or piece of equipment needs to be used, cleaned, disinfected or sterilised.

Instrument precleaning product: A cleaning solution applied before full cleaning begins (usually sprayed or soaked) to keep debris soft and moist. It needs to be TGA-listed.

Instrument pre-treatment product: Chemical or enzymatic agents used onsite or offsite to begin cleaning reusable medical devices by removing gross soil and preventing drying of contaminants.

Instrument-grade disinfectant: A disinfectant approved for use on reusable medical devices, registered with the TGA. Not to be confused with general-purpose or hospital-grade disinfectants.

Intermediate-level disinfectant: A disinfectant that destroys vegetative bacteria, most fungi, and viruses, and inactivates Mycobacterium tuberculosis, but does not reliably kill bacterial spores.

L

Laminate pouch: A pre-made sterilisation pouch consisting of paper backed with clear plastic, allowing sterilising agents to penetrate while keeping contents sterile after processing.

Leak test: A test performed on vacuum-assisted sterisers to verify that the chamber maintains an effective airtight seal, ensuring proper air removal for sterilisation.

Likelihood (risk matrix): The chance or probability that a specific hazard or threat will occur, used to calculate risk level.

Limitations of ultrasonic cleaners: Ultrasonic cleaners do not remove all debris or provide thermal disinfection and need to be followed promptly by washer-disinfector cleaning; they may damage certain materials like soft plastics, rubber, or delicate instruments.

Lint: Small textile fibres left behind on surfaces by some cloths. These fibres can cause a foreign body reaction in patients if transferred to medical instruments.

Load configuration: The arrangement and type of instruments in a steriliser during a cycle, validated to ensure effective sterilisation.

Load failure (washer-disinfector): A condition where the washer-disinfector cycle fails to meet validated parameters, requiring reprocessing of items before sterilisation.

Load separators: Devices used in the steriliser to space out items (eg kidney dishes) to prevent stacking that inhibits steam penetration and drying.

Loaned reusable medical devices: Reusable instruments borrowed from another healthcare provider, requiring complete reprocessing before use.

Low-level disinfectant: A disinfectant effective against most vegetative bacteria, some fungi, and some viruses, but not against mycobacteria or bacterial spores.

Low-lint cloth: A cloth that leaves minimal fibres behind.

Lumen: A hollow channel or tube within a reusable medical device.

M

Manual cleaning (as pre-treatment): Using manual methods (brushing, wiping) to remove visible soil before automated cleaning; no longer acceptable as the primary method except where specified.

Maximum hold time: The maximum amount of time reusable medical devices can be safely held after initial treatment before further cleaning or reprocessing, as specified by manufacturer instructions.

Microbiological surveillance testing: Optional periodic testing to check for the presence of bacteria or other microorganisms on equipment or in the environment.

Moist heat sterilisation: A sterilisation method that uses steam under pressure to kill all forms of microbial life. It is the most common and reliable method used in general practice.

Monitoring and measuring equipment: Devices used to observe, measure, or verify critical parameters (eg temperature, pressure, time, conductivity) during the reprocessing of reusable medical devices. These instruments need to be accurate, regularly calibrated, and traceable to recognised measurement standards to ensure reliable performance of reprocessing equipment.

Monitoring procedure: A defined activity to check that a critical limit or process step is being correctly performed and meets required standards.

N

Non-abrasive cleaner: A cleaner that does not scratch or wear down the surface of reusable medical devices.

Non-conformance procedure: A formal process for managing and correcting failures or deviations from established reprocessing protocols.

Non-conforming product: An item that does not meet required standards or specifications and needs to be removed, reprocessed, or discarded to avoid safety risks.

Non-conforming reusable medical device: A device that fails to meet reprocessing, packaging, or sterility requirements (eg if it is damaged, wet, not traceable, or expired).

Non-critical medical device: A medical device that comes into contact with intact skin but not mucous membranes.

Nonwoven material (SMS polypropylene): A fabric made from spunbond-meltblown-spunbond polypropylene layers, used as a disposable sterile barrier material that allows sterilising agents through while blocking contaminants.

O

Offsite reprocessing: Sterilisation and cleaning performed outside the practice, such as by a hospital, accredited facility or commercial provider.

One-way workflow: A strict, unidirectional flow in the reprocessing area from dirty to clean zones, preventing cross-contamination by ensuring dirty items never contact cleaned items.

Operational qualification (OQ): The documented process of verifying that equipment operates correctly and consistently according to its specifications and expected performance requirements under defined conditions.

P

Penetration (equilibration) time: The time required for the coolest or hardest-to-reach part of the steriliser load to reach the target sterilisation temperature.

Perforated instrument tray: Metal trays with holes or slots designed to allow steam penetration and air removal during sterilisation.

Perforated trays/cassettes: Metal trays with holes to allow steam penetration and drainage during sterilisation; solid trays are not to be used.

Performance qualification (PQ): The documented validation that equipment consistently performs as intended and produces reliable, acceptable results under routine operational conditions.

Personal protective equipment: Items such as gloves, gowns, eye protection or masks worn to protect staff from exposure to contamination during reprocessing.

