Appendix B: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy – Glossary

APPENDIX B – Glossary of Terms

Automated Endoscope Reprocessor (AER): Machine designed to assist with the cleaning and disinfection of endoscopes.

Antimicrobial agent: A product that kills or suppresses the growth of microorganisms.

Bacteria-free water: Water that has been filtered through a 0.2 micron filter to remove bacteria.

Bioburden: Population of viable microorganisms on a raw material, a component, a finished product and/or a package.

Biofilm: The process of irreversible adhesion initiated by the binding of bacteria to a surface by means of exopolysaccharide material (glycocalyx). The development of adherent microcolonies eventually leads to the production of a continuous biofilm on the colonized surface. Bacteria within biofilms tend to be more resistant to biocides than cells in batch-type culture.

Biomedical waste: Defined by the Canadian Standards Association (CSA) as waste that is generated by human or animal healthcare facilities, medical or veterinary settings, healthcare teaching establishments, laboratories, and facilities involved in the production of vaccines.

Cleaning: The physical removal of foreign material, e.g., dust, soil, and organic material such as: blood, secretions, excretions and microorganisms. It is accomplished with water, detergents and mechanical action. The terms “decontamination” and “sanitation” may be used for this process in certain settings, e.g., central service or dietetics. Cleaning reduces or eliminates the reservoirs of potential pathogenic microorganisms.

Contamination: The presence of microorganisms on inanimate objects (e.g., clothing, surgical instruments) or microorganisms transported transiently on body surfaces such as hands, or in substances (e.g., water, food, milk).

Critical items: Instruments and devices that enter sterile tissues, including the vascular system. Critical items present a high risk of infection if the item is contaminated with any microorganisms including bacterial spores. Reprocessing critical items involves meticulous cleaning followed by sterilization.

Decontamination: The removal of disease-producing microorganisms, to leave an item safe for further handling.

Disinfection: The inactivation of disease producing microorganisms. Disinfection does not destroy bacterial spores. Disinfectants are used on inanimate objects; antiseptics are used on living tissue. Disinfection usually involves chemicals, heat or ultraviolet light. Levels of disinfection vary with the type of product used.

Drug Identification Number (DIN): In Canada, disinfectants are regulated as drugs under the Food and Drug Act and Regulations. Disinfectant manufacturers must obtain a drug identification number from Health Canada prior to marketing, which ensures that labelling and supporting data have been provided and that it has been established by the Therapeutic Products Directorate that the product is effective and safe for its intended use.

Endoscope accessory instruments: Medical instruments designed for insertion into a flexible endoscope. These devices (other than the endoscope) are used during endoscopy and include, but are not limited to, biopsy forceps, snares, bite blocks, guide-wires, irrigation tubes, and dilators. Devices may or may not have lumens, porous or loosely joined surfaces or access ports for flushing, and may or may not be capable of being completely disassembled during reprocessing.

Endoscope-Flexible: Flexible fiberoptic or video endoscope used in the examination of hollow viscera (bronchoscope, colonoscope, duodenoscope, gastroscope, sigmoidoscope).

Enzymatic detergent: Low-sudsing cleaning formulations containing protease, lipase, amylase, alone or in combination, that aid in the removal of proteinaceous material on medical equipment/devices.

High level disinfection: Level of disinfection required when reprocessing semi-critical items. High level disinfection processes destroy vegetative bacteria, mycobacteria, fungi and enveloped (lipid) and non-enveloped (non-lipid) viruses, but not necessarily bacterial spores. High level disinfection chemicals (also called chemisterilants) must be capable of sterilization when contact time is extended. Items must be thoroughly cleaned prior to high level disinfection.

Infection: The entry and multiplication of an infectious agent in the tissues of the host.

  1. Inapparent (asymptomatic, subclinical) infection: an infectious process running a course similar to that of clinical disease but below the threshold of clinical symptoms
  2. Apparent (symptomatic, clinical) infection: one resulting in clinical signs and symptoms (disease).

Manufacturer: Any person, partnership or incorporated association that manufactures and, under its own name or under a trademark, design, trade name or other name or mark owned or controlled by it, sells medical equipment/devices.

Material Safety Data Sheet (MSDS): Descriptive sheet that accompanies a chemical or chemical mixture, providing the identity of the material; physical hazard, such as flammability; acute and chronic health hazards associated with contact or exposure.

Medical Device: Any instrument apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

  1. Diagnosis, prevention, monitoring treatment, or alleviation of disease.
  2. Diagnosis, monitoring treatment or alleviation of or compensation for an injury, or handicap.
  3. Investigation, replacement, or modification of the anatomy or of a physiological process or control of conception; and that does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but that may be assisted in its function by such means.

Minimum effective concentration (MEC): Lowest concentration of active ingredient necessary to meet the label claim of a reusable high-level disinfectant/sterilant.

Non-critical items: Those that either touch only intact skin but not mucous membranes or do not directly touch the patient. Reprocessing of non-critical items involves cleaning with or without low level disinfection.

Outbreak: An excess over the expected incidence of disease within a geographic area during a specified time period; synonymous with epidemic.

Patient-ready endoscope: An endoscope rendered visibly free from debris after being subjected to a validated cleaning procedure and, at minimum, a high level disinfection or sterilization process. If liquid chemicals are used for disinfection, the endoscope must also be rinsed to ensure that it does not contain residual chemicals in amounts that can be harmful to humans.

Personal protective equipment: Specialized clothing or equipment worn by staff for protection against hazards.

Reprocessing: The steps performed to prepare a used medical device for reuse.

Reusable device: A device that has been designed by the manufacturer, through the selection of materials and/or components, to be reused.

Risk Class: Classification assigned to a device involved in patient care based on the risk of infection involved with the use of the device. Classes are critical, semi-critical and non-critical.

Single use/disposable device: A device designated by the manufacturer for single use only.

Sterilant: Chemical germicide that has been cleared by the Therapeutic Product Division of Health Canada as capable of destroying all viable microorganisms, including bacterial spores.

Sterile: The state of being free from all living microorganisms.

Sterilization: The destruction of all forms of microbial life including bacteria, viruses, spores and fungi. Items must be cleaned thoroughly before effective sterilization can take place.

Threshold limit value - Time-Weighted Average (TLV-TWA): Airborne concentration of a substance to which all workers may be exposed day after day without experiencing any adverse health effects.

Ultrasonic Washer: A machine that cleans medical devices by agitation caused by sound waves which produce vigorous microscopic implosions of tiny vapour bubbles on the surface of objects immersed in the cleaning chamber.

Use - life: Statement by the manufacturer of maximum number of days a reusable high-level disinfectant/sterilant might be effective.

Validation: A documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.

Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

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