The US medical device regulating authority, the FDA, issued a Safety Communication on medical devices used for monitoring glucose levels. These devices are primarily used by patients with a high risk for diabetes. The warning covers a wide range of devices including insulin pumps, glucose monitoring systems and automated insulin dosing system.
In the document, it was stated that the FDA registration process for such devices should include not only the general examination but also the detailed review of all components of devices. In the case of electronic medical products providing information on glucose levels, the approval procedure should also include a review of the calculation methods used by the devices because the outcome of the calculation depends on algorithms converting data to the information displayed to the customer. The calculation methods are important since customers may take further steps according to the results the device shows them.
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Do It Yourself
The regulating authority also warns that the wide-spread principle called “DIY” (Do it Yourself) could lead to harmful situations when such a device could include a medical product that is not compatible with its other elements. The existing FDA registration process aims to check the applicability of the device, its safety and effectiveness. Where it is lacking is checking the compatibility with other devices in possible combinations. Sometimes devices can even include elements that have not been previously approved by the FDA, which could cause immense harm to patients. The main concerns of where harm can occur is the possibility of a malfunction occurring in the device which could lead to the display of wrong information or inappropriate insulin dosing.
According to the position of the FDA, the aforementioned devices provide customers with life-saving care, so any errors in their performance may lead to unexpected consequences that could cause harm to the health of patients. This is why it is strongly recommended to avoid the use of medical products other than those that passed the FDA registration process, including all applicable safety testing. As an example of the possible negative consequences, the regulating authority named the report on a real situation that took place where a patient used an unapproved medical device which increased the insulin dosing above the safety level. In turn, the patient required serious medical treatments. The malfunction came from the production of wrong signals from the glucose monitoring system which had not passed FDA registration process. Specifically, the glucose sensor itself had been approved, but not the algorithm used to calculate the final outcome which resulted in the wrong interpretation of electronic signals. That is why it is possible to say that the problem mostly lies in the sphere of the software rather than hardware. The manufacturers of such medical products could use algorithms that were not properly tested by the FDA, that leads to the results just as mentioned above.
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The FDA concealed the name of the device and its manufacturer, but there is information that the situation took place outside of the United States. At the same time, it is absolutely clear that the FDA would check all incident reports related to any medical product of this type and additional attention to the appropriate software.
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