Patent Publication Number: US-11045345-B2

Title: Drainage bag systems including at least one indicator element and methods of using the same

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation of U.S. application Ser. No. 15/324,114 filed on 5 Jan. 2017, which is a US Nationalization of PCT International Application No. PCT/US2016/015795 filed on 29 Jan. 2016, which claims priority to U.S. Provisional Application No. 62/111,088 filed on 2 Feb. 2015 and U.S. Provisional Application No. 62/249,752 filed on 2 Nov. 2015. The disclosure of each of the foregoing applications is incorporated herein, in its entirety, by this reference. 
    
    
     BACKGROUND 
     Generally, urinary catheterization involves insertion of a urinary catheter (e.g., a tube) through a patient&#39;s urethra into a bladder. The urinary catheter (e.g., a Foley urinary catheter) allows the patient&#39;s urine to drain from the bladder through a drainage tube into a drainage bag. 
     In some instances, a care provider may have protocols related to patient care during and/or after the patient&#39;s catheterization. However, such patient care protocols may be inconsistently performed and/or performed inaccurately. Improving compliance with such patient care protocols may improve patient care and/or reduce complications related to the patient&#39;s catheterization (e.g., catheter-associated urinary tract infection). 
     Accordingly, manufacturers and users of catheterization systems and methods continue to seek improvements thereto. 
     SUMMARY 
     Embodiments disclosed herein relate to drainage bag systems (e.g., catheterization and urine drainage bag systems) including at least one indicator element that may indicate that one or more patient care protocols were performed. For example, the drainage bag system includes a drainage bag including at least one indicator element (e.g., calendar, checklist, combinations thereof, etc.) configured to provide information indicating that the one or more patient care protocols were performed, such as verifying compliance with the one or more patient care protocols. 
     In an embodiment, a drainage bag system is disclosed. The drainage bag system includes a drainage bag. The drainage bag includes an inlet configured to receive a fluid from a patient. The drainage bag also includes one or more panels defining an interior space configured to hold the fluid therein. The drainage bag system further includes at least one indicator element. The at least one indicator element includes one or more indicator sites thereon. Each of the one or more indicator sites includes at least one of a blank or unfilled location. 
     In an embodiment, a method of using a drainage bag is disclosed. The method includes providing a drainage bag system to be operably connected to a patient. The drainage bag system includes the drainage bag defining an interior space configured to contain fluid. The drainage bag system also includes at least one indicator element including one or more indicator sites thereon. Each of the one or more indicator sites includes at least one of a blank or unfilled location. The method further includes performing one or more patient care protocols on the patient that is related to using the drainage bag with the patient. The method additionally includes marking the one or more indicator sites to show that the one or more patient care protocols were performed. 
     Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. Understanding that these drawings depict only typical embodiments of the present disclosure and are not therefore to be considered to be limiting of its scope, the embodiments of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1A  is a top plan view of a drainage bag system that includes a drainage bag having at least one indicator element in an inactive state, according to an embodiment; 
         FIG. 1B  is a top plan view of the drainage bag system shown in  FIG. 1A  having an indicator element in an active state, according to an embodiment; 
         FIG. 1C  is a top plan view of a package that may form a portion of the drainage bag system shown in  FIG. 1A , according to an embodiment; 
         FIG. 1D  is a top plan view of a package that may form a portion of the drainage bag system shown in  FIG. 1A , according to an embodiment; 
         FIG. 2  is a top plan view of a drainage bag system that includes a drainage bag with a plurality of indicator elements, according to an embodiment; 
         FIG. 3  is a top plan view of a kit that includes a drainage bag and at least one token, according to an embodiment; 
         FIGS. 4A-4D  are isometric views of indicator elements that are distinct and separate from a drainage bag, according to various embodiments; and 
         FIG. 5  is a side view of a drainage bag system including a drainage bag and a plurality of packages removably attached together, according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments disclosed herein relate to drainage bag systems (e.g., catheterization and urine drainage bag systems) including at least one indicator element that may indicate that one or more patient care protocols were performed. For example, the drainage bag system includes a drainage bag including at least one indicator element (e.g., calendar, checklist, combinations thereof, etc.) configured to provide information indicating that the one or more patient care protocols were performed, such as verifying compliance with the one or more patient care protocols. 
     The indicator element of the drainage bag may be in a first or an inactive state (e.g., during initial deployment of the drainage bag). The indicator element may be reconfigured into a second or active state, to provide information related to the patient&#39;s care, status of the urine drainage bag, etc. For example, in the active state, the indicator element may provide or display information related to one or more patient care protocols. Such information may include one or more of a date of deployment of the drainage bag, a date of insertion of a catheter operably connected to the drainage bag, date(s) and/or performance of the one or more patient care protocols, etc., which may be required and/or recommended by the one or more patient care protocols. 
