During surgery it is necessary to place surgical implements, such as sponges, scalpels, needles, gauzes, and the like near or into a wound cavity. Even though thorough manual counts are conducted following the completion of surgery, this method is time consuming, tedious and error prone. Indeed, surgical implements are too frequently left inside patients resulting in complications including trauma, pain, infection or death.
A number of conventional methods exist to make sure that all surgical implements have been removed from a patient, but all have drawbacks. The most well known method is to use X-rays. In this procedure, the surgical implements have radio opaque material embedded within them. Following the completion of surgery and suturing of the patient, an X-ray machine is moved over the patient and an X-ray is taken of the wound area to determine whether radio opaque materials are present in the patient. However, some materials may be too small to be easily seen on X-ray, or they may be otherwise obscured by bone or tissues within radio dense areas. If any surgical implements are found on the X-ray within the sutured area, then the patient is reopened to retrieve the retained materials. This way, implements left within a patient are removed. However, each time this procedure is performed, expensive operating room time is wasted and other patients may have their surgeries delayed. Furthermore, the patient is subjected to more anesthesia time and otherwise unnecessary radiation.
Another method suggested by U.S. Pat. No. 4,193,405 to Abels, detects a radio-frequency (“RF”) transponder embedded in a surgical sponge. In this method, tagging of surgical articles with ferrite or other semiconductor material is done such that when they are exposed to two selected frequencies the material will resonate. This resonance can then be detected by a RF receiver. However, this method merely relates to a transponder, no data is recorded as to type of object, time rank of object, nor does it allow for master categorization which would alert the user that an object is in fact missing, even in the absence of a detected failure. Hence, this level of safety is easily breached.
In U.S. Pat. No. 4,658,818 to Miller, a miniature battery-powered oscillator is attached to each surgical implement and activated prior to its initial use. The output of each oscillator is in the form of a low powered pulse which is coupled to the body's fluids and tissue. After the surgery is completed, but prior to suturing, a detection system is used to sense for any pulses generated within the body. However, this system also does not provide information as to object type, rank timing or master categorization, and merely serves as a pulse alarm.
Another system that has recently been devised is disclosed in U.S. Pat. No. 5,931,824 to Stewart. This system is drawn to placing machine-readable information on individual surgical sponges. In addition, each sponge has X-ray detectable material embedded within it. This system requires that each sponge is scanned which is tedious, and allows for neither non-orientational registration nor perimeter scanning.
Additionally, sub-optimal logistics result in medication and other errors, which have resulted in significant morbidity and mortality.
Furthermore, tracking and distributing medications and blood or tissue products from their points of origin to their appropriate administration to patients requires a very major commitment of dedicated resources to maintain acceptable safety and efficiency. Unfortunately, commonly utilized methodologies can be expensive, wasteful, and potentially hazardous as they rely heavily on human input and require sustainable levels of efficiency that may be unrealistically high. As any breach of vigilance resulting from suboptimal visual or other input, stress, fatigue, repetition or distraction can have dire consequences at multiple points, risk exposure is significant. Medications may be poorly tracked leading to shortages in inventory or inappropriate use of outdated medications. Inappropriate formulations or concentrations of drug may be found in improper locations in the hospital, clinic or other patient care facility and this can result in improper dosing.
Furthermore, allergies or other adverse medication reactions, as well as hazardous drug interactions may go unrecognized or ineffectively addressed by patient care providers or other ancillary medical staff. Blood product preparation is an expensive and complex endeavor and current procedures for tracking blood products at the point of collection through the point of distribution can be suboptimal. Additionally, the procedures can be subject to hazard as human error at several points can lead to fatalities. For example, one concern is the potential for busy clinicians to misread one or more of a series of numbers and letters on a patient ID bracelet or unit of packed red blood cells during a severe bleeding episode in an operating room. Hence, there is a need for effective and safe methodologies for tracking medications and blood and other tissue products from the point of production to the point of administration.
A number of tracking devices have been well documented. For example, U.S. Pat. No. 6,130,613 shows a radio frequency identification stamp (10) having a substrate (24) with a first surface (12) and a second surface (18). The first surface (12) is printed with indicia indicating at least a postage value. An antenna (16) is formed on the second surface (18) and a radio frequency identification circuit chip (20) is secured to the second surface (18) and coupled to the antenna (16). A layer (22) of adhesive is also disposed on the second surface (18). A mailing label (600) includes indicia (614) printed on a first surface, and an antenna (616) coupled to a radio frequency identification circuit chip (620) on a second surface (618). A layer (622) of adhesive covers the second surface. The layer bonds the circuit chip (620) to the second surface and couples the circuit chip (620) to the antenna (616). The circuit chip (620) may retain a tracking number, and more preferably, retains sender information (601), recipient information (602), service type information (603) and billing instructions (604).
USPTO Backgrounds
USPTO Backgrounds