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Quality Assurance

In the Medical Industry

The medical industry or healthcare industry is essential and plays a vital role by providing life-saving devices, drugs, and services to patients in need of care and treatment. The medical devices include X-ray computed tomography scanners, injection syringes, artificial hip and knee joints, dental implants, catheters, contact lenses, hearing aids, etc.

The accuracy of medical devices has a direct impact on public health. To ensure the safety of mankind, the medical industry is strictly regulated by high standards. Mitutoyo presents a wide range of measuring instruments for quality checks to achieve high-precision and high-accuracy end products.

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Common Parts Passing Through Quality Assurance in the Medical Industry

Orthopedic Implants

Orthopedic implants are medical devices that are used to replace or support damaged/diseased bones or joints in the musculoskeletal system. These implants are designed to mimic the function of the natural bones and joints, and may include screws, plates, rods, and prosthetic joints. They can be made from a variety of materials, including metal alloys, ceramics, and polymers, and are often customized to fit the unique needs of each patient. Because of the advanced materials, techniques, and even custom forms, rigorous quality control is something that is taken very seriously by manufacturers.

Quality Control Techniques

Form Measurement

Form measurement can be used to detect even small variations in the implant's shape or size, which can have a significant impact on its functionality and compatibility with the patient's body. Form measurement is an essential part of quality control in the production of orthopedic implants, helping to ensure that they meet regulatory requirements and industry standards for safety and effectiveness, and providing patients with the best possible outcomes from their implant surgery.

Dimensional Measurement

Not all implants are one in the same, with varying dimensions they all require scrutinous quality control. In most cases, a CMM is used to measure the dimensions of these implants but sometimes when they are much smaller and are in larger batches, machines like a VMM are the go-to method.

Hardness Testing

Orthopedic implants are often subjected to significant stress and pressure, and it is essential that they are able to withstand these conditions without losing their strength or integrity for obvious reasons. Hardness testing can be performed using a variety of methods, including microhardness testing and indentation testing, and can provide valuable information about the implant's mechanical properties.

Surface Testing

Since these implants will ultimately end up in contact with bone, flesh, skin, etc., the surface of each point of contact is of the utmost importance. Using a surface roughness tester such as a Formtracer Avant, these sections can thus be measured exactly to the specifications. This will determine whether or not they have enough or in some cases, little enough friction.

Dental Implants

Dental implants consist of a small titanium post that is surgically implanted into the jawbone, which serves as an anchor for a replacement tooth or bridge. These implants are designed to look, feel, and function like natural teeth, and can provide a more permanent and comfortable solution to traditional dentures or bridges. As they will be used every day with hope of not being replaced once again, the quality of the implant must be exceptional.

Quality Control Techniques

Form Measurement

Dental implants are designed to fit precisely into the patient's jawbone, which requires a high level of accuracy and precision during the manufacturing process. Form measurement involves the use of specialized equipment to measure the texture, angles, and contours of the implant components to ensure that they fit and perform accordingly. Often for these kinds of measurements, an advanced machine such as a model from the Formtracer Avant series is required.

Vision Measurement

As dental implants are relatively small and in some cases delicate, non-contact measurement using a VMM makes quick work of this. Used to examine surfaces and dimensions of these large batch items, a vision measurement system such as a Quick Image or the well-known Quick Vision are widely renowned for their accuracy and speed.

Syringe Needles

Syringes are the most thought of device when it comes to the medical industry and have many uses. More specifically, the needle on the syringe that comes in various sizes requires rigorous quality control to ensure that they are fabricated to these specifications. The selection of the appropriate gauge for a particular procedure is important to ensure optimal safety, comfort, and effectiveness. For example, smaller gauge needles are typically used for less viscous fluids, while larger gauge needles may be used for thicker fluids or medications that require faster administration. The use of syringe gauges is closely regulated to ensure patient safety, with strict quality control standards in place to ensure that needles are manufactured to the highest standards of precision and accuracy.

Quality Control Techniques

Vision Measurement

The quickest and most common form of measuring diameter of syringe needles is with a non-contact measurement machine. With the help of specialized fixtures such as those in the eco-fix lineup, many needles can be placed in rows where vision machines can make use of certain functions which are intended for this very purpose. With the Quick Vision’s “Strobe Snap” feature, measuring the diameter of thousands of needles will only take a matter of minutes.

Optical Inspection

The surface, general shape, beveling, and tip angle of needles on these syringes all can affect functionality in critical situations. In smart factories, this can be done a number of ways, one of which is by use of optical inspection via artificial intelligence. This can be paired with lenses that provide an extended depth of field such as the TAGLENS to give engineers a look into their production process in real-time.

Surgical blades (milling & grinding)

Made from high-quality, surgical-grade stainless steel or other specialized materials, and available in a range of sizes and shapes to suit different surgical needs, blades such as scalpels are no exception when it comes to quality control. To protect the patient and practitioner wielding them, the manufacturing and material quality must be unparalleled.

Quality Control Techniques

Hardness Testing

To make certain the base material of the blades used in the medical field is consistent there are various rounds of heat treatment and hardness testing throughout the manufacturing process. As the blades require edges of a certain hardness and a precise amount of flexibility in the spine of the blade, testers such as the HR-600 are placed in clean rooms and/or in the production line to periodically test material hardness.

Dimensional Measurement

In most manufacturing facilities producing surgical blades, handheld devices such as calipers or micrometers are used in tandem with a data management system to transmit the measurement data to central hub using SPC software such as MeasurLink. This method consolidates all of the information coming from the quality control processes, displays, and reports it to the QC Engineer in real-time.

Visual Inspection

Visual inspection is performed to identify any visible defects or flaws on the blade's surface or edge, including cracks, nicks, or burrs. This can be done in any number of ways, including the use of a Video Microscope Unit or “VMU” paired with an objective lens to get an up-close and accurate look at the blades’ surfaces.

TOP SELLING PRODUCTS FOR MEDICAL

Our advanced CMM systems, laser-optical scanning technology and software analysis techniques are ideal for the 3D measurement necessary for complex medical applications.

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CASE STUDY

Mitutoyo "Implants" advanced CMMs into Orthoplastics

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