Necessity of blood hemocompatibility evaluation in medical devices with indirect contact with blood
10.19745/j.1003-8868.2025142
- VernacularTitle:间接接触血液医疗器械血液相容性评价的必要性研究
- Author:
Chun-xia QIAO
1
;
Qiu-jin QU
1
;
Li HOU
1
;
Zeng-lin ZHAO
1
;
Xiang-yu CHU
1
;
Xiao-xia SUN
1
Author Information
1. 山东省医疗器械和药品包装检验研究院,济南 250101;国家药品监督管理局生物材料器械安全性评价重点实验室,济南 250101
- Publication Type:Journal Article
- Keywords:
medical device;
blood hemocompatibility;
medical device directly contacting blood;
medical device indirectly contacting blood;
cardiovascular medical device
- From:
Chinese Medical Equipment Journal
2025;46(8):44-49
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]
