Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
PPE is commonly used in health care settings such as hospitals, doctor’s offices and clinical labs. When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes). The barrier has the potential to block transmission of contaminants from blood, body fluids, or respiratory secretions. PPE may also protect patients who are at high risk for contracting infections through a surgical procedure or who have a medical condition, such as, an immunodeficiency, from being exposed to substances or potentially infectious material brought in by visitors and healthcare workers. When used properly and with other infection control practices such as hand-washing, using alcohol-based hand sanitizers, and covering coughs and sneezes, it minimizes the spread of infection from one person to another. Effective use of PPE includes properly removing and disposing of contaminated PPE to prevent exposing both the wearer and other people to infection.
When an infection outbreak affects a broad population in the United States, the Centers for Disease Control and Prevention (CDC), is responsible for making specific recommendations for infection control measures in different circumstances and settings. For example, the CDC has provided the following recommendations:
- What You Should Know about COVID19 Coronavirus
- What You Should Know about the Flu
- What You Should Know about Ebola
- What You Should Know about Zika
- What You Should Know about influenza
- What You Should Know about SARS
- What You Should Know about MERS
- What You Should Know about pneumonia
The FDA’s role in regulating personal protective equipment
All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA’s regulations and should meet applicable voluntary consensus standards for protection. This includes surgical masks, N95 respirators, medical gloves, and gowns. The consensus standards and the FDA’s requirements vary depending on the specific type of PPE. When these standards and regulations are followed, they provide reasonable assurance that the device is safe and effective.
Some PPEs are reviewed by the FDA before they can be legally sold in the United States. In this review, known as Premarket Notification or 510(k) clearance, the manufacturers have to show they meet specific criteria for performance, labeling, and intended use to demonstrate substantial equivalence. One way substantial equivalence may be demonstrated, in part, is by conforming to consensus standards for barrier performance and resistance to tears and snags. Voluntary consensus standards may also be used to demonstrate sterility (when applicable), biocompatibility, fluid resistance, and flammability. Manufacturers must validate the methods used to test conformance to standards and support each product with appropriate performance test data.
For additional information on the FDA’s role in regulating specific PPE, please go to:
- VENTILATOR AND CIRCUITS
The two main types of mechanical ventilation include positive pressure ventilation where air (or another gas mix) is pushed into the lungs through the airways, and negative pressure ventilation where air is, in essence, sucked into the lungs by stimulating movement of the chest.
A vigilant focus on lung protection. The Lung Protection tools in the ventilator calculate FRC, providing you with data for determining the optimal PEEP setting for the patient.
Positive end-expiratory pressure is the pressure in the lungs above atmospheric pressure that exists at the end of expiration. The two types of PEEP are extrinsic PEEP and intrinsic PEEP. Pressure that is applied or increased during an inspiration is termed pressure support
Prolonged ventilation is associated with a host of complications that can have significant health and cost implications.
What is a ventilator and how does it work?
A mechanical ventilator is a machine that’s used to support patients with severe respiratory conditions that impact the lungs, including pneumonia.
Before a patient is placed on a ventilator, often anaesthetists — will perform a procedure called intubation.
After a patient is sedated and given a muscle relaxant, a tube is placed through the mouth and into the windpipe.
With Covid-19 patients, medical staff need to take extreme precautions to make sure they do not become infected with the virus.
People are almost in full hazmat suits.
The breathing tube is then attached to the ventilator and medical staff can adjust the rate that it pushes the air and oxygen into the lungs, and adjust the oxygen mix.
When would a patient go onto a ventilator?
Before deciding to put a patient onto a ventilator, doctors are looking for signs of “respiratory failure”.
The breathing rate will increase, they’ll look distressed, the CO2 in the blood goes up and they can become sedated and confused.
While a normal breathing rate is about 15 breaths a minute, if the rate gets to about 28 times a minute, then this is a signal that ventilation may be needed.
Before going on a mechanical ventilator, there may be other attempts to increase a patient’s oxygen levels.
These “non-invasive” methods of ventilation can include masks and oxygen tanks.
With Covid-19, medical staff were looking to avoid non-invasive methods because patients would still cough and splutter, increasing the risk of the virus being transferred to medical staff.
How soon might a patient need a ventilator and for how long?
Once a doctor sees that a patient needs a ventilator, “it is required quickly”.
The patient can be sustained for short periods of time using manual forms of ventilation such as using a bag and mask system with oxygen, but usually being attached to a ventilator needs to happen within 30 minutes if critical.
In severe Covid-19 patients, a life-threatening condition can develop called acute respiratory distress syndrome (Ards) that requires ventilators to deliver smaller volumes of oxygen and air, but at higher rates.
This could mean a patient may need to be on a ventilator “for weeks”.
To avoid complications from the breathing tube going down the throat, a tracheostomy is carried out so the tube can go straight into the windpipe through the neck.
Patients can be more awake with tracheostomy and the hole just heals itself.
If patients develop ARDS they will be in an intensive care unit for weeks and they’ll die without ventilators.
Why a shortage of ventilators matters, and what’s being done to avoid it.
One of the most obvious ways to avoid a shortage of ventilators, is to reduce the numbers of people catching the disease in the first place. That means following all the health advice, including social distancing and hygiene rules.
The government is also investigating whether ventilators used on animals in veterinary clinics could be converted. Sleep apnoea machines and anaesthetic machines are also options.
Ventilators used in ambulances could be used as back up.
All of that work will be crucial in saving lives if the social distancing measures and community lockdowns don’t stem the flow of patients into critical care.
Health care workers responsible for managing severe life-threatening cases like Covid-19 are extremely concerned regarding their ability to use appropriate support for large numbers of patients expected to suffer respiratory failure.
In essence, this means that many will not be able to be treated with mechanical ventilation and difficult decisions will have to be made by staff, families and patients about the limits of support. There are many ethical dilemmas in this, and none can be easily resolved.
The ventilator circuit refers to the tubing that connects the ventilator to the patient, as well as any devices that might be connected to the circuit.
The basic components of the ventilator circuit and their maintenance are reviewed here. The information in this topic applies to patients who are ventilated through an endotracheal tube, tracheostomy tube, or noninvasive interface. Modes of mechanical ventilation are reviewed separately.
COMPONENTS OF THE VENTILATOR CIRCUIT
The ventilator circuit refers to the tubing that connects the ventilator to a patient, as well as any device that is connected to the circuit tubing. The most common devices include heaters and humidifiers, filters, suction catheters, and therapeutic aerosol generators (nebulizers and inhalers) .
Circuit tubing — The ventilator circuit tubing is generally corrugated plastic (22 mm inside diameter for adults), which has universal connectors (22 mm outside diameter, 15 mm inside diameter) that connect the ventilator to the endotracheal tube (ETT), tracheostomy tube, or noninvasive interface .
