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French agency forces recall and replacement of glucose monitors
Several large glucose monitor companies recently felt the sting of the French Medicines Agency (FMA) when their products were pulled off the market in what could be considered the European equivalent of a "voluntary" recall. In questioning the safety of glucose monitors, FMA conducted its own performance tests and decided to suspend the marketing and distribution of 12 models of monitors.
Manufacturers are crying foul, however, because FMA's testing protocol ignored product instructions and used venous rather than capillary blood, a clear contradiction of the draft international standard ISO 15197 on glucose monitors.
Despite several letters from the Health Industry Manufacturers Association (HIMA) and its overseas counterpart, the European Diagnostic Manufacturers Association (EDMA), FMA refused to repeat the testing. According to Donna Slingluff, HIMA's director of global strategy and analysis, "It seems that the French government just wanted to take older glucose monitors off the market even though they are used all over the world without safety problems."
| Manufacturer | Model |
| Bayer Diagnostics | Glucometer 2 Glucometer 3 |
| Chronolyss | Diascan S |
| IDT France | Checkmate Plus |
| Medisense | Medisense Sensor Card/ Medisense Blue Card Medisense Sensor Pen Precision QID Exactech Sensor Card Exactech Sensor Pen |
| Roche Diagnostics | Accuchek Easy Tracer |
| Vermed | Supreme |
Monitors affected by French recall and replacement order.
Manufacturers, of course, are worried not only by the loss of the French market, but also by the possible erosion of consumer confidence worldwide. Medisense Inc. (Bedford, MA) was hit especially hard, with all five of the company's models being suspended. Medisense spokesman Joe Daab called the FMA study "scientifically invalid" and pointed out that "we have performed many studies showing that our glucose monitors are reliable and accurate."
In several letters to FMA, HIMA expressed similar concerns. In the letters, Ed Rozynski, HIMA's executive vice president for global strategy and analysis, stressed that he was unaware of any patient claims against either the products or their safety. Rozynski further wrote of his concern that company reputations could be tarnished by market suspension of their products.
An EDMA press release went so far as to say that "safe and reliable products are being questioned as a result of a lack of coordination and poor decisions made by the public [health] authorities." EDMA also emphasized that the blood glucose monitors from well established manufacturers are safe and reliable when used as instructed. EDMA challenged FMA either to produce evidence to the contrary or issue a statement to restore public confidence.
To reduce public alarm, and at the urging of HIMA, FMA did agree to adopt a slower process of recall. Consumers will be able to return their monitors during normal doctor visits over the next six months, and will receive replacement units from the same manufacturers.
At present, FMA authorities are standing by their decision and declining to retest the monitors or rescind the recall. Slingluff worries that, "this situation could create a precedent. Other countries may start banning glucose monitors or even other types of devices.—Gary Woo
ILLUSTRATION BY KEN CORRÁL
