COVID-19 Resources

COVID-19 is a respiratory illness caused by a novel coronavirus. The virus can be spread from person to person by respiratory droplets produced when an infected person coughs or sneezes, and by touching an object that is contaminated with the virus and then touching facial mucous membranes (mouth, nose, eyes). For more information about COVID-19, refer to the CDCs fact sheet, What You Need to Know About Coronavirus Disease 2019 (COVID-19).

During an infectious disease outbreak, health care workers are on the front lines and therefore at increased risk of being exposed to and contracting the disease. The Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA) require health care workers caring for patients with suspected or confirmed infectious disease to wear respiratory protection. The COVID-19 pandemic has led to an ongoing shortage of respiratory protection devices. This shortage has revealed two critical information needs: (1) understanding of the various types of respiratory protection devices and the varying degrees of protection they provide, and (2) accurate information about approved respiratory protection devices.

This guide is intended to condense the wealth of available information into a concise, easy-to-read document to help members make informed decisions about the selection of proper respiratory protection for the COVID-19 crisis as well as other potential hazards.

Types of protection: masks and respirators

For the purposes of this resource guide, definitions used in the Food and Drug Administration’s (FDA’s) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Policy will be used and are outlined in Table 1. More detailed descriptions and discussion follow.

Table 1. FDA definitions of face masks, filter facepiece respirators and surgical respirators

Respiratory protection for COVID-19

The CDC has outlined specific recommendations for personal protective equipment (gowns, gloves and respirators) for health care workers on the CDC Personal Protective Equipment Recommendations resource page. The CDC recommends that personnel caring for patients with suspected or confirmed coronavirus disease use an N95 filtering facepiece respirator (FFR) approved by the National Institute for Occupational Safety and Health (NIOSH) for use in health care settings. These respirators filter at least 95% of particles as small as 0.3 microns and are effective at filtering many types of other particles, including viruses and bacteria.

Because there are several face masks and respirators on the market, a review of the options and their protection and performance criteria is provided below.

Face masks

Face masks (sometimes called surgical masks or procedure masks) are loose fitting and therefore do not prevent leakage around the mouth upon inhalation; they provide only barrier protection against large respiratory droplets and particles and most do not effectively filter small particles from inhaled air. Face masks are worn by patients with suspected or confirmed COVID-19 to prevent contamination of the environment when the patient coughs or sneezes. Face masks are not approved by NIOSH.

Surgical masks

Surgical masks are loose fitting and therefore do not prevent leakage around the mouth upon inhalation. They are fluid resistant and provide protection against body fluid and other hazardous fluids, but do not provide reliable protection from small airborne particles. Because of this, surgical masks are not considered a form of respiratory protection. Surgical masks are worn during surgical procedures to protect the sterile field as well as the patient. Surgical masks are cleared as a medical device by the FDA.

Respirators

A respirator is a personal protective device worn on the face or head that covers the nose and mouth. Particulate respirators filter out airborne particles and can be further categorized as:

• Disposable: The entire respirator is discarded after use.
• Reusable or elastomeric: The facepiece is cleaned or reused but the filter cartridge is discarded and replaced.
• Powered air-purifying: The respirator has a battery-powered blower that moves air through filters.

NIOSH-approved N95 respirators

NIOSH-approved N95 respirators are tested and certified as meeting the standards established in 42 CFR 84. For detailed information on the standard, see the NIOSH Guide to the Selection and Use of Particulate Respirators.

There are 10 classifications of NIOSH-approved particulate FFRs, described in Table 2. Respirators are classified according to filtration percentage and oil resistance. It is important to understand the differences in the types of NIOSH-approved respirators for use in U.S. health care settings, as they provide different levels of protection based on performance and quality standards. N95 respirators must be fit tested annually, and repeated as necessary. For detailed information, see the CDC’s webpage on Healthcare Respiratory Program Resources: Fit Testing — NIOSH Documents.

Table 2. NIOSH-approved filtering facepiece respirator classifications

Surgical N95 respirators

Surgical N95 respirators (sometimes called medical respirators) are approved by NIOSH the FDA. They are recommended for health care professionals who require protection from airborne and fluid hazards when exposure to splashes or sprays of blood or other body fluid is a risk. According to the CDC, a surgical N95 respirator is not necessary for providers caring for patients with suspected or confirmed COVID-19 disease; a standard N95 respirator can be used.

