Current Testing for Quality Assurance of Medical Device Materials and Components

Quality reviews are crucial to many manufacturing Processes, especially those where the goods directly impact the health and safety of consumers. We have all heard of issues and even tragedies connected with automotive, food, and medical devices which were poorly designed, tested, or manufactured. The answer to those failures is introducing an increasing quantity of industry and government regulations meant to prevent these issues. In the US, CFR Title 21 covers the principles of the Food and Drug Administration whose Center for Devices and Radiological Health CDRH monitors manufacturers of medical devices. As part of this regulatory process, the FDA regularly reviews medical device manufacturers to confirm compliance.

Testing for Medical Devices

The Importance of quality assurance in medical device manufacturing is acknowledged by ASQ, a worldwide organization dedicated to enhancing the quality of goods. ASQ devotes considerable resources regarding quality assurance for medical devices and understands that medical device manufacturers are challenged to balance the requirements of regulatory requirements while comprising production expenses. Material Quality and consistency are paramount for many medical devices, especially those elements that come in direct contact with the human body, whether permanently or temporarily. Eddy current is an efficient and cost-effective method for identifying defects and defects in lots of the conductive materials like cable and tubing used in the production of medical devices. Eddy¬†medical device testing can also make certain that heat treatment and annealing procedures needed for molded or machined medical elements haven’t jeopardized their structure or ethics.

A couple of examples below illustrate the crucial role that eddy current testing plays in the quality assurance of medical device materials and elements. Austenitic 316 stainless-steel, martensitic 440 and 420 stainless steel, and ceramic rods are machined to make pins, screws, affirms sticks scoliosis treatments used in orthopedic surgeries, in addition to dental implants. Before machining, the compounds should be inspected for structural consequences to ensure the lack of manufacturing seams and identify pitting that could promote infections once implanted in the body. Medical Tubing used for the production of syringes, catheters, and endoscopic tools –as well as tube that transports oxygen, saline solutions, or blood in medical devices–needs to be manufactured to standards that are consistent, frequently within extremely close tolerances. Inspections of medical-grade tubing used for syringes requires the ability to recognize microscopic flaws that affect wall thickness, distortions that would impede fluid flow or cause undue distress, or voids that raise the chance of syringe breakage.