Q: Is there a shortage of gowns? Surgical masks?
A: The FDA is aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be stressed if demand exceeds available supplies. We have received information from healthcare organizations that some distributors may have placed certain types of personal protective equipment (PPE) on allocation, basing the quantity available to the healthcare organization on previous usage, not projected use. Increased use may exceed the available supply of PPE, resulting in shortages at some healthcare organizations.
The FDA recommends conservation strategies for use by healthcare organizations and personnel—categorized for a range of clinical needs and supply levels—intended to assist healthcare organizations in determining conservation procedures during this time period. The FDA's recommendations are intended to augment, and not intended to replace, specific controls and procedures developed by health care organizations, the Centers for Disease Control and Prevention (CDC), or CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) to aid in infection prevention and control.
Q: Can respirators approved under standards used in other countries, such as KN95, be used in the U.S. during the COVID-19 pandemic?
A: Yes, under an emergency use authorization. The U.S. Food and Drug Administration (FDA) is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved are appropriate to protect the public health or safety.
Importing Non-NIOSH-approved N95 Respirators
- On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepted standards from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95s.
- On June 6, 2020, the FDA reissued the two EUAs covering imported respirators by tightening criteria in the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China as well as in the Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to not only include new language related to decontamination as noted above, but also to revise the Scope of Authorization with respect to which jurisdictions are included in the criteria for eligibility in both EUAs, among other revisions.
Non-NIOSH-approved N95 respirators made in China
- On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.
- On May 7, 2020, the FDA revised and reissued the April 3, 2020 EUA based in part on concerns raised about the performance of certain respirators authorized under the third criterion of the April 3, 2020 EUA. For example, data from NIOSH testing on some respirators that were listed in Appendix A showed that some respirators failed to meet the expected filtration performance efficiency.
- On June 6, 2020, the FDA reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated. The FDA also reissued multiple decontamination system EUAs, such that, among other things, they are no longer authorized to decontaminate respirators manufactured in China, where applicable.
The FDA also issued guidance outlining a policy to help expand the availability of general use face masks during this pandemic. Face masks may also be authorized for use as source control (for example, not as PPE) under the Face Mask umbrella EUA if certain criteria are met.
The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues. The FDA established a special email inbox, [email protected], for industry representatives to quickly communicate with the agency and address questions or concerns. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.
Q: How can manufacturers of personal protective equipment (PPE) who may be considering increasing availability of these products to the US market engage with the FDA?
A: The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA's door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
To facilitate a rapid response to your email, please see an example of information that FDA would find helpful to have initially below:
Subject of the email: "Product Codes XXX, Shortage Mitigation Options for FDA Engagement," where XXX represents the product code(s).
Body of the email:
- Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
- Describe the proposed mitigation approach.
- Identify what you are interested in discussing with FDA, such as:
- Expedited review of a premarket submission, or
- Expedited review of a manufacturing site change if you are a class III device manufacturer, or
- Information about importing certain products.
Q: Which gowns are FDA-cleared? Which surgical masks are FDA-cleared?
A: To identify FDA-cleared products, search the 510(k) Premarket Notification database using the product codes for gowns (FYA, FYB, FYC) and surgical masks (FXX, OUK, OXZ).
Q: Do gowns and surgical mask provide protection from coronavirus?
A: Gowns and surgical masks are intended to provide broad barrier protection. Please see current guidelines from the Centers for Disease Control and Prevention (CDC) on recommended use of PPE during the COVID-19 outbreak. At this time, FDA has not cleared, approved, or authorized any gowns or surgical masks for specific protection or prevention against the virus that causes COVID-19.
Q: Can we use expired gowns and surgical masks? Do they offer the protection needed?
A: These products were designed to serve as protective barriers and thus FDA believes they may still offer some protection even when they are used beyond the manufacturer's designated shelf life or expiration date. The user should visibly inspect the product prior to use and if there are concerns (such as degraded materials or visible tears) the product should be discarded. As a conventional capacity strategy, expired products may be used for training and demonstration purposes where barrier protection is not needed.
Q: Can I reuse a cloth gown?
A: Yes. Cloth gowns that will not be used in a sterile field, such as surgery, can be reused if they are laundered in enzymatic detergent or per the hospital's SOP.
Q: How can I know in advance that manufacturers will have a shortage of masks and gowns so I can prepare?
A: If you are a part of a group purchasing organization (GPO), you may want to contact the GPO staff to determine what communication they receive from their suppliers; otherwise, you can contact manufacturers directly.
Q: My health care organization already has a plan for protection against COVID-19, which includes other types of protective equipment (such as Powered Air Purifying Respirators (PAPRS) or Controlled Air Purifying Respirators (CAPRS)) and other strategies. Are we required to follow the FDA's recommendations listed in the letter to health care providers?
A: The letter to health care providers is intended to aid in the management of gowns and surgical masks. The FDA's recommendations in the letter should supplement a health care organization's policy.
Q:. How do I know what the manufacturer-designated shelf life is?
A: The manufacturer-designated shelf life may be found in the product labeling and if not, you can contact the manufacturer directly.