When x-ray inspection is used as part of a quality assurance program for any assembled device, steps must be taken early in the design stage to anticipate its use later in the development and production processes. Electronic assembly manufacturers learned this lesson years ago, and medical device manufacturers are now discovering it.
Just as radiologists must know human anatomy thoroughly before they can interpret a radiograph, so must medical device manufacturers understand the nature of their devices’ constituent parts and how these parts interact with the x-ray inspection process. For example, some manufacturers of molded catheter hubs have found that without a clear x-ray image, internal voids and defects in the hub that could harbor blood clots would not be detected. The polymers used for these moldings can exhibit very low x-ray opacity, making detection difficult.
There are several steps involved in learning how to interpret x-ray images and design for x-ray inspection. First, manufacturers need to understand the nature of the x-ray shadow and its modalities. Then, they need to see how medical device developers and manufacturers are using x-ray inspection. Finally, they must consider taking measures early in the design process to ensure a clear, accurate image when the assembled device undergoes x-ray inspection.
This article looks at key factors, including:
?x-ray imaging modalities,
?x-ray inspection in device manufacturing,
?designing for x-ray fluoroscopic inspection,
?and radiation levels employed in x-ray inspection
The article shows that while x-ray inspection and high-resolution magnification fluoroscopy are being used increasingly in the development and manufacture of medical devices (and preclinical study of those devices), the factors affecting the x-ray shadow are not always clearly understood by users—all of which can lead to misinterpretation of the x-ray image. By learning how to design for, interpret, and use x-ray inspection, in addition to other quality assurance instrumentation, medical device manufacturers can demonstrate their commitment to good manufacturing practices.
To read the article, click here.
About the author
Gil Zweig is president of Glenbrook Technologies Inc. (Randolph, NJ).