     The indicator element of the drainage bag may be reconfigured from the inactive state to the active state in a manner that facilitates authentication of the accuracy of the information related to patient care protocols provided or displayed by the at least one indicator element and/or prevents tampering therewith (e.g., compliance indicator elements). In an embodiment, the indicator element may be reconfigured from the inactive state into the active state using a specific and/or unique token. For example, the token may become available to the user (e.g., a medical practitioner) after starting or completing a predetermined task or sequence of tasks. 
     The one or more patient care protocols may vary depending on the application of drainage bag system (e.g., collect urine, blood, stool, etc.) and the specific needs of the patient. In an embodiment, the drainage bag may include a urine drainage bag. In such an embodiment, at least some of the patient care protocols may be configured to comply with the Center of Disease Control&#39;s (“CDC”) “Guideline for Prevention of Catheter Associated Urinary Tract Infections” released in 2009 and available at http://www.cdc.gov/hicpac/pdf/CAUTI/CAUTIguideline2009final.pdf, the disclosure of which is incorporated herein, in its entirety, by this reference. For example, the one or more patient care protocols verified by the at least one indicator element of the urine drainage bag may include one or more of the following: periodic cleaning of the perineal region of the patient, periodic cleaning of the periurethral region of the patient, periodic cleaning of a portion of the drainage bag system (e.g., about every 12 hours), routine removal of urine from the drainage bag, inspections of the drainage bag system to check for leaks, kinks, etc., proper hand hygiene when manipulating the drainage bag system, or proper aseptic techniques performed while inserting the urinary catheter. 
     The drainage bag systems disclosed herein are described as being urinary drainage bag systems. However, the drainage bag systems disclosed herein may be used in any drainage bag system that collects fluid from a patient. For example, any of the drainage bag systems disclosed herein may be used in a blood drainage system, a pleural drainage system, a peritoneal drainage system, a bowel drainage system (e.g., a stool collection bag), or another suitable drainage system. 
       FIG. 1A  is a top plan view of a drainage bag system  100  that includes a drainage bag  102  having at least one indicator element  104  in an inactive state, according to an embodiment. The drainage bag  102  includes a front panel  106  and a back panel bonded together to form a fluid tight container. However, in other embodiments, the drainage bag  102  may include and/or may be formed by three or more panels, or a single body. The one or more panels may define an interior space configured to hold a fluid (e.g., urine) therein. In an embodiment, a privacy barrier (not shown) may be provided that is integrally formed with the drainage bag  102 , attached to the drainage bag  102 , or separate from the drainage bag  102 , which is at least substantially opaque and configured to cover at least a portion of the drainage bag  102  (e.g., obscure the at least a portion of an interior space of the drainage bag  102  from view such as obscuring and/or concealing urine in the drainage bag  102 ). Moreover, it should be appreciated that the one or more panels of the drainage bag  102  may include flexible, rigid, resilient, or any suitable material or combinations of materials. In any event, the panels of the drainage bag  102  may be connected and/or bonded together in a manner that forms or defines the interior space of the drainage bag  102 , which may contain fluid therein. 
     Generally, the drainage bag  102  may have any suitable geometry. In the illustrated embodiment, the drainage bag  102  has a generally tear-shaped geometry. However, the drainage bag  102  may have a generally circular geometry, a generally rectangular geometry, etc. 
     The drainage bag  102  may also include an inlet  110 , which may be configured to accept a fluid flow from the patient (e.g., urine) into the drainage bag  102 . For example, the inlet  110  may receive or connect to a drainage tube  112  that may be in fluid communication with a catheter  114  that, for example, may be positioned in a patient&#39;s bladder. In the illustrated embodiment, the catheter  114  may include a Foley urinary catheter, such that urine may flow into the drainage bag  102  from the catheter  114  and through the drainage tube  112 . 
     In an embodiment, the drainage bag  102  may include an outlet  116  (e.g., at or near a bottom of the drainage bag  102 ). For example, the outlet  116  may be configured to allow a fluid collected in the drainage bag  102  to flow or drain from the drainage bag  102  (e.g., for collecting or extracting the fluid from the drainage bag  102 ). For example, the outlet  116  may include the Safety-Flow™ outlet device or another similar outlet device. 
     The front panel  106  of the drainage bag  102  may further include one or more graduated markings  118  that may indicate an amount of a fluid collected in the drainage bag  102 . For example, the graduated markings  118  may facilitate determining the amount of fluid discharged by the patient in a time span (e.g., predetermined time span). In some embodiments, the graduated marking  118  may facilitate determining or approximating a time and/or date for draining, removing, and/or changing out the drainage bag  102 . 
     The indicator element  104  may be configured to show completion of a task (e.g., a patient care protocol) related to the drainage bag system  100 . For example, the indicator element  104  may be marked by a user to show that a task has been performed. In an embodiment, the indicator element  104  may be a compliance indicator element configured to ensure compliance with one or more patient care protocols. For example, the indicator element  104  may include a type identifier  120  that provides general information to the user. The indicator element  104  may also include one or more indicator sites  122  that are marked by a user. For example, the indicator sites  122  may be configured to verify compliance with the one or more patient care protocols (e.g., compliance indicator sites). 
