Abstract:
A device and method are provided for improving patient safety preparatory to a surgical procedure. The device is affixable to or adjacent the patient and includes an audio recording and playback medium. The medium can be used to record a message thereon, preferably by the patient. The message is for communicating at least patient identity and planned procedure to, for example, a surgical team. The medium can be activated by a healthcare worker prior to initiating the procedure, such as during a planned “time-out” period. A second recording can also be made by a healthcare worker that contains patient and procedure data to provide yet another safety element. Both recordings are reviewed prior to beginning the surgical procedure to ensure the correctness of the procedure.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority to provisional patent application Ser. No. 61/305,696, filed on Feb. 18, 2010. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Technical Field 
         [0003]    The present invention relates to patient safety devices and methods, and, more particularly, to devices and methods for ensuring that a patient and related procedure to be performed are correlated correctly. 
         [0004]    2. Description of Related Art 
         [0005]    Patient safety is at the forefront of healthcare issues on the minds of both healthcare providers and the general public. The November 1999 report of the Institute of Medicine (IOM), entitled “To Err Is Human: Building A Safer Health System,” focused a great deal of attention on the issue of medical errors and patient safety. The report indicated that as many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors. Even using the lower estimate, this would make medical errors the eighth leading cause of death in this country—higher than motor vehicle accidents (43,458), breast cancer (42,297), and AIDS (16,516). 
         [0006]    Hospitals are not the only facilities that provide surgical procedures. Over the past 10 years, the number of elective surgical procedures performed in ambulatory and office-based settings have increased significantly. In 2008, 11.7 million cosmetic surgical and nonsurgical procedures were performed in the United States, a 162% increase since 1997. In 2005, the American Society of Anesthesiologists estimated that over 10 million surgical procedures were performed in a doctor&#39;s office. This number has doubled since 1995 and continues to grow. Today nearly 80% of all surgeries are performed in an outpatient facility, of which 10% are office-based. It is believed that the standard of care in an office surgical suite should be no less than that of a hospital or ambulatory surgical unit. 
         [0007]    In order to ensure safety, in 2004 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) proposed a tool to help reduce the incidence of medical errors by issuing the “The Joint Commission&#39;s Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.” The centerpiece of the protocol is the initiation of a process called a “time-out” or “pause.” The purpose of the “time-out” is “to conduct a final verification of the correct patient, procedure, site, and as applicable, implants.” The process is further described as an active communication among all members of the surgical procedure team, consistently initiated by a designated member of the team, conducted in a “fail-safe” mode; that is, the procedure is not started until any questions or concerns are resolved. 
         [0008]    Based upon careful review of 43 cases reported through its Sentinel Event Policy over a three-year period, the JCAHO issued the following recommendations for avoiding wrong-site surgery: (1) Mark the operative site and involve the patient in this process; (2) require oral verification of the correct site in the operating room by each member of the surgical team; (3) follow a verification checklist that includes all documents and medical records referencing the intended operative procedure and site; (4) directly involve the operating surgeon in the informed consent process; and (5) engage in ongoing monitoring to ensure verification procedures are followed. 
         [0009]    Among these recommendations, marking the operative site has received the most attention, and yet wrong-site procedures still occur despite time-outs and marking of the operative site. This is reflected in the fact that coordination of healthcare activities involving surgical procedures is highly variable within, as well as among, hospitals and surgical centers. In 2006, the number of surgical procedures performed in the United States was 32.6 million, of which 75% were outpatient procedures. 
         [0010]    Additionally, in 2009 the Joint Commission&#39;s  Comprehensive Accreditation Manual for Hospitals  issued a mandate that a time-out must be performed prior to initiating a procedure even if the physician is working alone. 
         [0011]    Therefore, it would be beneficial to provide a device and method for increasing the correlation between a patient and an associated planned surgical procedure. 
