Epidemiology of COVID-19

The COVID-19 pandemic has exploded since the disease was first identified in China in December of 2019. As of October 28, 2022 more than 629 million cases of COVID-19 have been reported globally, including more than 6.5 million deaths [45]. The actual numbers are likely significantly higher. According to mathematical estimates, less than one in five COVID-19 cases that occurred in the first 29 months of the pandemic are accounted for in cases that have been officially registered [44]. Individuals of all ages are at risk for infection and severe disease. However, the probability of serious complications and fatal disease is highest in people over the age of 65 years and those living in long-term care facilities or nursing homes. Others at particularly high risk for COVID-19 are people of any age with existing underlying conditions, especially when not well-controlled [2,3].

Transmission of COVID-19

The onset and duration of viral shedding and period of infectiousness are not completely defined. Asymptomatic or pre-symptomatic individuals infected with COVID-19 may have viral RNA detected in upper respiratory specimens before the onset of symptoms [4]. Additionally, transmission from asymptomatic individuals has been described [5].

The time from exposure to onset of symptoms is typically around five days but may range from two to fourteen days [6]. The virus is primarily spread between people during close contact, [7] often via small droplets produced by coughing, sneezing, or talking [8]. Additionally, these droplets fall to the ground or onto surfaces where people may also become infected by touching a contaminated surface and then touching their face, nose, mouth, or eyes [9].

Smaller respiratory droplets, known as aerosols, have the ability to remain suspended in air for a longer amount of time and can transmit the virus if they are inhaled by others. There have been reported outbreaks of COVID-19 in closed settings (such as restaurants, bars, and places of worship) where people were shouting, talking, or singing. These likely crowded and poorly ventilated spaces facilitated the spread of infectious aerosols [10].

It appears that the virus that causes COVID-19 can spread from people to animals in some situations. The USDA previously confirmed COVID-19 infection in one tiger at a zoo in New York after several large cats began to suffer from respiratory illness [11]. The CDC is aware of a small number of pets, including cats and dogs, reported to be infected with the virus that causes COVID-19. These infections occurred after the animals had close contact with people actively infected with COVID-19 [12]. Infected pets may show signs of illness or they may not have any symptoms. Of the pets that have been infected, most only had mild illness and fully recovered [13].

Clinical Presentation of COVID-19

The spectrum of illness from COVID-19 can range from asymptomatic infection to severe pneumonia with acute respiratory distress syndrome (ARDS) and death. In an early summary of 72,314 persons with COVID-19 in China, 81% of cases were reported to be mild, 14% were severe, and 5% were critical [14]. Symptoms may appear anywhere from 2-14 days after exposure to the virus. The most common symptoms of COVID-19 include: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, body aches, headache, loss of taste or smell, sore throat, runny nose or congestion, nausea or vomiting, diarrhea [15].

Using nasal or oral samples, viral testing determines the presence of an active infection with SARS-CoV-2, the virus responsible for COVID-19. The two most common forms of viral tests are antigen testing and nucleic acid amplification tests (NAATs). In certain circumstances, one test type may be preferred over another. All testing must be completed according to FDA guidelines.

Diagnosing COVID-19

PCR-based tests have become the gold-standard testing method and require processing in a laboratory. These tests are the most reliable diagnostics for symptomatic and asymptomatic patients alike. Following a positive test result, viral genetic material can stay in the body for up to 90 days, therefore it is not recommended that a PCR test be given within 90 days of a previous infection [41].

Rapid antigen tests provide results within fifteen to thirty minutes. They are less reliable than NAATs, particularly for those without symptoms. A single negative antigen test result cannot exclude the possibility of infection. For best infection identification, a negative antigen test must be repeated at least 48 hours apart (known as serial testing). To confirm the results of an antigen test, a follow-up NAAT is sometimes recommended.

Self-tests, also referred to as at-home tests, are generally antigen tests that may be done anywhere, without the need to attend a specialized testing facility. Follow the FDA and manufacturer's instructions for testing frequency, if necessary. Multiple negative test results does not necessarily indicate the absence of a COVID-19 infection [40].

Abnormalities in chest X-ray vary, but typically reveal bilateral multifocal opacities. Chest x-rays obtained early during the course of infection may not reveal significant changes [18]. Abnormalities seen in computed tomography (CT) of the chest also vary, but typically reveal bilateral peripheral ground-glass opacities with the development of areas of consolidation later in the clinical course [19].

Treatment of COVID-19

Patients with a mild clinical presentation (without viral pneumonia and hypoxia) may not require hospitalization, and many patients will be able to manage their illness at home. The decision to monitor a patient in the inpatient or outpatient setting should be made on a case-by-case basis [27]. This decision will depend on the clinical presentation, requirement for supportive care, risk factors for complications, and if the patient is able to self-isolate at home. Patients with risk factors for severe illness should be monitored closely given the possible risk of progression to severe illness during the second week following symptom onset [28,29].

The global availability of targeted COVID-19 treatments varies widely. An antiviral medication may reduce the severity of symptoms by preventing the SARS-CoV-2 virus from replicating inside the body. Antiviral treatment may be given orally, as a pill (oral antivirals), or intravenously (intravenous antivirals) (IV antivirals). Oral antiviral treatment must be administered within five days of the onset of COVID-19 symptoms. Intravenous antivirals must be administered within seven days of the onset of symptoms [42].

