21 NCAC 06V .0102         DEFINITIONS AND OVERVIEW

In addition to the terms defined in G.S. 88A, the following terms have the following meanings:

(1)           "Alcohol-based hand rub or gel" means a preparation that contains 60 percent to 95 percent ethanol or isopropanol that is designed for application to the hands to reduce the number of viable microorganisms on the hands.

(2)           "Antiseptic" means a germicide used on skin or living tissue to inhibit or destroy microorganisms.

(3)           "Aseptic technique" means the term used to describe the precautionary measures taken to help reduce the risk of post treatment infections by decreasing the opportunity for microorganisms to enter the body. Precautionary measures include handwashing, disinfection, sterilization of surfaces and instruments, use of protective barriers, containment and disposal of waste, and instrument and surface manipulations that minimize cross contamination.

(4)           "Autoclave" means a vessel used for sterilization by the application of saturated steam under pressure and heat.

(5)           "Chemical indicator" means a chemically treated paper strip used to monitor parameters of a heat sterilization process by means of a characteristic color change. A chemical indicator does not indicate that sterilization has been achieved, but a chemical indicator indicates that the temperature needed has been attained.

(6)           "Cleaning" means the removal of all visible organic material from objects using friction, detergent, and water prior to the disinfection and sterilization processes.

(7)           "Contaminated" means the presence of potentially infectious pathogenic microorganisms on surfaces of a objects.

(8)           "Continuing education unit" or "CEU" means one contact hour of participation in an organized learning experience that:

(a)           is related to the practice of electrolysis or laser light-based hair reduction;

(b)           is related to the scope of practice of a practitioner of electrolysis or laser light-based hair reduction;

(c)           occurs after the original granting of licensure; and

(d)           is approved by the Board at least 60 days before the event according to the standards set forth in G.S. 88A-13.

(9)           "Cross-contamination" means the process by which bacteria or other microorganisms are transferred from one substance or object to another with harmful effect.

(10)         "Critical items" means instruments, devices, objects, or environmental surfaces that will come in direct contact with the bloodstream or other normally sterile areas of the body.

(11)         "Decontaminate" means to neutralize or remove dangerous substances or germs from an area or object.

(12)         "Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy pathogens on a surface or item so that they are no longer capable of transmitting infectious particles and to render the surface or item safe for handling, use, or disposal.

(13)         "Disinfect" means to clean with a disinfectant to destroy bacteria.

(14)         "Disinfectant" means a chemical agent used on inanimate surfaces and objects to destroy infectious fungi and bacteria, but not necessarily their spores, and is classified into levels of potency as follows:

(a)           "High-level," which is utilized for the reprocessing of semi-critical instruments or devices and includes Food and Drug Administration (FDA) regulated substances such as glutaraldehyde-, chlorine dioxide-hydrogen peroxide, orthophthaldehyde-, and peracetic acid-based formulations;

(b)           "Intermediate-level," which is utilized for disinfecting tips for epilator needles and includes Environmental Protection Agency (EPA) regulated substances such as alcohols containing 70 to 90 percent ethanol or isopropanol, chlorine compounds, and certain phenolic or iodophor preparations as determined by the EPA;

(c)           "Low-level," which is utilized for disinfecting environmental or non-instrument surfaces and includes EPA regulated substances such as quaternary ammonium compounds and certain phenolic or iodophor preparations as determined by the EPA.

(15)         "Disinfection" means a procedure that reduces the level of microbial contamination and is classified into the following levels:

(a)           "High-level," which inactivates some, but not necessarily all, bacterial spores. This process will also kill Mycobacterium tuberculosis var. bovis and all microorganisms except for high levels of bacterial spores.

(b)           "Intermediate-level," which does not kill bacterial spores but can kill M. tuberculosis var. bovis, most vegetative bacteria and fungi, as well as viruses such as hepatitis B virus (HBV) and human immunodeficiency virus (HIV);

(c)           "Low-level," which inactivates most bacteria, some viruses, and fungi, but not bacterial spores or Mycobacterium tuberculosis var. bovis.

(16)         "Dry heat sterilizer" means a forced air oven-type device designed to sterilize items by exposure to high temperatures for designated exposure periods.

(17)         "Environmental surfaces" means surfaces in the electrology treatment room that may contribute to cross-contamination by contact with the electrologist or instruments that will subsequently contact clients.

(18)         "Enzyme detergent" means the detergent that helps break down organic soils and fats and suspends particles during cleaning. An enzyme detergent is used as a soaking solution for critical and non-critical instruments and as the detergent used in the ultrasonic device.

(19)         "Epilator" means an electrical device used to perform electrolysis.

(20)         "Epilator cords" means insulated plastic covered cords used to complete the current circuit between the epilator and the epilator needle or the indifferent electrode.

(21)         "Forceps" means the sterilized instruments or "tweezers" used in electrology treatments to lift the treated hair from the follicle.

