Sens. Marco Rubio (R-Fla.) and Chris Murphy (D-Conn.) asked FDA commissioner Stephen Hahn in a Feb. 6 letter whether the FDA “has the necessary tools to ensure the safety and supply” of pharmaceuticals and medical supplies imported from China. The letter addresses China’s predicament with the 2019-nCoV virus, and noted that the U.S. imported nearly $13 billion in goods from China in 2018, which includes pharmaceuticals and medical devices. That figure does not account for “certain organic chemicals” used to manufacture pharmaceuticals, also imported from China. Murphy and Rubio noted that while the U.S. Centers for Disease Control and Prevention had previously opined that it is unlikely that the coronavirus would be transmitted by the shipment of those products, the coronavirus pandemic in China could impede the FDA’s ability to conduct inspections of plants located there. They also noted that China’s domestic demand for drugs and devices could affect the volumes exported to the U.S. The letter requests that the FDA respond with information regarding whether the FDA is equipped to ensure that the coronavirus predicament will affect availability of drugs and devices, and whether the agency’s routine inspection schedule for the current calendar year has been affected. They urged the agency to respond by Feb. 18.
The U.S. FDA said the class I recall of the Carestation series of anesthesia systems by GE Healthcare, of Chicago, is due to the prospect that a loose cable connection could cause the ventilator to fail. The agency said it is in receipt of no reports of injuries or fatalities, adding that the recall affects roughly 3,600 units distributed in the U.S. between August 2018 and July 2019. The company recommended that customers perform routinely scheduled maintenance on the units to ensure the cables are properly connected.
Two members of the U.S. Congress have announced a new bill that would bolster the use of telehealth, the National Telehealth Strategy and Data Enhancement Act of 2020 (H.R. 5763). The bill is sponsored by Reps. Anna Eshoo (D-Calif.) and Greg Gianforte (R-Mont.) and would streamline both the administration of federal telehealth grants and the process for obtaining grants. The bill would also bolster federal government oversight of telehealth spending. Eshoo said in the statement that H.R. 5763 would “help ensure that patients can have access to doctors and specialists where it is convenient for them.”
DNV GL Presafe AS, of Hovik, Norway, has been designated a notified body (NB) under the European Union’s Medical Device Regulations, bringing the number of NBs for the MDRs to 10. DNV has been authorized to review several categories of devices, including active non-implantable devices, non-active implants and non-active, non-implants. The NB said it will seek designation for in vitro diagnostics as well.
The U.S. Centers for Disease Control and Prevention (CDC) said it began shipping test kits for the 2019 coronavirus to select qualified U.S. testing labs and others to aid in the containment of the 2019-nCoV pathogen. The test, a real-time polymerase chain reaction test, is intended for use with specimens from the upper and lower respiratory tract, and CDC said the test has not been reviewed by the FDA. However, the test does fall under the recent FDA emergency use authorization (EUA) for coronavirus test kits. Roughly 200 kits will be distributed to U.S. labs and another 200 to outside-U.S. labs as well under the terms of the EUA.