Clinical Use Guidelines for Single-Use Blood Hemoperfusion Devices, T/GDMDMA 0044-2025
T/GDMDMA 0044-2025
Basic Information
Scope
Scope: This document specifies the standardized operating procedures, treatment monitoring, and adverse event handling for single-use blood perfusion devices. This document applies to the clinical use of single-use blood perfusion devices and does not include related products such as plasma adsorption, DNA immunoadsorption, and protein A immunoadsorption. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Product characteristics of single-use blood perfusion devices 5. Principles of blood perfusion 6. Standardized operating procedures for blood perfusion 7. Treatment monitoring of blood perfusion 8. Adverse events and handling of blood perfusion Appendix A (informative) - Common models of perfusion devices Appendix B (informative) - Commonly used adsorbents Appendix C (informative) - Clinical indications and contraindications for blood perfusion