- In an effort to avoid shortages of medical products in the aftermath of Hurricane Michael, FDA said Thursday it is actively monitoring and coordinating with 11 manufacturers, which it did not name, of "critically important medical devices." The agency said the goal is to quickly address issues by allowing temporary alternate facilities or by allowing temporary importations.
- The Category 4 hurricane, which made landfall on the Florida Panhandle, has wiped out power to more than 1.2 million customers across Florida, Alabama, Georgia, North Carolina, South Carolina and Virginia. HHS Secretary Alex Azar has declared a public health emergency in Florida and Georgia.
- HHS said it is working with states to provide data on Medicare beneficiaries who rely on dialysis or other special medical equipment like oxygen concentrators. The department said it has moved 400 medical and public health professionals and medical equipment into impacted areas and has 300 more on alert from the National Disaster Medical System and the U.S. Public Heath Service Commissioned Corps.
FDA has activated its Emergency Operations Center and has staff assessing facilities producing critical medical products to avoid shortages.
"We have been closely collaborating with state and federal partners to provide technical assistance and support and we will continue to do so over the coming weeks as we will continue to assess the damage from this dangerous storm. We already have taken initial steps to identify FDA-regulated facilities in areas in the storm's path and are closely monitoring its impact," FDA Commissioner Scott Gottlieb said in a statement.
CMS Administrator Seema Verma says that the public health emergency allows the agency to temporarily waive certain Medicare, Medicaid and Children'’s Health Insurance Program requirements.
For example, CMS has suspended certain requirements to allow those who lost or sustained damage to their durable medical equipment to continue to access the devices they need.
The agency also announced it has activated the Kidney Community Emergency Response program and is working to survey dialysis facilities impacted by the storm.
DaVita Kidney Care said that it is opening its dialysis clinics to any patient regardless of where they typically receive treatment.
"Uninterrupted access to care is critical for dialysis patients, so we are prepared to support anyone in need, whether you typically treat with one of DaVita's coastal clinics or even with another dialysis provider," said Jeffrey Giullian, vice president of medical affairs at DaVita, in a press release.