Medical Device Reprocessing, MS

Program Description

The MS degree in Medical Device Reprocessing educates students from across the STEM disciplines to optimize reprocessing technology supporting safe and routine reuse of medical devices. Medical device “reprocessing” involves the cleaning, disinfection, and sterilization of medical devices and healthcare products after each use. This cross-disciplinary program integrates fundamental principles of bioengineering and industrial engineering, medical device design, and quality science in an industry immersion/training program.

Combined Bachelors/Graduate Programs

The Department of Bioengineering offers a combined BS/Graduate plan. Under the plan, Clemson students may reduce the time necessary to earn both a BS degree in Bioengineering or Biological Sciences and a graduate degree in Bioengineering/Biomedical Engineering by applying graduate credits to both undergraduate and graduate program requirements.

Students are encouraged to obtain the specific requirements for the dual degree from the undergraduate department or the Department of Bioengineering as early as possible in their undergraduate programs to ensure that all prerequisite and other program requirements are met. Enrollment guidelines and procedures can be found at http://www.clemson.edu/cecas/departments/bioe/academics/bs-graduate.html.

Summary of Degree Requirements

The MS degree in Medical Device Reprocessing is a one-year sequence of 11 courses that includes a minimum of 30 hours of graduate credit delivered in a fully online program. These courses are taught by multi-disciplinary faculty and industry professionals. The knowledge and skills gained through this MS degree program prepare globally-engaged STEM students to be innovative leaders in sustainable biomedical technology for solving global health issues and addresses the shortage of biomedical engineers trained in reprocessing technology. Reprocessing is recognized as one of the top 10 regulatory science priorities by the US Food and Drug Administration and is an essential practice in healthcare delivery. This program supports workforce development in this sector, heeding calls for training and innovation in modern reprocessing technologies used to ensure medical device safety.

Coursework

Fall

• BIOE 8660 - Global Regulatory and Legal Requirements of Quality for the MedTech Industry 3 Credits  
• IE 8000 - Human Factors Engineering 3 Credits  

Spring

• BIOE 8130 - Industrial Bioengineering 3 Credits  or BIOE 8140 - Medical Device Commercialization 3 Credits  
• BIOE 8150 - Design, Manufacturing and Validation Methods for Reusable Medical Devices 3 Credits  
• BIOE 8670 - Product Development and Validation for the MedTech Industry 3 Credits  
• BIOE 8680 - Medical Technology Risk and Failure Analysis 2 Credits  
• IE 6300 - Human Factors Engineering in Healthcare 3 Credits  

Summer

• BIOE 6380 - Engineering Controls and Validation for Microbiological Systems 3 Credits  
• IE 6620 - Six Sigma Quality 3 Credits  

Fall/Spring

• BIOE 8620 - Pre-Clinical Assessment and Regulatory Affairs for Medical Devices 3 Credits  or BIOE 8630 - Regulatory and Clinical Affairs for Medical Devices 3 Credits  

Fall/Spring/Summer

• BIOE 8510 - Mentoring Undergraduate Research Teams 1-3 Credits  or BIOE 8900 - Bioengineering Internship 1-6 Credits  

Outcomes, Learning Objectives, and Graduation Requirements

Outcomes

1. Develop student’s knowledge of regulatory cycle for medical devices and their reprocessing.
2. Develop student’s ability to design SUD for reprocessing purposes.
3. Develop student’s ability to apply theory and application of quality science for medical devices.
4. Develop student’s ability to involve supply chain, human factors and process improvement for medical device industry.
5. Develop student’s awareness and responsibility for sustainable environment.
6. Develop student’s ability to effectively communicate to professional audiences.

Learning Objectives

1. Students develop regulatory pathway plan for targeted medical devices and their reprocessing.
2. Students determine design criteria for facilitating reprocessing for safety and effectiveness.
3. Students use computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using technical and practical aspects expected in the regulated medical device and reprocessing industries.
4. Students use industrial engineering tools, specifically those grounded in human factors, to solve healthcare supply chain problems associated with medical device use and reprocessing.
5. Students discuss up-to-date knowledge for issues of regulation, compliance, and quality control in the medical device recycling and reprocessing industry to foster a sustainable environment.