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resterilization of implantable electrode
Telectronics
Summary: The resterilization of implantable electrodes by Telectronics is a process intended for reuse in clinical settings, primarily in low-resource environments. Key evidence highlights the potential for infection risks and the need for careful patient selection.
FDA Clearance Information
Pathway
510K
Number
K800891 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The resterilization of implantable electrodes by Telectronics was cleared by the FDA via the 510k pathway on May 28, 1980. It is classified as a Class 3 device.
What It Is
The resterilization of implantable electrodes involves cleaning and reprocessing used electrodes for reuse in patients. It is intended for use in settings where new devices are not readily available, providing an alternative for cardiac pacing needs.
Clinical Applications
This device is commonly used in scenarios where new implantable electrodes are unavailable, such as in low- and middle-income countries. It serves as a temporary solution for patients requiring cardiac pacing.
Evidence Summary
The available literature includes 10 studies, ranging from 2020 to 2023, encompassing various study types such as retrospective and prospective analyses. These studies explore the safety and efficacy of resterilized devices.
Reported Outcomes
Published studies report mixed outcomes regarding the efficacy of resterilized implantable electrodes. While some studies suggest they can be a viable option in resource-limited settings, concerns about infection rates and device longevity remain prevalent.
Safety Profile
Reported complications include a potential increase in infection rates associated with the reuse of resterilized devices. Studies highlight the importance of stringent sterilization protocols to mitigate these risks.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and long-term follow-up data. Further research is needed to establish standardized protocols and to better understand the long-term safety and efficacy of resterilized devices.
Frequently Asked Questions
What are the clinical indications for resterilization of implantable electrodes?
The clinical indications are primarily for use in settings where new devices are not available, such as in low-resource environments.
What outcomes have been reported in clinical studies?
Studies report mixed outcomes, with some indicating potential viability in resource-limited settings but also highlighting concerns about infection rates.
What complications have been reported?
Safety data indicate a potential increase in infection rates, emphasizing the need for strict sterilization protocols.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.