The epidemic of Acquired Immunodeficiency Syndrome (AIDS) has led to intense concern among health care workers about the risks they face in the hospital environment. Infections in health care workers have been attributed to needle-stick injuries. With needle-stick injuries in particular, despite safety guidelines and employee education, there is little evidence that the incidence of injury and contamination is abating. The potential medical and psychological consequences of needle sticks for health care workers and their spouses or sexual partners remain great.
Against this background, the National Academy of Sciences Committee on Trauma Research has concluded that improvements in product design are among the most successful approaches to the prevention of injury.
Many injuries are related to re-capping, or replacing a needle into a sheath. Contributing to these injuries is the risk of disassembling a device with an uncapped, contaminated needle and the difficulty of safely carrying several uncapped items to a disposal box in a single trip. Employees often attempt to dispose of accumulated debris by making a single trip to a trash container to avoid interrupting a medical procedure. Injuries then occur when workers pick up the debris or fumble with it in transit to the disposal box.
In practice, most problems with needle sticks occur after the needle has been used and before its disposal. Inadvertent skin penetration can occur while the needle is being recapped, when the sharp point penetrates a finger or thumb that is holding the needle sheath steady, either because the cap is missed or the cap is pierced. To avoid either risk, the free hand must be kept away from the path of an advancing and potentially contaminated needle tip. Also, inadvertent penetration can result from contact with the needle while the needle lies on an exposed surface, or during disassembly of the needle from the sheath, or because the sheath falls off after recapping.
During or after disposal, inadvertent skin penetration can result because a needle protrudes from trash, or while introducing the needle into the disposal box.
It would be desirable to produce a safe device for manipulating and disposing of needles which effects significant cost savings. In the United States for the year 1984, the average cost of a needle-stick injury, including costs of laboratory tests and time lost, but not the cost of treatment with immune globulin, was $64.50. Such funds could be put to better use, such as for the provision of hepatitis vaccine to susceptible personnel.
In light of the aforementioned problems, several solutions have been attempted. One is exemplified in U.S. Pat. No. 4,753,345. This patent discloses a hypodermic syringe tray which is adapted to hold at least one hypodermic syringe so as to secure the syringe and its cover during thermal sterilization. However, this approach holds the needle and sheath horizontally in close juxtaposition with adjacent needles, thereby rendering access and manipulation of each needle quite awkward. Another approach is exemplified by U.S. Pat. No. 4,742,910. This patent discloses a needle sheath holder with a hollow barrel member having an open upper end. In this approach, a needle sheath holder is hand-held, and is set on a stand next to the patient or set in a test tube rack. Following this approach, however, there is difficulty in handling a series of needles for efficiency in use. Moreover, setting the needle sheath holder in a test tube rack produces instability when the rack is inclined to a vertical position for ease of access to the needle sheath holder. Problems of disposal remain unsolved.
Despite efforts to solve problems of unwanted disease transmission through needle-stick, the results are still disappointing. The optimal solution appears to be to design devices which allow the needle to remain covered at all times, except during actual use. At a minimum, a fixed barrier should be provided between the hands and the needle after use.
It would be preferable to allow or require the worker's hands to remain behind the needle as it is covered to preclude the movement of the hands in the direction of used needles, as in recapping. To provide the greatest benefit, such a safety feature should be an integral part of the device and not an accessory item to be used optionally in combination with a hazardous item such as an infected needle. In this way, the integral safety feature remains in place precisely when and where it is needed. Moreover, the safety feature should be in effect before disassembly and should remain in effect after disposal, thus protecting the trash handler as well as the user. Finally, safety features should be as simple as possible and should require little or no training to use effectively.
Those skilled in the art may opine that the safest place for a used hypodermic needle is in its cover. However, recapping, with or without a guard, requires the movement of the hands toward a contaminated needle, which is an inherently risky maneuver. It would therefore be desirable to have a device which does not require the movement of hands toward a contaminated needle during the recapping operation, while being simple enough to use without special training or additional equipment.
USPTO Backgrounds
USPTO Backgrounds