FDA has cleared medtech companies and healthcare providers to make limited modifications to imaging devices to increase availability during the COVID-19 pandemic.
In guidance issued Thursday, FDA said organizations can make changes to the indications for use, hardware and other aspects of a range of devices to increase access to imaging inside and outside of hospitals.
FDA’s willingness to relax the rules reflects the role imaging equipment is playing in the care of patients infected with the coronavirus. With the virus targeting the lungs, devices that can visualize pulmonary abnormalities are in demand.
In recent weeks, FDA has issued guidance on infusion pumps, oxygenation devices and other pieces of medical equipment to counter the risk that the pandemic will cause patient demand to outstrip hospital availability. Now, FDA has similarly published guidance on the use of MRI, CT, X-ray and ultrasound devices during the pandemic, allowing certain changes to devices without the usual regulatory processes.
FDA outlined how imaging devices can be modified for portable use, through the addition of a battery and other changes, without creating an “undue risk.” Offering that option is intended to enable healthcare providers to image patients outside of their facilities, thereby potentially slowing the spread of the virus.
Likewise, FDA has no issue with the addition of barriers to protect the operator or patient from disease transmission, nor with design modifications intended to make devices easier to clean and disinfect. Those modifications apply to all types of imaging equipment covered by the guidance.
FDA also provided more specific regulatory flexibilities specific to certain types of imaging equipment. For example, regulators are okay with changes to ultrasound devices that are intended to enable healthcare professionals other than trained sonographers to capture images. FDA also proposed modifications to image analysis software, such as the addition of capabilities for lung segmentation and measurements.
The agency published the guidance on the same day as it released a document covering the use of fetal and maternal monitoring devices during the pandemic. Through certain modifications, FDA said healthcare providers can continue to gather prenatal data without requiring pregnant women to visit them for in-person exams.
Modifications permitted by FDA include the home use of prescription fetal dopplers by non-specialists. The devices, which listen for a fetal heartbeat, are typically used by healthcare professionals at their clinics. However, FDA thinks lay persons can use the devices at home under the direction of a healthcare provider during the pandemic.
In related news, the Medical Imaging and Technology Alliance on Friday sent a letter to the Centers for Disease Control and Prevention recommending the agency reference the recently issued consensus statement from the Fleischner Society in interim guidance to healthcare providers to inform patient management during the pandemic.
MITA also called for the "establishment of an ongoing partnership with the CDC, as well as other public health organizations, to support the broad dissemination of the latest research on imaging in the COVID-19 diagnostic and treatment spaces."