Quality Control and Assurance Through Measurement and Inspection of Medical Devices
The history of the development of medical technology is also the history of the miniaturisation of medical devices. These days, inspections with higher accuracy than ever before are required. High-standard quality control and quality assurance are especially required for medical devices that are used directly on the human body.
This section introduces inspection examples using KEYENCE’s latest 4K digital microscope, which—in response to the requirements for advanced inspections—not only enables observation with clear images but also improves the efficiency of various inspections by requiring only simple operations.
- Quality Assurance of Advanced Medical Devices
- 4K Digital Microscope Application Examples in Medical Device Inspection and Quality Control
- A 4K Digital Microscope that Meets Severe Requirements
Quality Assurance of Advanced Medical Devices
Because most of medical devices are used directly on the human body, the devices have high-level requirements for safety, functionality, and effectiveness. Strict quality control and quality assurance are essential especially for medical needles, catheters, stents, pacemakers, and other such products that are used within the body because microscopic scratches, burrs, and similar defects have a high chance of damaging the human body or putting the patient’s life in danger.
Manufacturers and vendors of medical devices or in vitro diagnostics and registered manufacturing sites of such items are required to conform with a Quality Management System (QMS), which is a standard related to the manufacturing control and quality control of the products. Quality assurance is realised in quality control by meeting strict inspection requirements that conform to the QMS standard in all steps of the overall procedure from raw materials to the manufacturing process to the shipping of the final product.
4K Digital Microscope Application Examples in Medical Device Inspection and Quality Control
As medical treatment becomes more advanced, so too do the requirements for the functionality of medical devices and the requirements for the inspection and analysis of products. Extremely high-level inspections and analyses that make use of optical microscopes and digital microscopes are required not only in product manufacturing but also in research and development.
KEYENCE has manufactured new digital microscopes for over 30 years by listening to on-site customers and striving to solve their problems. The VHX Series 4K ultra-high-definition Digital Microscope is our latest series of digital microscopes and can be said to represent a new generation of these products.
This section introduces the latest applications of inspections and analyses of medical devices using the VHX Series to realise advanced quality control and quality assurance.
Catheter inspection
Balloon catheter inspection
The VHX Series 4K Digital Microscope realises a deep depth of field with its newly developed high-resolution lens, 4K CMOS sensor, and depth composition. This depth of field makes it possible to fully focus the image of the entire target in inspections of three-dimensional balloon catheters.
Guide wire inspection
The VHX Series 4K Digital Microscope is equipped with a High Dynamic Range (HDR) function that expresses high colour gradation with 65536 colours by capturing multiple images with different shutter speeds. This function enables observation with high definition and high contrast even of microscopic locations on guide wires.
Hydrophilic coating inspection
With the VHX Series 4K Digital Microscope, hydrophilic coatings, which were difficult to observe up to now, can also be observed with high-definition 4K images created with easy operations. Also, the coating film thickness can be measured by performing 2D measurements from the image.
3D shape measurement and appearance inspection of a catheter surface
With the VHX Series 4K Digital Microscope, depth composition is immediately performed on images having different focus positions even at high magnifications. Hence, 2D images in which the entire target is fully focused are displayed and 2D measurements are possible.
Furthermore, by creating a 3D image and performing 3D measurements on the surface status and observing it from various angles, it is possible to measure subtle surface scratches and understand the structure of parts.
Consequently, it is possible to perform magnified observation at high magnifications, to quantify appearance inspections and dimensional measurements, and to greatly improve the efficiency of an entire series of work operations.
Medical needle inspection
Medical needle tip observation
The deep depth of field of the VHX Series 4K Digital Microscope makes it possible to quickly and easily obtain fully-focused images even in the high magnification observations of needle tips, which have three-dimensional shapes.
Also, the HDR function can quickly obtain an image with high colour gradation by obtaining multiple images at varying shutter speeds, thereby enabling observation at high levels of definition and contrast.
Medical needle tip shape inspection
With the VHX Series 4K Digital Microscope, 2D measurement can be performed directly from observation. Various tools can be used to easily and quickly perform different types of measurements such as angle and width measurements.
3D measurement is also possible, enabling the inspection of the detailed shapes of medical needle tips by displaying the 3D shape and measuring the profile. This one unit is all that is needed to quickly perform observations with clear images, perform 2D and 3D measurements, and use numeric data.
