- R.F Wittmeyer
- March 9, 2019
According to a Kaiser Health News investigation, the FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.Since 2016, the FDA has entered 1.1 million incidents into an alternative summary reporting repository. This is different than their MAUDE system, which medical experts trust to identify potential problems for patients. Currently, they must report deaths in MAUDE. However, they placed incidents about approximately 100 devices in this hidden repository. The types of devices include surgical staplers and balloon pumps snaked into vessels to improve circulation and mechanical breathing machines. Agency records provided to Kaiser showed that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.
What Does the FDA Say?
Kaise reports that the FDA has also opened many pathways to report injuries. Many of these pathways appear private or obscured. A registry exemption was created without any public notice or regulations. All the device manufacturer needs to do is request such an exemption. Such exemptions have been given to pelvic mesh and devices implanted in the heart.
After the reported 480,000 injuries or malfunctions in 2017, Alison Hunt, another FDA spokeswoman, said the majority of device makers’ “exemptions” were revoked. She continued by saying that a program took shape that requires a summary report to be filed publicly.
The FDA stated the alternative summary reporting program two decades ago. They wanted to cut down on redundant paperwork. Due to the under-reporting of device problems, they had an influx of thousands of reports each month. Since many of the reports looked similar, they proposed a solution. A device maker would seek an exemption to avoid reporting certain complications and would instead send a spreadsheet on a specific timetable of all injuries. Additionally, the public could see the list of the exempted devices. However, at some point, that list became private.
The Surgical Stapler
An example of the risks associated to these hidden databases is how doctors turned to surgical staplers. Although some had concerns, only 84 injuries or malfunctions were openly submitted. However, nearly 10,000 lived in the hidden database. The public databases reported 250 deaths related to staplers since 2001. One of the market leaders stated they used the reporting exemptions to file stapler-related reports.
Based on this reporting, the FDA has announced a plan to investigate surgical staplers and their safety. Dr. William Maisel said, “Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts.”
What Does This Mean for You?
“The public has a right to know about this,” said Dr. S. Lori Brown, a former FDA official who accessed the data for her research. Dr. Brown told Kaiser that if doctors only rely on the public reports, they can easily reach incorrect conclusions. Other experts say that the FDA has handed over the regulations to the device manufacturers.
Your doctors generally take great care of you. But they rely on these systems when they choose the tools to help you. Although a doctor does not have to always talk to you about the procedures, you can ask questions. Some questions can include:
- Has this device ever been subjected to human clinical trials? What information do you have about those trials? Who sponsored the research?
- Is the way you want to use the device “off-label”? Are there any warnings or contraindications on the device label?
- Do you have any written information about this device? What about materials that do not come from the manufacturer?
- What has been your personal experience with the device?
Your doctors want to help and you want the reassurance of your safety as you go through these procedures.
If you or someone you love has been injured after a medical procedure, contact the Law Offices of R.F. Wittmeyer, Ltd. today at (847) 357-0403 for a free consultation.