Medical Devices in the Time of COVID
The two best medical devices for fighting the pandemic
If I asked you to name the most common medical devices getting us through the COVID-19 pandemic, you might think of ventilators first. While ventilators are certainly important for severely ill patients, two of the most common devices are actually right under (or hopefully, covering) your nose. The ubiquitous facemasks have emerged as the most common pandemic-related medical devices, followed closely by in vitro tests used to diagnose COVID-19 infections.
The Food and Drug Administration (FDA) regulates medical devices in the US, primarily through the Center for Devices and Radiological Health (CDRH). This is different than the center that reviews drugs (Center for Drug Evaluation and Research (CDER)) or vaccines (Center for Biologics Evaluation and Research (CBER)).
The FDA definition for medical devices is actually quite lengthy, but essentially it is this:
If an item is intended to diagnose, treat, or prevent a disease, and its primary function doesn’t need to be metabolized or have a chemical reaction to work, it is a device.
Masks physically block infectious virus particles in droplets from being inhaled, helping to prevent disease spread. Since standard masks don’t chemically inactivate the virus or require metabolism, they are devices. You may have also heard about respirators, specifically N95 respirators (which block 95% of particles of a specified size). Interestingly, surgical N95 respirators used in medical facilities are cleared as medical devices through the FDA and approved by the National Institute of Occupational Health and Safety (NIOSH), a part of the Centers for Disease Control and Prevention (CDC). Standard N95 respirators used in non-medical workplaces (like construction) are overseen by NIOSH alone because they are not intended to treat or prevent a disease.
Diagnostic tests can either detect if a person is currently shedding the virus (mouth or nasal swab to screen for viral nucleic acids) or if a person was exposed and mounted an immune response to the virus (blood samples to see if there are anti-COVID-19 antibodies present, indicating prior exposure). COVID-19 diagnostic tests are devices because they are used to identify currently infected individuals (who can be isolated and prevent additional infections) and identify asymptomatic people who recovered from the infection.
Normally, if you wanted to sell a facemask as a medical device (e.g., a surgical mask), you would need to submit paperwork to the FDA to clear the device for marketing. However, in emergency situations where masks are critically needed but in short supply, the FDA can issue an Emergency Use Authorization (EUA). An EUA issued on April 18, 2020 authorizes facemasks (including cloth face coverings) to be marketed and sold in the US without submitting an application to the FDA for review.
In the end, until we all have access to a vaccine or a drug that can reliably prevent infections, we will continue to depend on these medical devices to get us through the pandemic. Reliably using masks and submitting samples for diagnostic testing are two things that we can all use to stop the spread.