     The type identifier  120  may provide information related to the drainage bag  102  and/or patient care. For example, the type identifier  120  may include information related to the patient (e.g., the patient&#39;s name, the procedure performed on the patient, etc.), information related to the caregiver (e.g., the responsible physician&#39;s name, the responsible nurse&#39;s name, etc.), the catheter  114  insertion date, etc. The type identifier  120  may also identify what patient care protocols are being indicated as having been performed and/or verified by the indicator sites  122 . The type identifier  120  is not configured to verify performance of the one or more patient care protocols. 
     In an embodiment, the type identifier  120  may be configured to be marked by a user. For example, the type identifier  120  may include a surface that is configured to be marked using writing utensils, receive a token (e.g., sticker, stamp, etc.), or other suitable forms of input. Marking the type identifier  120  may enable the indicator element  104  to display information that may be unique to each individual drainage bag  102 . In some embodiments, at least a portion of the type identifier  120  may be preprinted. The preprinted portions may include information related to the patient care protocols tracked by the indicator sites  122  and/or facilitate marking the type identifier  120 . For example, the preprinted portions of the type identifier  120  may include the phrase “Insertion Date:”, “Patient Name:”, “Physician;” similar phrases, or combinations thereof. Adjacent to the preprinted portions, the type identifier  120  may include a surface configured to receive input from the user. 
     In an embodiment, the type identifier  120  may include labeling (not shown) that facilitates performance and standardization of the one or more patient care protocols verified by the compliance indicator sites. The labeling may include step-by-step instructions and/or pictographs detailing how to perform the one or more patient care protocols verified by the compliance indicator sites. The labeling may conform to patient care protocols promulgated by the CDC, individual hospitals, or other healthcare organizations. Having the instructions included in the type identifier  120  may help standardize the one or more patient care protocols, prevent a user (e.g., a physician, nurse, certified nurse&#39;s assistant, etc.) from incorrectly performing the one or more patient care protocols, refresh the user&#39;s memory on how to correctly perform the one or more patient care protocols, etc. As such, the labeling may further verify compliance with the one or more patient care protocols. 
     The indicator sites  122  may be configured to be marked by a user to indicate that a task related to the drainage bag system  100  has be performed. For example, the indicator sites  122  may be compliance indicator sites configured to verify compliance with one or more patient care protocols. Each of the indicator sites  122  may include a blank or unfilled location that corresponds to one or more patient care protocols that may be performed. The blank or unfilled locations may be configured to be marked by a user, for example, when one or more patient care protocols are performed. For example, the blank or unfilled locations may be marked just before, during, or after the one or more patient care protocols are performed. As such, the indicator sites  122  may be configured to be marked using a writing utensil, at least one token, or another suitable form of input. As such, marking the indicator sites  122  may indicate and verify compliance with a patient care protocol (e.g., compliance indicator sites). 
     In some embodiments, the indicator sites  122  may include one or more markings thereon (e.g., preprinted thereon) configured to facilitate marking by the user. For example, the indicator sites  122  may include a box defining at least one indicator site  122 , an underlined portion indicating where to mark, one or more phrases (e.g., “_/_/20__” indicating a date to be marked), etc. 
     In the illustrated embodiment, the indicator sites  122  at least partially form a calendar  123  (e.g., an indicator displaying one or more dates). In an embodiment, the calendar  123  may be configured to verify compliance with one or more patient care protocols. For example, each of the of the indicator sites  122  may be compliance indicator sites that may correspond to a date (e.g., calendar date), day (e.g., number of days after an event), and/or time that the one or more patient care protocols are to be performed and/or verify when the one or more patient care protocols are performed. In the illustrated embodiment, the calendar  123  has less than 31 indicator sites  122  (e.g., less than 30 indicator sites  122 ). However, in other embodiments, the calendar  123  may include at least 30 indicator sites  122  (e.g., 31 indicator sites  122 ) to correspond to each day of a given month of a year. The indicator sites  122  may at least partially form the calendar  123  if the one or more patient care protocols are to be performed at certain time intervals, on certain dates and/or times; or it is desirable to track the performance of the one or more patient care protocols over a period of time. Such patient care protocols may include, for example, washing the perineal and/or periurethral region of the patient if the drainage bag  102  is used with the urinary catheter  114 , periodic inspections of the drainage bag system  400  by the user, etc. 
     In an embodiment, at least some of the dates provided on the calendar  123  may exhibit different colors. For example, the calendar  123  may include a first time period (e.g., including one or more days) that exhibits a first color and a second time period that exhibits a second color. In an embodiment, the different colors may be used to indicate when the catheter  114  (e.g., the catheter  114  that operably connected to the drainage bag  102 ) should be removed from the patient. For example, the first time period of the calendar  123  may represent the CDC&#39;s recommend time period that the catheter  114  is inserted into the patient (e.g., about one to three days). The calendar  123  may also include a second time period immediately after the first time period that exhibits a different color than the first time period. As such, the second time period may indicate that the CDC recommends removing the catheter  114  from the patient. Additionally, the calendar  123  may include one or more additional time periods immediately after the second time period that exhibit a color that is different than the first time period and the second time period. In other embodiments, the one or more colors may indicate time periods within which one or more specific patient care protocols may be performed, when the one or more patient care protocols change, etc. 
