The country’s leading producer of N95 respirator masks, 3M, says that more than 10 million counterfeit versions of the personal protective equipment (PPE) have been seized since the pandemic’s onset in the U.S. Even big names like the Cleveland Clinic have been duped by cleverly counterfeited N95s.
Now the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH) has issued a notice about the fake N95s that are circulating and how physicians and others in health care charged with obtaining PPE can properly identify them.
Respirators approved by NIOSH have an agency approval label somewhere on the packaging, either on the box or included with the user instructions. Notice about approval also will appear on the filtering facepiece respirator itself, in abbreviated form.
According to NIOSH, here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for:
- No markings at all on the filtering facepiece respirator.
- No approval number on filtering facepiece respirator or headband.
- No NIOSH markings.
- NIOSH spelled incorrectly.
- Presence of decorative fabric or other decorative add-ons.
- Claims of approval for children—NIOSH does not approve any type of respiratory protection for children.
- Filtering facepiece respirator has ear loops instead of headbands
The agency also warns about these potential red flags to look for before placing large orders from third-party marketplaces or websites you haven’t ordered from before:
- If a listing claims to be “legitimate” and “genuine,” it likely is not.
- Examine transactions history and feedback if possible.
- Fluctuations of items marketed over time—high or low periods of transactions.
- Price deviations and fluctuations that make pricing seem too good to be true.
- Advertising “unlimited stock” when there is an industrywide shortage.
- Contact email addresses unconnected to the website
- Bad grammar, typos and other errors.
A NIOSH-approved mask will feature these markings on the exterior of respirator:
- Approval number.
- Brand name, registered trademark or easily understood abbreviation.
- NIOSH name in block letters, or NIOSH logo.
- Filter class (N, P or R) and filter efficiency level (95, 99 or 100).
- Lot number—recommended, but not required.
- Model number.
Learn more about how to spot counterfeit respirators at the NIOSH National Personal Protective Technology Laboratory, which features a listing—with pictures—of masks that are wrongly being marketed as having NIOSH approval.
Meanwhile, NIOSH maintains a list of approved filtering facepiece respirators by class and filtration level, with contact information for the manufacturers.
How AMA is helping
Amid the COVID-19 pandemic, the AMA has been the leading physician and patient ally—voicing recommendations to leaders in Congress, the White House, agency staff, state policymakers and private sector stakeholders.
On PPE and medical supplies, the AMA:
- Secured the use of the Defense Production Act to provide PPE and other needed resources to front-line responders and physician practices.
- Partnered with the nonprofit Project N95 to make PPE available to AMA members.
- Developed a new CPT code to help physicians pursue payment for additional supply costs associated with caring for patients during the COVID-19 public health emergency.
Find out more about the AMA’s ongoing COVID-19 advocacy efforts.