April 7 is the deadline to comment on proposed guidance issued by the U.S. Food and Drug Administration (FDA) that would set differing accuracy standards for blood glucose monitoring systems used in nursing homes and other healthcare settings versus at home. The agency says the changes, which were published in the Federal Register on Jan. 7 and in part call for increased meter accuracy, are being driven by a need for tighter regulatory standards as well as changes in the way diabetes is treated and managed.
"FDA believes that by distinguishing where these devices are used they can be better designed to meet the needs of their intended populations and ensure greater safety and efficacy," Courtney Lias, director of a division within the FDA's Center for Devices and Radiological Health, wrote in the FDA Voice blog. Accuracy of clinical meters can be affected by abnormal oxygen levels and other psysiological variables in healthcare settings, she said. Other government entities in the past have said that blood contamination and infection-related issues should factor into device design and maintenance.
The guidelines are not new rules for healthcare providers or individuals, according to the agency; rather, they apply to manufacturers and the information they should submit in the future when seeking product clearance. For instance, meters designed for self-monitoring must contain a prominent warning that they are not be to used in healthcare settings. The guidance also calls for labels to specify meter accuracy.
But some healthcare professionals have expressed concern that approval of more stringent clinical standards would adversely affect the availability of acceptable monitoring systems.
"I hope that the FDA listens to the complaints, because clearly there will be lots," David B. Sacks, MB, ChB, FRCPath, of the National Institutes of Health Clinical Center, said at a recent European Association for the Study of Diabetes meeting in widely publicized remarks. "I think that it's going to be very difficult for manufacturers to meet these criteria. If they don't make them more lax, there will be no glucose meters approved in the future," he added.
During the comments period, the FDA is encouraging members of the public to explain the reasons for elements they don't like, send suggestions for changes and ask for clarification of anything they don't understand. For instructions on how to comment, click here.
The FDA decided against using the guidance to designate meters specifically for type 1 or type 2 diabetes, instead saying that labeling could help users determine which meter was most appropriate for their use.
The meters are not intended to diagnose or screen for diabetes, to monitor glycemic control or hospital patients who do not have diabetes, for use with those who are critically ill or for use during diabetes screenings at health fairs and community events, according to the agency.