       SUMMARY 
       [0012]    The present invention is directed to a device and method for improving patient safety by providing a device having associated therein a verification stream identifying the patient and a planned surgical procedure for the patient, wherein the verification stream can comprise at least one of an audio and a video stream. The device is activatable by a healthcare worker preparatory to performing surgery on the patient in order to optimize a correct correlation of patient and procedure. 
         [0013]    The device comprises a base affixable to or adjacent the patient. Associated with the base is a recording and playback medium. The medium can be used to record a message thereon, preferably by the patient, although this is not intended as a limitation. The message is for communicating at least patient identity and planned procedure to, for example, the surgical team. The medium can be activated by a healthcare worker prior to initiating the procedure, such as during a planned “time-out” period. 
         [0014]    Among the benefits of the present device and method can be included, but are not intended to be limited to, that it is patient-directed. The patient is empowered in the process by having his/her own voice agree to the basic information of a time-out prior to the procedure, during which time he/she might be under anesthesia or under the influence of psychotropic drugs. Additionally, the invention serves to standardize the time-out process. Recording substantially the same information on every patient is intended to eliminate the variability inherent in time-outs among healthcare workers. 
         [0015]    The device and method also reduce errors inherent in known systems. With the device on the patient, the recording eliminates the possibility of an incorrect medical record being used to identify the patient. From the perspective of the healthcare facility, liability is decreased, as a patient-directed time-out serves as a powerful rebuttal to any liability if the procedure as recorded in the patient&#39;s script has been followed. 
         [0016]    The device as conceived at present is intended to be produced economically, and thus would not significantly impact the cost of a procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a flowchart of an exemplary method of the present invention. 
           [0018]      FIG. 2  is an exemplary schematic drawing of an embodiment of a device of the present invention. 
           [0019]      FIG. 3  is a top/side perspective view of an exemplary device of the present invention. 
           [0020]      FIG. 4  is a bottom perspective view of the device of  FIG. 3 . 
           [0021]      FIG. 5  is a side perspective view of the device of  FIG. 3 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0022]    A description of the preferred embodiments of the device  10  and method  100  of the present invention will now be presented with reference to  FIGS. 1-5 . Throughout the description provided herein, it will be understood by one of skill in the art that the designation “patient” can refer to the patient him/herself, or can refer to a healthcare surrogate, parent, or guardian, depending upon the age and condition of the patient him/herself. 
         [0023]    The construction and form of a device  10  can be conceived in a plurality of embodiments, with a device schematic given in  FIG. 2 . An exemplary device  10  could comprise an affixing element comprising a wristband  11 . One of skill in the art will appreciate that a wristband is by no means the only affixing element that could be used, but is useful for purposes of description. 
         [0024]    Affixed to the wristband  11  is a recording and playback element  12  comprising a processor  13  and a recording medium  14 , a receiver comprising at least one of an audio receiver and a video camera  15 , and playback element comprising at least one of an audio speaker and a screen  16  in signal communication with the processor  13 . One of skill in the art will recognize that, in the video embodiment, the playback element could comprise an element for transmitting a playback signal to a screen separate from the device  10 . An activation (“record”) button  17  is adapted to initiate recording scripts A and B, as received via the receiver  15 . A playback (“play”) button  18  is adapted to initiate playing back scripts A and B from the recording medium  14 . The record  17  and play  18  buttons can in certain embodiments comprise different indicia for ease of distinguishing them from each other, for example, but not intended to be limited to, different colors such as green for the play button  18  and red for the record button  17 . Also provided within the recording and playback element  12  is an indicator, such as an LED  19 , the use of which will be described in the following. A battery  20  is in signal communication with the processor  13  and the LED  19  for providing power thereto. 
         [0025]    Software  21  is resident on the processor that is adapted for assisting in carrying out the method  100  of the present invention, as will be described in the following. Additionally, the software  21  is adapted to provide an indication when the battery  20  is running low, such as a specified signal via the LED  19  and/or the playback element  16 . When the battery  20  reaches a predetermined lower limit, the processor  13  shuts the device  10  down and implements a signal, for example, through the LED  19  and/or the playback element  16 . 
