Latex Product Safety Policy
Final Rules & Regulations
Rules and Regulations
Pertaining to the use of Latex Gloves
By Health Care Workers,
In Licensed Health Care Facilities, and
By Other Persons, Firms, or Corporations
Or Registered by the Department
State of Rhode Island and
Department of Health
- Section 1.0
- Section 2.0
- Section 3.0
- Appendix "A": Warning
These rules and regulations are promulgated under the authority of Chapters 23-73 and 23-17 of the General Laws of Rhode Island, as amended, and are established for the purpose of adopting requirements for the use of latex gloves by health care workers, by other persons, firms, or corporations licensed or registered by the Department of Health, and the use of latex gloves in licensed health care facilities. The use of disposable, non-sterile and sterile natural rubber latex gloves shall be prohibited by any person, firm, or corporation, registered pursuant to sections 21-27-10 and 21-27-11 of the Rhode Island General Laws, as amended (e.g., retail food service establishment).
The Rhode Island General Assembly found that latex allergies are increasingly becoming a problem for people who are exposed to disposable non-sterile and sterile latex gloves, such as health care workers, patients, food service workers, manufacturers, hair dressers, child care workers, and children. There are three (3) types of reactions that can occur in persons using latex products:
- irritant contact dermatitis;
- allergic contact dermatitis (delayed hypersensitivity); and
- immediate hypersensitivity latex allergy.
Reaction to latex may manifest through skin rashes, hives, itching, swollen skin, swollen lips and tongue, shortness of breath, dizziness, fainting, eyes or sinus symptoms, asthma and difficulty breathing, coughing spells, wheezing, and shock. In 1997, the National Institute for Occupational Safety and Health issued an alert concerning the danger of exposure to latex products and requested assistance preventing allergic reactions to natural rubber latex among workers who use gloves and other products containing latex.
On April 12, 1999, the Occupational Safety and Health Administration, United States Department of Labor, issued the Technical Bulletin concerning the potential harm to workers from natural rubber latex gloves and other natural rubber products, such as gloves, airway masks, medication vial caps, anesthesia bags, catheters, intravenous supplies, dental dams, balloons, and other products. Latex gloves are the major contributor for latex allergies. The United States Food and Drug Administration requires medical devices containing latex to carry a warning about potential allergic reaction.
In 1995, the American College of Allergy, Asthma, and Immunology concluded that the single greatest product causing adverse reaction to latex rubber are latex gloves. The National Institute of Safety and Health concluded that latex allergies can be prevented if employers establish policies that protect workers and the public from unnecessary latex exposure.
Pursuant to the provisions of section 42-35-3(c) of the General Laws of Rhode Island, as amended, consideration was given to:
- alternative approaches to the regulations;
- duplication or overlap with other state regulations; and
- significant economic impact placed on small business as defined in Chapter 42- 35 of the General Laws as a result of the amended regulations.
No alternative approach, overlap or duplication nor any significant economic impact was identified, consequently the regulations are adopted in the best interest of the health, safety and welfare of the public.
Wherever used in these rules and regulations, the following terms shall be construed as follows:
"Department" means the Rhode Island Department of Health.
"Director" means the Director of the Rhode Island Department of Health.
"Health care facility", pursuant to Chapter 23-17 of the Rhode Island General Laws, as amended, means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including but not limited to hospitals; nursing facilities; home nursing care provider (which shall include skilled nursing services and may also include activities allowed as a home care provider, or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services or as a nursing service agency); nursing service agency; rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities, and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care, and physician office settings providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in chapter 5.1 of title 7, as amended (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). Individual categories of health care facilities shall be defined in rules and regulations promulgated by the licensing agency with the advice of the Health Services Council. Rules and regulations concerning hospice care shall be promulgated with regard to the "Standards of a Hospice Program of Care", promulgated by national hospice organization. Any provider of hospice care who provides such hospice care without charge shall be exempt from the licensing provisions of Chapter 23-17 of the Rhode Island General Laws, as amended, but shall meet the "Standards of a Hospice Program of Care." Facilities licensed by the Department of Mental Health, Retardation and Hospitals, and the Department of Human Services, and clinical laboratories licensed in accordance with chapter 16.2 of Title 23, as well as Christian Science institutions (also known as Christian Science Nursing Facilities) listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of Chapter 23-17 of the Rhode Island General Laws, as amended.
"Health care provider" means any person holding a license, certificate, or registration issued by the Director and/or the Department that authorizes the person to provide health care services. For the purposes of these regulations, "health care provider" does not include those persons who are employed by a "health care provider" or those persons employed by a licensed health care facility.