Stent inspection
Stent free-angle observation
Using the free-angle observation system and the high-accuracy XYZ motorised stage of the VHX Series 4K Digital Microscope enables stent observation from a wide variety of angles.
The VHX Series is equipped with adjustment mechanisms that allow for easy field-of-view alignment, rotation, and oblique axis motion. Eucentric design ensures that the target stays centred in the field of view, even if the lens is tilted or rotated, thereby making it possible to easily observe stents—which are three dimensional and have complicated shapes—from a variety of angles.
Stent strut bend radius measurement
The VHX Series 4K Digital Microscope uses high-resolution 4K images to perform 2D measurements with high accuracy. The stent strut bend radius can be measured in a non-destructive manner: use the easy operation of merely selecting the measurement location in one of the various tools.
Also, the glare removal and ring-reflection removal functions can be used to eliminate the effect of reflections from the metal surfaces that are characteristic of stents. Furthermore, the HDR function can obtain an image with high colour gradation by imaging at varying shutter speeds, thereby enabling inspections of appearance defects such as strut fractures.
Bioabsorbable stent inspection
The VHX Series 4K Digital Microscope can accurately observe bioabsorbable stents by minimising reflections. Subtle fractures and other such defects can also be detected by using high-resolution 4K images to perform appearance inspections at high magnifications.
Furthermore, 3D shape and profile measured values can be obtained quickly and easily, so defects in strut appearance such as scratches and the 3D structure of struts can be understood accurately.
Implant wire inspection
Implant wire observation and measurement
The VHX Series 4K Digital Microscope uses a 4K CMOS to enable observation with clear and fully focused images even when the target is a medical implant wire. Also, 2D and 3D measurements are possible directly from the magnified image, thereby making inspections much more efficient.
Pacemaker failure analysis
Pacemaker component inspection
The VHX Series 4K Digital Microscope can be used to observe defects in pacemaker components such as fractures and cracks with clear, 4K images. Also, by combining the free-angle observation system and backlighting, side walls of holes can also be inspected quickly and easily.
With the VHX Series, real-time depth composition makes it possible to obtain in real time fully-focused and clear images of the entire target even in high-magnification observation of three-dimensional objects. Because such images are obtained, users are freed of the hassle of adjusting the focus, thereby leading to rapid improvements to work efficiency.
Pacemaker Component 3D Shape and Profile Measurement
One advantage that the VHX Series has is the ability to create 3D images by obtaining height information. By using high-resolution images, submicron-order 3D shapes and profile measurement data can be obtained from high-magnification images.
Packaging inspection
Resin packaging appearance inspection
Packaging defects affect items such as the protection, preservation, safety, and reliability of the product contained therein. The quality assurance of medical devices is first completed by way of the quality control of the product packaging prior to shipment.
By using polarising illumination, the VHX Series 4K Digital Microscope can minimise reflections from films and package surfaces made of plastic (resin; a material commonly used in packaging), thereby enabling accurate appearance inspections.
Resin Packaging Magnified Observation and Measurement
High-magnification observation of packaging using materials made of plastic (resin) can be difficult because it is hard to focus the image.
The VHX Series 4K Digital Microscope can use its HDR function, which obtains images with high colour gradation and high contrast while changing the shutter speed, to observe clear, high-magnification images. The ability to perform accurate measurement using HDR images with easy operations leads to drastic improvements to inspection accuracy and speed.
Resin packaging 3D shape inspection
The deep depth of field and clear HDR images of the VHX Series 4K Digital Microscope make it possible to obtain fully-focused high-magnification images even when the target has an uneven surface. Furthermore, 3D images can be created from these high-magnification images and can be used to express and measure 3D shapes, thereby enabling a single VHX Series unit to quickly complete the entire series of tasks that an inspection requires.
A 4K Digital Microscope that Meets Severe Requirements
With the VHX Series, KEYENCE’s latest high-definition 4K Digital Microscope, a single unit is all that is needed to complete the inspections required in the quality control and quality assurance of advanced and miniaturised medical devices. Everything from high-magnification observation with clear, 4K images to high-accuracy measurement and inspection, to the outputting of reports can be performed seamlessly, leading to rapid improvements to work efficiency.
For details on the VHX Series, click the button shown below to download the catalogue. For inquiries, click the other button shown below to contact KEYENCE.
