The benefits to patients in hospital intensive care units of measuring capillary blood samples using blood glucose meters (BGMs) outweigh the potential risks, according to an advisory committee convened by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).
The panel – which discussed BGM use and considerations for obtaining Clinical Laboratory Improvement Amendments (CLIA) waivers in the second day of a two-day meeting last week – reached the consensus though the volume of associated adverse events is the among the highest for any type of medical device, CDRH reported Monday.
The total number of medical device reports (MDRs) for BGMs saw a sharp decrease from 2016 to 2017 – 75,039 vs. 34,873. There was a similar drop in the number of reported malfunctions for these devices, which went from 72,584 in 2016 to 32,780 in 2017.
However, the number of serious injuries reported via MDRs has remained steady since 2011, totaling 2,082 last year, and deaths increased to six from two the year prior.
“This may be due to the large population of people with diabetes in the US, the significant risks people with diabetes face every day, and the widespread use of these devices in patient management and care,” the agency clarified. The MDR volume “is also consistent with the criticality of the information they provide and extent to which people depend on these devices on a routine basis.”
According to FDA, millions of patients with diabetes across the US are now using portable BGMs to aid in self-management, which has led to many technological advancements from manufacturers in the space, including smaller blood samples and design feature adds to facilitate integration into healthcare settings.
Another caveat to the MDR analysis, however, relates to the “not possible” distinction between BGMs used at home versus those used in hospitals. The lack of robust data fuels the “poor understanding in the clinical community of the accuracy and reliability of capillary blood glucose results in certain hospital settings,” FDA said.
In addition to the benefit/risk justification, the panel was asked to deliberate on the current CLIA status for BGM use in intensively treated populations. Originally, simple glucose meters designed as over-the-counter devices with insignificant risks of providing false results were automatically CLIA-waived.
But companies manufacturing BGMs for use in hospital populations were later encouraged to seek both FDA clearances as well as CLIA waivers after 2013 guidance from the Centers for Medicare and Medicaid Services, which delegated to FDA the authority to assign in vitro
diagnostic tests to complexity categories to aid in insurance coverage determinations, clarified citations may be issued if these devices were being used in intensive care settings without meeting high complexity requirements.
FDA sought to reconsider this approach but there were mixed reviews from panel members on the concurrent FDA clearance and CLIA waiver status under the existing BGM regulation.
“The panel felt that a major issue was the quality of the capillary blood sample being assessed by the blood glucose meter rather than the blood glucose meter itself,” FDA said. “As such, there was no consensus as to whether modifications of the current CLIA status of blood glucose meters in the hospitalized setting would address this issue.”
2018 Meeting Materials of the Clinical Chemistry and Clinical Toxicology Devices Panel