Breaking news on catheter hubs
Dendritic discharge patterns in a polymer may look stunning, as the image here attests, but if you're making a catheter hub, as opposed to a random act of art, it can lead to catastrophic device failure. Cambridge Polymer Group (CPG), a contract materials research lab headquartered in Boston, MA, recently shared a case study of a customer whose catheter hubs were cracking during the manufacturing process. The group determined that the sterilization technology used by the manufacturer was causing the problem and found a solution.
July 11, 2014
Dendritic discharge patterns in a polymer may look stunning, as the image here attests, but if you're making a catheter hub, as opposed to a random act of art, it can lead to catastrophic device failure. Cambridge Polymer Group (CPG), a contract materials research lab headquartered in Boston, MA, recently shared a case study of a customer whose catheter hubs were cracking during the manufacturing process. The group determined that the sterilization technology used by the manufacturer was causing the problem and found a solution.
The medical device manufacturer was using E-beam technology to terminally sterilize the polycarbonate in which the electronics and catheter are embedded. This sterilization technique, which involves bombarding the workpiece with high-energy electrons, is commonly used in medical manufacturing, but it has drawbacks when treating certain materials. The high flux and beam energies cause rapid charge buildup on components, explains CPG, and if it is uncompensated, the charge can arc between the charged surface and metal contacts, resulting in fracture of the insulating polymer. The effect is similar to a lightning storm.
A breakdown of the polymer dielectric caused by an excessive charge during the high-flux E-beam radiation process was determined to be the root cause of the device failure. CPG recommended switching to gamma-based sterilization, which allowed the manufacturer to achieve process requirements with almost no other changes.
Understanding the relationship between materials and processing conditions is vital, says CPG. The company has deep expertise in synthesizing, understanding, and analyzing synthetic and natural polymers in all shapes and forms, and provides materials consultation, R&D, testing, due diligence, and litigation and expert witness services. Instrument design and prototyping, testing and validation of hardware, and biomedical materials research and testing are also supported.
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