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Related Experiment Video

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Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart

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Ventricular assist systems for temporary life support: device readiness testing.

¹Nat. Inst. of Health, Bethesda, MD.

IEEE Engineering in Medicine and Biology Magazine : the Quarterly Magazine of the Engineering in Medicine & Biology Society

|January 1, 1988

Summary

This summary is machine-generated.

A robust quality control program ensures ventricular-assist-device (VAD) safety and efficiency before clinical use. Pre-clinical testing proved effective, with no device-related failures in temporary VADs, highlighting the program's success.

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Area of Science:

Biomedical Engineering
Medical Device Development
Cardiovascular Technology

Background:

Temporary ventricular-assist-devices (VADs) require rigorous pre-clinical evaluation for safety and efficiency.
Clinical experience with temporary VADs necessitates a structured approach to reliability testing.

Purpose of the Study:

To describe a quality control and reliability program for short-term VADs.
To establish pre-clinical safety and efficiency benchmarks for VADs prior to clinical application.

Main Methods:

Implementation of a stringent quality control and assurance program.
In vitro reliability testing with a target of 80% for permanent VAD systems.
Animal testing protocols requiring sustained usage consistent with in vitro reliability goals.
Freezing of device and system design throughout the entire development and testing process.

Main Results:

The pre-clinical reliability testing program demonstrated effectiveness, with zero device-related failures observed in temporary VADs.
Established strict guidelines for determining device-related failures in permanent VAD systems.
Defined animal testing requirements to validate VAD reliability in vivo.

Conclusions:

The described quality control and reliability program is effective in ensuring VAD safety and efficiency.
The program's success is evidenced by the absence of device-related failures in clinical use.
Freezing design is a critical component for maintaining reliability throughout the VAD lifecycle.