Regulatory Complicance —COVID-19 and Respiratory Protection

CDA Practice Support

The onset of new regulatory requirements for dentistry earlier this year was brought about by the SARS-CoV-2 virus and the CDC and Cal/ OSHA recommendations for dental health care workers to wear respirators for their protection. When an employer makes the decision to use respirators in their office, the employer must comply with regulations that help ensure the safe and effective use of the respirators. The Cal/OSHA respiratory protection regulation [1] applies to the use of respirators at California workplaces.

The most used respirator in the U.S. health care industry is the N95 model. Technically known as “disposable filtering facepiece respirators,” surgical N95s are typically inexpensive and disposed of after single use. They are normally approved by both the National Institute of Occupational Safety and Health (NIOSH) and the U.S. Food and Drug Administration (FDA). The COVID-19 pandemic created great demand for the N95, which led to worldwide shortages. In response to the demand, the FDA issued a series of emergency-use authorizations [2] permitting health care providers the use of:

■ Non-FDA approved, NIOSHapproved particulate filtering respirators. These include nonsurgical N95s, N99, N100, R95, P95, P99, P100 and reusable half- or full-facepiece elastomeric respirators. The elastomeric respirators are reusable because they can be disinfected.

■ Imported non-NIOSH approved particulate filtering respirators. Most of these respirators are manufactured by 3M in several countries and have different respirator model numbers.

■ Non-NIOSH approved particulate filtering respirators manufactured in China. There are several different model numbers, including the KN95.

Health care providers may also use powered air purifying respirators, also known as PAPRs. This type of respirator is typically worn by someone who is unable to wear a tight-fitting respirator as determined by a fit test.

To assure a tight-fitting respirator provides the wearer with necessary protection, it should be fit tested. Employers are required to provide the initial and annual fit tests and training on the use, maintenance and care of the respirator. The annual fit-test requirement is suspended for the duration of the pandemic. The regulation also requires that an employer prepare a written respiratory protection program that designates a program administrator and describes:

■ Respiratory hazards.

■ Type and characteristics of respirators available for use by employees.

■ Medical evaluation — what is involved; information provided to the evaluator; when additional medical evaluation is necessary.

■ Fit-testing process and when it needs to be redone.

■ Respirator use.

■ Maintenance and care of respirators.

■ Training and information — why respirators are necessary; limitations of their use; how to inspect, put on, perform seal check and remove; recognition of medical signs and symptoms that limit an employee’s effective use of a respirator.

■ Program evaluation – includes evaluation of respirator alternatives in the workplace and employee involvement.

If the dental office protocol does not include staff respirator use but an employee chooses to wear one, a medical evaluation and fit test are not required as long as the employer has determined that the employee’s use of the respirator will not create a hazard. The employer must provide the employee with basic information on respirator use and maintenance.

A properly fit-tested respirator will provide the best protection to an individual who is at high risk of exposure to the SARS-CoV-2 virus.

REFERENCES

1. Title 8 CCR Section 5144. www.dir.ca.gov/ Title8/5144.html.

2. U.S. Food and Drug Administration. Emergency Use Authorizations.www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-use-authorizations.

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