CSPDT key terms

The amount of organic soil, including blood, tissue, and microorganisms, remaining on an item before it is cleaned or sterilized. High bioburden can shield microbes and cause disinfection or sterilization to fail.

A system that sorts medical devices into critical, semicritical, and noncritical groups based on how they contact the body, which then sets the minimum level of reprocessing each device needs.

A process that destroys all microorganisms except large numbers of bacterial spores. It is used for semicritical devices, such as endoscopes, that touch mucous membranes but do not enter sterile body areas.

Barriers such as gloves, gowns, masks, eye protection, and shoe covers worn to protect the technician from contact with blood, body fluids, and contaminated items during reprocessing.

The designated, physically separated room where soiled items are received, cleaned, and disinfected. It is kept at negative air pressure relative to clean areas so contaminants stay contained.

A cleaning product containing enzymes that break down proteins, fats, and carbohydrates on instruments. It is used at the manufacturer's recommended dilution, temperature, and contact time before disinfection or sterilization.

A machine that uses high-frequency sound waves to form bubbles that implode and lift soil from instrument surfaces, including hinges and serrations. It performs cleaning only, not disinfection or sterilization.

Immediate bedside care of a soiled instrument, such as wiping it or applying a moistening gel, so soil does not dry and harden before the item reaches the decontamination area.

An abnormally folded infectious protein that causes diseases such as Creutzfeldt-Jakob disease. Prions resist routine disinfection and sterilization, so special manufacturer and public health protocols are required.

The step in which cleaned instruments are checked for cleanliness, damage, and function, then arranged into a set according to its count sheet before packaging.

A list of every item and its quantity that belongs in a particular instrument set. It is used during assembly and again at the point of use to confirm the set is complete.

A basket or container holding a specific group of instruments needed for a procedure, configured according to a count sheet and processed as one packaged unit.

Instruments with box locks, hinges, or ratchets are packaged unlocked and open so steam or sterilant can reach every surface. Closed or locked instruments can trap air and block sterilization.

A medical-grade material, such as nonwoven polypropylene or woven cotton, used to wrap items so sterilant can enter and leave while microorganisms are kept out after processing.

A sealed paper-and-film package used for small or single instruments. The clear film lets staff see the item, and the package peels open cleanly for aseptic presentation.

A reusable metal or plastic box with a lid and a filter or valve system that holds instruments during sterilization and protects them afterward. It must be validated for the sterilizer type used.

A machine that closes peel pouches using controlled temperature, pressure, and dwell time to form a continuous seal. Seal quality is checked visually and by periodic strength testing.

A strip, dot, or tape that changes color when exposed to one or more sterilization parameters such as temperature, steam, or a chemical agent. It shows exposure but does not prove sterility.

A test strip or vial containing bacterial spores with known high resistance to a specific sterilization process. It is the most reliable routine evidence that the process actually killed microorganisms.

A spore-forming bacterium used in biological indicators for steam and hydrogen peroxide sterilization because its spores are highly resistant to those processes.

A process that uses saturated steam under pressure at a set temperature and time, commonly 132 degrees Celsius for four minutes, to kill microorganisms by denaturing their proteins.

A steam sterilizer that first pulls a vacuum to remove air from the chamber before admitting steam. Air removal is more complete than in gravity units, so cycles run faster.

A test pack run in an empty chamber of a prevacuum steam sterilizer to detect air leaks and poor air removal. It is typically performed at the start of each operating day.

A low-temperature process using a toxic, flammable gas to sterilize heat- or moisture-sensitive items. Loads require aeration afterward so toxic residues are removed before use.

The probability that a single item is nonsterile after a validated sterilization process. For medical devices it is usually set at one in a million, written as 10 to the minus sixth power.

Also called flash sterilization: processing an unpackaged item for immediate use when a full cycle cannot be done. It is reserved for urgent situations and needs documented justification.

The principle that a properly packaged sterile item stays sterile indefinitely unless the package is damaged, wet, or compromised, or storage conditions fail. It replaces fixed expiration dates.

A clean, restricted room where processed items are held before use. It is separated from soiled areas and has controlled temperature, humidity, and traffic to protect package integrity.

A sterile package that is torn, punctured, wet, stained, or has a broken seal. Sterility can no longer be assumed, so the item must be reprocessed before use.

A stock rotation method in which the oldest processed items are used first. It helps ensure supplies are used before materials degrade or storage conditions affect them.

A cart assembled with the supplies and instrument sets needed for one scheduled procedure. It is prepared in advance and delivered so operating room staff do not search for items.

Restricting who enters sterile storage and how people move through it, such as limiting access and requiring clean attire, to reduce airborne contamination and package damage.

The manufacturer's written directions for cleaning, packaging, sterilizing, and storing a device or sterilizer. Following them is required because the device's validation depends on those exact steps.

Documented evidence that a process consistently produces the intended result, such as a sterilization cycle proven to reach the required sterility assurance level under defined conditions.

A widely used consensus standard for steam sterilization and sterility assurance in healthcare facilities. It covers cleaning, packaging, loading, monitoring, storage, and quality control practices.

Infection control practices applied to every patient's blood and body fluids, including gloves, gowns, masks, eye protection, and hand hygiene, because any patient may carry a transmissible disease.

An OSHA regulation requiring employers to protect workers from blood and other potentially infectious materials through an exposure control plan, protective equipment, training, and hepatitis B vaccination.

Planned checks and records, such as indicator results, temperature logs, and seal tests, that show reprocessing steps are working as intended and let problems be found early.

Written records of each reprocessing step, including load contents, cycle parameters, and monitoring results. Good records provide traceability and are essential when investigating a sterilization failure.

The process of retrieving and reprocessing or discarding items from a load after a failed biological indicator or other sterilization failure, and notifying anyone who may have received them.