Clemson University Establishes Engineering Program for Recyclable Medical Device Design

Clemson University, the “Tigers” of Clemson, S.C., has established a program to train engineers to design medical devices that can be recycled and reprocessed, and also to manage reprocessing. The first program of its kind in the United States, the Medical Device Recycling and Reprocessing Certificate Program is offered by the Clemson University Biomedical Engineering Innovation Campus, and was developed in response to the dramatic market adoption of reprocessing in recent years.

Medical device reprocessing has been identified as a core component of green technology and is predicted to be one of the top 20 fastest-growing industries in the next five years. Millenium Research Group (MRG) found in a recent report that the U.S. market for reprocessed medical devices, which has been growing steadily, will continue to do so averaging almost 9 percent per year through 2017. According to MRG, this growth will be driven by budget-conscious hospitals seeking cost savings. Already large, this market will become increasingly significant in the coming years.

The university found that it needed highly qualified and educated engineers to create device designs that were optimized for reprocessing, and to manage medical device reuse.

“Clemson’s unique certificate program is geared towards engineers who seek to enter the medical device industry in product development or research,” said Melinda Harman, Ph.D., assistant professor in the bioengineering department. “The internship immersion training will prepare them to design medical devices for reprocessing and to develop methods to assure patient safety in compliance with FDA [U.S. Food and Drug Administration] regulations. We are partnering with local health-care facilities and leaders in the reprocessing industry to help meet the demands for this growing field.”

Clemson’s program is made possible, in part, by contributions from the third-party reprocessors, including Stryker Sustainability Solutions, a division of Kalamazoo, Mich.-based medical device and equipment company Stryker Corporation.

“Clemson deserves to be recognized for developing a new program that meets an important industry need,” said Brian White, president of Stryker Sustainability Solutions. “Reprocessing is one of the top financial and environmental sustainability initiatives currently employed by U.S. hospitals. We’re pleased to be a part of an initiative that will result in more highly trained experts who will be focused on developing future medical devices specifically designed for reprocessing.”

Reprocessing is the cleaning and sterilization of single-use medical devices by FDA-regulated, third-party reprocessors. Hospitals can buy them for half the cost of original devices, allowing them to save on supply costs and divert medical waste from landfills. They are particularly popular—and important—in emerging markets such as India and China, where populations and hospitals may not have the income and budgets necessary to spring for brand new medical devices and equipment.

“Hospitals are among the largest contributors of waste in the country, and the medical-device reprocessing effort will help reduce environmental harm,” said Harman. “This effort also reduces supply costs for health-care providers while maintaining safety and quality control.”

Medical devices considered suitable for reprocessing are diverse, and impact nearly all hospital departments. A few examples of reprocessed devices include electrophysiology catheters for cardiac irregularities and numerous devices used during endoscopic surgery, as well as non-invasive products such as pulse oximetry sensors and various disposable compression therapy devices.

Critics of reprocessing claim, however, that some medical devices aren’t designed for multiple uses and should not be reprocessed, which can lead to increased patient risk.

Photo of Melinda Harman, Ph.D., courtesy of Clemson University.