Medical Device

Powdered materials used in manufacturing, and particulate produced during normal wear of medical devices are analyzed for particle size and shape characteristics to ensure that products meet strict quality and safety standards. Meeting these specifications and standards is crucial in the medical industry for patient safety.

Foreign particulate matter on implants such as knee, hip, or breast implants can cause infections and other health risks. Determining the size of these particles can allow improvements in cleaning processes and quality control measures to ensure devices are safe and suitable for use.

Wear particles from artificial joints can be sized to evaluate if they will present a long-term adverse effect in the body. Large wear particles from an artificial joint can cause pain, inflammation and premature failure of the joint surface. To test particles, manufacturers place the joint into a saline bath and then move it thousands of times in a simulated “stress test.” This saline is then submitted to PTL where we analyze the fluid for the particle size of wear and debris as well as perform scanning electron microscopy to illustrate the shape of the particles. This information can be used by designers as a predictor of joint performance.

Nebulizers and Inhalers are medical devices that provide an effective way to dose medication to a patient rather than by oral digestive routes. The particle size of the droplets need to be within a certain size range to allow presentation and deposition in the lungs. Knowledge of the particle size and distribution allows engineers to design nozzles that generate an optimal narrow particle size range.

Examples of medical device materials we have analyzed include: 

Catheters

Ocular implants

Stints

Wear debris from simulated stress conditions

 

This is only a small representation of the particle material types we have analyzed  for the medical device industry.

Please contact us with any questions, or click here to fill out a quote request form for all of your particle characterization needs.  We look forward to hearing from you.