Should Microbial Ingress Evaluation Be Carried Out For Needleless Connector Products For Infusion? How To Choose The Test Microorganism When Conducting Microbial Ingress Test?

Manufacturers should conduct microbial ingress evaluation on needleless connector products for infusion and submit a test report. Administrative counterpart can refer to YY/T 0923 and YY 0581.2 Appendix C to conduct microbial ingress tests. The test should use the disinfection method declared as the clinically used disinfection method by the enterprise, and the number of uses determined by simulating the maximum number of clinical uses or the number of longest days of uses. The type and number of microorganisms used in the test should be similar to the morphology of microorganisms that may be infected with at the clinically used device access site. These microorganisms selected for the test should be common microorganisms in clinical infusion related infections which Refer to the “Guidelines for the Prevention and Treatment of Intravascular Catheter-related Infections” (published by the Chinese Society of Critical Care Medicine of Chinese Medical Association) to select the microorganisms. It should use least one type of gram­negative bacterium and one type of gram-positive bacterium. It is recommended to use two types of Gram-negative bacteria and two types of Gram-positive bacteria. The administrative counterpart should note in the product IFU the disinfection method, number of uses and other information consistent with that evaluated in the microbial ingress evaluation test.