There are two types of circuits commonly used:
Double-limb respiratory circuit
The double-limb respiratory circuit is composed of an inspiratory and expiratory limb whose proximal ends are connected to the inspiratory and expiratory ports, respectively, of the ventilator (where the inspiratory and expiratory non-rebreathing valve are positioned), while the distal parts are connected to the so-called Y-piece ending in the patient interface . The effective compliance of the respiratory circuit is a combination of the tubing compliance and gas compressibility. Some HCVs provide automatic compensation for circuit compliance and resistances after a calibration manoeuvre (e.g. MEK-ICS Pneuma series, ResMed Elisèe series). Others have the option of choosing between adult and paediatric circuit configurations (e.g. Philips Respironics Trilogy 100/200, Covidien PB 520/560 series). However, some HCVs still lack this automatic compensation Although double-limb respiratory circuits usually measure inspiratory and expiratory tidal volume (VT), they can also be equipped with a proximal flow sensor that can be used either as a simple monitoring tool or to control some of the ventilator functions.
Figure 1 — Double limb respiratory circuit a) without and b) with a flow sensor (F) sited distal to the Y-piece. The black and yellow arrows indicate the direction of inspiratory and expiratory flow, respectively. See the main text for further explanation.
Single-limb circuits are directly attached to the patient’s invasive or noninvasive interface. As use of a single tube for both inspiration and expiration would lead to carbon dioxide rebreathing two different systems are used to avoid this problem .
A single respiratory circuit with a non-rebreathing expiratory valve (e.g. a mushroom valve driven by ventilator pressure) is usually labelled as a “non-vented” respiratory circuit. This valve has an on–off function and often works as a positive end expiratory pressure (PEEP) valve (see the section on: inspiratory and expiratory valves and output variable control). This type of respiratory circuit allows complete elimination of carbon dioxide. Usually, if they do not have a proximal flow sensor, as shown in for the double respiratory circuit, they provide only inspiratory VTmeasurement.
Figure 3 — Examples of single limb “vented” circuits. Exhalation occurs through single or multiple orifices sited either in a) the mask shell or in the swivel connector (O), b) a whisper swivel (W) or a hole orifice at the distal end of the circuit (H), or c) a “Plateau Valve” (P) positioned between the circuit and the mask. The black and yellow arrows indicate the direction of inspiratory and expiratory flow, respectively. See the main text for further explanation.
A single respiratory circuit without a “true” non-rebreathing valve is usually labelled as a “vented” respiratory circuit or intentional leak respiratory circuit . Carbon dioxide is vented out through different modalities, and may be affected by many factors . Inspiratory or expiratory VT are not directly measured but are calculated by an algorithm .
2. FACIAL AND RESPIRATORY PROTECTION
N95 Respirators and Surgical Masks (Face Masks)
N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) also regulate N95 respirators.
It is important to recognize that the optimal way to prevent airborne transmission is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.
N95 Respirators Not for Use by the Public
The Centers for Disease Control and Prevention (CDC) does not recommend that the general public wear N95 respirators to protect themselves from respiratory diseases, including coronavirus (COVID-19). The best way to prevent illness is to avoid being exposed to this virus. However, as a reminder, CDC always recommends everyday preventive actions, such as hand washing, to help prevent the spread of respiratory diseases.
For the general American public, there is no added health benefit to wear a respiratory protective device (such as an N95 respirator), and the immediate health risk from COVID-19 is considered low.
Surgical Masks (Face Masks)
The Centers for Disease Control and Prevention (CDC) does not recommend that people who are well wear a face mask to protect themselves from respiratory diseases, including coronavirus (COVID-19).
A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks.
Surgical masks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you.
If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others.
While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the face mask and your face.
Surgical masks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.
The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death.
Comparing Surgical Masks and Surgical N95 Respirators
The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.
The similarities among surgical masks and surgical N95s are:
- They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability and biocompatibility.
- They should not be shared or reused.
General N95 Respirator Precautions
People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their health care provider before using an N95 respirator because the N95 respirator can make it more difficult for the wearer to breathe. Some models have exhalation valves that can make breathing out easier and help reduce heat build-up. Note that N95 respirators with exhalation valves should not be used when sterile conditions are needed.
All FDA-cleared N95 respirators are labeled as “single-use,” disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. Wash your hands after handling the used respirator.
N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection.
N95 Respirators in Industrial and Health Care Settings
Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. They are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC)
However, some N95 respirators are intended for use in a health care setting. Specifically, single-use, disposable respiratory protective devices used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material. These surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.
N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:
- The respirator is intended to prevent specific diseases or infections, or
- The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
- The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).
The FDA has a Memorandum of Understanding (MOU) with CDC NIOSH which outlines the framework for coordination and collaboration between the FDA and NIOSH for regulation of this subset of N95 respirators.
For additional differences between surgical masks and N95 respirators, please see CDC’s infographic.
Respirators protect the user in two basic ways. The first is by the removal of contaminants from the air. Respirators of this type include particulate respirators, which filter out airborne particles; and “gas masks” which filter out chemicals and gases. Other respirators protect by supplying clean respirable air from another source. Respirators that fall into this category include airline respirators, which use compressed air from a remote source; and self-contained breathing apparatus (SCBA), which include their own air supply.
Respirators should only be used when engineering control systems are not feasible. Engineering control systems, such as adequate ventilation or scrubbing of contaminants, are the preferred control methods for reducing worker exposures.
NIOSH issues recommendations for respirator use. Industrial type approvals are in accordance to the NIOSH federal respiratory regulations 42 CFR Part 84. Development of respirator standards are in concert with various partners from government and industry.
Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?
The 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 NIOSH-approved are appropriate to protect the public health or safety.
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 accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators made per China’s standards in this EUA because of concerns about fraudulent products listed as KN95s.
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 is authentic.
The FDA also issued guidance to provide a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators, if they are on the Centers for Disease Control and Prevention (CDC) list of respirator alternatives during the COVID-19 pandemic. Although not required, if a KN95 respirator does not have an EUA, importers may want to take appropriate steps to verify authenticity of these products.
The FDA is ready and available to engage with importers to minimize disruptions during the importing process. The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.
3 Layer Face Masks — Level 1,2,3
Level 1, 2 and 3 Face Masks protect healthcare professionals based on procedures performed. The masks comply with guidelines set forth by the ASTM (American Society for Testing and Materials) and feature a new 4-fold design for improved breathability.
Level 1 — masks (ASTM low barrier) are designed for procedures with low amounts of blood, fluid, spray and/or aerosol exposure. Common clinical examples include patient exams, operatory cleaning, impressions, lab trimming and orthodontic work. Available in blue, pink, and white (sensitive), these masks feature dual fit chin contour technology. Level 1 masks are fiberglass/latex free and made with a form-fitting pliable nose and chin band.
