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Dental Industry Regulations

The following information describes several topics which are of primary concern to the dental industry including regulations and guidelines from various agencies and organizations. This article is not meant to be all-inclusive and does not provide all of the information necessary for compliance.

Bloodborne Pathogens

Dental professionals are exposed to a variety of pathenogenic microorganisms in the blood and body fluids of patients. These pathogens can cause infectious diseases such as tuberculosis, hepatitis B virus (HBV) and Acquired Immuno-deficiency Syndrome (AIDS).

In December of 1991, OSHA (the Occupational Safety and Health Administration) enacted the standard for Occupational Exposure to Bloodborne Pathogens (BBP), 29 CFR 1910.1030. The standard applies to all occupational exposure to blood or other potentially infectious materials.

The requirements of the bloodborne pathogen standard were written to protect employees. OSHA does not have the legal authority to mandate requirements to protect patients or employers. Although some aspects of the BBP standard provide patient and employer protection, the standard does not include all the infection control practices recommended by the Centers for Disease Control (CDC) and the American Dental Association (ADA) to protect patients, employers and employees from the transmission of infectious disease.

Dentists are required by law to comply with the OSHA standard that protects employees. Dentists should also follow the CDC and ADA guidelines for prevention of transmission of infectious diseases between the employees, patients and dentists. The ADA advises dental offices to obtain a thorough medical history for all new patients at the first visit and update it at subsequent visits. However, not all patients with infectious diseases can be identified by medical history. The use of effective infection control procedures and universal precautions in the dental office or lab will prevent cross contamination between the dental team and patients. Universal precautions is an approach to infection control in which all human blood and certain human bodily fluids are treated as if they were known to be infected with HIV, HBV or other bloodborne pathogens. This means that the same infection control procedures are used for all patients.

The BBP standard requires the creation of a written Exposure Control Plan, describing how the employer will protect employees from exposure. The following components must be included:

Exposure Determination

An exposure determination is a listing of all job classifications in which certain employees are routinely exposed (i.e. dentists and hygienists) or employees who may occasionally be exposed to potentially infectious materials on the job. (i.e. custodians and office workers) Any specific procedures or tasks in which exposure occurs must also be listed without regard to the use of personal protective equipment (PPE).

Control Measures

The BBP standard states that the employer shall take appropriate preventative measures against occupational exposure. These include engineering controls and work practice controls. Engineering controls permanently remove the hazard or help isolate the worker from exposure (i.e. sharps containers). Work practice controls reduce the likelihood of exposure (i.e. Hand Washing Policy).

Employee Education and Training

Employees must receive annual training to be sure they understand the hazards associated with blood-borne pathogens, the modes of transmission, the Exposure Control Plan, the regulation itself, and the use of and limitations of engineering controls, work practices and PPE. Other topics discussed at this training should include: what to do when confronted with an emergency involving blood or other potentially infectious materials; post-exposure evaluations; the hepatitis B virus (HBV) vaccine; and the use of signs and labels.

HBV Vaccinations

Dental health care workers are at a greater risk than the general population of acquiring hepatitis B through contact with patients. It is an ADA policy that dentists and their employees receive HBV vaccinations. OSHA’s BBP standard requires that once employees receive training, vaccinations should be made available to those who run the risk of exposure at the employer's expense within 10 working days of the assignment of tasks that may result in exposure.

Post-Exposure Evaluation and Follow-Up

Employers are required to provide a confidential medical evaluation for any employees involved in an exposure incident. The purpose of this evaluation is to document the exposure route and circumstances surrounding the incident, blood testing, HIV/HBV status of source and appropriate medical and psychological treatment.

PPE

Employers must provide personal protective equipment (PPE) to employees with occupational exposure to eliminate or minimize the risk of infectious material entering their bodies. PPE is considered to be appropriate only if it does not permit blood or other potentially infectious materials to pass through or reach the employee’s outer clothing, undergarments, skin, eyes, mouth or other mucous membranes under normal conditions of use. Following is a list of PPE and when it should be used.

Gloves: Gloves must be worn when skin contact with body fluids or mucus membranes is anticipated or when touching other potentially infected materials. After contact with each patient, gloves must be removed and discarded. Hands must be washed and then regloved before treating another patient. Disposable, single-use gloves cannot be re-used.

Utility gloves used for cleaning instruments and environmental surfaces may be re-used if decontaminated, but must be discarded if cracked, discolored, punctured or showing any signs of deterioration.

The need for occupational protection has increased the use of latex gloves. This has resulted in increased reports of allergic reactions to latex. There are now many non-latex gloves and glove liners available. Many dentists are considering latex-free environments for the safety of both the dental team and the patient.

