Defective medical devices can pose serious consequences to patients. Recent media reports suggest there may be many more patient deaths from faulty medical devices than previously known.
The U.S. Food and Drug Administration is the federal agency responsible for the regulation of medical devices in this country. Before medical devices hit the market for patient use, manufacturers must prove they are safe to gain FDA approval.
Reports of Defective Medical Devices
The FDA also monitors the safety of medical devices after approval. One way this is done is through the FDA’s Manufacturer and User Facility Device Experience (“MAUDE”) - an online portal to report adverse medical events involving medical devices.
Those required to submit these reports are:
· Medical device manufacturers
· Medical device importers
· Facilities that use the medical device
Those who may voluntarily report serious patient harm due to medical device malfunctions include:
· Healthcare professionals
· Patients
· Consumers
The FDA clarifies the MAUDE portal reports of unsafe medical devices are inherently limited as they largely rely on self-reporting measures that may be incomplete or biased.
When an adverse medical device event is reported to the FDA, it must be placed in one of four categories:
· Patient death
· Patient injury
· Medical device malfunction
· Other
The adverse event must be categorized as a patient death if the medical device caused or contributed to the death, or the cause of death is unknown.
23% of Medical Device Deaths Not Reported Correctly
A team of researchers reviewed this database and determined the number of patient deaths from medical device adverse events is vastly underreported. JAMA Internal Medicine published the study online in July (“Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death”).
Applying a “natural language” algorithm, researchers found 290,141 reports of serious patient injury or death, with a little more than half (52.1%) classified as a patient death.
But the researchers found that 23% of the reported events with a patient death were not placed in the system’s appropriate death category. That equates to about 31,500 patient deaths due to a defective medical device between December 31, 1991 and April 30, 2020 that were incorrectly reported.
This helps illustrate the extent of preventable patient deaths caused by unsafe medical devices.
For example, the nonprofit media outlet Propublica recently reported that a faulty heart pump implant either caused or contributed to an estimated 3,000 patient deaths. According to the report, even more troubling is that the manufacturer and the FDA were aware of potential defects but never stopped the sale of the heart pumps until just recently.
Negligent medical care can lead to preventable patient deaths. But so can unsafe medical devices. When defective medical devices cause serious injuries or death, many entities may be responsible, including those who make them and those who sell them.
If you believe a loved one’s death was linked to an unsafe medical device, speak with an experienced personal injury lawyer about your legal options.
The choice of a lawyer is an important decision that should not be based solely on advertisements.
Authored by Gray Ritter Graham, posted in Blog September 3, 2021
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