How to identify NIOSH-approved respirators

According to the CDC and NIOSH, FFRs are required to have the following printed on the respirator itself:

• Name of the approval holder or manufacturer, a registered trademark, an easily understood abbreviation of the approval holder’s or manufacturer’s name as recognized by NIOSH, or, if applicable, a private-label brand name.
• NIOSH in block letters or the NIOSH logo
• NIOSH testing and certification approval number (e.g., TC-84A-XXXX)
• NIOSH filter series and filter efficiency level (e.g., N95, N99, N100, R95, P95, P99, P100)Model number or part number: The approval holder’s respirator model number or part number, represented by a series of numbers or alphanumeric markings (e.g., 8577 or 8577A)

NIOSH also recommends, but does not require, that the lot number and/or date of manufacture be included.

The figure below shows the markings used to identify approved NIOSH respirators.

Figure. NIOSH-approved respirator markings

Source: Centers for Disease Control and Prevention.

The CDC offers several resources to help identify NIOSH-approved products. The CDC website provides a list of NIOSH-approved particulate FFRs.

For products not included on the approved NIOSH list noted above, the Certified Equipment List resource is available. To look up a NIOSH-approved disposable particulate respirator:

• Access the Certified Equipment List.
• In the “For Protections Against” section, select N95, N99, N100, R95, P95, or P100.
• In the “Facepiece Type” section, select only Filtering Facepiece.
• Click the View Results button.

If the product searched is not included in the results list, scroll through the list of private-label products. For additional assistance with the Certified Equipment List, see the instructions and tips page.

The CDC and NIOSH recommend that consumers always verify that respirators are listed on the approved NIOSH list. For more information, see the NIOSH publication Respiratory Awareness: Your Health May Depend on It.

This informational guide has been created in response to forecasted shortages in the fabrics that are used in the production of personal protective equipment (PPE).

Nonwovens: the primary material component of PPE

According to the European Disposables and Nonwovens Association, nonwovens are innovative, high-tech, engineered fabrics made from fibers that are used in a wide range of consumer and industrial products.¹

The expensive machinery that produces these products works by melting polypropylene pellets and injecting the liquid through tiny holes to make micron-sized threads. These threads congeal and are converted into a featherweight nonwoven fabric that can trap microscopic particles and droplets.²

Nonwovens are extensively used in the medical field, since their critical safety properties provide protection against infections and diseases. Nonwovens play a vital role in the fight against cross-contamination and the spread of infectious strains of bacteria and viruses.³

Spunbond/melt blown/spunbond (SMS), a primary nonwoven tri-laminate material used in the manufacture of PPE, consists of a middle layer of melt blown polypropylene fabric thermally sandwiched between two layers of spunbond polypropylene fabric. Each of these individually manufactured fabric layers’ properties contribute to the overall SMS end product. When combined, these two nonwoven fabrics provide water resistance as well as breathability and comfort.⁴

How is SMS fabric manufactured?

The spunbond process

The spunbond process converts melted polypropylene granules into nonwoven fiber. The fabric is produced by depositing extruded, spun filaments onto a collecting belt.⁵ This is followed by the bonding process, which imparts strength and integrity to the web by applying heated rolls to partially melt the polymer and fuse the fibers. Compared with melt blown fabrics, spunbond fabrics contain coarser fibers and a much greater tensile strength.⁶

The melt blown process

The one-step melt blown process, similar to the spunbond process, converts melted polypropylene granules into a low-diameter nonwoven fiber web. Extruded filaments are attenuated using high-velocity hot air streams; these impinge on the filaments as they emerge from extrusion nozzles, enabling much finer filaments to be obtained.⁷

The melt blown process is the only large-scale commercial process currently being used to produce melt-spun fibers that have diameters in the submicron range, without splitting or chemically dissolving away polymer. It is used to create nonwoven fabrics of various widths and thicknesses on large rolls.

Melt blown fabrics are composed of submicron filaments that have a large variation in diameter and therefore have superior filtration properties compared with spunbond fabrics.⁷ Figure 1 shows how the melt blown process is used to create fabric for medical masks.

Figure 1. Process and fabrics used to create surgical masks

Where is SMS fabric used?

Disposable nonwovens are extensively used in the medical field. Since products manufactured from these materials are single-use and are incinerated after use, the spread of contaminants is reduced due to minimized handling.³

Nonwovens are used in a wide variety of applications, including:

How are protective materials and PPE rated?

