Page 41 - Glucose Monitoring Devices

Postmarket analytical performance 37

Postmarket analytical performance
Despite the rigorous process that manufacturers must endure to obtain initial market-
ing clearance for their SMBG devices by regulatory agencies, the postmarketing
surveillance of such devices has not been mandated because the 510(k) process
has very little room for product recall unless there is proof that the manufacturer
falsified data when obtaining clearance or there is proof that the product ingredients
are being adulterated following clearance. In the absence of surveillance programs,
independent studies have repeatedly demonstrated that many FDA-cleared systems
do not meet the latest ISO or FDA guidelines, and some do not even meet the less
strict ISO 15197:2003 guideline.
A 2018 review by King and colleagues analyzed 58 studies published between
January 1, 2010 and July 12, 2017 that assessed the accuracy of 143 BGMs, 59 of
which had been cleared by the FDA [14]. The number of BGMs evaluated per study
was 4.86. In addition to assessing whether the studies demonstrated that the evaluated
BGMs met ISO 15197:2003 or ISO 15197:2013 guidelines, the article also stratified
the results by FDA approval status, year of market clearance, and whether the study
was supported by device manufacturers (as opposed to independently supported).
The review article discovered that newer meters outperformed older meters and
that FDA-approved meters outperformed non-FDA approved meters. However, out
of the 59 FDA approved BGMs, only 75.4% managed to pass the older ISO 15197
2003 standard. When evaluated according to the newer ISO 15197 2013 standard,
only 46.4% of FDA-cleared BGMs passed the test. The authors concluded that
even fewer would pass the most recent 2016 FDA guidelines because they are
even more rigorous than the ISO 15197 2013 standard.
The analysis also demonstrated that FDA-cleared BGMs assessed in
manufacturer-supported studies were statistically significantly more likely to pass
the requirements set forth in ISO 15197 2003 (OR ¼ 22.4, CI 8.73e21.6, P <.001)
and ISO 15197 2013 (OR ¼ 23.08, CI 10.2e60.0, P <.001), when compared with in-
dependent studies. Furthermore, manufacturer-supported studies were discovered to
be statistically significantly more likely to meet ISO 15197 2003 (OR ¼ 37.2, CI
4.62e299, P <.01) and ISO 15197 2013 (OR ¼ 56.1, CI 11.9e263, P < .01) criteria
when testing their own product versus when testing a competitor’s product.
Prompted by these concerning studies, the Diabetes Technology Society gath-
ered a panel of experts in clinical chemistry, clinical diabetes management, and
regulatory affairs to create a consensus protocol for the DTS-BGM Surveillance Pro-
gram that would independently assess the BGM accuracy of systems postmarket
release through a surveillance program. Findings from this study were published
in 2018 [9] that evaluated 18 BGM systems that had been cleared by the FDA. These
18 systems represented approximately 90% of all commercially available systems
used from 2013 to 2015. This study included 1035 subjects across three clinical sites
and only used testing supplies that were obtained from consumer outlets (as opposed
to being supplied by the manufacturer) to best assess real-world performance.
Because the 2016 FDA guideline had not yet been formally adopted at the time