FDA delayed the approval of medical devices for use in the emergency department for more than a year because the devices have no standard operating procedures and are not required to be properly designed, according to a new report.
A team of researchers from Stanford University and the University of Minnesota reviewed more than 500,000 patient-reported reports from the National Health and Medical Research Council (NHMRC) of the U.S. Department of Health and Human Services and concluded that the devices are “unsuitable for emergency use,” the New York Times reported.
The researchers concluded that “the devices have insufficient safety features to ensure safe use,” according to the report.
The FDA’s Office of Medical Devices is required to approve medical devices under certain circumstances, but this is not one of them, according a spokesperson for the agency.
The device makers involved are in the process of developing standards for their products and “have not submitted their final design for review,” the spokesperson told the Times.
The makers of the devices “are actively working to develop standard operating procedure (SOP) specifications for these devices, and are in discussions with regulators about this,” according the spokesperson.
The report was published on Sunday, and the agency is expected to issue a final rule in the coming months.