With new interim guidelines on COVID-19 response from the American Dental Association (ADA), Occupational Safety and Health Administration (OSHA), the Centers for Disease Control and Prevention (CDC) and more, it may be difficult to digest so much information and make the right safety decisions for your practice. Add to that a massive shortage of N95 masks and other personal protective equipment (PPE) due to the worldwide pandemic and an onslaught of counterfeit products on the market, and the potential for mass confusion is high.
Thankfully, Benco is here to help by answering some Frequently Asked Questions.
Q: What is an N95 mask?
A: An N95 mask is a polyester-based filtering facepiece respirator. It is regulated by the National Institute for Occupational Safety and Health (NIOSH). The “N” stands for “Non-Oil,” meaning that it offers protection against solid and non-oil-based particles. The “95” refers to the efficiency rating; in the case of N95, masks should be filtering at least 95% of particles.
Q: How is an N95 mask different from a surgical mask?
A: Surgical masks are those most often seen being worn by laypeople at the grocery store. According to the CDC, they are fluid resistant and provide protection against liquid sprays, splashes, and droplets and also protect others from the wearer’s respiratory emissions. They are loose-fitting vs. an N95 which is tight-fitting, they do not need to be seal checked or fit-tested, they do not provide filtration, and are prone to leakage around the edges. Surgical masks are regulated by the Food and Drug Administration (FDA).
Q: Do N95 masks have ear loops or elastic headbands?
A: NIOSH-certified N95 masks have elastic headbands. This is important because the elastic headbands ensure a tighter fit and seal, creating a barrier between the mask and face. If your N95 has ear loops, it is not an N95!
Q: What is a KN95 mask?
A: While N95 masks are the United States standard for respirator masks, KN95 masks are the Chinese standard. The masks are considered to be “equivalent” and “can be expected to function very similarly to one another, based on the performance requirements stated in the standards and confirmed during conformity,” according to manufacturer 3M. Here is a list of technical differences.
However, KN95 masks are treated differently than respirators in the U.S. While they filtrate better than a surgical, Level 3 mask, they are not considered a respirator and therefore do not need to meet the same FDA standards as respirators. Many will have ear loops vs. elastic headbands and do not need to be fit tested. As a result, you will not see KN95 masks listed on FDA or CDC documentation.
Q: How do I know that my N95 respirator is genuine?
A: A recent Wall Street Journal article reported that many imported N95 masks do not meet the U.S. specifications, and that one tested “filtered out as little as 35% of particles.” N95 masks are evaluated, tested, and approved by NIOSH so look for the NIOSH stamp on the mask. Also, N95 masks are attached to the face via a headband, not ear loops as in a surgical mask. It is important you purchase your PPE, including masks, from a reputable dental distributor.
The CDC maintains a list of approved manufacturers, as well as photo examples of counterfeit masks.
According to the CDC, there are several signs that an N95 respirator may be counterfeit. They include:
• No markings at all
• No approval number
• No NIOSH stamp
• “NIOSH” spelled incorrectly
• Presence of decorative fabric or other decorative add-ons (e.g., sequins)
• Claims for the of approval for children
• Presence of ear loops instead of headbands
Q: How do I know if my KN95 mask is genuine?
A: First, it is important you purchase your PPE, including masks, from a reputable dental distributer. Benco’s regulatory team has investigated more than 100 vendors and is focused on following the FDA guidelines before we purchase and sell a KN95 mask.
Secondly, to validate a KN95 mask, the manufacturer needs to ensure accurate labeling and testing by an equivalent to NIOSH, which is usually a Chinese regulatory agency.
KN95 masks need to follow the FDA rules regulating imported, non-NIOSH-approved disposable filtering facepieces and will need to be listed on the FDA’s Appendix A or Exhibit 1 lists. Masks do not.
Q: How does Benco confirm the N95 masks they sell are genuine?
A: Benco only buys and sells N95 masks from the following approved U.S. manufacturers: 3M, Alpha-Protech, Cardinal, Crosstex, and Myco (San-M). Each manufacturer runs a test on the mask’s efficacy
Q: How does Benco confirm the KN95 masks they sell are genuine?
A: Our regulatory team vets manufacturers by following the FDA recommendations for KN95 masks. They must be registered on the FDA website, provide proper certificate of insurance (COI), and include a Chinese regulation stamp.
Q: Should the entire dental team be wearing masks?
A: According to the ADA, because patients may be infected with COVID-19 yet remain asymptomatic, “it should be assumed that all patients can transmit the disease.” Thus it is recommended that anyone coming in contact with a patient should be wearing a mask.
Q: Do employees need to be medically evaluated before wearing an N95 mask?
A: Any time an N95 respirator is required for use in a dental setting, the OSHA Respiratory Protection Standard (29 CFR 1910.134) applies. As a result, every staff member needs to have a medical evaluation to determine if the employee is fit to wear a respirator prior to wearing it for the first time. An employee may need to be re-evaluated if he/she develops medical signs or symptoms which affect their ability to wear a respirator, if a change in workplace conditions creates a substantial increase in the physiological burden of the respirator user, or if recommended by health care professional, supervisor, or program administrator.
Q: Do employees need to be trained on N95 masks?
A: Yes. Employees should be trained in the proper use (donning and removing) of the mask, limitations of its usage, and storage procedures. Initial and annual training are required. In addition, training is to be repeated if the user does not demonstrate required understanding or skill to wear a respirator.
Q: Do N95 masks need to be fit-tested?
A: Yes. The OSHA Respiratory Protection Standard training requires an initial “fit test” to determine that the respirator selected for use fits properly, and then annual testing thereafter. (Note: OSHA has relaxed the annual (not initial) fit testing requirements during the pandemic.)
Fit testing is also required if changes in workplace/activities or type of respirator affect fit, such as facial or dental changes, or body weight change of more than 10-20 lbs.
Only wear the model and size of respirator that you had fit tested. Additional fit testing would be required if a new model and/or size were being used.
Q: Do KN95 masks need to be fit-tested?
A: No. A KN95 mask is not considered a tight-fitting respirator and therefore does not require a fit test per OSHA regulations.
Q: What are the alternatives to N95 masks if I cannot purchase them?
A: The ADA recommends N95’s first, then “Equivalent” KN95’s, then a surgical mask with a face shield. As always, please refer to your state dental association guidelines as well.