     In an embodiment, the indicator element  104  may initially be in an inactive state ( FIG. 1A ). The indicator element  104  is considered to be in an inactive state when the type identifier  120  and/or each indicator site  122  include a blank or unfilled location. For example, the type identifier  120  that is in an inactive state does not provide any information and instead merely provides a location to receive input. Similarly, the indicator sites  122  that are in an inactive state merely provide locations that are configured to be marked by the user and/or indicate that no patient care protocols have been performed. 
     However, the indicator elements  104  may be reconfigured from an inactive state to an active state when the type identifier  120  and/or at least one of the indicator sites  122  are marked by the user.  FIG. 1B  is a top plan view of the drainage bag system  100  shown in  FIG. 1A  having the indicator element  104  in an active state, according to an embodiment. As such, when the indicator element  104  is in an active state, the type identifier  120  may provide general information about the drainage bag  102  and/or patient care while the indicator sites  122  may indicate that a task related to the drainage bag system  100  has been performed (e.g., verify compliance with one or more patient care protocols and/or that one or more patient care protocols have been performed). For example, in the illustrated embodiment, the indicator sites  122  includes compliance indicator sites in an active state that show that patient care protocols have been performed at least three times over a two day period. However, the illustrated indicator sites  122  include compliance indicator sites that also show that at least one patient care protocol may not have been performed. In some embodiments, the type identifier  120  may initially be in an active state. For example, all the information provided by the type identifier  120  may be preprinted on the indicator element  104 . 
     The indicator sites  122  may be configured to be marked by the user using different mechanisms. In an embodiment, the indicator sites  122  may include or provide one or more locations (e.g., surfaces) that may be marked using at least one writing utensil (e.g., marker, etc.). For example, the indicator sites  122  may include paper or another surface that may be marked mark by the writing utensil. The indicator sites  122  may be configured to be marked in a specific manner, such as with a date or a symbol identifying the user (e.g., signature, initials, etc.). In some embodiments, the indicator sites  122  may be include material that may only be marked using a specific writing utensil. For example, the indicator sites  122  may include one or more dark or black locations, which may accept markings from a light-colored writing utensil. 
     Alternatively or additionally, the indicator sites  122  may be configured to be marked using at least one token  126  (see  FIGS. 1B and 1C ). The token  126  may be any suitable identifying marking that may be placed, attached, stamped, or otherwise imposed on the indicator sites  122 . For example, the token  126  may be a sticker, a stamp, paper, etc. that includes an adhesive thereon that adheres to the drainage bag  102 . In some embodiments, the token  126  may be a specific token. For example, the token  126  may exhibit a specific size, shape, color, or combinations thereof; and/or may have a specific symbol printed thereon (e.g., a user&#39;s name) In some embodiments, the token  126  may only be accessed at certain times, thereby reducing or eliminating incorrect or backdated markings on the indicator element  104 . 
     The indicator element  104  may be positioned on the drainage bag  102 . For example, the drainage bag  102  may have a geometry that includes or provides a suitable location for the indicator element  104 . For example, the indicator element  104  may be placed in a location that may not be covered or obscured by the inlet  110 , the outlet  116 , the drainage tube  112 , or any other device of the drainage bag system  100 . Additionally or alternatively, the indicator element  104  may be spaced or distanced from the graduated markings  118 . 
     In any event, the indicator element  104  may be located on any panel or portion of the drainage bag  102 . For example, the indicator element  104  may be attached to the front panel  106 , the back panel, or the privacy barrier. Moreover, it should be appreciated that references to the front panel  106  and back panel of the drainage bag  102  are made for ease of description, and either panel of the drainage bag  102  may be considered as the front or back panel thereof. In the illustrated embodiment, the indicator element  104  may be located on the front panel  106  of the drainage bag  102 . For example, the indicator element  104  may provide information to the user if the front panel  106  of the drainage bag  102  is generally facing the user. In alternative or additional embodiments, the drainage bag  102  may include multiple indicator elements (e.g., the indicator element  104  may be provided or included on the front panel  106  and another indicator element may be included on the back panel of the drainage bag  102 ), which may increase the likelihood that at least one of the indicator elements will generally face the user under some use conditions. 
     The indicator element  104  and/or portions thereof may have any number suitable sizes or dimensions, which may vary from one embodiment to the next. In some embodiments, the indicator element  104  may have relatively large dimensions, which may improve visibility thereof from a distance. In other embodiments, one or more portions of the indicator element  104  may have relatively small dimensions, which may facilitate display of additional information (as compared with the larger indicator element or corresponding portions thereof). In an embodiment, the indicator element  104  may be configured to provide or display (e.g., to a user, such as a health care provider) information related to one or more patient care protocols. 
