The American Diabetes Association has gone on record: The FDA needs to do more to assure the accuracy of BG test strips. In a Statement by the American Diabetes Association on the Need for Food and Drug Administration’s Regulation of Blood Glucose Test Strips, the ADA said “It is critical that FDA oversight extend beyond the initial pre-marketing approval to continual monitoring of the post-marketing product to assure that accuracy remains within established standards.”
The FDA does an initial approval when a manufacturer wants to sell BG strips in the US, and if the product is up to snuff, it’s granted a “510(k) clearance” -- but then no FDA followup. That’s like verifying that your new car has appropriate tire pressures when you first get it, but never again checking the pressures. Sooner or later, something may happen – and it’s unlikely to be good!
The FDA does occasionally announce recalls of BG strips when someone spots a problem (see for instance FDA announces a voluntary recall of Nova Max Blood Glucose Test Strips) but the FDA does not routinely re-test new lots of test strips that previously received 510(k) clearance to see if they are as accurate as they are supposed to be. Hence the ADA’s request.
There’s now a website, Strip Safely, which was set up by some PWD to “help the general public understand that there are inaccurate blood glucose test strips. We hope to get folks involved to do something about that. By something, we mean write the FDA, elected officials, and the news media.” Take their quiz – if you’re like me, you’ll miss several of the questions. And write the FDA and/or your friendly politician – Strip Safely has a sample letter to work from.
You can report problems with strips, meters or CGM devices to the manufacturer (who is supposed to report adverse events to the FDA – if they don’t, they get nasty warning letters) or directly to the FDA.
Strip safety is too important for PWD to have some slipshod manufacturers foist inferior products off on us. Hopefully there can be sufficient pressure put on the FDA that they will monitor strip safety more closely in the very near future.
Published On: August 23, 2013