Post-market device surveillance – boring though very important

Thanks to Claudia Pagliari for passing me a news item from the Diabetes Technology Society, announcing that the Steering Committee has been assembled for its Surveillance Program for Cleared Blood Glucose Monitors. To quote:

“This program is intended to identify poorly performing blood glucose monitoring products on the market.   This surveillance program will provide an independent assessment of the performance of cleared blood glucose monitors following Food and Drug Administration (FDA) clearance.  The program will generate information that can assist patients, healthcare providers, and payers in making informed product selections.  The information will also be provided to FDA, which is the government agency that regulates these products.”

So why is this so important? Well one of the things this Editor discovered when doing research into how to encourage GPs to recommend medical apps is that none of the existing organisations that evaluate medical apps appear to recognise adequately that every change of operating system, every upgrade in functionality needs to be carefully checked to ensure the app is still as safe and effective as it was when the app was first evaluated. For example, some apps such as Mersey Burns check that the mobile is running the required operating system superbly; most don’t.

“After a product has been cleared for use by the FDA, there is currently no systematic post-market surveillance program that monitors for ongoing product quality post-clearance. Poorly performing BGM system can interfere with the ability of people with diabetes to reliably monitor their blood glucose levels, and make correct decision based upon the readings.  Inaccurate readings can lead to incorrect actions and therefore to adverse outcomes. Ongoing efforts by the FDA to improve accuracy standards for pre-market clearance would be undermined if performance was not maintained post-market.  Therefore, a post-market surveillance program is critically important to ensure the accuracy of cleared products for people with diabetes.”

So hats off to the Diabetic Technology Society – let’s hope others pick up this excellent initiative, particularly for medical apps. As David Klonoff, M.D., founder of Diabetes Technology Society and a Clinical Professor of Medicine at University of California, San Francisco said “This surveillance program will provide a significant benefit to both patients and manufacturers”.

 

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