     In an embodiment, one or more portions or elements of the indicator element  104  may be preprinted on, attached to, or secured to the drainage bag  102 . For example, at least a portion of the type identifier  120  and/or the indicator sites  122  may be printed on the front panel  106 , the back panel, and/or the privacy barrier of the drainage bag  102 . In other embodiments, at least a portion of the indicator element  104  (e.g., at least one of the type identifier  120  and/or indicator sites  122 ) may be printed on a device (e.g., paper, sticker, stamp, etc.) that is attached to the front panel  106 , the back panel, or the privacy barrier of the drainage bag  102 . The device that includes at least a portion of the indicator element  104  may be provided from, for example, a package  124  ( FIG. 1C ). For example, the drainage bag system  100  may not initially include the indicator element  104  and the indicator element  104  is added to the drainage bag system  100  after the drainage bag system  100  is provided (e.g., after opening a kit, after insertion of the catheter  114 , etc.) 
     In some embodiments, the drainage bag system  100  may include one or more patient care protocol packages  124  (“packages”).  FIG. 1C  is a top plan view of a package  124  that may form a portion of the drainage bag system  100 , according to an embodiment. The package  124  may include any device (e.g., token  126 ) that is configured to perform, verify, and/or assist at least one of the one or more patient care protocols or the device may be omitted. In an embodiment, the package  124  may be configured to perform and/or assist at least one of the one or more patient care protocols that are verified by the indicator sites  122  (e.g., compliance indicator sites). For example, in the illustrated embodiment, the package  124  is a wipe container. The wipes present in the package  124  may be used to wash one or more regions of the patient and/or one or more portions of the drainage bag system  100  according to one or more patient care protocols. The package  124  may include other devices, such as syringes used to remove fluid from the drainage bag  102 , a container including gloves therein, or combinations thereof. 
     In some embodiments, the package  124  may include at least one token  126  associated (e.g., attached to, positioned within, incorporated into, etc.) therewith. For example, the at least one token  126  may be positioned on a surface of the package  124 . The token  126  is configured to be removed from the package  124  and attached to the indicator sites  122 . Positioning the token  126  on the package  124  permits the user to only have access to the token  126  just before, during, and for a short period of time after one or more patient care protocols are performed. Restricting the time period during which the user has access to and can mark the indicator sites  122  with the token  126  may further verify compliance with the one or more patient care protocols (e.g., compliance indicator sites). In particular, restricting when a user has access to the token  126  reduces or eliminates incorrect or backdated markings of the compliance indicator sites. 
     In an embodiment, the token  126  may be positioned on the surface of the package  124  such that the token  126  acts as a tamper proof seal. For example, the token  126  may straddle and/or cover a portion of an exterior surface of the package  124  that is configured to grant access to an interior region of the package  124  or be otherwise used. As such, an at least partially torn token  126  or a missing token  126  may indicate that the package  124  may have been tampered with. 
     In some embodiments, the indicator sites  122  may be configured to receive the token  126  from the package  124 . For example, the indicator sites  122  may exhibit a size and/or shape that correspond to the size and/or shape of the token  126  on the package  124 . 
     In an embodiment, the token  126  may be positioned within the package  124 . As such, the token  126  positioned within the package  124  may only be accessed after the package  124  is opened. For example, the token  126  may be positioned under the wipes that are within the package  124  such that the token  126  may only be accessed after the wipes are removed from the package  124 . The token  126  positioned within the package  124  may be used in conjunction with the token  126  positioned on the surface of the package  124 . In other embodiments, at least one of the token  126  positioned within the package  124  or the token  126  positioned on the surface of the package  124  may be omitted. 
     In an embodiment, the package  124  may include labeling  128  that facilitates performance and standardization of the one or more patient care protocols. In some embodiments, the labeling  128  may facilitate correct usage of the package  124  and correct performance of the one or more patient care protocols that use the package  124 . For example, the labeling  128  may include step-by-step instructions and/or pictographs detailing how to perform the one or more patient care protocols that utilize the package and/or how to correctly use the package  124 . The labeling  128  may conform to patient care protocols promulgated by the CDC, individual hospitals, other healthcare organizations, or combinations thereof. Having the labeling  128  included on the package  124  (e.g., preprinted on the package  124 ) may help standardize the one or more patient care protocols that utilize the package  124 , standardize the operation of the package  124 , prevent a user from incorrectly performing the one or more patient care protocols and/or incorrectly using the package  124 , refresh the user&#39;s memory on how to correctly use the package  124 , etc. As such, the instructions may further verify compliance with the one or more patient care protocols. 