Point of use: The location or moment a reusable medical device is used on a patient.

Pre-cleaning: See Initial treatment at point of use.

Pre-sterilisation cleaning: The cleaning process performed on reusable medical devices to remove bioburden and contaminants before sterilisation.

Pre-sterile zone: The area where reusable medical devices are cleaned, dried, and packaged, but not yet sterilised. See ‘Clean zone’.

Pre-treatment (offsite): Initial cleaning steps done at the location where instruments are used, including wiping, rinsing, and chemical treatment, before transport back to the practice.

Pre-treatment holding solution: A temporary holding solution for contaminated instruments if there’s a delay before cleaning. It prevents drying and bacterial growth.

Preventive action: Measures taken to stop problems before they happen based on identified risks or past trends.

Preventive maintenance: Routine servicing (eg calibration, part replacement) of reprocessing equipment to ensure continued safe and effective performance.

Printout: A hard copy record produced automatically by the steriliser detailing the cycle parameters during a sterilisation process.

Process challenge device (PCD): A device designed to simulate the most challenging conditions for sterilisation, used to verify that the sterilisation process is effective – particularly for complex or difficult-to-sterilise instruments – often incorporating biological or chemical indicators.

Process definition: A detailed, validated specification of each step required to safely reprocess reusable medical devices, ensuring they are clean, disinfected, sterilised, and safe for reuse.

Process flow: A step-by-step outline of the actions taken during the reprocessing of reusable medical devices, from the moment of use through cleaning, disinfection, sterilisation, and storage.

Process indicator: A chemical or physical marker used to differentiate between sterilised and non-sterilised items, but does not confirm sterility.

Process validation: A documented process to confirm that equipment and procedures used in reprocessing consistently produce results that meet pre-established specifications and quality attributes.

Product families (for validation): Groups of reusable medical devices with similar design, materials, and reprocessing requirements. Grouping devices this way allows for representative validation testing of similar items.

Q

Qualified technician: A person with recognised training and competence to perform equipment validation, maintenance, and testing.

Quality assurance (QA): A structured and risk-based approach to ensure processes, equipment, and outcomes related to reprocessing meet safety and effectiveness standards.

Quarantine (in reprocessing): Isolating non-compliant or faulty medical devices until corrective action can be taken.

Quarantine (of sterilised loads): Holding reprocessed items aside and not releasing them for use until all validation and monitoring (eg biological indicators) confirm successful sterilisation.

R

Recall (of reusable medical device): A process to identify, retrieve, and prevent the use of devices found to be improperly reprocessed or unsafe.

Release criteria: The set of minimum standards a reusable medical device needs to meet to be deemed safe for patient use following reprocessing.

Reprocessing: The steps taken to clean, disinfect, and sterilise reusable medical devices to make them safe for reuse.

Reprocessing area: A designated, segregated physical space specifically for cleaning, disinfecting, packaging, sterilising, and storing reusable medical devices.

Reprocessing log: A record-keeping system that tracks each sterilisation or cleaning cycle, including details of loads, parameters, and operator actions.

Reprocessing team: A group responsible for overseeing and supporting the safe and effective reprocessing of reusable medical devices. The team typically includes the IPC coordinator, practice management, clinical and reprocessing staff, and may also involve external experts. The team collaborates on risk management, hazard analysis, and continuous improvement of reprocessing practices.

Requalification: Revalidation or retesting of equipment after repairs, modifications, or at regular intervals to ensure continued compliance.

Reusable medical device: Any medical device designed and validated by the manufacturer to be reprocessed and reused on multiple patients.

Reverse osmosis water filtration system: A device that filters water by pushing it through a semi-permeable membrane, removing impurities and minerals to produce high-purity water suitable for sterilisation processes.

Rigid reusable sterilisation container: A hard, durable container designed for sterilising and storing surgical instruments, allowing steam penetration and protection during storage.

Risk analysis: A systematic method of identifying and evaluating potential hazards that may impact the effectiveness or safety of reprocessing reusable medical devices.

Risk assessment: The systematic process of identifying, analysing, and evaluating risks or hazards related to reprocessing.

Risk category/rating: The result of risk assessment, based on likelihood and consequence. Common categories are low, medium, high, and extreme.

Risk evaluation: The process of determining the significance of identified risks based on a risk matrix, and deciding on appropriate control measures.

Risk management system: An ongoing process that identifies, assesses, and controls risks to ensure that the reprocessing of reusable medical devices is safe and effective.

S

Safety data sheet: A document from the manufacturer that outlines the safe use, hazards, environmental impact, and disposal of a chemical product. Safety data sheets need to be reviewed annually.

Segregation: The physical or procedural separation of dirty (contaminated) and clean (sterile or disinfected) zones within the reprocessing area to prevent cross-contamination.

Self-sealing pouch: A sterile barrier pouch with an adhesive strip that allows sealing without heat or tape.

Semi-critical medical device: A medical device that comes into contact with mucous membranes or non-intact skin.

Shadowing effect: A phenomenon in ultrasonic cleaning where large or improperly positioned items block ultrasonic waves, resulting in poor cleaning of certain surfaces.