Level 2 — — masks (ASTM moderate barrier) are ideal for procedures where moderate to light amounts of fluid, spray and/or aerosols are produced. Level 2 masks are suitable for restoratives, prophylaxis, sealants, limited oral surgery and endodontic work. Available in blue, pink, and white, these masks feature dual fit chin contour technology. Level 2 masks are fiberglass/latex free and made with a form-fitting pliable nose and chin band.
Level 3 — — masks (ASTM high barrier) are designed for procedures with moderate to heavy amounts of blood, fluid, spray and/or aerosol exposure. High barrier protection is needed for procedures such as implant placement, crown preparation, and periodontal or complex oral surgery. Protecting against high bacterial infiltration, Level 3 masks feature a 4-ply design with a fluid resistant outer layer. These masks are available in blue, pink, and white. In addition, Level 3 is available as a blue mask with shield.
FACE SHIELDS AND GOGGLES for infection control
Face shields are personal protective equipment devices that are used by many workers (e.g., medical, dental, veterinary) for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are generally not used alone, but in conjunction with other protective equipment and are therefore classified as adjunctive personal protective equipment. Although there are millions of potential users of face shields, guidelines for their use vary between governmental agencies and professional societies and little research is available regarding their efficacy.
Healthcare workers’ faces have been reported to be the body part most commonly contaminated by splashes, sprays and spatter of body fluids.
A face shield is classified as personal protective equipment (PPE) that provides barrier protection to the facial area and related mucous membranes (eyes, nose, lips). A face shield offers a number of potential advantages, as well as some disadvantages, compared with other forms of face/eye protection used in healthcare and related fields (Table 1). The millions of potential users of face shields include healthcare workers, dental providers, veterinary care personnel, laboratory workers, pre-hospital emergency medical providers, police, firefighters, and custodial staff dealing with spills and contaminated waste.
It is not precisely known when eye protection first came to be used in the medical field, but records indicate that a 1903 patent was granted to Ellen Dempsey of Albany, New York, for a transparent “sanitary face shield for protection from inhaling disease producing germs.”
In 1974, James H. Bolker was granted a patent for a surgical hood with a clear, plastic faceplate that included a suction system to remove the exhaled breath from under the face plate and, in 1989, a cap with an incorporated face shield designed for non-surgical medical personnel was patented.
The introduction of the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard 1910.1–030, as well as recent outbreaks of serious airborne infectious diseases (e.g., Severe Acute Respiratory Syndrome [SARS], Avian Influenza, etc.) and severe infectious agents associated with the potential for body fluid exposures (e.g., Ebola virus), have resulted in increased attention to face/eye protection. The purpose of this article is to provide the reader with a review of the use of face shields for infection control purposes in order to assist in the selection and proper utilization of this type of PPE.
Advantages and disadvantages of face shields compared with other forms of face/eye protection (i.e., protective facemasks [filtering facepiece respirators, medical/surgical masks], goggles, safety glasses).[11, 12, 16, 19, 21, 22, 38–44]
Face shield design and structure
The majority of eye and face protection currently used in the U.S. is designed, tested, and manufactured in accordance with the American National Standards Institute (ANSI)/International Safety Equipment Association (ISEA) Z.87.1–2010 standard. The major structural components of a face shield include the following:
- Visor. Visors, also referred to as lenses or windows, are manufactured from any of several types of materials that include polycarbonate, propionate, acetate, polyvinyl chloride, and polyethylene terephthalate glycol (PETG) and come in disposable, reusable, and replaceable models (Figures 1–3). Acetate provides the best clarity and PETG tends to be the most economical, but polycarbonate is one of the most widely used. Polycarbonate and propionate offer better, although still somewhat imperfect, optical quality that aids in reducing eye strain associated with face shield wear.[9, 11] Visors can be treated with advanced coatings to impart anti-glare, anti-static, and anti-fogging properties, ultraviolet light (UV) protection, and scratch resistance features to extend the life of the visor. Some models come with built-in goggles that are incorporated into the visor.[9, 10] Visors are available in different lengths that include half facepiece length extending to the mid-face, full facepiece length that extends to the bottom of the chin, and a face/neck length that also covers the anterior neck area (Figures 1 and and2).2). Most visors curve around the face and come in different widths; wider visors offer more peripheral protection. Some one-piece face shields have visors that conform to the wearer’s face upon donning (Figure 3).Recommendations from the Centers for Disease Control and Prevention (CDC) are for visors that are of sufficient width to reach at least the point of the ear, as this will lessen the chances of the likelihood that a splash could go around the edge of the face shield and reach the eyes. In addition, visors should have crown and chin protection for improved infection control purposes.[7, 13] Some models of disposable medical/surgical face masks are available with an integral, thin plastic visor fitted to the top of the mask with an anti-fogging device between them to reduce the effects of exhaled moisture (Figure 4).[12, 14]
Figure 1 — Half face piece face shield with eyewear-like temple bars (Figure courtesy of the CDC).
Figure 2 — Frontal (a) and lateral (b) views of a reusable face/neck length face shield with brow cap, top band, and ratchet adjustment.
Figure 3 — Disposable one-piece face/neck length face shield visor assembly with foam forehead cushion and elastic strap.
Figure 4 — Surgical face mask with integral visor (Figure courtesy of Walter Reed National Military Medical Center).
- Frame. Face shield frames used in healthcare are generally made of lightweight plastic. There are a variety of frame styles, including adjustable and nonadjustable frames that fully or partially encircle the circumference of the skull or those with eyeglass-type temple bars that are worn like standard eyewear (Figures 1and and2)2) There are also metal clip-on frames available that are designed to attach face shield visors to prescription eyewear, and some frames allow for the visor to be flipped up when not in use. A number of manufacturers offer detachable frames for easy change-out of the face shield visor. Some models also incorporate a brow cap (Figure 2) into the frame that affords additional splash protection in the forehead region, as well as allowing for more visor distance from the face that better accommodates the wearing of additional PPE (e.g., goggles, loupes, prescription eyewear, respirators) (Figure 2). Disposable visor-only face shields are also available that have a forehead foam cushion that provides a comfortable seal to the forehead (Figure 3).b)
- Suspension Systems. There are a variety of face shield suspension systems on the market that offer either fully or partially circumferential attachment features. Fully circumferential suspension systems include plastic headbands that are adjustable for comfort by a ratchet mechanism, pin-lock systems, or Velcro®; nonadjustable systems employ elastic straps (Figures 2b, ,3).3). Some models utilize eyeglass-type temple bars for suspension (Figure 1) with or without eyewear-like nose pads and bridge assemblies to assist in maintaining face shield position and stability on the face. A top band that is adjusted for depth is found on some models (Figure 2b).