         [0026]    A timer  34  that is in signal communication with the processor  13  can also be provided in order to place the device  10  into a power saving mode if inactive for a predetermined time. An indication of entering the power saving mode can be provided to the user, such as, but not intended to be limited to, a signal via the LED  19  and/or the playback element  16 . 
         [0027]    An exemplary case  22  for the device  10  is illustrated in  FIGS. 3-5 . Preferably the case  22  should be constructed of a durable material and be substantially water-proof. The case  22  should also be lightweight and small to avoid interfering with the patient&#39;s procedure. A back face  23  of the case  22  should preferably be smooth so as to avoid irritating the skin of the patient. Sides  24  and top  25  faces should also preferably be smooth to avoid catching on gowns and drapes, and to avoid puncturing surgical gloves. The case  22  can be make by means known in the art, such as, but not intended to be limited to, plastic extrusion methods. The case  22  can comprise a top  26  and a bottom  27  half that are affixable together by means known in the art to form a substantially continuous surface. 
         [0028]    The case  22  further has a first  28  and a second  29  end joining the sides  24 . The first  28  and second  29  ends comprise in an exemplary embodiment an aperture  30  through which the strap  11  can be threaded. 
         [0029]    The top face  25  has an aperture or plurality of apertures  31  for admitting sound therethrough, to which end the play button  18  and receiver  15  are preferably positioned adjacent thereto. 
         [0030]    The side faces  24  have opposed apertures  32  extending into an interior  33  of the case  22 , through which protrude the play  18  and record  17  buttons, which are constructed as known in the art for pressing inward to activate and return to a “home” position upon release. In an exemplary embodiment, the record button  17  can comprise a translucent material. In some embodiments substantially the entire case  22  can be translucent. The LED  19  can then be positioned therebehind for illuminating the record button  17  when activated. 
         [0031]    Further embodiments could include additional features, such as a GPS locator, wireless capability  37  for communication with the healthcare facility&#39;s processor, permitting such actions as uploading and downloading information into and from the device  10 , and a scannable medium for correlating the patient device  10  with the patient file, for example. For example, a copy of the recorded material could be transmitted to a processor  35  at the healthcare facility in order to have redundancy in the records and in case review is desired at a later date. In addition, it will be understood by one of skill in the art that such communication between devices can encompass handheld communication devices such as “smart” phones and tablets as well as server-mediated communication. 
         [0032]    A flowchart of an exemplary method  100  of the present invention is depicted in  FIG. 1 . In a particular embodiment an information and safety device  10  is obtained or accessed by a healthcare worker (block  101 ). For example, the device  10  could be contained in packaging that is preferably hypoallergenic and water-proof. The device  10  can also have (preferably unique) indicia associated therewith, such as a serial number, bar code, etc. 
         [0033]    The device can be provided to the patient upon admission, or later as deemed desirable. The device indicia are then associated with the patient&#39;s medical file (block  102 ). As an example, not intended to be limiting, the device and/or packaging could have associated therewith a tag with adhesive that is removable from the device  10  and/or packaging that can be transferred to the patient&#39;s file. 
         [0034]    Preferably the device  10  is also labeled with patient-specific indicia (block  103 ), which can be accomplished in similar fashion to the bracelets commonly used in hospitals at present, although this is not intended as a limitation. The device  10  is then placed on or adjacent the patient (block  104 ). In the embodiment discussed above, the device  10  is attached to the patient&#39;s wrist using the strap  11  provided. 
         [0035]    The patient is then instructed in a procedure for using the device  10  (block  105 ), which can include a procedure similar to that used for recording messages on greeting cards, although this is not intended as a limitation. The device  10  has associated therewith an “on” procedure and a first activation element (e.g., a button) for patient use. 
