To support response efforts during the coronavirus disease 2019 (COVID-19) pandemic, the US Food and Drug Administration (FDA) has issued guidance for facilitating the availability of coagulation systems to measure whole blood viscoelastic properties to assess hemostasis.
“Modified use of these devices in hospital patient healthcare settings may increase access to important examination of whole blood viscoelastic properties to facilitate patient management by healthcare providers during the COVID-19 public health emergency,” wrote the authors of the guidance document.
As there is currently no cleared or approved coagulation systems for measuring whole blood viscoelastic properties in a hospital patient healthcare setting, the FDA issued immediate guidance, which is only intended to remain in effect for the remainder of the public health emergency associated with COVID-19.
The enforcement policy applies to the following legally marketed coagulation systems: multipurpose systems for in vitro coagulation studies and coagulation systems for the measurement of whole blood viscoelastic properties.
Some modifications to device indications, hardware, and software that may create an undue risk to patients include:
- Changes made to hardware or software that directly affect the measuring capabilities and functionality of viscoelastic devices
- The modified device is to be solely or primarily relied up by healthcare professionals for the clinical diagnosis or treatment decisions related to COVID-19 or coexisting conditions
To ensure that users better understand the device modifications, the FDA recommends the following:
- Device manufacturers provide a detailed description of any changes to the device from specifications that were cleared by the FDA
- Clear instructions for the intended user
- Minimum installation and qualification testing before installation and inspection following installation
- A clear statement that the device is not indicated for the diagnosis of COVID-19
- A clear statement for both patients and healthcare providers that results that are generated by the device are supporting and should not be used in the sole or primary diagnosis or treatment of COVID-19-associated coagulopathy
- A clear statement that all results are intended to be interpreted by a licensed healthcare provider
“FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the availability and capability of coagulation systems for measurement of whole blood viscoelastic properties,” the policy authors noted.
US Food and Drug Administration. Coagulation systems for measurement of viscoelastic properties: enforcement policy during the coronavirus disease 2019 (COVID-19) publish health emergency. Guidance for Industry and Food and Drug Administration Staff. Updated January 14, 2021. Accessed January 22, 2021.