Development of a Coring Test for Non-Coring Huber Needles

摘要

Huber needles were designed to penetrate an implantable port septum without producing cores, or shaving off slivers of material from the septum which can cause the port to leak or fail. Needles with manufacturing flaws resulting in sharp rear bevel edges [1] have been undetected in some products. That sharp rear bevel edge (sharp anti-coring heel) is the major factor in producing cores (i.e. plugs of septum material) during the septum perforation. When a core is produced the small piece of silicone (a core) can be flushed from the needle into the port, possibly entering the blood vessel. This can lead to adverse health events. In recent years about two million Huber needles were voluntarily recalled from the market due to the possibility of coring. There is no standardized coring test for Huber needles. Some manufacturers sell their ports and needles as a kit while a majority of needle manufacturers sell their needles without specifying compatibility with specific ports. Port septa differ in shape, hardness, and how they are clamped into the body of the port. Healthcare providers believe that any Huber needle can be used with any implantable port, even when a port manufacturer specifies that a specific brand of Huber needle should be used. This is due to the assumption that all Huber needles are non-coring for any application. Since the performance of Huber needles has been inconsistent [1], the food and drug administration (FDA) developed an anti-coring test and is working with ASTM to use this test as a basis for a voluntary standard for testing Huber needle coring.