Reprocessing of single use medical devices: A new proposal for a regulation

Objective: 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. Methods: In this study, a nationwide survey has been conducted in order to get the opinions of the relevant actors in the health system and then the survey results evaluated in terms of the five criteria such as patient safety, cost effectiveness, patient information, legislation and environmental effects. The Cronbach Alpha Test was used to measure the reliability of the survey. Results: The most of the respondents have agreed on the thought of "Reprocessing of SUDs can help to reduce the healthcare spending with a strong regulation providing patient safety". The general message from the respondents is that a strong legislation should be introduced and patient safety should be guaranteed in this process. We, therefore, introduced a new regulation model that involves a stepwise approach for reprocessing of SUDs. This model requires drawing up a standard of procedure (SOP) document for each device to be reprocessed and defines new roles such as external reprocessor and reprocessing expert. Conclusions: Current situation reveals that inappropriate reuse of SUDs cannot be prevented by imposing a ban alone as the reprocessing of SUDs is highly preferred due to resource constraints and cost effectiveness. Therefore, instead of imposing a ban, a comprehensive regulation that takes patient safety and health into consideration can be implemented. To that end, good regulatory practices for reprocessing, if applicable, should be taken into consideration, a robust tracking system should be established and risk assessment should be conducted in determining the devices to be reprocessed.