It is estimated that 1,000,000 inadvertent exposures to blood as a result of needle-stick or blood to skin contact occur in the U.S. each year. Each exposure carries the risk of transmission of a bloodborne pathogen i.e. HBV, HCV, HIV, etc. The annual U.S. post exposure testing cost is estimated to be $3.6 billion. The problem of needle sticks has been well documented.

A lesser-known but just as dangerous exposure risk is the problem of blood leakage that contacts a health care professional. This hazard represents one-third of all reported blood borne pathogen exposures. Non-safety IV catheter needles are the number one cause of high-risk needle stick injuries that may transmit hepatitis B and C viruses and human immunodeficiency virus to healthcare workers. The need and market for safety IV catheters is greatly expanding because of recent United States federal legislation to help protect healthcare workers against sharps injuries (Needle Stick Safety and Prevention Act, November 6, 2000).

Blood safety devices are one of the fastest growing market sectors in healthcare, driven by regulatory enforcement proceedings regarding bloodborne pathogen exposure, and the overall need to contain healthcare costs, including the cost of follow-up treatments for health care professionals exposed to communicable diseases through such exposure. Current catheter designs are flawed; the current open hub design allows blood to flomanipulation for the attachment of additional components to prevent these blood outflows and to provide a point for access. In addition to increasing the chance of blood exposure to the provider each manipulation increases the chance of patient infection and catheter clotting.