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SUBJECT PUBLISH

Reuse of single-use Medical Devices: Current evidence and regulations

PUBLISH DATE 2009.12.01
PERSON IN CHARGE Sang Moo Lee
FILE
[Executive Summary] Reuse of single-use Medical Devices_Current evidence and regulations.pdf

Summary

Even though many Korean medical centers have been reusing single use devices after sterilization processing, there were no regulations or recommendations established by a legal legislative unlike countries like USA, Germany and Australia that allows the reuse of single use devices.


The issue of reusing single use devices has been brought up to the society’s attention when the reuse of disposable pain adjustment devices has aired on the news in 2003. From then on, the issues of hospitals billing the insurance for the use of single use devices when they have been reusing them have brought up to the society’s attention.


However, the insurances were also taking such conditions into their consideration and took the liberty of assuming the reuse of single use devices and applied such assumptions when calculating the costs paid out to the hospitals for using single use devices. Therefore, in order to prevent continuous loss of capital by using single use devices only once, the reuse of single use devices has become prevalent in the Korean medical practices.


In February 2009, Anti-Corruption and Civil Rights Commission has brought up the issue of "hospitals wrongfully billing the insurance for the use of new single use device when they are actually reusing them after sterilization". Not only that, but they went further and addressed the lack of Food and Drug Administration(FDA) regulations to control the reuse of single use devices and the risk of relying solely on sterilization company’s standards. Also, they have addressed the existence of two opposing views from Korea Food and Drug Administration(KFDA) and the Ministry of Health, Welfare and Family Affairs regarding this matter. They also addressed the risk of "lethal secondary infections" from the reuse of single use devices and suggested "Regulations to control wrongful insurance billings for single use devices" to the congress to "define single use devices and prevent the reuse of single use devices".


The issue of reusing single use devices has been debated for 30-40 years in other countries as well. The first issue that has been debated regarding the establishment of regulations for reuse of single use devices has to do with increased infection rates and deterioration of device functions that leads to increased patient mortality and morbidity. Second issue had to do with increased medical costs due to frequent use of single use devices without reusing them. Finally, environmental issues regarding the disposal of single use devices have been debated in order to establish related regulations.


Therefore, this research is focused on reviewing the current policies regarding the reuse of single use devices, performing safety and effectiveness analysis on the reuse of single use devices and introducing legal, social and ethical issues to aid the establishment of national regulations regarding the reuse of single use devices.

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