New Catheter Materials Fail To Prevent Infections, Complications: Study

Catheters with special coatings fared no better than polyurethane when it came to infection and thrombosis risks.

Tests conducted on two new materials promoted for use in the construction of certain catheters suggests that they are not significantly better than older polyurethane designs, which have been associated with infection risks and device failures.

In a study published in the New England Journal of Medicine on January 8, Australian researchers compared outcomes for various materials used in the construction of peripherally inserted central catheters (PICCs), including traditional polyurethane, and more recently developed alternatives, such as hydrophobic or chlorhexidine PICCs. However, they found little improvement over the older polyurethane devices, according to the report.

PICC lines are thin, flexible tubes inserted into the upper arm to deliver intravenous fluids, medications and chemotherapy directly to a large vein near the heart. However, their use comes with an increased risk of catheter infections and blood clots, with much attention focused on the materials used to manufacture them.

Beyond infections and thrombosis, PICC lines can also lead to complications such as bleeding, nerve damage, irregular heart rhythms, vein injury and device malfunctions. Despite these potential risks, infections and blood clots remain the most common concerns.

Little Difference Seen in Catheter Infection and Injury Rates

In this study, a research team led by Dr. Amanda J. Ullman compared the performance of hydrophobic and chlorhexidine PICCs to traditional polyurethane catheters. They conducted a randomized, controlled, superiority trial in three Australian hospitals, assigning adults and children to catheters made of one of the three materials, with 365 assigned to each of the newer materials, and 368 assigned to polyurethane catheters.

The researchers looked for device failures, infections, thrombosis, breakage or occlusion complications. According to the findings, there was little difference in device failures. However, the researchers discovered slightly higher complications in the chlorhexidine group.

“Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs,” the researchers concluded.

Bard PowerPort Catheter Lawsuits

These findings emerge amid a rising number of port catheter lawsuits filed in recent years against manufacturers of the devices, each claiming that the catheter devices contain dangerous design defects that can result in either fractures, migrations or increased risks of infections.

Unlike other implanted port catheters, Bard PowerPort devices are marketed as high-pressure ports, which are designed to withstand the increased pressure required for certain types of injections, such as contrast injections in CT scans.

However, a growing number of Bard PowerPort lawsuits have been filed in recent years, alleging that the materials designed to withstand high-pressure injections can cause the catheter to degrade over time, resulting in an increased risk of Bard PowerPort fractures and migrations.

Additionally, a series of PowerPort infection lawsuits have been filed by individuals who claim that the deterioration of barium sulfate used in its polyurethane materials can entrap air, creating fissures, cracks and pits in the catheters where bacteria can accumulate, resulting in blood clots, bloodstream infections, device failures and the need for revision surgery.

Given common questions of fact and law raised in complaints filed throughout the federal court system, a Bard PowerPort MDL was established before U.S. District Judge David G. Campbell in the District of Arizona in August 2023, where the parties have been preparing a group of representative claims for early trial dates to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Angiodynamics Port Catheter Lawsuit

Dozens of similar AngioDynamics port catheter lawsuits have also been filed, alleging that similar problems led to the development of microfractures in those devices, resulting in infections and failures, due to the materials used in their construction.

Similarly, all AngioDynamics port catheter lawsuits have been centralized for pretrial proceedings under U.S. District Judge Jinsook Ohta in the Southern District of California.

Both MDLs are working on the development of a bellwether trial process, which will result in the selection of a handful of representative cases for early trial dates. These trials will allow both parties to evaluate how juries may react to evidence and testimony that will be presented repeatedly throughout the courts during the litigation.