[Reuse of single-use medical devices: current evidence and regulations]
Lee SM, Seo HJ, Shin S, Park JE, Lee YJ, Park JY
Record ID 32014000429
Korean
Original Title:
진단 및 치료재료의 재사용 원칙에 관한 연구
Authors' recommendations:
Medically, there are two contrasting perspectives. The first perspective argues that there is not enough clinical evidence to support the reuse of single-use devices as being safe as the initial use of single-use devices. The second perspective argues that there is no concrete evidence to say that the reuse of single-use devices increases the risk for both patients and physicians, despite the enforced system that requires medical centers to report complications caused by reusing single-use devices.
From the perspective of the former, a dialyzer is the only single-use device that may be reused based on concrete evidence that supports its safety and efficacy even after its initial use. Also, the reuse of an electrophysiology catheter, trocar, sphincterotome and orthopedic external fixator is recommended only when extensive regulations for their sterilization processes are in place.
The latter perspective, taken by the US-FDA and GAO, argues that after implementing an extensive system that both monitors the reuse of single-use devices and controls their complications, it can be concluded that there is no evidence that supports an increased risk for patients from reusing single-use devices.
Therefore, this research concludes that there is a need to consider the potential danger to patients, the existence of a follow-up system for reused single-use devices and the scope of social benefits before determining the national policy on reusing single-use devices in Korea.
Details
Project Status:
Completed
Year Published:
2009
URL for published report:
https://www.neca.re.kr/lay1/program/S1T11C145/report/view.do?seq=122
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
South Korea
MeSH Terms
- Equipment and Supplies
- Sterilization
Contact
Organisation Name:
National Evidence-based healthcare Collaborating Agency
Contact Address:
National Evidence-based Healthcare Collaborating Agency (NECA), 3~5F Health and Welfare Social Administration B/D, 400 Neungdong-ro, Gwangjin-gu, Seoul, Korea.
Contact Name:
int@neca.re.kr
Contact Email:
int@neca.re.kr
Copyright:
National Evidence-based Healthcare Collaborating Agency (NECA)
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