(22)         "Gloves" means coverings for the hands that provide a protective barrier against infections and toxic substances.

(23)         "Hand hygiene" means the general term that applies to:

(a)           "Hand washing," the decontamination process for the removal of soil and transient microorganisms from the hands by a vigorous rubbing together of all surfaces of hands lathered with plain soap for at least 15 seconds, followed by rinsing under a stream of water;

(b)           "Antiseptic hand wash," the washing of hands with water and soap or other detergents containing an antiseptic agent;

(c)           "Antiseptic hand rub," the application of an alcohol-based hand rub product, to all surfaces of the hands to reduce the number of microorganisms present; and

(d)           "Hand antisepsis," a preoperative antiseptic hand wash or antiseptic hand rub to eliminate transient microorganisms and reduce resident hand flora.

(24)         "Health History Assessment File" means the cumulative and permanent documentation of a client's medical and treatment record that is maintained by the electrologist as set forth in Rule .0409 of this Section.

(25)         "Hirsute or Hirsutism" means the excessive growth of hair that is thickened caused by hormonal or biochemical imbalances or genetic predisposition.

(26)         "Home study" means an educational activity undertaken by an individual, completed by correspondence or online, and with a certification of completion awarded at the end of the course.

(27)         "Hospital-grade disinfectant" means a chemical germicide that is classed in a spectrum of activity as either low-level or intermediate-level, as defined in Item (15) of this Rule, with labeled claims for effectiveness against Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa.

(28)         "Indifferent electrode" means a stainless steel bar held by the client during electrology treatments to complete current circuit with galvanic electrolysis modality or with the use of a timer delay switch in automatic delivery epilators.

(29)         "In-person seminar" means continuing education that occurs in a physical location rather than online.

(30)         "Instruments" means tools or devices designed to perform a specific function within the field of electrology, such as grasping, holding, or retracting.

(31)         "Intact skin" means skin in which the natural protective barrier has not been altered by infection or trauma.

(32)         "Microbial" means a minute life form; a microorganism, especially a bacterium that causes disease.

(33)         "Nitrile" means non-sterile, latex-free substance from which gloves are manufactured.

(34)         "Needle" means the pre-sterilized, disposable wire filament that is inserted into the hair follicle for application of electrical current in electrology.

(35)         "Non-intact skin" means skin in which there is a break in the skin's natural integrity, for example, exposed skin that is chapped, abraded, or afflicted with dermatitis.

(36)         "Packaging" means a generic term meant to include all types of containment, such as woven or non-woven wraps, paper or film pouches, or rigid container systems.

(37)         "Pathogen" means a microorganism or substance capable of producing a disease.

(38)         "Phoresis rollers" means sterilized stainless steel rollers used to apply current to skin before or after electrology treatment.

(39)         "Plain soap" means a detergent-based cleanser without antimicrobial additives that is used for the physical removal of dirt and transient microorganisms.

(40)         "Protective disposable barrier" means a disposable, moisture-resistant covering that reduces the potential for contaminating environmental or medical device surfaces that may be difficult or inconvenient to clean and disinfect routinely, for example, tables, pillows, or hard-to-clean surfaces, such as light handles and epilator surfaces.

(41)         "Reprocessing" means the process of cleaning, disinfecting, or sterilizing a reusable instrument that has been used or contaminated in order to be made safe for its intended use.

(42)         "Semi-critical items" means instruments, devices, objects, or environmental surfaces that may come in contact with mucous membranes and non-intact skin, but do not ordinarily penetrate body surfaces. Semi-critical items require sterilization or exposure to high-level disinfection as set in Item (41) of this Rule.

(43)         "Sharps container" means a manufactured and labeled, leak-proof, rigid, puncture-resistant, durable plastic container into which needles are placed after use and that is designed to be disposed of as an item of medical waste regulated by the North Carolina Department of Environmental Quality.

(44)         "Standards" means the level of quality or excellence.

(45)         "Sterility assurance file" means the record containing the sterilizer maintenance and use log and culture report from each biological monitor.

(46)         "Sterilization" means the process that destroys all forms of microbial life. The methods of sterilization of instruments and items used in the practice of electrology are the dry heat sterilizer or the autoclave.

(47)         "Treatment room" means the operatory where electrolysis treatments are performed.

(48)         "Ultrasonic cleaner" means a device that uses ultrasonic waves transmitted through the cleaning solution in a mechanical process known as cavitation. The transmitted sound waves produce tiny air bubbles on instrument surfaces that scrub tightly adhering or embedded particles from solid surfaces and remove soil deposits from hard-to-reach areas.

History Note:        Authority G.S. 88A-6; 88A-13; 88A-16;

Eff. December 1, 2010;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. May 1, 2018;

Amended Eff. November 1, 2022;

Recodified from 21 NCAC 19 .0404 Eff. January 1, 2023.