Reopening America Again and the FDA Guidelines

Reopening America Again Guidelines

On April 13th 2020, the President of the United States issued the Reopening America Again Guidelines to help guide the State Governors and community leaders in a path to reopen businesses in this post COVID-19 environment.

As each state, region or metropolitan area moved past their peak outbreaks and into a more manageable situation, the guidelines established three distinct phases where businesses and operations could return to a more normal state of operations. The Reopening America guidelines presented responsibilities for the States, Individuals and Employers.

The States are responsible for testing, contact tracing, screening of the most vulnerable, health care capacity and planning to limit and mitigate further outbreaks. Individuals are responsible for personnel hygiene, using face mask and staying home if they are sick.

Employers are responsible for developing and implementing appropriate policies in accordance with Federal, State and local regulations and guidelines bases on industry best practices to protect their workforce. Those include:

  • Workplace social distancing and protective equipment
  • Temperature checks
  • Testing, Isolating and contact tracing of employees
  • Sanitation
  • Use of disinfection of common and high traffic areas
  • Business travel
  • Develop and implement policies and procedures for workforce contact tracing following COVID-19 + test

The Reopening America Guidelines want you to monitor your workforce for indicative symptoms and not allow symptomatic employees to physically return to work until cleared by a medical provider. IACL’s focus is different from many companies because we want to help advise on a broad range of these recommendations instead of just temperature checks.

We can definitely help with the Temperature Check, but there is much more in these recommendations that just temperature checks. Everything basically starts with your company’s Policies and Procedures. The Reopening America Again Guidelines have these recommendations spread between the three phases of reopening.

Phase One for Employers to encourage telework whenever possible and then allow for a return to work in phases. Close common areas where people gather, congregate and interact to enforce social distancing protocols. Strongly consider special accommodations for personnel who may be especially vulnerable to COVID-19. There are other restriction related to specific types of business and employers.

Phase Two still encourages telework whenever possible as is feasible with your business operations. They still want common areas closed where employees are likely to congregate to enforce moderate social distancing. It does allow non-essential travel to resume but still strongly considers special accommodations for especially vulnerable personnel. There are other relaxed restrictions related to specific types of business and employers.

Phase Three basically allows unrestricted staffing activities on worksites with some mild restrictions on some specific employers.

People think of the transition from Phase One to Phase Two to Phase Three as a linear progression in one direction. If there are further outbreaks of infection in a region, state or locality, our society could move from Phase One or Two directly to Phase Three and then back to Phase One. We will be dealing with COVID-19 for years to come and with the high mortality rate, it will affect your business’s ability to be productive and profitable for a long time. That is why planning and preparation is so important.

FDA Thermographic Guidelines

In mid-April 2020, the Food and Drug Administration (FDA) issued enforcement policies for Thermographic systems when evaluating body temperatures for symptomatic people in the workplace. These policies are not binding or enforceable but designed to provide guidance for Employers during the COVID-19 public health emergency. The term Telethermography means using thermography to determine temperature gradients on the surface of the human body to determine underlying conditions.

What is Human Febrile Temperature Screening (or Fever Screening), and what does it have to do with thermal infrared (IR) imaging?

Normal core body temperature in the human body varies, but the average is 37°C or 98.6°F. Infections usually cause the body’s temperature to rise. When a human’s body temperature rises, this is called a fever. A fever is considered any core temperature above 38°C or 100.4°F. Fever Screening is accomplished by a qualified person and is the act of checking the internal temperature of a human being by placing an analog or digital thermometer in the mouth, armpit or rectum.

Also, tympanic thermometers (infrared ear thermometers) have gained popularity because they are mostly accurate, more non-contact and faster than other types. At entry points into buildings, a check point can be set up and people can be screened using this method before entry is granted. However, at airports, factories and other buildings where there is a high flow of people per hour, this is an extremely slow process. This is where thermal IR Imaging comes into play.

Since there is a locked relationship between the internal and external body temperatures of humans, it has been determined that; a) to reduce screening times, and b) to reduce the risk of cross-infection between the incoming person and the screener, that thermal infrared imaging does have an acceptable level of accuracy and repeatability to be used confidently as a primary screening method of fever screening.

In the primary fever screening process, when people with a skin surface temperature higher than that of a given set point are found by using thermal IR imaging, this apparent elevated body temperature warrants that person should be directed to secondary fever screening, using thermometers to determine if they actually do have a fever.

International and US protocols recognize thermal infrared imaging as a valid method of detecting Elevated Body Temperature in humans by using Skin Temperature Measurement which will significantly speed the process of employees and visitors safely entering buildings using Human Febrile Temperature Screening.

The FDA recommends that if you are using Infrared Thermal Imaging for febrile body temperatures, a secondary temperature evaluation process should be used if an elevated body temperature is discovered using an infrared device. For better accuracy, this is usually preformed using a digital or contact thermometer. The close proximity of people taking this secondary test will require the use of PPE and procedures to clean or use disposable components to prevent the spread of the virus

The current standard indicates that Infrared equipment should include at least ± 0.9° F (0.5° C) sensitivity for temperatures between 93.2° – 102.2° and temperature drift of less than 0.36° F and use a Black Body temperature reference source.

The labeling or instruction for the device should include language about setup factors, locations for body measurements, conditions of screening sites, factors based on the design of facility and criteria for testing based on spatial resolution and camera performance. Much of this detail will be discussed in the next section.

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