Face shields provide a barrier to acutely-expelled aerosols of body fluids and are commonly used as an alternative to goggles as they confer protection to a larger area of the face. However, as highlighted in a recent Institute of Medicine report, little is known about the effectiveness of face shields in preventing the transmission of viral respiratory diseases. Utilizing a cough aerosol simulator loaded with influenza virus (aerosol volume mean diameter of 8.5 μm) and a breathing simulator, Lindsley et al. reported 96% and 92% reductions in the risk of inhalational exposure immediately after a cough for a face shield at distances of 18 in (46 cm) and 72 in (183 cm), respectively. Decreasing the aerosol size to 3.4 μm resulted in the face shield blocking 68% of the inhalational exposure at 18 in (46 cm) immediately after the cough and 23% over 1–30 min post-cough (during which time the larger aerosol particles had settled out and droplet nuclei had formed and remained airborne so that flow occurred more easily around the edges of the face shield).Shoham et al. sprayed a fluorescent dye (particle diameter ~5μm) at a distance of 20 in (50 cm) away from a mannequin head outfitted with various types of PPE. They found that a face shield with head/neck length, three separate contact points at the forehead, and side curve reaching to the point of the ear (Bettershield™, Southmedic, Barrie, Ontario, CA), or the combination of this face shield and an N95 filtering facepiece respirator (N95 FFR), protected the eyes, nares and mouth from contamination. Conversely, these same investigators found that use of safety glasses with either a surgical mask or N95 FFR resulted in some eye contamination.Mansour III et al. utilized a mannequin head to study eye (conjunctival) contamination during performance of a femoral osteotomy and found a 30% incidence of contamination when using a combination surgical mask with integral eye shield (visor) and 3% for disposable plastic glasses. Utilizing an aerosolized dye (mean particle size 4.8 μm) emitted at a distance of 6 in (15 cm) from subjects wearing two models of face shields, Christensen et al. noted that the face shields were inferior to two models of surgical face masks tested similarly for particle penetration and that the combination of one of the face-masks with a face shield improved results only marginally. These face shield results were attributable to the lack of a peripheral fit. In a human study using sprayed water during simulated surgery, Loveridge et al.observed a 40.5% incidence of contamination of the inner surface of a combination surgical mask with integral visor and 6.5% contamination of the wearers’ face. Bentley et al. demonstrated that use of a face shield by dental personnel during simulated dental procedures on a mannequin head did not prevent aerosol contamination of a concurrently worn, cup-shaped surgical face mask. Monkey-related Cercopithecine herpesvirus 1 (B virus) infection has been reported in an animal handlerand SARS in a nurse, both of whom were wearing a combination surgical mask with integral visor. An epidemiological study reported that the nonuse of face shields by nurses, during high-risk aerosolizing procedures on patients with respiratory infections, resulted in a greater than three-fold increased risk of infection. Use of face shields alone for three months, compared with the use of face masks alone for an equal period, during thoracic and general surgeries resulted in no difference in infection rates of patients. Clearly, there is a need for further research into the protection from infectious airborne pathogens afforded by face shields either worn alone or in conjunction with other PPE worn simultaneously. This should include well-designed aerosol transmission studies, as well as possibly pursuing innovative approaches to design and function (incorporating miniature fans to purge air from the face shield deadspace, application of biostatic films for decontamination purposes, etc.).
There is currently no universal standard for face/eye protection from biological hazards. Therefore, the recommendations for the proper use of face shields vary widely, indicating the need for a consensus on the use of certain face/eye protection for specific medical procedures. OSHA’s Bloodborne Pathogens standard (1910:1030 subpart (d)(3)(i)) states: “Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated.” Face shield product performance specifications are found in the recently-revised voluntary ANSI/ISEA Z87.1–2015 American National Standard for Occupational and Educational Eye and Face Protection that identifies face shields, from an industrial standpoint, as being designed to protect from impact, optical radiation, droplet, and splash (e.g., chemical), dust and fine dust particles, but does not cover bloodborne pathogens, X-rays, high-energy particulate radiation, microwaves, radio-frequency radiation, lasers, masers, and sports and recreation. Face shields do not protect fully from impact hazards, so that OSHA requires their use in conjunction with additional eye protection (goggles, prescription spectacles with side shields, etc.). From the infection control standpoint, no standards currently exist regarding performance standards, but the ISEA Eye and Face Protection Group has initiated development of a voluntary standard that sets forth criteria related to the general performance requirements, test methods, and permanent markings of protectors to minimize or prevent eye and face exposure of the wearer to sprays, splashes, or droplets of blood, body fluids, excretions, secretions, and other potentially infectious materials in occupational and educational environments where biological hazards are expected and routine. Face shields are considered Class I medical devices that are exempt from Food and Drug Administration (FDA) Pre-Market Notification (Form 510[K]), but are subject to the FDA’s Quality System Regulation (21 Code of Federal Regulations 820) that includes periodic inspection and enforcement actions (warning letters, injunctions, seizure, civil monetary penalties). Face masks (surgical, medical, etc.) that incorporate a face shield or visor into their design are considered Class II medical devices and required to submit an FDA Form 510(K).
There is great variance in official (governmental) and professional society (medical, dental, etc.) guidelines for the appropriate use of face shields in the context of protection from biological hazards. Healthcare Infection Control Practices Advisory Committee/CDC Standard Precautions guidelines for prevention of transmission of infectious agents in healthcare venues includes the use of face shields (with a medical/surgical face mask) when sprays, splashes, or splatter are anticipated. The World Health Organization’s health care facility recommendations for standard precautions include a face shield as an alternative to the use of a medical/surgical or procedural mask with eye protection (eye visor or goggles). Similarly, the Ohio State Dental Board guidelines for infection control states that dental healthcare workers need not wear medical/surgical masks when wearing an appropriate face shield that provides protection at both the top and the sides. The Organization for Safety, Asepsis, and Protection, an advocacy group for dental practitioners, advises that use of a face shield alone for protection from contamination by body fluids is likely insufficient, and it is prudent to assume that in those situations where a face shield is used to protect against splash or splatter, a medical/surgical mask would also be indicated.New York State mandatory infection control training offered by approved providers to healthcare workers and medical and physician assistant students states: “When skin protection, in addition to mouth, nose and eye protection, is needed or desired, for example, when irrigating a wound or suctioning copious secretions, a face shield can be used as a substitute to wearing a mask or goggles. The face shield should cover the forehead, extend below the chin, and wrap around the side of the face.” The use of a minimum of an N95 FFR, concurrent with a face shield, has been advocated for protection from serious airborne respiratory infectious diseases (e.g., novel influenza A viruses, SARS) and during procedures on infected persons that result in aerosolization of body fluids (airway suctioning, intubation, etc.).[35, 36] The CDC and U.S. Air Force Dental Evaluation and Consultation Service both promote the use of a medical/surgical mask with a face shield during dental procedures,[37, 38] whereas an Association of Surgical Technologists’ standard on eye protection during surgery mandates the wearing of goggles with face shields during invasive surgical procedures. The ISEA Eye and Face Protection Group has initiated development of a voluntary standard that sets forth criteria related to the general performance requirements, test methods, and permanent markings of protectors to minimize or prevent eye and face exposure of the wearer to sprays, splashes, or droplets of blood, body fluids, excretions, secretions, and other potentially infectious materials in occupational and educational environments where biological hazards are expected and routine.