         [0036]    The patient is provided with a first script, referred to as “script A” (block  106 ). Script A can include, for example, patient name, date, surgical procedure to be performed (e.g., ACL repair), the location of the procedure (e.g., left knee), the healthcare worker(s) performing the procedure, and any other relevant information (e.g., patient allergies, DNR instructions). The patient reviews script A and indicates agreement or disagreement therewith (block  107 ). If the patient does not agree with script A, corrective action may need to be taken by the healthcare facility regarding the information contained therein (block  108 ). Alternatively, the patient could be incorrect in his/her disagreement, and an explanation may need to be provided to the patient. 
         [0037]    Once script A is settled in form, the patient activates the device and records script A (block  109 ) by long-pressing the record button  17 , upon which an indication can be provided that the device  10  is ready to record. Such an indication can include, but is not intended to be limited to, the sounding of a tone through the playback element  16  and/or a flashing of the LED  19 . 
         [0038]    The patient continues to depress the record button  17 . Upon completion, the patient releases the record button  17 , which initiates a playback of script A (block  110 ) to ensure that it is correct (block  111 ). The script can be re-recorded as desired until the patient is satisfied, at which point a permanent “save” is activated on the device, for example, by taking no action for a pre-determined time period (block  112 ), after which the recording of script A cannot be changed. Should a change be desired at this point, a new device will typically need to be provided and activated, although other methods of over-riding a permanent “save” may be envisioned by one of skill in the art. 
         [0039]    Another element of the method  100  can include a healthcare worker&#39;s being able to record a second script, referred to as “script B.” Script B is provided to and is approved by a healthcare worker (block  113 ). Script B can include such elements as, but not intended to be limited to, name(s) of healthcare worker(s) performing the procedure, an identification of type and location of procedure, patient name, patient allergies, date of procedure, and other relevant information (e.g., acknowledgment of DNR order). The healthcare worker enters a mode for recording script B (block  114 ), for example, by a predetermined sequence of actions. In a particular embodiment, the healthcare worker first depresses both the record  17  and the play  18  buttons substantially simultaneously, and then alternately pushes the record  17  and play  18  buttons. A message issues from the playback element  16 , such as “You have entered the Physician mode.” 
         [0040]    The device  10  then plays back the patient recording (block  115 ). If the healthcare worker wishes to hear the patient recording again (block  116 ), the healthcare worker depresses the play button  18  again (block  115 ); otherwise, the patient recording is committed (block  117 ). 
         [0041]    The healthcare worker is then permitted to record script B into the device  10  by pressing and holding the record button (block  118 ), and, following the issuance of a signal (block  119 ), records script B (block  120 ), along with the physician&#39;s name, the date, an acknowledgment that the patient&#39;s recording has been reviewed, and a description of the procedure to be undertaken. 
         [0042]    When the record button  17  is released, the healthcare worker&#39;s recording plays automatically (block  121 ). If not satisfied with the recording (block  122 ), the message can be re-recorded (block  118 ) by long-pressing the record button as above. As above, a permanent “save” of script B is activated (block  123 ) if nothing further is done. In some instances it may be desired for the software  21  to direct a time and date stamping of the recording (block  124 ). 
         [0043]    Typically a next step is to prepare the patient for the designated procedure (block  125 ). During a “time-out” period (block  126 ) before beginning the procedure, a surgical team member activates the A and B recordings (block  127 ). If the patient and procedure do not correlate (block  128 ), appropriate corrective action is taken (block  129 ). If the correlation is correct (block  128 ), the team can proceed with the procedure (block  130 ), subject to other facility and medical protocols. 
         [0044]    Once the procedure is complete, device  10  is removed from the patient (block  131 ). It may be desired to store an audio and/or written copy of the recordings to associate with the patient&#39;s file for subsequent review as needed/desired (block  132 ), which can be accomplished by transmitting the recordings to the hospital processor  35  either wirelessly or directly from the device  10 . This is not intended as a limitation, as one of skill in the art will appreciate that communication and data transfer can occur between devices in ways known in the art as well as in ways and using devices that will be developed in the future. An electronic verbal version of the recordings could be made using a speech recognition protocol or transcription.