Inspection Equipment

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A new software tool aims to make computer-aided tissue analysis faster, more accurate, and more consistent.

Researchers at the University of Michigan Health System and their colleagues have developed a software tool that aims to make the detection of abnormalities in cell and tissue samples faster, more accurate, and more consistent. The technique, known as Spatially-Invariant Vector Quantization (SIVQ), can pinpoint cancer cells and other critical features from digital images made from tissue slides.

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This system offers advantages over traditional optical comparators, including the ability for multiple operators to compare parts to the CAD file at any one time.

Manufacturers of orthopedic implants take great care to ensure that their products are of the highest quality. One way they do this is by performing numerous inspection operations at various stages throughout the manufacturing process. These have great value — however, they also represent considerable expense. Until recently, implant manufacturers reaped only a small fraction of the potential benefits of these efforts mainly because, in the end, few records of the inspection operations remained. Those that did exist were of poor and irregular quality. This is reasonable, considering in-process inspections are performed on the shop floor by system operators, whose primary function is to manufacture parts. Most inspection records consisted of a few checkmarks on a paper report indicating that the required inspection had indeed been performed successfully. These records do not do justice to industry-wide, high-quality standards.

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DISCUS Software Company (Columbus, OH) has released the DISCUS 5.0, an update that further streamlines first article inspection and process planning for quality engineers. The release includes a new product, DISCUS CMM, a revamped DISCUS OCR product, and enhanced tools and functionality. The software module allows quick extraction of measurement results directly from PCDMIS text reports, and allows easy import of results into CMM reports. A new set of comprehensive controls allows quality engineers to adjust settings to exact specification, extract detailed requirements from documentation, and populate inspection report part lists and product accountability information.

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North Star Imaging (Rogers, MN) has introduced the X25 X-ray/ Computed Tomography (CT) system, which is shielded for up to 160kV and designed to integrate with a number of X-ray tubes and flat panel detectors for various applications. It features an anti-vibration cabinet design and is capable of achieving submicron resolution on ideal objects. It offers a 9" × 9" scanning envelope and a rotational stage capable of handling parts up to 25 lbs., and it can still fit through a standard 35"-wide interior door for limited space environments. The system comes standard with efX-DR and efX-CT software, which both feature an intuitive user interface. efX-CT offers a 5-step, start-to-finish interface that guides the user through the calibration, acquisition, and reconstruction stages of a 3D CT scan.
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Quality Vision International (Rochester, NY) has introduced the full function benchtop digital measuring machine, the QVI SNAP™. SNAP’s digital megapixel camera with Native Video™ image processing provides high definition video images with up to 50:1 sub-pixel resolution. Six digital zoom positions provide “zoom anywhere” capability. It is equipped with Measure-X® 2D metrology software, which provides a range of feature measurements. It features 78 mm field of view, with 75 mm vertical stage adjustment, and can measure parts up to 100 mm tall.
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Near-patient in vitro diagnostic (IVD) tests depend on medical devices to perform diagnoses, generally in controlled environments and using non-invasive techniques external to the patient. Rapid availability of IVD results is advantageous to both physicians and patients. Reagent discs are used by physicians in portable point-of-care clinical chemistry systems to analyze minute whole blood samples and perform routine on-site multi-chemistry panels in order to quickly diagnose potential patient illnesses.
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Medical device companies should weigh the advantages and disadvantages of different approaches to monitoring critical environments.

Worldwide, there is growing concern about how to protect public safety and increase cooperation among regulatory agencies to audit medical device companies and their suppliers. Regulatory agencies are increasingly looking to global organizations such as the Global Health Task Force (GHTF) to adopt harmonization in regulatory practices. As recent as August 2010, the GHTF made medical device suppliers inclusive of site auditing guidelines. (“A supplier delivering materials, components, or services, that may influence the safety and performance of the product.” GHTF/SG4/N33)

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