The Role of NIOSH with Medical Devices

by | Aug 8, 2023 | COVID-19, FDA, Labeling, Labels, Medical Devices, NIOSH, Safety

The National Institute of Occupational Safety and Health (NIOSH) was established in Section 22 of the Occupational Safety and Health Act of 1970 [1]. NIOSH began operations in 1971, a year in which the first toxic substances list was published. Since their initiation, NIOSH has grown to not only be a governance body but also a research institute. They are usually at the forefront with other federal departments when human safety is a main risk. Some examples of past human safety risks are the 2001 anthrax attacks, the 2009 H1N1 influenza pandemic, and most recently the Sars-Cov-2 pandemic [2].

During the Sars-Cov-2 pandemic, NIOSH played a very large part in the testing and labeling of filtering facepiece respirators (FFR) for consumer use. These tested FFRs are categorized into three levels for filter efficiency; 95%, 99%, and 99.97% and three levels for resistance to filter degradation; N (Not resistant to oil), R (Resistant to oil), and P (oil Proof). During the pandemic, the N95 (not oil resistant and 95% filter efficiency) were commonly seen and used. To obtain NIOSH certifications for your FFR, it requires strict and rigorous testing of the FFR.

One of the more notable artifacts of the pandemic was the counterfeit versions of N95 masks that entered the market. NIOSH approved N95+ masks can be searched in their database on their Certified Equipment List (CEL). Also, on the exterior view of the mask, there are multiple lines of text that include approval holder (company), approval number, model/part number, protection level, and lot number. If it is not obvious whether the mask is NIOSH approved from the text on the front, a simple search in their database will clear up all concerns.

NIOSH and FDA are sister agencies within HHS but have different authorities and responsibilities. To delineate between the two, specifically when it comes to medical devices/equipment such as Respirators and FFR’s, there is an existing Memorandum of Understanding (MOU) between the two agencies that outlines the roles of each.

If you need help understanding the regulations and rules for your NIOSH applicable devices, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.


Resources:

[1] Howard, John. (2020, May). NIOSH: A Short History. American Journal of Public Health vol. 110,5: 629 – 630. doi:10.2105/AJPH.2019.305478

[2] CDC. Notable Milestones in NIOSH History.  Center for Disease Control and Prevention. https://www.cdc.gov/niosh/timeline.html

Emma International

Emma International

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