"Health care worker" means any person who has or may have direct patient contact in a health care facility, including, but not limited to, a physician, dentist, nurse, optometrist, podiatrist, physical therapist, social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency who has or may have exposure to latex gloves or other latex products. For the purposes of these regulations, "health care worker" shall also mean those non-employee staff, such as volunteers, who are involved in direct patient contact. Transient employees not involved in direct patient contact or outside contractors not involved in direct patient contact are exempt from the requirements stated herein.
"Latex gloves" or "natural latex gloves", as used herein, mean gloves that are made, in whole or in part, of natural rubber latex, including gloves that are packed in powder which includes natural rubber latex particles.
"Other person, firm, or corporation licensed or registered by the Department", as used herein, means any individual or facility that is licensed or registered by the Department and does not fall into the category of either health care provider or health care facility, as defined herein, and uses latex gloves in the course of rendering services for which the license or registration is issued (e.g., tattoo artist, hair dresser).
"Person" means any individual, trust or estate, partnership, corporation (including associations, joint stock companies), limited liability company, state, or political subdivisions or instrumentality of a state.
In those instances where a health care provider is employed by a health care facility or by another health care provider, the employer (i.e., health care facility or health care provider) shall be responsible for implementing the regulatory requirements contained herein.
The use of disposable, nonsterile and sterile natural rubber latex gloves shall be prohibited by any person, firm, or corporation, registered pursuant to sections 21-27-10 and 21-27-11 of the Rhode Island General Laws, as amended (e.g., retail food service establishments, restaurants, cafeterias).
Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department that utilize latex gloves shall post a notice informing and warning employees and the public:
- that natural rubber latex gloves are used;
- that exposure to latex may result in the development of an allergy;
- that allergic reactions to natural rubber latex can manifest by skin rash, hives, nasal and eye irritation, asthma, and shock; and
- that should you or your family experience allergic reaction symptoms, then you should contact your health care provider.
The notice required in section 2.3 shall include letters which are at least three-eighths (3/8) of an inch high and shall be posted in conspicuous areas (e.g., lobby, patient care areas, employee bulletin boards) throughout the premises.
The notice required in section 2.3 shall be posted in English, Spanish and other languages, as appropriate, to the language needs of the individuals served by the health care provider, health care facility, or other person, firm, or corporation licensed or registered by the Department. An example of an English language notice that contains the minimum required language appears in Appendix A. (For sample notices in languages other than English, please reference the Department's website: www.healthri.org).
Health care providers and licensed health care facilities shall provide health care workers with initial education and annual in-service education pertaining to latex safety. Such education may include:
- Obligations and requirements under the Act and the rules and regulations herein;
- Nature of latex allergy;
- Products and procedures that have been adopted by the facility or provider to minimize occupational allergy.
Licensed health care facilities shall ensure that health care workers are represented on latex allergy or safety committees.
Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department shall minimize health care workers’ exposure to latex consistent with maintaining safety in regulated industries whose workers are exposed to blood borne pathogens pursuant to the provisions of the OSHA Blood Borne Pathogens Standard (See Reference 1). Non-latex gloves which provide a blood borne pathogen barrier are available which can minimize health care workers exposure to latex and protect the health care worker from blood borne pathogens.
Health care providers, licensed health care facilities, and other persons, firms, or corporations licensed or registered by the Department shall be engaged in latex minimization activities that may include the following components:
- Establishing protocols that evaluate symptoms suggestive of latex allergy during pre-employment and periodic evaluations;
- Systematically evaluating and replacing latex gloves with non-latex gloves;
- Utilizing only latex products that are non-powdered; and
- Assessing the impact of preventive measures.
If any provision of these rules and regulations or the application thereof to any person or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the rules and regulations which can be given effect, and to this end the provisions of the rules and regulations are declared to be severable.
Thursday, May 02, 2002
"Blood Borne Pathogens", Occupational Safety and Health Administration (OSHA), 29 Code of Federal Regulations Part 1910-1000 to end, section 1910.1030.
NIOSH Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplace. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH publication number 97-135, August 1997. Available by calling: 1-800-356-4674 or online at http://www.cdc.gov/niosh/latexalt.html:
Latex gloves are used in this facility.
Repeated contact with latex may cause a latex allergy or may worsen a present latex allergy.
- Reactions to latex may include:
- Skin Rashes
- Eye or Sinus Symptoms and
- Allergic Shock (Anaphylactic Shock).
If you or your family are having these symptoms, call your health care provider (your physician, nurse, or dentist) immediately.
PURSUANT TO R.I. GEN. LAWS § 23-73-2 (b)