Most peripheral venous catheters on the market are not certified for the administration of drugs in continuous mode, as they are classified in class 2a in accordance with Annex IX, rule 7 of Dir. 93-42 EEC and its amendments.
The Tipro-ONE P peripheral venous catheter with a closed system, being registered in CLASS 2b in accordance with Annex IX, rule 7, last paragraph of Dir. 93-42 EEC and its amendments, is certified for peripheral venous catheterization in order to connect a vessel to other connectable devices for blood sampling or administering therapeutic fluids (various kinds of solutions, blood products, blood, etc.) in continuous mode, and drugs and specialty medicines in extemporaneous and continuous mode. The administration can take place by gravity or by pumps and also by high-pressure injectors.
The added value of this registration in class 2b is twofold:
Firstly, it ensures product compatibility with various types of pharmacological solutions and aggressive drugs (for which in-depth laboratory tests were conducted), including:
5- FLUOROURACIL: representative of the category of chemotherapeutic or anticancer drugs, in the anti-metabolites family;
PROPOFOL: representative of anaesthetics;
IOHEXOL: radio opaque contrast agent frequently used in diagnostics;
EPIRUBICIN: representative of the class of antibiotics- vitaminics, and also widely used as a chemotherapeutic drug;
TAXOL: chosen as a representative of chemotherapeutics of natural sources, used in anticancer therapies for specific cancers.
Secondly, the Tipro-One P device is certified for the administration of drugs and medicinal products in continuous mode for the ENTIRE time the catheter remains in the vein. While the devices registered in class 2a are allowed exclusively for temporary administration, i.e. for less than 60 minutes, Tipro-ONE P allows prolonged infusions, thus considerably increasing the possibilities of the device's use.