Materials for surgical and isolation gowns, as well as surgical drapes, are rated based on their ability to act as barriers to liquids or liquid-borne pathogens. There are four levels of protection per the Association for the Advancement of Medical Instrumentation’s standards. For more detailed information, refer to the Vizient guide to isolation and surgical gown selection.

Respirators are classified by the National Institute for Occupational Safety and Health based on their ability to filter out microscopic particles as well as their oil resistance. For more detailed information, refer to the Vizient Covid-19 guide to face masks and filtering facepiece respirators.

Is there a shortage?

Nonwoven manufacturers around the globe are shifting capacity and investing in machinery in response to the COVID-19 pandemic. The global health crisis has caused an unprecedented demand for nonwoven products such as face masks and medical gowns.⁸

The global Organization for Economic Cooperation and Development noted that:⁹

• There are bottlenecks in the face mask value chain, most notably with nonwoven fabrics manufactured with polypropylene
• Current demand could be 10 times higher than world production capacity
• Some countries have initiated restrictions on mask exports

Concerns for Vizient contracted suppliers

Our suppliers have expressed concerns over nonwoven supply chain challenges related to the global pandemic, such as price volatility and using up inventory reserves. One of our currently contracted suppliers has forecasted the likelihood of a critical shortage or outage of the middle melt blown SMS layer by the fourth quarter of 2020.

In addition, suppliers are apprehensive about the availability of most nonwoven polypropylene materials at scale, which is extremely limited. To address this challenge, one of our suppliers is working toward relocating some of its production to the North Americas; however, this move won’t take place until the first quarter of 2021.

Forging a path toward greater supply chain resilience

Although shortages of essential medications and products are not a new problem for hospitals, the COVID-19 pandemic has exacerbated supply chain disruptions.

In response, Vizient® has expanded its Novaplus® Enhanced Supply Program to include the PPE that providers need to protect themselves against COVID-19, as well as other viruses and workplace hazards.

References

1. What are nonwovens? EDANA. Accessed August 4, 2020.
2. Baldwin W. Where’s the fabric for masks and gowns? Forbes. March 26, 2020. Accessed August 5, 2020.
3. Why use nonwovens in medical and healthcare? EDANA. Accessed August 4, 2020.
4. An introduction into SMS material. Blue Thunder Technologies. May 23, 2019. Accessed August 4, 2020.
5. Silva E. The spunbond process. Academia. 2010. Accessed August 4, 2020.
6. Tensile strength. ScienceDirect. Accessed August 4, 2020.
7. Melt blown process. ScienceDirect. Accessed August 4, 2020.
8. McIntyre K. Nonwovens supply shift: Capacity investments target needs brought on by COVID-19. Nonwovens Industry. May 5, 2020. Accessed August 5, 2020.
9. The face-mask global value chain in the COVID-19 outbreak: Evidence and policy lessons. OECD. May 4, 2020. Accessed August 4, 2020.

Overview

According to the Centers for Disease Control and Prevention (CDC), health care workers have the potential for exposure to biological fluids that are capable of transmitting diseases caused by viruses such as hepatitis B, hepatitis C, human immunodeficiency virus, Ebola and others. The design of protective clothing (e.g., isolation gowns, coveralls and surgical gowns) shields health care workers and patients from harmful microorganisms transferred by blood and body fluids and should be worn when a threat of exposure exists.

There a variety of protective products available, so here are factors and details to help guide your selections.

Gown types

Figure 1. Personal protective equipment gown types

Type	Example	Coverage
Isolation gowns		Isolation gowns do not provide continuous whole-body protection (e.g., possible openings in the back, coverage to the mid-calf only)
Coveralls		Coveralls typically provide 360-degree protection because they are designed to cover the whole body, including back and lower legs and sometimes head and feet as well
Surgical gowns		Surgical gowns do not provide continuous whole-body protection (e.g., possible openings in the back, coverage to the mid-calf only)

Gown selection factors

There are three primary factors that influence personal protective equipment (PPE) gown selection:

1. Purpose
   Isolation gowns are generally the preferred PPE clothing. Choose isolation gowns for instances you anticipate arm contamination. Gowns should fit comfortably over the body, cover the torso, and have long sleeves that fit snuggly around the wrists.
2. Materials
   Gowns are made primarily from cotton or a spun synthetic material. Each of these materials are available in varying degrees of fluid resistance. If fluid penetration is a concern, then choose a fluid resistance gown.
3. Risk
   Choose clean or sterile gowns, depending on the particular risk factors involved. Use clean gowns generally for isolation purposes, while sterile gowns are only necessary when performing invasive procedures, such as inserting a central line. In this case, a sterile gown would protect both the patient and the health care worker.

