The U.S. FDA said it is “concerned” that certain filtering facepiece respirators imported from China may fail to consistently provide adequate respiratory protection to health care personnel during the COVID-19 outbreak. The agency said this conclusion is based on testing conducted under standards developed by the National Institute for Occupational Health and Safety, which demonstrated that these items did not provide a minimum particulate filtration efficiency of 95%, adding that among the manufacturers whose respirators failed the test are Guangdong Nuoakang Medical Technology Co. Ltd. and Daddybaby Co. Ltd.
The FDA stated that it has become aware of the potential for health care facility staff to misinterpret indicators used to validate sterilization of medical devices, a problem seen in association with two hydrogen peroxide vapor sterilization systems. The issue revolves in part around the absence of a standard indicator color to disclose the completed sterilization of the device, but the FDA said there have been no reports of injuries associated with the systems in question. The two indicators are the 3M 1248 indicator, which turns from blue to pink to indicate the sterilization of an unsterilized device, and the Aesculap MD334 indicator card, which reverses that chromatic change. The agency said it is working with the manufacturers on the question of a standardized colorization scheme, and advised users of these devices to revisit the manufacturers’ labeled instructions.
The FDA announced in the Federal Register that it will not pursue development of a regulatory mechanism whereby a device maker can file a premarket application for a drug-delivery device when the drug manufacturer does not wish to collaborate or pursue the new intended use. The agency proposed the notion in September 2017, at which point the FDA acknowledged that such new intended uses of the drug component may entail new dosing, route and/or rate of administration, or a new indication for use. During a Nov. 16, 2017, advisory hearing, regulatory attorney Brad Thompson, who was representing the Combination Products Coalition, advised that the framework of such a path would exclude the cooperation of the drug manufacturer in many instances, which would leave the device maker in a position of providing a de novo demonstration of the safety and the efficacy of the drug component, which would likely be economically impractical. Thompson also remarked that the drug manufacturer and the maker of the device might be “fundamentally on a different page message-wise” regarding the public health benefits of the drug component, given the novel route of administration. He also pointed to the attendant difficulties where adverse event reporting is concerned, given that the device maker may be unaware of such reports should such data be transmitted first or solely to the manufacturer of the drug. Consequently, the FDA said it does not intend to further pursue this approach.