     In an embodiment, the package  124  may further include the indicator element  104  therein or thereon. For example, the indicator element  104  may include a sticker, a piece of paper, a postcard-like device, etc. that is attached to and/or positioned within the package  124 . The indicator element  104  may then be removed from the package  124  and attached to the drainage bag system  100 , such as attached to the drainage bag  102 . For example, the indicator element  104  may be attached to the front panel  106 , the back panel, the privacy barrier, or otherwise associated with the drainage bag  102  ( FIGS. 4A-4D ). In an embodiment, the indicator element  104  may be attached to the drainage bag system  100  using an adhesive, a string, an elastic band, a clamp, or another attachment method. 
       FIGS. 1A-1C  also illustrate a method of using the drainage bag system  100 , according to an embodiment. Referring to  FIG. 1A , the drainage bag system  100  may be provided, which may be configured to be used as a urinary drainage bag system including the catheter  114 . In such an embodiment, the indicator element  104  may be configured to indicate completion of a task related to the drainage bag system  100  (e.g., verify performance and/or compliance with one or more patient care protocols related to pre-insertion of the catheter  114  and/or post-insertion of the catheter  114 ). For example, the indicator element  104  may include compliance indicator elements configured to verify compliance with the post-insertion patient care protocol of washing portions of the periurethral and perineal regions of the patient, and/or washing portions of the drainage bag system  100 , in particular, portions of the drainage bag system  100  positioned proximate the periurethral and perineal regions of the patient (“post-insertion patient care protocol”). In some embodiments, the post-insertion patient care protocol may be required to be performed about every 12 hours. As such, the indicator element  104  may include the calendar  123  where each date on the calendar  123  includes two indicator sites  122  that correspond to one of the 12 hour periods. Initially, the indicator element  104  may be provided in an inactive state. 
     Referring to  FIG. 1C , in the illustrated embodiment, the package  124  may be used to facilitate performance of a patient care protocol related to the drainage bag system  100 . In an embodiment, the package  124  may also be configured to verify compliance with a patient care protocol (e.g., the post-insertion patient care protocol). For example, the package  124  may include a container that includes wipes therein. In some embodiments, the post-insertion patient care protocol may require that five different portions of the patient&#39;s periurethral region, the patient&#39;s perineal region, and the drainage bag system  100  be washed using, for example, non-antiseptic wipes. As such, the package  124  may include at least five different wipes therein, each wipe corresponding to a different portion of the patient&#39;s periurethral region, the patient&#39;s perineal region, and the drainage bag system  100 . An example of wipes that may be included in the package  124  include Provon® products available from GOJO.com. 
     The package  124  may include labeling  128  thereon that facilitates performance and standardization of the post-insertion patient care protocol. For example, the illustrated labeling  128  may state that the first and second wipes present in the package  124  may be used to clean the genitalia of the male (e.g., wipe the foreskin and the meatus, foreskin, the periphery thereabout) and/or female (wipe the meatus). The labeling  128  may also state that the third and fourth wipe present in the package  124  may be use to clean the inner thigh of the patient. Finally, the labeling  128  may state that the fifth wipe is used to clean a portion of the catheter  114 . It is noted that the labeling  128  may instruct the user to perform the post-insertion patient care protocol in a different order, modify certain acts, and/or omit or add certain acts. For example, the labeling  128  may instruct the user to first clean a portion of the catheter  114  before cleaning the genitalia of the patient and/or clean the male shaft instead of the periphery about the male genitalia. 
     As previously discussed, the package  124  may include the token  126 . The token  126  may be removed from the package  124  and attached to one of the indicator sites  122  (e.g., compliance indicator sites). Referring to  FIG. 1B , the indicator element  104  is considered to be in an active state after the token  126  is removed from the package  124  and attached to an indicator site  122 . For example, the indicator element  104  verifies that the post-insertion patient care protocol has been performed at least three times during a two day period. However, the indicator element  104  may also illustrate that the indicator element  104  does not verify that at least one post-insertion patient care protocol was performed. 
       FIG. 1D  is a top plan view of a package  124 ′ that may form a portion of the drainage bag system  100 , according to an embodiment. Except as otherwise described herein, the package  124 ′ shown in  FIG. 1D  and its respective elements and components may be similar to or the same as the package  124  ( FIG. 1C ) and its respective elements and components. Additionally, the package  124 ′ illustrated in  FIG. 1D  may be used with or used instead of the package  124  illustrated in  FIG. 1C  in any of the drainage bag systems disclosed herein. 
