Special Enterprise Series: Diabetes Device Recalls
- Part 1: An In-Depth Look at Trends & Policy
- Part 2: Diabetes Device Recalls: A Tale of Patient Impact
- Part 3: The Human & Legal Toll
- Part 4: The Path Toward Patient-Centric Solutions (Currently Reading)
By Michael W. Hoskins, DiabetesMine Managing Editor
Tracking the trends of diabetes device recalls is no easy task, whether you're a regulator, manufacturer, patient or provider -- or even a casual observer of medical device safety.
But steps are already being taken to fix parts of the system that aren't working as well as they could.
Here's a snapshot of what is happening, and what our Diabetes Community might expect as we move forward. This is all based on conversations with FDA regulators, industry experts, and policy wonks who've been raising their collective voices and pushing for change on how med-tech recalls work.
Creating a National Medical Device Evaluation System
As we've reported throughout this series, we experienced for ourselves just how complicated the system is -- making it nearly impossible to get a clear picture of how safe our devices really are, and what happens if and when a product is recalled. But there is movement toward a more transparent and responsive framework.
One of our D-Community peers, data entrepreneur and advocate Anna McCollister-Slipp, notes that the FDA is working on the device surveillance issue behind the scenes. She sits on the "executive operations committee" for the Medical Device Epidemiology Network Initiative (MDEpiNet), which is a driving force behind the creation of a National Medical Device Evaluation System.
OpenFDA
The agency is working to improve public access to data through a new FDA open-source database. While currently in Beta testing, it represents a massive improvement over legacy systems, allowing users to search for adverse events more granularly. We believe this is a vital step toward making the system more "digestible" for the average patient.
Focus on Detailed Reports
Dr. Courtney Lias of the FDA notes that the effectiveness of these databases relies on the quality of patient reports. She encourages users to be as specific as possible when reporting malfunctions, as vague reports often cannot be used to identify widespread trends. If you encounter an issue, report it directly to the manufacturer, and also directly to the FDA if you feel the company's response is inadequate.
Tracking Litigation
Some experts suggest we could benefit from a system like the one the TSA uses to monitor automotive litigation, using product liability lawsuits as a "guidepost" to identify potential medical device defects before they result in widespread harm.
Incremental Improvement
We know patients are often left frustrated by the current landscape. Rest assured that the FDA is working on ways to improve, however incremental these changes may be. At the end of the day, we're encouraged to see these efforts to fix the system—or at least, to make it suck less than it does now.
Missed Part of the Series?
Re-examine the full scope of our diabetes device recall investigation:
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