Selection of face shields
Face shields are meant to be used as barrier protection for the facial area and associated mucous membranes from airborne body fluids (blood, saliva, bronchial secretions, vomit, urine, etc.) expelled as a result of various physiological processes (vomiting, coughing, sneezing, etc.) and medical, dental, and veterinary procedures (suctioning the airway, placing nasogastric tubes, obstetrical procedures, surgery, dental procedures, etc.). Inasmuch as there are currently no standards for face/eye protection against biological hazards, and research data is scant, recommendations for the proper selection of face shields for infection control must rely on currently available knowledge, the task to be performed and the anticipated risk associated with the procedure.The selection of the most appropriate face shield model(s) will depend on the circumstances of exposure, other PPE used concurrently, and personal vison needs. Face shields with single Velcro or elastic straps tend to be easiest to don and doff;doffing can be accomplished with a single hand. In order to be efficacious, face shields must fit snugly to afford a good seal to the forehead area and also to prevent slippage of the device. Visors manufactured from acetate, propionate, and polycarbonate offer improved visual clarity and optical quality with the potential for less eye strain.[8, 9, 11] Visors that offer protection from UV light would be an important feature for individuals utilizing UV light sources (e.g., dental personnel). Face shields should be selected that have visors treated for anti-glare, anti-static, and anti-fogging properties. For improved protection from infectious agents, face shields should be, at a minimum, full face length with outer edges of the face shield reaching at least to the point of the ear, include chin and forehead protectors, and cover the forehead.[7, 12, 13] Brow caps or forehead cushions should be of sufficient dimensions to ensure that there is adequate space between the wearer’s face and the inner surface of the visor to allow for the use of ancillary equipment (medical/surgical mask, respirator, eyewear, etc.). Cost-effective considerations include disposable face shields vs. reusable models and those that offer replaceable parts. Although some models of industrial face shields could be used for infection control purposes (e.g., in the event of face shield shortages), they generally tend to be more expensive, heavier and bulkier than face shields used for infection control purposes.
Proper use of face shields
Correct use of a face shield is dependent upon the indications for use. Appropriately fitted, indirectly vented goggles offer the most reliable practical eye protection from splashes, but face shields are considered an alternative to goggles for prevention of eye contamination with infectious agents. Any additional protection afforded the eyes when protective eyewear (e.g., safety glasses or goggles) is combined with a face shield has not been thoroughly investigated, though the combination of a face shield and goggles has been espoused for use during invasive surgical procedures. The combined use of some forms of protective eyewear with a face shield may impact visual clarity and limit peripheral vison to some extent and these effects must be taken into consideration before use. Goggles have also been reported to fog more than face shields.[39, 40]Also, if a respirator is required in conjunction with face shield use, goggles may not fit properly over the respirator. Use of a face shield alone for eye, face, and mucous membrane protection from contamination by body fluids is likely insufficient and it has been recommended that in those situations where a face shield is used to protect against splash or splatter, a medical/surgical mask would also be indicated. Face shields are not meant to function as primary respiratory protection and should not be used alone because aerosols can flow behind the visor,[16, 19, 21, 41] so a protective facemask (medical/surgical mask, N95 FFR, etc.) should be worn concurrently. In those instances where aerosolization of body fluids of infectious individuals is likely to occur (suctioning the airway, intubation, etc.), a respirator (e.g., N95 FFR, at a minimum) should be used in conjunction with the face shield.Medical/surgical masks with integral visors should not be relied upon as optimal protection, as evidenced by facial and ocular contamination in human and nonhuman research studies[17, 18, 20] and human ocular exposure to infectious agents when wearing these combination devices.[22, 23] The recommended PPE donning and doffing sequence for a face shield in healthcare settings should be followed (donning sequence is gown, protective facemask, face shield [or goggles] and gloves; the doffing sequence is the reverse) keeping in mind that it may vary according to the equipment needed for the particular hazard. Although some models of industrial face shields could be used for infection control purposes (e.g., in the event of face shield shortages), they generally tend to be more expensive, heavier and bulkier than face shields used for infection control purposes.
Face shields are PPE that are commonly used as barrier protection for infection control purposes by numerous workers. There currently is no standard regarding face/eye protection from biological hazards and this deficit needs to be remedied as quickly as possible. Due to the lack of a good facial seal peripherally that can allow for aerosol penetration, face shields should not be used as solitary face/eye protection, but rather as adjunctive to other PPE (protective facemasks, goggles, etc.). Given the dearth of available data regarding the appropriate use of face shields for infection control, scientifically sound research needs to be conducted on the use of this form of PPE.
3. PROTECTIVE APPAREL
Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy.
Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met.
When to use medical gloves
Use medical gloves when your hands may touch someone else’s body fluids (such as blood, respiratory secretions, vomit, urine or feces), certain hazardous drugs or some potentially contaminated items.
What you should know before using medical gloves
- Wash your hands before putting on sterile gloves.
- Make sure your gloves fit properly for you to wear them comfortably during all patient care activities.
- Some people are allergic to the natural rubber latex used in some medical gloves. FDA requires manufacturers to identify on the package labeling the materials used to make the gloves. If you or your patient is allergic to natural rubber latex, you should choose gloves made from other synthetic materials (such as polyvinyl chloride (PVC), nitrile, or polyurethane).
- Be aware that sharp objects can puncture medical gloves.
- Always change your gloves if they rip or tear.
- After removing gloves, wash your hands thoroughly with soap and water or alcohol-based hand rub.
- Never reuse medical gloves.
- Never wash or disinfect medical gloves.
- Never share medical gloves with other users.
On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body’s immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications. For a detailed description of the risks that the FDA identified, please refer to the final rule.
- Medical Glove Guidance Manual — Guidance for Industry and FDA Staff(PDF — 771KB)
- FDA Consumer Update: Don’t be Misled by “Latex Free” Claims
- Medical Device Bans
- Final Rule: Banned Devices: Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove
MEDICAL GOWNS/ COVERALLS
Gowns are examples of personal protective equipment used in health care settings. They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the gown wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems. Gowns are one part of an overall infection-control strategy.
A few of the many terms that have been used to refer to gowns intended for use in health care settings, include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.
In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. Product names are not standardized.
A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as a surgical gown.
Surgical Isolation Gowns
Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. As referenced in Figure 2, all areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown. Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.
Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.