Single-use medical device: A medical device intended by the manufacturer to be used on one patient during a single procedure and then discarded.

Sink (Reprocessing sink): A deep, purpose-built fixture designed for immersion, manual cleaning, rinsing, and flushing of reusable medical devices. In the reprocessing area, sinks are designated as ‘dirty’ (for washing contaminated items) or ‘clean’ (for rinsing after washing). Reprocessing sinks are never to be used for handwashing or for general disposal of liquids.

Spaulding Classification Scheme: A risk-based framework used to determine the level of reprocessing required for medical devices based on how and where they are used on the body (critical, semi-critical, non-critical).

Splashback: A vertical surface (usually behind a sink or bench) designed to protect walls and surfaces from water or chemical splashes during cleaning.

Standard operating procedure: A written, detailed instruction that describes how a specific task or process (such as loading a steriliser) should be performed to ensure consistency and compliance.

Steam penetration test: A test, often synonymous with Bowie-Dick, used to verify that steam can penetrate steriliser loads effectively.

Steel wool/domestic abrasives: Harsh cleaning tools that are not to be used because they damage instruments and can leave residue or cause rusting.

Sterile barrier system: A packaging material or system designed to maintain the sterility of a medical device after sterilisation until the point of use.

Sterile zone: The area where sterilised devices are stored, protected from contamination, and ready for use. See ‘Clean zone’.

Sterilisation: The validated process used to render a reusable medical device free from all viable microorganisms, including spores.

Sterilisation cycle parameters: Key factors including time, temperature, and pressure that need to be monitored and controlled to achieve sterilisation.

Sterilisation indicator tape: Tape that changes colour when exposed to sterilisation conditions, used to confirm that the sterilisation cycle occurred (not for self-sealing pouches).

Sterilisation labelling: Markings on sterilisation packs that include at least the sterilisation date and batch/load number, enabling stock rotation and traceability.

Steriliser / Autoclave: A machine that uses steam under pressure (or another validated method) to sterilise reusable medical devices.

Steriliser identification number: A unique number or code used to differentiate between multiple sterilisers in the same practice for recordkeeping and traceability.

Steriliser printout: A recorded document from the steriliser cycle detailing cycle parameters and results, used to verify successful sterilisation.

Sterility maintenance: The process of ensuring that a sterilised medical device remains sterile until point of use, requiring intact packaging and protection from environmental contamination.

Stock rotation: A system ensuring older sterilised stock is used before newer stock to prevent expiry or damage.

Sub-atmospheric steriliser: A steriliser operating below atmospheric pressure during sterilisation.

Supra-atmospheric steriliser: A steriliser operating only above atmospheric pressure during sterilisation.

T

Testing instruments: Devices used to measure or verify critical parameters (such as temperature, pressure, time, or water quality) during the reprocessing of reusable medical devices. They support equipment validation, performance testing, and routine monitoring.

TGA (Therapeutic Goods Administration): The Australian government authority that regulates medical devices and ensures their safety and quality.

TGA-registered (cleaning agents/disinfectants): Refers to products that have been reviewed and approved by the Therapeutic Goods Administration for safe use on medical devices.

Thermal disinfection: Disinfection achieved through high temperatures in an automated washer-disinfector, eliminating many microorganisms but not necessarily sterilising.

Timeliness (in cleaning): The principle that cleaning and disinfection steps should occur as soon as possible after use (within 1 – 4 hours) to prevent soil drying and ensure effective reprocessing.

Tip protectors: Validated devices placed on sharp instrument tips during packaging to prevent perforation of sterile barrier systems and protect staff from injury.

Traceability: The ability to track a reusable medical device through each stage of cleaning, sterilisation, and use, via documentation.

Trans-atmospheric steriliser: A steriliser system where chamber pressure cycles above and below atmospheric pressure during sterilisation.

Transportation: The safe collection and movement of used reusable medical devices within a practice or to an external reprocessing facility, using appropriate containers to prevent contamination or injury.

Turnaround time: The total time required for a reusable medical device to be cleaned, sterilised, and returned for use.

U

Ultrasonic cleaner: A device using ultrasonic waves to clean instruments by removing soil and debris, typically used as a pre-cleaning step.

Ultrasonic cleaning: A pre-cleaning method using ultrasound waves to remove debris from instruments, often used before washer-disinfector cleaning.

Unloading protocol: A standardised procedure to safely remove sterilised loads without compromising sterility, including checks of packaging, chemical indicators, and printouts.

Utility gloves (for packaging): Non-sterile, latex-free, puncture-resistant, chemical-resistant gloves with preferably long cuffs, worn during packaging to protect staff and maintain cleanliness.

V

Validation: A documented process that provides objective evidence that equipment or procedures are correctly installed, operate as intended, and consistently achieve the required outcomes.

W

Washer-disinfector: An automated machine that cleans and disinfects reusable medical devices using controlled water temperature, detergents, and disinfection cycles.

Wet pack: A sterilised package that remains damp at the end of the sterilisation cycle, indicating a possible steriliser malfunction or drying failure. Wet packs are considered non-sterile and need to be reprocessed.