Technical specifications of medical devices for the case management of COVID-19 in healthcare settings. Interim recommendations, 3 March 2020

Abstract

• In December 2019 a novel coronavirus (SARS-CoV-2) was identified as the causative agent of pneumonia (COVID-19) among people exposed to a seafood market in Wuhan, China. • There are gaps in the knowledge about the natural history of COVID-19, including viral shedding, reservoirs and patterns of transmission. On February 17, 2020, the Chinese Center for Disease Control and Prevention published a study with 72,314 recorded cases, of which 44,672 (62%) were confirmed for COVID-19. Among the confirmed cases, 31.2% were over 60 years of age and accounted for 81% of the total deaths. The overall case-fatality rate was 2.3%. The most prevalent comorbid conditions were hypertension, diabetes, and cardiovascular disease. The spectrum of disease included 81% of mild cases (non-pneumonia and mild pneumonia cases), 14% severe (dyspnea, respiratory frequency higher than ≥) 30/min, blood oxygen saturation lesser than ≤ 93%, PaO2/FiO2 ratio lesser than ≤ 300, and/or lung infiltrates > 50% within 24–48 hours), and 5% of critically ill patients, with respiratory failure, septic shock, and/or multiple organ dysfunction or failure. • The implementation of timely, effective, and safe supportive therapies (oxygen, antibiotics, hydration & fever/pain relief) is the cornerstone of therapy for patients that develop severe manifestations of COVID-19.• At the moment, there is no specific treatment for COVID-19, such as antivirals. There have been anecdotal reports on the use of these agents; however, its efficacy and safety are yet to be determined. The medical devices listed in this document provide minimum standards and technical description and specifications of medical devices for supportive treatment of COVID-19. • These medical devices are not limited, and to be adaptable to all countries in the region irrespective of their different health care systems and socioeconomic disparities. In addition, they are recommended for: o Early supportive therapy and monitoring of severe acute respiratory illness (SARI) when COVID-19 infection is suspected; o Management of hypoxemic respiratory failure and Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients; o Management of septic shock in COVID-19 patients.