19 CRR-NY 192.10NY-CRR

STATE COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 19. DEPARTMENT OF STATE
CHAPTER V. DIVISION OF LICENSING SERVICES
SUBCHAPTER H. HEARING AID DISPENSERS
PART 192. HEARING AID DISPENSERS
19 CRR-NY 192.10
19 CRR-NY 192.10
192.10 Decontamination and infection control.
(a) Definitions.
As used in this section:
(1) OSHA means the Occupational Safety and Health Administration and the statutes, rules and regulations relevant thereto.
(2) EPA means the Environmental Protection Agency.
(3) Cleaning is the removal of gross contamination from an object or surface by the physical removal of all visible dust, soil, and any other foreign material.
(4) Disinfection is the process that kills or destroys a specific number of disease producing organisms, the number of which is determined by the level of disinfectant used.
(5) Sterilization is the process that kills all disease producing organisms (including bacteria, viruses, fungi and spores).
(b) The dispenser shall follow the OSHA Standard for Bloodborne Pathogens (29 CFR § 1910.1030) and the OSHA Standard for Hazardous Material Communication (29 CFR § 1910.1200), where appropriate, incorporated by reference herein. In addition, the dispenser shall comply with the procedures, where not in conflict with OSHA regulations, set forth in this section. Such Federal regulations are authored by the United States Department of Labor, Occupational Safety and Health Administration, revised as of July 1, 1999, and published by the United States Government Printing Office via GPO Access, Washington, DC. A copy is available for public inspection and copying at the Division of Administrative Rules, Department of State, One Commerce Plaza, 99 Washington Avenue, Suite 650, Albany, NY 12231-0001.
(c) General procedures for cleaning, disinfection and sterilization.
The dispenser shall use scientifically accepted infection prevention techniques appropriate for the cleaning and disinfection or sterilization of instruments, devices, materials and work surfaces, utilization of protective garb, and the storage of contamination-prone equipment. Such techniques shall include but not be limited to the following:
(1) Prior to disinfection or sterilization, all items and surfaces must first be cleaned of gross contamination. This should be accomplished by cleaning with warm water and soap or detergent, rinsing thoroughly, drying with clean or disposable toweling, or allowing to thoroughly air dry. Disinfection and sterilization must be accomplished in accordance with the manufacturer's recommendations for the item or surface.
(2) All disinfectant processes prescribed herein must be accomplished by the use of an EPA-approved hospital grade disinfectant.
(3) Sterilization may be accomplished by using an autoclave or by soaking for a minimum of 10 hours in an approved two percent glutaraldehyde solution or in any other EPA-approved chemical sterilant solution in accordance with the manufacturer's directions. Porous items should not be soaked in glutaraldehyde solution.
(4) Items for autoclaving must be packaged prior to sterilization. Gloves must be worn when handling chemical sterilant solution and precautions must be taken to insure that the solution does not come into contact with any skin surface.
(5) Following disinfection or sterilization, items must be rinsed, dried and stored in a clean drawer, cabinet or covered container.
(6) All solutions and equipment used for disinfection and sterilization must be stored, maintained and monitored according to the manufacturer's directions so as to protect from contamination and to assure the continued integrity of the intended process. Such solution and equipment must be maintained in the original packaging with active ingredients and scope of use clearly described on the original label.
(7) Each registered business location must have on file all material safety data sheets (MSDS) for inspection. MSDS must be stored in a metal file accessible to all employees.
(8) All “clean” and “dirty” equipment or items must be transported to and from remote locations in covered containers. Clean items and supplies must be kept in containers separate from those that have been used and all items and supplies must be marked according to their status.
(d) Specific procedures and schedules for cleaning, disinfection and sterilization of surfaces and implements.
(1) Hearing aids and earmolds must be cleaned and disinfected prior to any handling by office staff. Hearing aids must be disinfected using an approved wipe or spray; earmolds must be disinfected using approved wipe, spray or submersion system. In all cases, disinfection must be accomplished according to the manufacturer's directions. In addition, clients must be instructed in the appropriate manner of cleaning and disinfecting appliances for their own use.
(2) In general, headphone ear cushions, bone conduction oscillators, and headbands must be cleaned and disinfected using an approved disinfectant wipe or spray at least once per week. Following use on a client with evidence of a sore on the ear, scalp or face, with any ear drainage, or with questionable hygiene, disinfection must be performed prior to re-use.
(3) Otoscope specula, real ear probe tubes, otolight tips, or any other item that comes in contact with the ear must be cleaned and disinfected using an approved wipe or submersion system prior to each client use. The use of disposable specula, probe tubes and tips after each client use is encouraged and will eliminate the need for disinfection.
(4) Hearing aid cleaning tools and listening stethoscope couplers must be cleaned and disinfected using an approved wipe or submersion system before re-use.
(5) Reception countertops and tabletops used in testing rooms must be cleaned and disinfected using an approved wipe or spray at least once per day.
(6) Arm rests used by clients in testing rooms must be cleaned and disinfected using an approved wipe or spray at least once per week.
(e) Procedures with respect to blood, body fluids and client contact.
(1) All blood, mucous or other body fluid encountered in the workplace must be treated as if infectious. Direct contact with blood should be avoided and disposable gloves used whenever such contact can be reasonably anticipated. Cerumen is a potentially infectious material only when it is contaminated with blood or mucous (drainage). Since cerumen is dark and viscous it is often difficult to determine if it is contaminated and the content of cerumen cannot be determined through visual inspection. Consequently, cerumen should be treated as an infectious substance. In addition to any other statutory or regulatory procedures with respect to blood, body fluids and client contact, the following precautionary measures must be taken:
(2) A hearing aid or earmold must not be handled upon removal from the ear with bare hands until it has been cleaned.
(3) Either gloves must be worn while disinfecting a hearing aid appliance or earmold, or a disinfectant towelette or spray must be used to hold, clean and disinfect the appliance.
(4) Any disposable materials coming into contact with blood or other contaminated or potentially contaminated body fluids must be disposed of in a plastic bag which will be sealed in a manner that protects the dispenser, dispenser's staff, client and others, such as sanitation workers, who may come into contact with the material.
(5) Any disposable sharp object that comes into contact with blood or other body fluids shall be disposed of in a sealable rigid puncture proof container which is strong enough to protect from accidental cuts or puncture wounds that could happen during the disposal process.
(f) Hygienic practices.
(1) Hands must be washed before and after direct contact with each client.
(2) Bar soap for more than one person is prohibited. Liquid or powder soap dispensers or antimicrobial waterless hand cleaners may be used.
(3) Disposable paper towels or hot air dryers shall be available for hand drying when antimicrobial waterless hand cleaners are not used.
(4) Direct client care and handling of client care equipment is forbidden if the dispenser has exudative lesions or weeping dermatitis and the condition has not been medically evaluated and determined to be safe or capable of being safely protected against in providing direct client care or in handling client care equipment.
19 CRR-NY 192.10
Current through October 15, 2021
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