It is important to understand the critical, primary protection zones of a gown when making a selection for a particular patient care scenario. The illustrations below indicate critical areas of both surgical and nonsurgical gowns.

Figure 2. Critical primary protection zone for surgical gowns

• The entire front of the gown material (areas A, B and C) is required to have a barrier performance of at least level 1. See table 1.
• The critical zone comprises at least areas A and B.
• The back of the surgical gown (area D) may be nonprotective material.

Figure 3. Critical zones for surgical isolation and nonsurgical gowns

Standards and performance requirements

Consensus standards for testing gown performance

The rating for isolation and surgical gowns is based on their ability to act as a barrier to liquids or liquid-borne pathogens. The Food and Drug Administration (FDA) recognized standard for gown rating was created by two organizations: the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI).

ANSI is a private nonprofit organization that oversees the development of voluntary consensus standards for products, services, processes, systems and personnel in the United States. AAMI is an organization for advancing the development, and safe and effective use of medical technology. The FDA recognized standard from ANSI/AAMI is PB70:2012 and is known as the liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Table 1. Defining four protective material levels

The FDA requires that surgical gowns get additional testing for tear resistance, seam strength, lint generation, evaporative resistance and water vapor transmission. The standard recognized by the FDA for this testing (ASTM F2407) was created by ASTM International.

ASTM International (formerly known as The American Society for Testing and Materials) is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems and services.

Table 2. Summary of ASTM standards the FDA recognizes

Covid-19 pandemic relevance

In response to the COVID-19 pandemic, on May 22, 2020, the FDA authorized emergency use of protective gowns and other apparel through the issuance of an Emergency Use Authorization (EUA) document in order to help address insufficient supply.

The FDA is allowing health care personnel to use the following otherwise-unapproved items, providing there is “no adequate, approved and available alternative” during the COVID-19 public health emergency:

• Conductive shoes and shoe covers
• Operating room shoes
• Surgical apparel accessories
• Nonsurgical isolation gowns
• Operating room shoe covers
• Surgical helmets
• Surgical caps

These gowns and other apparel are deemed acceptable under the EUA when intended for use by health care personnel in health care settings, and in accordance with CDC recommendations to protect personnel and patients from the transfer of SARS-CoV-2 in low- or minimal-risk-level situations.

Criteria for issuance of the authorization

1. The virus that causes COVID-19, a serious or life-threatening disease, can cause other conditions, including severe respiratory illness, to humans infected by this virus
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the authorized gowns and other apparel worn by health care providers may be effective at preventing the transfer of microorganisms, bodily fluids, and particulate material in low- or minimal-risk situations by providing minimal-to-low barrier protection to health care personnel and patients to prevent the spread of COVID-19
3. There is no adequate, approved and available alternative to the emergency use of these gown or other apparel

Capacity strategies

The CDC is providing options and strategies for optimizing the supply of isolation gowns.

These strategies are divided into three general strata with the intention to prioritize measures to conserve isolation gown supplies along the continuum of care:

Conventional capacity

• Use isolation gown alternatives that offer equivalent or higher protection

Contingency capacity

• Shift gown use to cloth isolation gowns
• Consider the use of coveralls
• Use expired gowns beyond the manufacturer-designated shelf life
• Use gowns or coveralls that conform to international standards

Crisis capacity

• Cancel all elective and nonurgent procedures and appointments for which health care providers typically use a gown
• Extend use of isolation gowns
• Re-use of cloth isolation gowns
• Prioritize gown type selection per procedure type

Overview

Exam gloves are considered essential personal protective equipment (PPE) for health care workers. They provide a protective barrier for hands and fingers against infectious agents that can be harmful if they make direct contact with skin. COVID-19 — along with its related complications — has increased the need for gloves due to the rapid rise in the number of patient hospitalizations.¹ As a result, specific conservation strategies to manage the limited supply of exam gloves are vital.

Types of exam gloves

The Occupational Safety and Health Administration (OSHA) requires that employees be protected from workplace hazards to avoid injuries.² Thus, it is essential for health care providers to have access to PPE such as gowns, gloves, eye and facial protection (e.g., goggles, face shields and helmets), and respirators. PPE provides a protective barrier for health care workers and helps to minimize their exposure to potential risks while providing care to patients.

