Resource: Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Source: U.S. Food and Drug Administration
Synopsis: The FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Hypercoagubility has been observed in patients with COVID-19. The guidance is intended to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measurement of whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the COVID-19 public health emergency.
Comment: We know that clotting disorders are more prevalent after COVID-19 infections. The seriousness of the thrombotic event seems to be related to the seriousness of the COVID-19 infection. These thrombotic events affect the lungs, the heart, the peripheral cardiovascular system, and possibly many other major organ systems. This new guidance as previously outlined in the summary will help guide treatment protocols. As of this date, there are no definitive treatment parameters amongst the medical community. Many different agencies and medical specialties have their own guidelines. Hopefully, the efforts by the FDA will allow all of us to come to agreement on more definitive recommendations for diagnosis and treatment of post COVID-19 thrombotic phenomenon.