Like surgical isolation gowns, non-surgical gowns should also cover as much of the body as is appropriate to the task. As referenced in Figure 2, all areas of the non-surgical gownexcept bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated. All seams must have the same liquid barrier protection as the rest of the gown.
Figure 1 - Critical Zones for Surgical Gowns
- The entire front of the gown (areas A, B, and C) is required to have a barrier performance of at least level 1.
- The critical zone compromises at least areas A and B.
- The back of the surgical gown (area D) may be nonprotective.
Figure 2 - Critical Zones for Surgical Isolation Gowns and Non-Surgical Gowns
- The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.
- Surgical isolation gowns are used when there is a medium to high risk of contamination and need for larger critical zones than traditional surgical gowns.
Standards for Gowns
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a summary of ASTM F2407 standard recognized by the FDA.
- Tensile Strength: ASTM D5034, ASTM D1682
- Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
- Seam Strength: ASTM D751 (stretch woven or knit)
- Lint Generation (ISO 9073 Part 10)
- Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.
Type of PPE Feature Tested Standard Designation Sub headingsDescriptionApplicabilityGownsLiquid Barrier PerformanceAAMI PB70:2012
Classifies a gown's ability to act as a barrier to penetration by liquids or liquid-borne pathogens based on four levels.
The critical protective zones for surgical and non-surgical gowns are defined differently by the standard.
While the critical zones designate different protective areas for the different gowns, the levels of protection are the same for both surgical and non-surgical gowns
Liquid barrier performance is not related to the strength of the material.
This standard references several other standards
- Used for MINIMAL risk situations
- Provides a slight barrier to small amounts of fluid penetration
- Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
basic care, standard hospital medical unitLevel 2
- Used in LOW risk situations
- Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking
- Two tests are conducted to assess barrier protection performance:
- Water impacting the surface of the gown material
- Pressurizing the material
Blood draw from a vein, Suturing, Intensive care unit, Pathology labLevel 3
- Used in MODERATE risk situations
- Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
- Two tests are conducted to test barrier protection performance:
- Water impacting the surface of the gown material
- Pressurizing the material
Arterial blood draw, Inserting an IV, Emergency Room, TraumaLevel 4
- Used in HIGH risk situations
- Prevents all fluid penetration for up to 1 hour
- May prevent VIRUS penetration for up to 1 hour
- In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.
Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid exposure over long periods
Conformance with recognized consensus standards is voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner.
Sterility Information for Gowns
For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This information may include:
- Sterilization method that will be used.
- A description of the method that will be used to validate the sterilization cycle, but not the validation data itself (for established sterilization methods).
- Reference to a standard method (e.g., AAMI Radiation Standard) usually is sufficient for established sterilization methods with FDA-recognized standards.
- The sterility assurance level (SAL) for the device which the firm intends to meet. An SAL of 10-6 is required for surgical drapes and surgical gowns which are to be used during surgical procedures.
- A description of the packaging’s ability to maintain the device's sterility.
- If sterilization involves ethylene oxide (EtO), the maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol which remain on the device. The levels should be consistent with the draft Federal Register Notice on EtO limits.
- In the case of radiation sterilization, the radiation dose.
Biocompatibility Information for Gowns
Surgical gowns are devices that are considered a surface-contacting device with intact skin with a contact duration of ≤ 24 hours. The FDA recommends that cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation or intracutaneous reactivity (ISO 10993-10) is evaluated for a device. For more information about biocompatibility end point assessment, please refer to the final guidance document entitled, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Choosing Which Gown to Use
- Guidance: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings - Guidance for Industry and Food and Drug Administration Staff
- Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes
- Guidance: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Below is a summary of ASTM F2407 standard recognized by the FDA.
- Tensile Strength: ASTM D5034, ASTM D1682
- Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
- Seam Strength: ASTM D751 (stretch woven or knit)
- Lint Generation (ISO 9073 Part 10)
- Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737–75
4. TESTING KITS / SWABS
The two tests that will help to predict spread of Covid-19
Only by implementing carefully controlled programmes that use two very different Covid-19 test kits will it be possible to predict how the disease will affect the country, researchers have revealed.
Scientists emphasised the need to understand, as quickly as possible, where and when new cases of infection were appearing. At the same time, it was vital to pinpoint individuals who had already been infected, possibly without realising it, so that scientists could understand the disease’s behaviour over the coming months. Two different tests would be able to achieve these separate goals.
- PCR Test — To locate those in the first category — the newly infected — medical staff need to use a polymerase chain reaction (PCR) test, which can find viral particles on a person. The test locates a particular coronavirus gene sequence and creates multiple copies that can then be easily detected.
2. Antibody Test — To identify those who have already been infected and who should now be immune from reinfection, doctors need to use a test that shows antibodies generated in response to a past infection of Covid-19 .
PCR test was in itself very effective for detecting the virus but that that efficacy was dependent on how well healthcare workers took samples from patients, from the nose and the back of the throat.
If a virus is not picked up on the swab, the result will be negative. Thus, how effectively the swab is taken, and the amount of virus present at the sampling sites, will determine whether the virus is detected from an infected person.
More testing is to be carried out, as governments announce testing for after healthcare , starting with critical care doctors and nurses. However, there is a shortage of PCR machines, of staff trained to use them and, most worryingly, of reagents needed to run them. That will limit the uptake of the tests.
The PCR test will be used as the disease continues to spread this year, but over the next few months we will see the introduction of antibody tests.
Testing people across the country to find if they have been infected by Covid-19 will tell us precisely how the disease is behaving.
This will create certainty about where we stand and about the measures we need to take to limit the spread of the virus. We are not in dark anymore as the antibody test is up and running.
5. NON CONTACT INFRARED THERMOMETERS
A non-contact thermometer is a way to take someone’s temperature without touching them. Non-contact infrared thermometers (NCIT) 1 are as accurate as contact thermometers and are low cost. Training is easier and the thermometers are easier to use and do not need as much work to set them correctly.
Thermal scanner cameras2 can measure temperature from a greater distance although they have not been evaluated for use as a primary diagnostic tool or for screening multiple individuals in an uncontrolled environment, such as an airport. They are not as accurate as NCIT’s and may be more difficult to use effectively.
1 Non-contact infrared thermometers regulated by FDA under Product Code “FLL”
2 System, Telethermographic (Adjunctive Use) cleared by FDA under Product Code “LHQ”
A non-contact thermometer is a way to take someone’s temperature without touching them.
Temperature measurement is just one tool used to find out if a traveler might have Ebola/COVID19 and other viral infections. Other tools, such as looking carefully at the traveler, health questionnaires, and interviews can give a fuller picture of the risk so that authorities can do more effective screening and take appropriate public health action.
The average normal body temperature is 98.6°F (37°C).
Fever is a measured body temperature above normal.
Fever is often a sign that the body is fighting a disease that could be infectious.