Exam gloves protect the hands against blood, bodily fluids, hazardous drugs or infectious diseases. Many different types of gloves are available based on indication for use. According to OSHA, the following factors should be reviewed prior to making a glove selection²:

• Type of chemicals handled
• Nature of contact (e.g., total immersion or splash)
• Duration of contact
• Area requiring protection (i.e., hand only, forearm or whole arm)
• Grip requirements (i.e., dry, wet or oily)
• Thermal protection
• Size and comfort
• Abrasion or resistance requirements

Table 1 provides a condensed review of the chemical and liquid resistance of various types of gloves used in health care, based on material type, along with the type of protection provided to the user. Chemical-resistant gloves such as natural rubber, neoprene, nitrile, butyl or plastic polyvinyl (vinyl) can be blended or laminated. These additional layers and thickness provide increased performance and chemical resistance, although finger grip and dexterity may be compromised.²

Table 1. Types of chemical- and liquid-resistant gloves

Data derived from Occupational Safety and Health Administration.²
Abbreviation: FDA = U.S. Food & Drug Administration.

Due to the risk of patients and health care providers having latex allergies or developing latex sensitivities, the use of latex gloves in the health care industry is decreasing, although they continue to be an option for hand protection. Approximately 8%-12% of health care workers are latex sensitive³; symptoms vary from contact dermatitis to asthma to  systemic shock. Anyone with a latex allergy or latex sensitivity should use an alternative such as hypoallergenic gloves, glove liners or powderless gloves.

In 2016, the U.S. Food & Drug Administration (FDA) banned powdered gloves due to the substantial risk of harm to health care providers and patients.⁴ Powdered gloves have been linked to severe airway inflammation and hypersensitivity reactions when internal body tissue is exposed to the powder.⁴ In addition, powder particles have the potential to cause tissue to form around the particles (granulomas) or cause scar tissue formation (adhesions), leading to surgical intervention.⁴

The American Society for Testing and Materials (ASTM) evaluates the performance and safety of exam gloves through specific testing procedures, and has created standards for exam gloves used in health care settings. Additional information about ASTM’s test procedures and recommended standards can be found on its website.⁵

Surge capacity

The Centers for Disease Control and Prevention (CDC) has been tracking the number of COVID-19 cases in the U.S. with assistance from state, local and territorial health departments,⁶ with a weekly update available on its website.¹ The goals of the surveillance are to:

• Monitor spread and intensity of COVID-19 disease in the U.S.
• Understand disease severity and the spectrum of illness
• Understand risk factors for severe disease and transmission
• Monitor changes in the virus that causes COVID-19
• Estimate disease burden
• Produce data for forecasting COVID-19 spread and impact

The CDC’s monitoring of COVID-19 also enables it to identify surges or significant increases in patient visits in outpatient centers, emergency departments and hospitals. The increase of patients needing medical care also means health care providers need additional PPE — including gloves — to provide safe and effective care.

The CDC refers to surge capacity as a facility’s ability to manage a sudden increase in patient volume that severely challenges or exceeds the present capacity.⁷ This increase forces health care facilities to find unique ways to conserve supplies to meet patient needs. The CDC created the Personal Protective Equipment (PPE) Burn Rate Calculator to help facilities prepare and prioritize measures to conserve these supplies.⁸ The calculator can be used to optimize the use of gowns, gloves, surgical masks, respirators and face shields by calculating the average consumption rate, and estimates how long the remaining supply of PPE will last.⁸ The tool can also help determine which strategy to use to conserve PPE supplies for continuation of patient care.⁸

The CDC has identified three strategies to describe surge capacity along with conservation measures to extend the life of PPE supplies: conventional capacity, contingency capacity and crisis capacity. Each measure is meant to be used sequentially, with a facility’s standard protocol resuming when the PPE supply is replenished. Prior to implementing contingency and crisis strategies, the CDC recommends that facilities:

• Understand their current PPE inventory and supply chain
• Understand their PPE utilization rate⁸
• Communicate with local health care coalitions and federal, state and local public health partners (e.g., public health emergency preparedness and response staff) to identify additional supplies
• Implement conventional capacity measures if they haven’t already done so
• Provide health care providers with required education and training, including having them demonstrate competency donning and doffing any PPE ensemble that is used to perform job responsibilities, such as the provision of patient care

Conventional capacity strategies

Conventional capacity measures are standard protocols already established for infection prevention that consist of engineering, administrative and PPE controls.⁹ Double gloving is not recommended by the CDC when caring for a patient with suspected or confirmed COVID-19 and patient care should continue as normal. The CDC also recommends the following actions while using conventional strategies:

