PPE Standards: Essential Clarifications
Current recommendations for COVID-19 response outline the need for everyone to wear protection when safe social distancing can't be maintained. So it's essential to clarify the definitions of effective personal protective equipment (PPE) and adequate equipment standards.
Field Ready strongly advocates that useful innovations – particularly local manufacturing – are fully supported while meeting equipment standards and maintaining quality. To this end, we believe that the need for basic protections can be at least partially met through locally making needed items. Invasive items shouldn't be made or used except by fully competent professionals (see the discussion of ventilators below). To combat COVID-19, we stress practical solutions such as washing hands, wearing face masks and social distancing to prevent transmission of infectious micro-organisms as shown in the diagram here.
Below, we discuss the relevant hierarchy of standards and outline what they are.
What are Standards?
Field Ready has addressed standards before because they're such an important part of our work. Part of the challenge in discussing standards is that there's often little common understanding of what exists or how to think about them. To address this challenge, we present a hierarchy here to consider PPE in light of the current pandemic. This ordering of standards starts in descending order from laws to suggestions.
Laws are legally binding statements passed by a country’s legislative body and its equivalent, and in some cases approved by the government’s executive. There are lots of variations of this but that starts to go beyond our scope here. Violation of law, of course, can be met with criminal or civil penalties.
Regulations takes a previous recommendation or guideline and makes it a legal requirement. In many countries, government agencies are tasked with implementing laws by drafting regulation. While countries may handle regulatory violations differently, repeated violations are often serious.
Guidelines or Recommendations is a statement of advice or instruction pertaining to practice. These originate in an organization with acknowledged professional standing or by a group of individuals who have expertise or broad experience in the subject matter. Guidance is supplemental material provided by the regulatory body that helps clarify existing laws and regulations. This can be helpful but is not binding.
Standards: This is criteria for a certain task. It differs from a guideline or recommendation in that it carries great incentive for universal compliance. Standards further differ from a regulation in that compliance is not necessarily legally required. Standards are usually legitimized or validated based on scientific or epidemiological data - or, when this evidence is lacking, it represents the widely agreed-upon, state-of-the-art, high-quality level of practice.
Policy: A policy is how an organization interprets and implements regulations, guidance, guidelines and standards.
Suggestion: A suggestion is an organization’s or person’s opinion which might or might not be informed by well-supported evidence.
Facemasks: Types and Uses
PPE is a broad category of items but there is one important universal item: the facemask. Before discussing the standards associated with facemasks, it is helpful to understand the different types. For our purposes, there are three types meant to block or filter harmful substances from inhaled air:
1. Dust or non-medical facemasks: These often homemade of breathable fabrics and can be commercially available as well. There are numerous designs for fabric masks, but they generally cover the nose and mouth, are secured with ties or elastic loops, include multiple layers of fabric, and can sometimes be washed and re-used. These are useful for everyone to reduce the chances of transmitting contagious airborne pathogens, including COVID-19.
2. Surgical or medical facemasks: According to the Word Health Organization, these have a minimum three layers of synthetic, non-woven materials and have filtration layers sandwiched in the middle. These masks are available in different thicknesses, have various levels of fluid-resistance and two levels of filtration. These medical masks reduce saliva or respiratory droplet transfer from the wearer to others and to the environment. They also decrease the likelihood of other people's potentially infectious droplets reaching the wearer's mouth and nose.
3. Respirators: Particulate respirator masks can only filter out particles and aren't effective against gases or vapors. A numerical rating (such as 95 or 99) is sometimes assigned to such a respirator indicating the percentage of particles filtered. Letters can also be assigned to indicate whether it's somewhat resistant (R), not resistant (NR) or strongly resistant (P) to the degrading effects of oil on proper respirator function. The WHO says these are specifically designed for healthcare workers who provide care to COVID-19 patients in medical settings. Respirators are used to protect the wearer when medical procedures aerosolize smaller-than-normal particles into the air. Healthcare workers should be fit-tested before using a respirator to ensure the respirator is properly fitted and sealed tightly on the wearer’s face. Respirators with valves shouldn't be used as the purpose of source control.
Standards for Facemasks
There are no widely applicable regulations related to PPE, or facemasks in particular. The world’s most authoritative health and safety organizations (e.g., WHO, U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention) have provided guidelines and suggestions but not regulations. As a result, there are no exact rules to follow.
According to the WHO, the use of masks made of other materials (e.g., cotton fabric), also known as nonmedical masks, in a community setting hasn't been well-evaluated to date. There is no current evidence to make a recommendation for or against their use in this setting. WHO is collaborating with research and development partners to better understand nonmedical masks' effectiveness and efficiency. The WHO is also strongly encouraging countries issuing recommendations for mask use in healthy people in the community to conduct research on this critical topic. The organization plans to update its guidance when new evidence becomes available, but stresses that it's critical that medical masks and respirators be prioritized for health care workers.
While the evidence about the benefits of these masks is limited so far, according to the WHO, one good quality study showed that the risk of respiratory infection increased (and not reduced) in health care workers using cotton cloth masks when compared to medical masks. Cloth masks are currently being recommended by some countries as a means of source control in the general population. Although their protective effectiveness to the wearer is unknown, these masks might protect others if the wearer is a pre-symptomatic or asymptomatic carrier. The concept behind this is evident in the diagram shown at the start of this blog.
Regarding "non-medical masks," WHO says it's “continuing to gather and review data as new studies become available and will update guidance accordingly.”
Similarly, the U.S. FDA. issues non-binding recommendations that it considers the "Least Burdensome Approach" to enable manufacturers to make what they feel is necessary. The FDA recommends that surgical masks that aren't National Institute of Occupational Safety and Health-certified N95 respirators are evaluated for filter efficiency performance (particle challenge study using 0.1-Micron) and bacterial filtration efficiency using one of several available methods. Yet testing against viruses in this standard isn't mentioned nor is there discussion of non-medical dust masks.
Despite no actual regulatory mask requirement, some are suggesting it exists. So what’s happening? At least one thing that appears to be happening is a false memory of mask regulations or what is sometimes called the "Mandela Effect." The best advice is for everyone to use some form of respiratory protection -- even those made locally.
A Final Note About Ventilators
A ventilator, also called a breathing machine or respirator, is a serious medical item used only when a person can't breathe unassisted. When most people talk about a person being on life support, they're usually talking about a ventilator. The ventilator keeps oxygen flowing throughout a semi-conscious patient by pushing air into the lungs. The breathing tube is placed through the person's mouth or an opening in the neck into the windpipe (trachea) by a highly trained medical professional.
Field Ready discourages the building of ventilators by “makers” and instead recommends that only the most qualified companies and government agencies undertake such efforts. The reason is simple; as an invasive device, ventilators pose a high risk and resources can likely be better spent elsewhere. With COVID-19 infections, the chance for survival once a person is on a ventilator is not high. Fixing a once well-functioning ventilator or its parts can be life saving in an extreme situation, but creating one at a DIY level is not.