Masks, Eye Protection, and Face Shields: Combinations of masks, face shields and eye protection must be worn to protect the face, eyes, oral mucosa and nasal mucosa when splatter, spray or droplets of infectious body fluids is anticipated.

Gowns, Aprons, and other Protective Clothing: Protective clothing should be worn whenever exposure to the body, head, feet or clothing is possible. The type and characteristics of the covering will depend on the task and the exposure anticipated.

Record Keeping

The employer shall maintain medical and training records for each employee who faces the possibility of being exposed or who has been occupationally exposed to a bloodborne pathogen. The employer shall maintain the records required for at least the duration of employment, plus 30 years.

Tags, Labels, and Bags

Warning labels shall be attached to all containers used for the storage or transport of potentially infectious materials. The labels shall be orange or red-orange with the biohazard symbol in a contrasting color. Red containers or bags can be substituted as warning labels if necessary.

Waste Disposal

All contaminated sharps and forms of blood or infectious materials, contaminated items that could release infectious materials must be placed in appropriate sharps containers or closable, color-coded or properly labeled leakproof containers or bags. Infectious waste shall be disposed of in accordance to federal, state and local regulations.

Housekeeping

The BBP standard states that the employer must cre-ate a schedule and procedures for periodic cleaning and appropriate disinfections to ensure that the work place is kept clean and sanitary. The ADA has more detailed guidelines specifically for dental instruments and equipment.

Sterilization means the use of a physical or chemical procedure to destroy all microbial life, including highly-resistant bacterial endospores. Suitable methods of sterilization include steam under pressure (autoclave), dry heat and ethylene oxide gas.

Disinfection reduces the level of microbial contamination but does not destroy all life as in sterilization. Disinfection may be accomplished by using a chemical disinfectant and following the manufacturer's instructions for use. In a dental office or lab, the disinfectant must be an Environmental Protection Agency (EPA) registered disinfectant and must be tuberculocidal. Virucidal efficacy must include both lipophilic and hydrophilic viruses.

Surgical and other instruments that normally penetrate soft tissue or bone must be sterilized after each use or discarded.

Any surfaces or equipment that may come in contact with potentially infectious pathogens or that may have been touched by contaminated hands must be disinfected.

Waste Anesthetic Gases (WAGs)

OSHA Fact Sheet No. 91-38 describes nitrous oxide and halogenated agents such as halothane, enflurane, methoxyflurane, trichloroethylene and chloroform as waste anesthetic gases that can cause harmful effects

such as spontaneous abortions, congenital abnormalities in children, neurological effects and effects on the kidneys and liver. Exposure concentrations of halogenated agents should not exceed 2 parts per mil-lion (ppm) in 45 liters per air over a sampling period not to exceed one hour. When nitrous oxide is used as the sole anesthetic agent, the recommended exposure limit shall not exceed 25 ppm during the anesthetic administration.

WAG Management Program

If WAGs are to be used, a complete WAGs management system shall be put in place. This system consists of a collecting device, a ventilation system and a method for limiting both positive and negative pres-sure variations in the breathing circuit. Most anesthetic equipment being manufactured today includes a scavenging system.

The remainder of the WAGs management program should include work practices minimizing gas leaks, routine maintenance programs, exposure monitoring and providing adequate ventilation. 

Respiratory protection may be used if engineering controls do not bring WAGs levels below their recommended exposure limits.

A medical surveillance program shall be made avail-able to all employees who are subject to occupational exposure to WAGs. The program shall contain medical and occupational histories, paying special attention to the outcome of pregnancies of an employee or their spouse, as well as any effects on the hepatic or renal systems. The record of any abnormal pregnancy shall be documented and kept for the duration of employment plus 30 years.

References:

Latex Allergies and Reactions; EZ Facts^® 126 

Code of Federal Regulations, 29 CFR 1910.1030; Bloodborne Pathogens 

Infection Control Recommendations for the Dental Office and the Dental Laboratory; American Dental Association 

EZ Facts^® 220, OSHA Ergonomics Standard 29 CFR 1910.900 

OSHA Fact Sheet 91-38, Waste Anesthetic Gases 

NIOSH Alert Publication No. 94-100 Controlling Exposures to Nitrous Oxide During Anesthetic Administration 

29 USC 654 Section 5 (a) (1) General Duty Clause

Sources For More Information

Centers For Disease Control and Prevention (CDC) www.cdc.gov 

American Dental Association (ADA) www.ada.org 

Occupational Safety & Health Administration (OSHA) www.osha.gov

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