• Continue using approved disposable medical gloves in accordance with standard¹⁰ and transmission-based¹¹ precautions in health care settings and when indicated for other exposures such as handling cleaning chemicals
• Reinforce indications and recommended practices for nonsterile disposable glove use
• Prioritize sterile gloves for surgical and other sterile procedures
• Prioritize medical gloves for health care providers handling chemotherapy agents (chemotherapy gloves) and other hazardous drugs
• Remind health care providers about indications that require gloves, as well as common care situations when gloves may not be needed

Contingency capacity strategies

Contingency capacity strategies should be used in anticipation of an expected PPE shortage and after conventional capacity measures are no longer suited to the patient load.⁹ This measure should be implemented in cases of uncertainty regarding future PPE supply availability even if current utilization is being met. The CDC recommends that facilities:

• Reduce the length of stay for medically stable patients with COVID-19
• Selectively cancel elective and nonurgent procedures and appointments where gloves are routinely used by health care providers
• Use gloves beyond their manufacturer-designated shelf life for training activities
• Use gloves conforming to other U.S. and international standards; additional information about international standards can be found on the CDC’s gloves webpage⁷

Crisis capacity strategies

Crisis capacity strategies should only be implemented after conventional and contingency capacity strategies have been reviewed because they do not align with U.S. standards of care.⁹ These strategies should be applied when the PPE supply will not meet the needs of the facility, and include the following:

• Cancel all elective and nonemergent procedures for which gloves are typically used
• Use gloves past their manufacturer-designated shelf life for health care delivery
• Prioritize the use of nonsterile disposable gloves
• Consider non-health care glove alternatives such as food service or industrial chemical-resistant gloves
• Extend the use of disposable medical gloves, including wearing gloves without changing into a new pair between patients

The CDC recommends discarding medical gloves when:

• Visible soiling or contamination due to blood, respiratory or nasal secretions, or other bodily fluids is apparent
• Any signs of damage (e.g., holes, rips or tearing) or degradation are observed
• A maximum of four hours of continuous use has been reached

Previously removed gloves should not be worn again, as the risk of tearing and contamination increases. Additional information about the extended use of disposable gloves can be found on the CDC’s website.⁷

Government guidance addressing the U.S. exam glove shortage

In March 2020, the FDA issued guidance to address the shortage related to the increased use of gloves due to COVID-19. The Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency was created to help expand the availability of gloves in the U.S.¹² Gloves are identified as a device if they are expected to be used for medical purposes, such as diagnosing a disease or other conditions or in curing, mitigating, treating or preventing disease. The FDA uses the following criteria when evaluating whether products are intended for medical use:

• Gloves are labeled or otherwise intended for use by a health care professional
• Gloves are labeled or otherwise intended for use in a health care facility or environment
• Gloves include any drugs, biologics, or antimicrobial or antiviral agents

Gloves intended to be used by the general public and for nonmedical purposes are not considered devices and therefore authorization is not required by the FDA. Manufacturers, importers and distributors of nonmedical gloves may market their products without receiving prior approval from the FDA.

Patient exam gloves are subject to premarket notification requirements because they are a Class I device intended for medical use under section 510(k) of the Federal Food, Drug, and Cosmetic Act.^12,13 A 510(k) is a premarket submission made by the submitter or manufacturer that states their device is substantially equivalent to a legally marketed device with supporting evidence. The submitter can only market their product in the U.S. when they have received an approval that states their product is substantially equivalent to a legally marketed device. This process can take up to 90 days and is based on the supporting evidence submitted to the FDA. The FDA provides additional information for evaluating substantial equivalence for the 510(k) program on its website.¹⁴

The FDA is aware of the shortage of gloves due to increased demand. As a result, it will not object to the distribution and use of patient exam gloves where the gloves do not create an undue risk during the COVID-19 public health emergency. The FDA states patient exam gloves do not create an undue risk when:

• The gloves include labeling that:

• Accurately describes the product as an “unpowdered glove” (as opposed to a “surgeon’s glove”).
• Accurately describes the product’s sterility status (e.g., nonsterile).
• Does not claim that the product is latex-free or otherwise free of a specific material.
• Includes a list of the body contacting materials.
• Includes recommendations and general statements that would reduce the risk of use. Examples include:

• A statement that the gloves have not been cleared by FDA
• A recommendation against using when FDA-cleared gloves are available
• A recommendation against using in surgical settings
• The product is not intended for any use that would create an undue risk. For example:

