Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
2002-01-09
2004-08-31
Mohandesi, Jila M. (Department: 3728)
Special receptacle or package
For a tool
Body treatment
C206S370000, C206S438000, C220S908300
Reexamination Certificate
active
06783003
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to hypodermic needle holders, suture needle disposal and disposal structures, and more specifically to a hypodermic needle holder and disposal structure that minimizes the risk of inadvertent needle sticks that may result from coupling or uncoupling a hypodermic needle from a hypodermic syringe or recapping a hypodermic needle, or may result from improper storage of a hypodermic needle while the needle is temporarily not in use.
BACKGROUND OF THE INVENTION
Use and handling of hypodermic needles is a frequent occurrence in the field of medicine. Hypodermic needle systems typically consist of a hypodermic syringe that is quickly and easily removably attachable to a variety of hypodermic needle types and sizes by frictional engagement or by screw-on engagement, the latter of which is usually achieved using a LUERLOCK system. Handling and use of hypodermic needles inherently includes a certain amount of risk of accidental needle stick either to the person who may be administering an injection or to others in the immediate vicinity if a used hypodermic needle is improperly stored or carelessly placed prior to disposal.
Recapping a hypodermic needle after an injection is a likely cause of a large percentage of the composite risk factor for needle sticks in health care settings; most institutions discourage recapping of hypodermic needles under any circumstances. In some states and counties, safety laws prohibit recapping and other unsafe disposal practices. Unfortunately, this may also mean that the person responsible for disposing of a used hypodermic needle and syringe may have to travel more than a short distance to reach a sharps disposal container, thereby exposing more people than necessary to the potential hazard of incurring a needle stick and increasing their own risk for injury en route.
In some procedures, and for a given patient, there arises the need to re-use a needle during the procedure. For dentists who apply numbing medication in the oral cavity, repeated applications may be required with corresponding re-use of the needle. In other re-anesthetizing uses, such as during suturing, a needle may be re-used. For example, where the tissue requires further, later in time handling of the syringe and needle to either continue anesthization or to move on to another area on the patient's body. In these and many other re-use scenarios, there is simply no proper procedure for interim protection of personnel, isolation of the used and to be used again needle. In some hospitals it is required that a drape cover the sterile field when significant time elapses between a procedure and the next procedure, or where when significant time elapses between a series of procedures. The use of a drape can pick up contamination and spread it with subsequent manipulation of the drape. The drape may catch on the needle or other objects in the sterile field and produce a stick through the drape or even catch the needle and cause it to drop to the floor when the drape is removed. Although the use of the drape to block dust and airborne contaminants, the increased risk of sticks, cuts and upset spills of the materials in the field increase several fold when the drape covers the objects in the field, and there is furter increase of accident each time the drape is handled after its initial deployment.
Even systems which are tauted to be “needle-less” continue to create a danger of needle stick. One recent system includes a seventeen gauge tube with a generally blunt (transverse even tubular end) end which is supposed to be protected by a sleeve. If anything, this system is just as apt to create accidental stick contamination as the needle end is hidden until it makes contact with the skin, and the temporary hiding of the needle in the sleeve causes unwarranted reliance on the sleeve with increased carelessness.
Further, in health care settings, certain intravenous medications are required to be given in incremented doses and are repeated until a desired effect is achieved. When this is the case, it is not uncommon to repeatedly fill the same hypodermic syringe with medication and to perform repeated intravenous injections into a port that leads directly to a vein or leads into an intravenous fluid line that terminates in a vein. This is usually the case, for example, with patients who have problems of an emergent nature, such as cardiac or respiratory arrest, or problems of an urgent nature such as heart failure or respiratory difficulty, or even for patients undergoing surgery. Because large volumes of fluid may be drawn up into a hypodermic syringe in anticipation of needing them, they are often drawn up using a large gauge hypodermic needle, such as an 18 or even a 16 gauge hypodermic needle for speed and convenience, and this may include the above “needle-less” system. Injecting an intravenous port with such a large gauge hypodermic needle even once could damage the membrane of the port, causing leakage at the port, and thus rendering the entire intravenous tubing useless such that it would have to be replaced. For this reason, administration of intravenous medications typically takes place using a smaller gauge hypodermic needle, usually less than a 20 gauge. This may require that the large gauge needle and the small gauge needle be intermittently exchanged for one another, and certainly requires that whichever needle is not in use be kept from contamination. In dire circumstances, where the patient's condition may be serious and where the environment is likely to be somewhat chaotic as a result, the chances of improper placement of a used hypodermic needle increases significantly. Subsequently, the risk of hypodermic needle contamination increases, as does the risk for inadvertent needle stick for personnel who are caring for the patient, and even for family members or others who may be present.
In caring for a patient who receives frequent injections of any kind at the bedside, health care personnel may have their attention diverted from the task at hand by some distraction, and may subsequently place a used hypodermic needle on a bedside table or even on the bed beside the patient in order to address the distraction. Not only could this practice cause unintentional injury to the patient, but health care personnel and others who may have occasion to enter a patient's room after the fact are also at risk of being stuck or otherwise injured by the stray hypodermic needle.
Yet another potentially harmful procedure is that of drawing up medications from a vial that requires puncture of a membrane in order to access the medication within the vial. Although the hypodermic needle is not biologically contaminated, this practice still presents the potential for injury to the health care worker or others, since it requires recapping the hypodermic needle until the medication is to be administered. Similarly, medications contained in scored glass vials that require breakage of the vial and drawing up of the medication through a hypodermic needle is another practice that increases risk of needle stick, primarily because of the need for recapping the hypodermic needle prior to giving the injection.
A carelessly placed hypodermic needle that causes injury may result in temporary incapacitation of the health care team member who sustains the injury. Prompt treatment of the injury is encouraged by most institutions, and incident reports are mandatory, thereby potentially compromising patient well-being by decreasing the number of staff available for immediate patient care.
Yet another potentially injurious situation is that involving hypodermic needle disposal. Disposing of an uncapped hypodermic needle, even into a designated sharps container, can be a dangerous act in itself. Because of the design of most sharps containers, if the container is nearly full, it can prove to be difficult if not impossible to safely insert an exposed hypodermic needle into the box without injury either from the hypodermic needle being inserted or from other
Emis Dale
Simm Kendell
Harrington Curtis L.
Moh'andesi Jila M.
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