Treatment with monoclonal antibodies (mAb) enhances the body's ability to fight COVID-19. The mAb therapy can prevent the SARS-CoV-2 virus from entering cells, hence reducing the amount of virus in the body. These antibodies assist the immune system in recognizing the pathogen and responding more effectively. A mAb treatment may prevent symptoms from getting severe enough to require hospitalization. The medication must be administered within the first seven days of the onset of symptoms for individuals at high risk for developing severe COVID-19 symptoms. The mAb therapy may be administered via intravenous infusion or as a series of injections [43].

A patient may require hospitalization for severe symptoms or complications from a COVID-19 infection. The majority of inpatient management revolves around the supportive management of the most common complications of severe COVID-19: pneumonia, hypoxemic respiratory failure/ARDS, sepsis and septic shock, cardiomyopathy and arrhythmia, acute kidney injury, and complications from prolonged hospitalization including secondary bacterial infections, thromboembolism, gastrointestinal bleeding, and critical illness polyneuropathy/myopathy [35,36,37,38].

Home Care for COVID-19

In patients where only mild symptoms are present, supportive measures and in home care are recommended with the appropriate guidelines and precautions being adhered to [39].

The OSMS Home Care Guide is a repository of recommendations, guidance, and research for the management of COVID-19 at home.

Clinical Resources

Information for Healthcare Professionals about Coronavirus (COVID-19) (CDC)

ADA Coronavirus (COVID-19) Center for Dentists (ADA)

Question and Answers Hub COVID-19 (WHO)

Coronavirus Disease 2019 (COVID-19) (FDA)

A Note About Safety and Liability

There are engineering and manufacturing risks around medical devices. Though the FDA has issued Emergency Use Authorizations (EUA) (Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, FDA), to avoid doing more harm than good, it is recommended to attempt to the best of your ability and circumstances to follow regulations, which may seem cumbersome, but exist for good reason.

Regulatory standards that apply to the supplies and devices in question:

eCFR: QUALITY SYSTEM REGULATION (especially Identification and Traceability, Production and Process Controls, and Labeling)

eCFR: GENERAL HOSPITAL AND PERSONAL USE DEVICES

Resources

Technical Considerations for Additive Manufactured Medical Devices (FDA)

General Controls for Medical Devices (FDA)

Counterfeit Respirators / Misrepresentation of NIOSH-Approval | NPPTL | NIOSH (CDC)

Good Samaritan Laws in the United States

In the United States, Good Samaritan laws offer legal protection from civil lawsuits to people who voluntarily provide reasonable aid to those who are injured, ill, in danger, or otherwise incapacitated. A claim of negligent care can also be raised if the injuries or illness were made worse by the volunteer's negligence. Laws generally do not exempt a Good Samaritan who acts in a willful, wanton or reckless manner in providing care, advice, or assistance.

We are providing you with the specifications you will need to manufacture items which are much-needed during this pandemic; however, you are responsible for your creations, so please practice due diligence (the care that a reasonable person exercises to avoid harm to other persons or their property). We want your contributions to help, not harm!

If you are familiar with similar laws in other countries, please reach out to us with relevant references.

References: Good Samaritans (US Legal)

Social Action, Responsibility and Heroism (SARAH) Act in the United Kingdom

Effective in England and Wales, the Social Action, Responsibility and Heroism (SARAH) Act seeks to provide protection to individuals who act voluntarily to provide reasonable aid to those who are injured, ill, in danger, or otherwise incapacitated. The Bill contains language to make clear its overarching purpose: to “take a range of measures to encourage volunteering and involvement in social action”.

Access to Medical Treatments (Innovation) Act 2016, the United Kingdom

This Bill, applicable to England and Wales, was enacted “...to promote access to innovative medical treatments (including treatments consisting in the off-label use of medicines or the use of unlicensed medicines) by providing for (a) the establishment of a database of innovative medical treatments, and (b) access to information contained in the database.”

We are providing you with links to designs for items that are much-needed during this pandemic; however, you are responsible for your creations. Please practice due diligence (the care that a reasonable person exercises to avoid harm to other persons or their property). We want your contributions to help, not harm! If you are familiar with similar laws in other countries, please reach out to us with relevant references.

References: SARAH Act; Access to Medical Treatments (Innovation) Act 2016 (UK Legal)

Design, Manufacturing, & Engineering Projects

PPE (Personal Protective Equipment) is critical to the protection of healthcare workers, acting as a barrier and therefore controlling exposure to COVID-19. Some of the most fundamental items comprising PPE include gloves, goggles, surgical masks, respirators, protective gowns, and disinfectant. Many of these crucial PPE items are now in short supply due to interruptions in the supply chain, and also from the massive demand as the number of patients infected continues to grow exponentially.

Numerous medical devices are required to treat the COVID-19 patient and will also fall into short supply (e.g. ventilators). Shortages of necessary PPE and medical devices will continue to pose a significant problem for healthcare workers and patients around the globe. Anyone with production capabilities should carefully consider the manufacture of known designs and development of new designs for the following items.

PPE Use Guide

OSMS has compiled research from twelve sources to give the public a comprehensive view of what kinds of personal protective equipment (PPE) should be used to minimize the risk of COVID-19 infection during different types of activities. Please reference our OSMS PPE Use Guide for more information.

Supply Categories

OSMS lists the included reference materials in service to the ongoing development of global COVID-19 response efforts. The inclusion of any reference or resource should not be construed as endorsement, promotion, or support of any organization. Since medical developments occur daily, this page may contain outdated material. While reasonable efforts are made to present current and accurate information, no guarantee of any kind is made and OSMS is not liable for any damage or loss related to the accuracy, completeness or timeliness of any information contained on or linked from this page.