Although a primitive catheter might be painful to imagine, for at least 3,500 years, urinary catheters have been used to drain the bladder when it is unable to empty on its own. Other types of catheters are used to administer medications, remove blood clots from arteries and veins, or to inject the dye used in angiogram procedures. And while copious amounts of people rely on catheters to stay healthy and improve their quality of life, widespread issues with these medical supplies have recently called their safety into question.
In fact, the problem has gotten so bad that nearly 4 million defective catheters have now been recalled. Dozens of people have reported injuries as a result of broken catheters, an issue that has been linked back to the degradation of the catheters and their components. In most cases, the catheter tips have been fractured or other components have separated within the patient’s body. These nightmare-inducing events cause catheter components to float freely within the bloodstream, often resulting in serious injury or death.
In 2016, the death of one Texas woman was directly caused by an 8-inch catheter fragment that was left in her heart during a procedure back in 2007. Her husband has filed a lawsuit against the hospital for failing to remove the fragment for seven years.
Considering how often catheters are utilized in medical procedures, more lawsuits are expected to be filed in the coming months and years as more death by catheter cases come to light.
Several recalls have taken place over the last year or so. The largest, issued last April by Cook Medical, covered more than 4 million Beacon-Tip catheters. The FDA reported at least 30 injuries were linked back to this catheter, which has a tip that can easily break off. Other recalls were issued due to excess material in the tip, peeling catheter coatings, and other problems.
One overarching cause could actually be linked back to the FDA itself. The administration’s 510(k) Clearance was designed to bring a product to market on a faster schedule. This can be helpful for doctors who have patients with a time-sensitive medical need. But the 510(k) clearance has often been used as a loophole because it allows a given manufacturer to make updates to an existing product without further scrutiny as long as the product is performing well and the design is inherently similar to the product that’s already on the market. Thus, the updated product doesn’t have to go through the same sort of rigorous clinical tests of a new device.
Although this may not apply to every case here, it will make patients question whether a life-saving medical product is truly safe. And that could present a big problem for both patients and the entire medical industry.