By Brent Ibata, PhD, JD, FACHE, CPHQ
Current as of Apr. 22, 2020
As hospitals face shortages of personal protective equipment, it is important to know what is regulated, what is not regulated and how to navigate the gray area in between. The U.S. Food and Drug Administration and Centers for Disease Control & Prevention are incrementally granting broader discretion to hospitals to allow crisis capacity alternatives to PPE. In its recent COVID-19 guidance (Page 3), the FDA acknowledged the dilemma of choosing between no PPE or homemade alternatives to PPE:
FDA recognizes that, when alternatives, such as FDA-cleared masks or respirators, are unavailable, individuals, including healthcare professionals, might improvise PPE. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.
The CDC has a similar statement on its COVID-19 website:
In settings where facemasks are not available, HCP might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort. However, homemade masks are not considered PPE, since their capability to protect HCP is unknown. Caution should be exercised when considering this option. Homemade masks should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.
Homemade alternatives to PPE are not the only options when faced with crisis shortages of PPE. There are a various rules that allow for limited alternatives for PPE during declared public health emergencies. The following information is subject to change, but is current as of April 22, 2020:
- Emergency use authorizations.In 2013, Congress expanded FDA’s authority to issue Emergency Use Authorizations during public health emergencies to expand and expedite the availability of drugs, biologics, and devices. For helpful information, view the Emergency Use Authorizations for Medical Products and Related Authorities.
- Surgical masks. Surgical masks and N95 respirators are Class 2 devices and require premarket approval, according to FDA Product Code FXX.
- Nonsurgical masks. Under FDA Product Code QKR, nonsurgical face masks not intended for the prevention of disease are not regulated by the FDA. However, the FDA has issued guidance that allows enforcement discretion (i.e., not explicitly regulated) for nonsurgical face masks intended to be worn by the general public or healthcare personnel. In an ideal world, we would test samples from batches of nonsurgical masks—but something is better than nothing, and the public/staff can wear homemade nonsurgical masks outside of isolation areas if permitted by hospital policy.
- Public health emergency mask. A filtering facepiece respirator for use by the general public in public health medical emergencies should cover the nose and mouth of the wearer to help reduce the wearer’s exposure to pathogenic biological airborne particulates during a public health medical emergency. A public health emergency mask is a Class 2 device requiring premarket approval.
- Overstocked nonmedical N95 respirators.The FDA has issued several Emergency Use Authorizations to allow hospital use of nonmedical (e.g., construction) masks approved by the National Institute of Occupational Safety and Health and some imported non-NIOSH-approved N95 masks (that satisfy one of the listed foreign quality standards). If a community partner has nonmedical N95 masks, hospitals could accept them for use under the FDA EUA.
- Medical N95 respirators. Crisis alternatives for N95 respirators are the most challenging to quickly ramp up alternative sources of supply. The FDA has issued an Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.
GOWNS, CAPS AND OTHER APPAREL
- Gowns, aprons and caps. Garments that are not intended for use in the prevention of disease are not “devices” within the meaning of the Federal Food, Drug, and Cosmetic Act (21 USC § 321) and are not subject to FDA rules. The FDA does not regulate gowns or aprons unless they make a therapeutic claim (e.g., a gown intended for use as a surgical or isolation gown would be regulated; a gown/apron for cleaning would not).
- Isolation gowns. Under FDA Product Code OEA, nonsurgical isolation gowns are Class 1 devices and are exempt from premarket approval. Isolation gowns can be manufactured and distributed by any entity that is registered and listed with the FDA (a quick and easy process). The regulatory hurdles to make and distribute isolation gowns are low: registration, listing and a quality management system (good manufacturing practices, or GMP). A risk-based approach should be used when deploying alternative to PPE when supply is at crisis capacity levels. Fortunately, the FDA provides such risk-based guidance.
- Surgical apparel. Surgical apparel (FDA Product Code LYU) and surgical caps (FDA Product Code FYF) are regulated under 21 CFR 878.4040 and are Class 1 devices exempt from premarket approval (requiring only registration, listing, and record keeping/GMP). However, surgical gowns (FDA Product Code FYF) are Class 2 devices requiring 510(k) premarket approval.
Brent Ibata, PhD, JD, FACHE, CPHQ, is the system director of accreditation and quality assurance for Lee Health in Southwest Florida. Ibata teaches a graduate course on biomedical innovation for Northeastern University and led a session titled “Creating and Sustaining a Culture of Innovation to Achieve Zero Events of Preventable Harm” at the 2017 Congress on Healthcare Leadership.