• The labeling does not include uses with chemotherapy drugs, fentanyl and other opioids; for allergy or dermatitis prevention; for antimicrobial or antiviral protection; or for infection prevention or reduction

References

1. Key updates for week 45, ending November 7, 2020. Centers for Disease Control and Prevention. Updated November 13, 2020. Accessed November 13, 2020.
2. Personal protective equipment. Occupational Safety and Health Administration. Accessed November 13, 2020.
3. Latex allergy. Occupational Safety and Health Administration. Accessed November 13, 2020.
4. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Federal Register. December 19, 2016. Accessed November 13, 2020.
5. ASTM standards and COVID-19. ASTM International. Accessed November 13, 2020.
6. Purpose and methods. Centers for Disease Control and Prevention. Updated August 28, 2020. Accessed November 13, 2020.
7. Strategies for optimizing the supply of disposable medical gloves. Centers for Disease Control and Prevention. Updated October 27, 2020. Accessed November 13, 2020.
8. Personal Protective Equipment (PPE) Burn Rate Calculator. Centers for Disease Control and Prevention. Updated April 7, 2020. Accessed November 13, 2020.
9. Optimizing supply of PPE and other equipment during shortages. Centers for Disease Control and Prevention. Updated July 16, 2020. Accessed November 13, 2020.
10. Standard precautions for all patient care. Centers for Disease Control and Prevention. Accessed November 13, 2020.
11. Transmission-based precautions. Centers for Disease Control and Prevention. Accessed November 13, 2020.
12. Enforcement policy for gowns, other apparel, and gloves during the coronavirus disease (COVID-19) public health emergency. U.S. Food & Drug Administration. March 2020. Accessed November 13, 2020.
13. Premarket notification 510(k). U.S. Food & Drug Administration. March 13, 2020. Accessed November 13, 2020.
14. The 510(k) Program: Evaluating substantial equivalence in premarket notifications [510(k)]. U.S. Food & Drug Administration. July 2014. Accessed November 13, 2020.

In June 2020, the U.S. Food & Drug Administration (FDA) issued an important alert advising consumers not to use hand sanitizers that contained the hazardous substance methanol.1 Due to the increasing incidence of methanol contamination, the FDA issued a recall of hand sanitizer products that contained this substance, and encouraged manufacturers to remove those products from stores and online marketplaces.¹ As of August 2020, the FDA expanded the recall to include hand sanitizers that also contain 1-propanol.² To verify which hand sanitizers are safe for use, visit the FDA’s list of recalled hand sanitizers.

Methanol and 1-propanol: Two toxic ingredients in hand sanitizer

As the U.S. works to decrease the spread of the coronavirus, frequent and proper hand hygiene is essential in reducing transmission. As a result, there is an increased demand for hand sanitizer. As manufacturers work to produce hand sanitizer for the public, the FDA has taken a closer look at its chemical components.

Methanol

According to the National Institute for Occupational Safety and Health (NIOSH), methanol is an alcohol routinely used as a solvent, pesticide and alternative fuel source. Also known as “wood alcohol,” this colorless liquid can be found in food and drinks that contain aspartame. Methanol can be harmful when absorbed through the skin or inhaled in high concentrations, and is also considered life-threatening when ingested. This substance is highly flammable and can be easily ignited by heat or sparks. Additional information about methanol and its characteristics can be found on the NIOSH’s Methanol: Systemic Agent webpage.

Signs and symptoms of methanol poisoning may not be observed for up to 72 hours due to the body’s metabolization process. Initial side effects include drowsiness, a reduced level of consciousness and decreased muscle movement. According to the FDA, methanol toxicity can also produce³:

• Nausea
• Vomiting
• Headaches
• Blurred vision
• Permanent blindness
• Seizures
• Coma
• Permanent damage to the nervous system
• Death

For additional information about the effects of methanol exposure, refer to the FDA’s updates on hand sanitizers consumers should not use.

1-propanol

Another toxic substance that may be found in certain hand sanitizers is 1-propanol. This solvent and chemical intermediate is not the same as 2-propanol or isopropyl alcohol. The National Center for Biotechnology Information states that 1-propanol can be used to make cosmetics, pharmaceuticals, antifreeze, rubbing alcohols and acetone. The FDA warns that ingesting 1-propanol can lead to death by depressing the central nervous system. Other symptoms may include decreased consciousness and slowed breathing. Skin or eye exposure to 1-propanol can lead to irritation, with rare cases of allergic skin reactions. Additional information on symptoms and proper disposal of products containing 1-propanol can be found on the FDA’s updates on hand sanitizers consumers should not use webpage.