For different infectious diseases, fever is considered to be significant if the temperature is above a specific measurement.
o For Ebola, a fever of 101.5°F (38.6°C) or higher is considered significant.
Other causes of fever include other medical conditions, severe trauma or injury, and some medicines.
Infected persons will likely not have a fever during the incubation period for Ebola (2 to 21 days).
An ill person’s temperature could be normal after taking fever-reducing medicine.
Types of Temperature Measuring Devices
Usually, temperature is measured using contact thermometers on many places on the body; commonly the mouth, ear, forehead, armpit, and rectum.
o Some devices such as non-contact thermometers also measure temperature on the forehead.
A rectal thermometer is the most accurate way to measure body temperature, especially in small children.
Non-contact infrared thermometers (NCITs)
Depending on the manufacturer, NCITs are held between 1.2 and 6 inches (3–15 cm) from the body.
Most NCITs measure temperature by placing a probe over the middle of an individual’s forehead.
o Temperature over other body surfaces may also be measured depending on the manufacturer’s specifications, including the neck, navel, and armpit.
Since NCITs do not touch any body surfaces, the risk of cross-infection is low and probe covers do not need to be disinfected or thrown away, unless they come in contact with the skin.
Some NCITs are FDA-regulated or CE-Marked for use as thermometers and will not need to have temperature confirmed.
o Another measurement can be taken if needed during secondary screening evaluation.
Operational advantages: non-contact, accurate, lower cost, smaller size, easier training and use, and less need for re-setting to correct readings. Because some models are FDA-regulated or CE-Marked for use in medical facilities, they can be repurposed if no longer needed at airports.
Operational disadvantages: slower for screening large numbers of people, meaning that more units and personnel are needed to operate them compared to mounted, camera-style scanners.
Optimal conditions for use vary by manufacturer but include measuring:
o Over dry body surfaces; over non-hairy body surfaces; in a draft-free room; at a constant temperature between 60.8°F (16°C) and 104°F (40°C); and at humidity below 85%.
Ability of NCITs to detect fever
o Product-to-product comparisons are difficult because: different targets are used, there are few direct studies which compare specific devices, and new devices are developed.
o From a few review studies (2015–2019), overall performance characteristics reported were
Sensitivity: 80% — 99%
Specificity: 75% — 99%
Positive predictive value: 31% — 98%
o The optimal cut-off point for predicting fever is different for each device and may be different from how fever is defined for a specific disease.
So for any device used for fever-screening, the choice of the cutoff value can result in false-positive and false-negative results.
o Some reports suggest that taking the average of several readings improves accuracy.
o These devices are FDA cleared specifically for adjunctive use only — meaning they are only cleared to be used in addition to another clinical diagnostic procedure. These devices are not cleared as a sole primary screening/diagnostic tool. No thermal scanner cameras are cleared or approved specifically for mass screening of fever or specific diseases.3
o Temperature readings from thermal camera scanners should only be interpreted along with an FDA-regulated (or CE-Marked i.e. EU approved) thermometer.4
Operational advantages: non-contact and relatively accurate.
o Thermal scanner cameras can measure temperature from a greater distance than other non-contact temperature devices. However, Ebola is not spread through the air, so there is no real safety advantage from the greater separation distance.
o Mounted camera models can screen large numbers of people, meaning that fewer devices and screening personnel are needed.
Operational disadvantages: much higher cost, more difficult to use, more extensive training requirements, more frequent re-setting and calibration to correct readings for variations in ambient environmental conditions, less precise, maintenance needs, and a FDA-regulated temperature-measuring device must be used to confirm temperature.
3 For some FDA-cleared manufacturers’ devices, the 510(k) summaries indicate the devices can be used in both healthcare and public environments, such as airports; however, the performance of the device may vary depending on the ambient environmental, and any estimated temperature needs to be confirmed with an FDA-cleared thermometer.
4 At optimal cutoff values for detecting fever, temperature estimates by some thermal scanners have been found to be relatively accurate; however, they can yield false positive (i.e. incorrectly high temperature readings) and false-negative results (i.e. incorrectly low temperature readings) and are less precise than NCITs.
Different countries may have different medical device approval process and criteria.
In the United States, medical devices are approved, cleared, or are exempted from review by the Food and Drug Administration (FDA).
o FDA does not develop or test products. FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers.
o If FDA grants a 510(k) clearance, for a thermometer, it means the agency has reviewed that the product is as safe and effective as other currently marketed thermometer products.
In the European Union, the approval process is called CE Marking.
o Valid CE Marking on a product indicates it complies with European product safety standards.
FDA-regulated devices for measuring temperature are categorized into the following types:
o Clinical color change thermometer (21 CFR 880.2900)
A disposable device used to measure a patient’s oral, rectal, or armpit body temperature using heat-sensitive chemicals sealed at the end of a plastic or metal strip. These chemicals change colors depending on the temperature.
o Clinical electronic thermometer (such as non-contact infrared thermometer) (21 CFR 880.2910)
An electronic device used to measure body temperature that has a display unit.
o Clinical mercury thermometer (21 CFR 880.2920)
A device that measures oral, rectal, or armpit body temperature using mercury, which expands and contracts depending on temperature.
o Liquid crystal forehead temperature strip (21 CFR 880.2200)
A device applied to the forehead that monitors body temperature by displaying the color changes of heat-sensitive liquid crystals that are sealed in plastic.
o Telethermographic system (“thermal scanners”) (21 CFR 884.2980)
A device intended for measuring changes in body temperature as an adjunctive tool to another diagnostic test. This electronic device does not require physical contact to measure infrared radiation that goes along with body temperature variations.
A searchable FDA database for FDA-regulated products and firms is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
FDA warns consumers about fraudulent Ebola treatment products: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410086.htm
A catheter is a soft hollow tube, which is passed into the bladder to drain urine. Catheters are sometimes necessary for people, who for a variety of reasons, cannot empty their bladder in the usual way, i.e. passing urine into a toilet or urinal.
Following are the CDC / WHO guidelines
Coronavirus Disease 2019 (COVID-19)
This interim guidance has been updated based on currently available information about COVID-19 and the current…
7. HAIR COVERS / BOOT COVERS
Disposable Boot Covers
Keep dirt and dust out of hospitals , work spaces and keep employees safe.
Avoid cross-contamination by keeping boots clean with disposable boot covers.
Disposable boot covers are lightweight and have an elastic opening for a snug fit.
Choose from fluid resistant and skid-free disposable boot covers.
Protects carpets and floors. Economical and disposable.
Disposable boot covers are similar to shoe covers but provide extra material on the top portion to protect even more of the ankle and calf area. They’re typically finished with an elastic opening for a snug fit around the top portion of your boots. These disposable products are excellent for keeping spaces clean and safe, homes, especially laboratories, cleanrooms and medical facilities.
