| 초록 |
Objectives: Peritoneal dialysis (PD) requires a well-functioning catheter, adaptor, and transfer set. PD complications result in significant poor outcomes including termination of PD therapy, hospitalizations, invasive treatment, and death. This study aimed to evaluate the feasibility of detection of various PD complications for CDM-based surveillance of PD-related medical devices.
Methods: We studied a retrospective observational cohort who underwent maintained PD procedure from January 2001 to January 2023, Based on the CDM database (table 1). Outcomes included infectious, mechanical complications, and death during PD period.
Results: A total of 2820 PD patients in 16 centers were enrolled. The Mean numbers of patients with PD procedures and medical devices were 176 (3~825) and 180 (0~750), respectively. Of them, 988 and 225 patients experienced infectious and mechanical complications, respectively. 572 patients expired. Incidence rates of complications and death were very different according to centers (figure 1).
Conclusions: Although PD-related medical devices and complications were detected in the CDM, there was a lack of coincidence according to the center. Experienced researchers, methodologies, and data managers are required to achieve medical device vigilance using CDM.
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