Guidelines for purchasing hand sanitizer

Unfortunately, methanol and 1-propanol are sometimes omitted from the product labels of certain hand sanitizers; when the FDA tested their contents, methanol and 1-propanol were present although not indicated on the labels. The FDA recommends that consumers avoid purchasing a hand sanitizer product if it²:

• Has been tested by the FDA and is found to contain methanol or 1-propanol
• Is labeled to contain methanol
• Has been tested and is found to have microbial contamination
• Is being recalled by the manufacturer or distributor
• Has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride
• Is purportedly made at the same facility as products that have been tested by the FDA and has been found to contain methanol or 1-propanol

The FDA recommends the immediate disposal of products containing methanol and 1-propanol due to their toxic nature; contaminated hand sanitizer should be placed in a hazardous waste container or follow your local waste and recycling center’s recommendations.⁴ Additional information about local waste programs can be found on the United States Environmental Protection Agency’s website.

Increased production of hand sanitizers

Manufacturers that regularly produce products in other industries are working to increase the supply of hand sanitizers to meet demand, although they must request permission to do so during the COVID-19 pandemic. This permission is granted by the FDA.

The FDA regulates hand sanitizer as a nonprescription or over-the-counter drug. As stated in its Temporary Policy for Manufacture of Alcohol, for the duration of the pandemic the FDA will not take action against manufacturers of alcohol or alcohol-based hand sanitizer products that use ethanol as their active ingredient. Manufacturers are encouraged to review the following FDA policies for additional information:

Homemade hand sanitizer

Due to potential harmful risks, the FDA recommends that consumers avoid making their own hand sanitizers.⁵ Homemade sanitizers may not contain effective levels of ethyl or isopropyl alcohol, and there have been reported injuries such as skin burns. The FDA also encourages health care professionals and consumers to report adverse reactions to hand sanitizers to the MedWatch Program to ensure adequate tracking and documentation.

Hand-washing and hand sanitizer recommendations

The Centers for Disease Control and Prevention (CDC) states that coronavirus disease 2019 is spread from respiratory droplets, mainly from person to person. Transmission occurs when an infected person sneezes, coughs or talks. People infected with COVID-19 can also spread the disease even if they do not exhibit symptoms such as a fever, cough, or loss of taste and smell.

The CDC recommends hand-washing as the best way to prevent the spread of infection, including COVID-19.⁶ Individuals should wash their hands with soap and water for a minimum of 20 seconds.⁶ If soap and water are not available, an alcohol-based rub with at least 60% alcohol can be used.⁶ This method of infection prevention should be used after blowing the nose, coughing, sneezing or being in a public place.⁶

The World Health Organization (WHO) states that wearing gloves is not a substitute for proper hand hygiene. Pathogens can be transferred from gloved hands to surfaces, including the mouth and eyes. The use of gloves in public spaces is not recommended nor proven as a prevention measure. For additional hand hygiene resources visit the CDC’s handwashing webpage or the WHO’s Q&A on cleaning and disinfecting environmental surfaces webpage.

Additional resources

• Topical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps
• Vizient: COVID-19 Clinical Resource Guide
• Vizient: Hand Hygiene Clinical Resource Guide
• Vizient: Emerging Practices to Combat Coronavirus Disease (COVID-19): Managing critical supplies

References

1. FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem. U.S. Food & Drug Administration. June 19, 2020. Updated June 29, 2020. Accessed August 31, 2020.
2. FDA updates on hand sanitizers consumers should not use. U.S. Food & Drug Administration. August 12, 2020. Accessed August 31, 2020.
3. Coronavirus (COVID-19) update: FDA takes action to warn, protect consumers from dangerous alcohol-based hand sanitizers containing methanol. U.S. Food & Drug Administration. July 2, 2020. Accessed August 31, 2020.
4. Q&A for consumers: Hand sanitizers and COVID-19. U.S. Food & Drug Administration. Updated July 29, 2020. Accessed August 31, 2020.
5. Safely using hand sanitizer. U.S. Food & Drug Administration. Updated July 8, 2020. Accessed August 31, 2020.
6. Handwashing. Centers for Disease Control and Prevention. Updated July 11, 2020. Accessed August 31, 2020.