     The package  124 ′ may include a plurality of distinct labelings thereon that facilitate performance and standardization of the post-insertion patient care protocol. In the illustrated embodiment, the plurality of distinct labelings may include a first labeling  128   a , a second labeling  128   b , and a third labeling  128   c . The first labeling  128   a  may include general information related to the package  124 ′, such as ingredients present in the package  124 ′. The second labeling  128   b  may state how the wipes present in the package  124 ′ are to be used. For example, the second labeling  128   b  may state that the first wipe present in the package  124 ′ may be used to clean a portion of the drainage bag system  100  (e.g., the catheter  114  shown in  FIG. 1A ), the second wipe present in the package  124 ′ may be used to clean a meatus of a male patient or a far-side of a meatus of a female patient, the third wipe present in the package  124 ′ may be used to clean a shaft of the male patient or a near-side of the meatus of the female patient, and the fourth and fifth wipes present in the package  124 ′ may be used to clean both inner thigh regions of the patient. The second labeling  128   b  may include pictures (e.g., photographs, drawings, schematics, etc.) and/or words to convey how the wipes present in the package  124 ′ are to be used. The third label  128   c  may state how the package  124 ′ (e.g., not just the wipes present in the package  124 ′) is to be used. For example, the third label  128   c  may state that the package  124 ′ may be configured for single patient use, that the wipes present in the package  124 ′ are to be used according to the second labeling  128   b , that proper hand hygiene is to be performed before using the package  124 ′, that hospital protocols are to be followed, a token  126 ′ present on and/or in the package  124 ′ is to be placed onto an indicator element, that the wipes present in the package  124 ′ are not to be flushed down a toilet, etc. 
     In an embodiment, one or more of the first labeling  128   a , the second labeling  128   b , or the third labeling  128   b  may be used on the package  124  shown in  FIG. 1C  instead of the labeling  128 . In an embodiment, one or more of the first labeling  128   a , the second labeling  128   b , or the third labeling  128   b  may be omitted from the package  124 ′. In an embodiment, the package  124 ′ may include one or more additional labelings thereon. In an embodiment, all of the labels are placed on the same surface of the package  124 ′. In an embodiment, at least one of the labels are placed on a different surface of the package  124 ′. For example, at least one of the labels is placed on a front surface of the package  124 ′ and at least one of the labels is placed on a back surface of the package  124 ′. 
       FIG. 2  is a top plan view of a drainage bag system  200  that includes a drainage bag  202  with a plurality of indicator elements (e.g., two indicator elements), according to an embodiment. The drainage bag  202  may be similar to the drainage bag  102  shown in  FIG. 1A . For example, the drainage bag  202  may be in fluid communication with a catheter  214 . As mentioned above, the drainage bag  202  may include any suitable number of indicator elements. In the illustrated embodiment, the drainage bag  202  includes a first indicator element  204   a  and second indicator element  204   b . However, the drainage bag  202  may include more or fewer than two indicator elements. 
     The first indicator element  204   a  may include a first type identifier  220   a  that may be marked by a user in any manner described above. In the illustrated embodiment, the first indicator element  204   a  also includes a display  230  (e.g., digital display) that provides or displays information to the user. The first indicator element  204   a  may also include one or more inputs  232  that may allow the user to interact with the first indicator element  204   a . The inputs  232  may also allow the user to input any number and/or type of suitable information into the first indicator element  204   a . For example, the inputs  232  may be used to input the insertion date of the catheter or other general information related to the drainage bag system  200  and/or patient care. As such, the display  230  may be a type identifier and, in some embodiments, the first type identifier  220   a  may be omitted. In another embodiment, the inputs  232  may be used to verify compliance with the one or more patient care protocols. As such, the display  230  may be an indicator site, such as a compliance indicator site. In particular, the display  230  may be inactive (e.g., the display  230  is blank (e.g., a blank location) and does not display information indicating (e.g., verifying) compliance with patient care protocols) and may be activated using the inputs  232 . In some embodiments, the display  230  may be both a type identifier and an indicator site (e.g., compliance indicator site). In some embodiments, the first indicator element  204   a  may also include the display  230  and one or more indicator sites similar to any of the indicator sites disclosed herein. 
     In some embodiments, the first indicator element  204   a  may include a timer which may use the display  230  to show a time passed from an event and/or time left to an event. The event may include any act that is related to the drainage bag system  200 . For example, the event may include the insertion of the catheter  114 , the performance of one or more patient care protocols (e.g., the post-insertion patient care protocol), etc. In some embodiments, the user may use the one or more inputs  232  to indicate when an event occurred. For example, the user may use the one or more inputs  232  to enter a time, reset the timer, start the time, stop or pause the timer, etc. The first type identifier  220   a  may indicate the event that the display  230  is counting from and/or towards. In an embodiment, the digital display  230  may include memory that stores one or more instructions thereon and a processor that executes the one or more instructions stored on the memory. The user may input instructions into the digital display  230  using the inputs  232 . The instructions may include when an event is to occur, what event occurred, or combinations thereof. 
     It should be appreciated that the timer may include any suitable timer, which may vary from one embodiment to the next. In some embodiments, the timer may be an electronic timer, which may be autonomously powered (e.g., may include one or more batteries or similar power supply sources) or may be connected to an external power supply (e.g., electrical outlet). Additionally or alternatively, the timer may include a mechanical mechanism that may be operated to change the time/date displayed to a user (e.g., wound to operate the display  230 ). Furthermore, in some embodiments, the timer may be controlled or operated by a chemical reaction (e.g., a chemical reaction may progressively cause or result in a change in color along a time and/or date scale, thereby indicating time elapsed after initiation of such reaction, which may be caused by user input). 
