• A new regulatory model is proposed for reprocessing of single-use medical devices.

• Traceability and management of reprocessing of single use medical devices are discussed.

• A nationwide survey was conducted and analyzed with a detail assessment methodology.

• A conceptual design is proposed for a software based tracking of reprocessing.

Reprocessing of single use medical devices (SUDs) has become very popular after the new European Union Medical Device Regulation (MDR) was published in 2017. The purpose of this study is to propose a new regulation model and tracking system for reprocessing of SUDs considering the opinions of the stakeholders.

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