Medical Device Evaluation Project

• Choose a real medical device from our KU supply. The device should be one that is of some interest to your team. With the instructor’s approval, you can bring in your own medical device to analyze if it is in the original packaging.

• “Dissect” the product, noting:
• how it was packaged
• how/why it was labeled
• what the expiration date means for your product
• what materials were used in packaging and why they were chosen
• sterilization needs, considerations and concerns
• how different types of sterilization techniques might affect the material(s)
• how the device functions
• what materials were used in the actual device
• why those materials were chosen (material design considerations)
• potential product-specific issues from the patient/material interaction
• any special material treatments that were done (such as surface treatments), being sure to discuss what the fancy name for the treatment really means from a material perspective
• how and why those treatments were “advertised” on the package/name
• other marketing concerns
• decide what the FDA classification of your device would be
• other FDA considerations
• more recent product developments that may make these products obsolete or not as useful
• recommendations for design improvement or different material selection

• Prepare a short team report on these issues to submit to the instructor. One report must be submitted per team. Each team member should focus on one or two special aspects of the device. For example, one person should be the FDA specialist, another should research sterilization methods, etc. Each team member must educate the remainder of the team on his/her aspect of the project. The “role” of each person on your team must be reported. The report should be thorough, but concise and professional.

• Please work on your evaluation throughout the semester and apply what we learn to your device. DO NOT wait until a few days before the evaluation is due to start! Evaluations are due on 11/25/03.

• You will be required to give an informal presentation of your analysis to the class in a group discussion format on 12/02/03. Please note that during the presentations, questions on the different areas will be directed toward one of the team members who is not the specialist in that area.