Biocompatibility Summary
The following document serves as a summary of the biocompatibility testing issues associated with the dual port, single lumen peripheral IV catheter. The IV catheter will provide a means to access the body in order to administer and collect fluids and it can be classified as an external communicating device because it contacts the blood path and serves as a conduit for entry into the vascular system. The device is only intended for one-time use, for reuse of the device places both the user and patient at high risk for complications. The external portion of the device consists of two polyurethane luer locks connected by a hub made of the same material. The internal portion is made of a silicone material and is connected to the hub with a stainless steel ring.
Because polyurethane, silicone and stainless steel are standard materials for current IV catheters on the market, they have been thoroughly tested in the past for biocompatibility. However, some of the biological hazards may include cytotoxicity, irritation of the skin or intracutanous reactivity, sensitization, subacute and subchronic toxicity, genotoxicity, implantation, haemocompatibility, systemic toxicity and infection. Even if these hazards occur, they would not be a result of the materials involved, but instead an issue of the transcutaneous nature of the product. To prevent most of the biological hazards listed above, the IV injection site should be monitored on a daily basis. The device will have a prolonged exposure to the body and should be in contact with the body for no more than five days. However, the amount of exposure time will depend on the care and condition of the IV injection site.
To the intended user, the IV catheter is a contact device that will be used for a limited amount of time. The potential hazards associated with its use are cytotoxicity, sensitization, irritation or intracutaneous reactivity.