Avoid cross-contamination with fluid-resistant boot covers featuring a multi-layer material that provides maximum fluid protection. This type of boot cover is ideal for applications where you need to keep your boots and socks protected from moisture while also ensuring that your work environment is safe and free of contamination.
Also a huge assortment is needed of non-skid boot protectors featuring a built-in bottom thread that delivers excellent traction, effectively reducing the risk of slips and falls in your workspace. Most styles feature an 18-inch height for extra protection and feature breathable designs to keep you cool.
These covers should be designed to perform well in wet and dry applications, and protect workers against non-toxic liquid spray, dirt and dust. What’s more, they’re made for all-day protection and are strong enough to resist tears. Microporous boot covers are a cost-effective alternative , and feature excellent barrier protection and repellency..
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Guidance on Personal Protective Equipment
In your doffing area, you will have two chairs. One will be where you sit to take off your boot or shoe covers only. This chair will be marked clearly as dirty.
Once you sit down, be careful not to touch one leg with the other. Then grasp the outside of the boot or shoe cover and pull down toward your ankle. Then, lift the boot or shoe cover over your heel, pull it off your foot, and dispose of it correctly. The exact way to remove the boot or shoe covers will vary based on the manufacturer’s instructions.
Guidelines for Environmental Infection Control in Health-Care Facilities
Please note: An erratum has been published for this article. To view the erratum, please clickhere. Persons using…
Healthcare Equipment | Disinfection & Sterilization Guidelines | Guidelines Library | Infection…
Concerns about Implementing the Spaulding Scheme One problem with implementing the aforementioned scheme is…
8. X-RAY MACHINE / CT MACHINE
The American College of Radiology (ACR) released its first official guidance for radiologists facing the expanding COVID-19 pandemic. Their advice outlines the radiologic evidence surrounding the virus, as well as how radiologists and their facilities can best use imaging with potential cases.
These published guidelines come on the heels of the announced from the World Health Organization (WHO) that the COVID-19 outbreak has now reached pandemic status.
With the number of cases continuing to grow in the United States, the ACR, which already deems chest CT “usually not appropriate” for acute respiratory illness, recommended providers and health systems adhere to guidance published by the Centers for Disease Control & Prevention (CDC). The CDC does not currently recommend chest CT or chest X-ray as a diagnostic method for COVID-19 infection.
COVID-19 symptoms aren’t specific and can be easily confused for other infections, such as flu, H1N1, SARS, and MERS, and the concurrent flu season can make accurate identification even more difficult. According to the CDC, even if a chest CT or X-ray suggests COVID-19, viral testing is the only specific method for diagnosis.
Based on their research, the ACR made these four recommendations:
- CT should not be used to screen for or as a first-line test to diagnose COVID-19.
- CT should be used sparingly and reserved for hospitalized, symptomatic patients with specific clinical indications for CT. Appropriate infection control procedures should be followed before scanning subsequent patients.
- Facilities may consider deploying portable radiography units in ambulatory care facilities for use when chest X-rays are considered medically necessary. The surfaces of these machines can be easily cleaned, avoiding the need to bring patients into radiography rooms.
- Radiologists should familiarize themselves with the CT appearance of COVID-19 infection in order to be able to identify findings consistent with infection in patients imaged for other reasons. In this vein, the ACR Data Science Institute published its first AI Use Case that includes pertinent clinical information.
Even though chest CTs are not recommended as the first-line diagnostic test, radiology departments will still encounter a growing number of patients suspected of infection in the coming weeks and months. Consequently, the ACR recommended putting good infection-control measures in place to contain viral spread as much as possible.
“These measures to eliminate contamination for subsequent parties may reduce access to imaging suites, leading potentially to substantial problems for patient care,” the ACR statement said.
Any imaging suite — and all surfaces — used for scanning a patient suspected of COVID-19 infection should be environmentally cleaned and decontaminated by someone wearing proper protective equipment. The air-flow in fixed X-ray or CT rooms should also be considered before bringing in the next patient. Consider the air exchange rates, understanding that rooms may need to be completely avoided for roughly an hour after imaging infected patients.
Overall, the ACR emphasized, knowledge about COVID-19 is constantly emerging, and urged providers to remember online sources of information are consistently being updated.
9. OXYGEN TANKS AND CONCENTRATORS
You can receive oxygen therapy from tubes resting in your nose, a face mask, or a tube placed in your trachea, or windpipe. This treatment increases the amount of oxygen your lungs receive and deliver to your blood. Oxygen therapy may be prescribed for you when you have a condition that causes your blood oxygen levels to be too low as in case of ARDS caused by COVID19. Low blood oxygen may make you feel short of breath, tired, or confused, and can damage your body.
Oxygen therapy can be given for a short or long period of time in the hospital, another medical setting, or at home. Oxygen is stored as a gas or liquid in special tanks. These tanks can be delivered to your home and contain a certain amount of oxygen that will require refills. Another device for use at home is an oxygen concentrator, which pulls oxygen out of the air for immediate use. Because oxygen concentrators do not require refills, they won’t run out of oxygen. Portable tanks and oxygen concentrators may make it easier for you to move around while using your therapy.
Oxygen poses a fire risk, so you should never smoke or use flammable materials when using oxygen. You may experience side effects from this treatment, such as a dry or bloody nose, tiredness, and morning headaches. Oxygen therapy is generally safe.
10. MODULAR HOSPITALS / BEDS / ICU
a. Product Information — the horizontal beam provides media fixtures on both sides — media for primary care are on the rear side, while media for emergency care on the front side, suspended from the beam are manoeuvrable and rotating equipment carts which can be positioned wherever they are required. Namely right next to the patient. Moreover, an extensive array of accessories ensures that the optimum equipment is available for every situation. A highlight is that it comes with an integrated dynamic light control system — which provides simulated daylight for helping long-stay patients in particular to relax and feel good.
b. Applications — Our modular FRP/ Polymer modular hospital products offers everything that is necessary for completely serving a patient “Workspace” in intensive care.
i. Modular OT
ii. Medical Gaspipeline System
iii. CSSD Systems
iv. Hospital Furniture
vii. Modular ICU / CCU / NICU
viii. Wall Guard and Corner Guard
ix. Nurse Call System
x. Cubical Partition Track System
11. BIO HAZARD BAGS
1. Product Information- OSHA and CDC certified package for contamination-free carriage and handling of chemical components such as urine , blood samples and bio hazardous waste.
2. Applications- These bags are popular in the law enforcement, laboratory, and medical service industries.
- Material: 100% Virgin Low Density PolyEthylene (LDPE)
- Color: Clear
- Gauge: 2 MIL
- Closure: Seal Top
- Recyclable: Yes
- Document Pouch –Yes
- Universal Biohazard Tag –Yes
Body Bags Specifications
i. Measures 36" x 90" with a 72" girth
ii. Includes 3 toe tags
iii. No Handles