     In some embodiments, the first indicator element  204   a  may be removable and/or replaceable. For example, a user may remove the first indicator element  204   a  from the drainage bag  202  when replacing the drainage bag  202  and may place the first indicator element  204   a  on a new drainage bag. Alternatively or additionally, the user may attach the first indicator element  204   a  to any suitable location near the drainage bag  202 . Moreover, any of the indicator elements described herein may be removable and/or replaceable. 
     In some embodiments, the first indicator element  204   a  may be configured to be tamper resistant and/or minimize falsification. For example, the first indicator element  204   a  may require a code before a user may input any information into the first indicator element  204   a . In an embodiment, the code may be located inside a package. Alternatively, the code may be unique to the user thereby identifying the user. 
     The second indicator element  204   b  may include a second type identifier  220   b  that may receive input from a user in any manner described above. In the embodiment, the second indicator element  204   b  may also include a list or checklist  223 . The list or checklist  223  may be at least partially formed from one or more second indicator sites  222   b  that may be substantially similar to any of the indicator sites disclosed herein. For example, the second indicator sites  222   b  may each initially include a blank or unfiled location configured to be marked by the user in any manner described therein. The list or checklist  223  may include second indicator sites  222   b  that do not correspond to a certain time or date. For example, the list or checklist  223  may be used when the one or more patient care protocols do not need to be performed at a certain time or date, when the second indicator sites  222   b  are configured to receive input that is configured to convey a time or date (e.g., each token corresponds to a date), when at least some of the second indicator sites  222   b  verify compliance with different patient care protocols (e.g., compliance indicator sites), etc. 
     While the first indicator element  204   a  and the second indicator element  204   b  are illustrated as including the display  230  and the list or checklist  223 , respectively; it is understood that the first indicator element  204   a  and/or the second indicator element  204   b  may include any indicator element disclosed herein. For example, the first indicator element  204   a  and the second indicator element  204   b  may be substantially the same. Additionally, the drainage bag system  200  may further include more than two indicator elements. Moreover, as described above, one, some, or all of the indicator elements  204   a ,  204   b  may be tamper resistant. 
     As discussed above, the drainage bag system  200  may include an indicator element (e.g., the first indicator element  204   a  and/or the second indicator element  204   b ) thereon configured to verify compliance with one or more patient care protocols. For example, the indicator element may be configured to be marked using a writing utensil and/or a token that is associated with a package (e.g., the package  124 ,  124 ′ shown in  FIGS. 1C-1D ). In some embodiments, the package may facilitate performance of one or more patient care protocols pre-insertion and/or post-insertion of a catheter. For example, a package that facilitates performance of one or more patient care protocols pre-insertion includes a kit, such as a Foley catheterization kit. In some embodiments, the writing utensil and/or token may be located in the kit. 
     For example,  FIG. 3  is a top plan view of a kit  334  that includes a drainage bag  302  and one or more tokens  326 , according to an embodiment. For example, the drainage bag  302  may include an indicator element  304  thereon that includes a type identifier  320  and/or one or more indicator sites  322 . As described above, the one or more indicator sites  322  may be configured to have one or more tokens (e.g., token  326  and/or  326 ′) attached thereto, thereby indicating compliance with one or more patient care protocols (e.g., compliance indicator sites). The kit  334  may include a catheter (not shown, obscured under drainage bag  302 ) and a drainage tube  312  connected or connectable to the drainage bag  302 . In some embodiments, the kit  334  may be a Foley catheterization kit that may include sterile water  336  to inflate a balloon of the catheter, lubrication gel  338 , one or more swabs  340 , an antiseptic, at least one other suitable apparatus or device, or combinations of the foregoing. In some embodiments, the kit  334  may include a package  324  therein that that is used to perform one or more patient care protocols pre-insertion or post-insertions (e.g., the package  124 ,  124 ′ shown in  FIGS. 1C-1D ). The package  324  may include at least one token  326  associated therewith or the token  326  associated with the package  324  may be omitted. 
     In an embodiment, the kit  334  may include a token  326  located in a tray  342  of the kit  334 . For example, the token  326  may be accessed after the completion of one or more tasks related to the patient care and/or compliance with one or more patient care protocols displayed on the indicator element  304 . The token  326  (e.g., the token located on the package  324  and/or the token located in the tray  342 ) may verify performance and/or compliance of a pre-insertion patient care protocol. More particularly, for example, the pre-insertion patient care protocol may include one or more of cleaning the catheter, the meatus of the patient, or the inner thighs of the patient using wipes present in the package  324  prior to insertion of the catheter into the patient. 
     In an embodiment, the token  326  located in the tray  342  may be located under the drainage bag  302 . As such, the token  326  may be accessed after the drainage bag  302  is removed from the kit  334 . Alternatively, the token  326  may be located at a number of other suitable locations in or on the tray  342  of the kit  334  (e.g., under the sterile water  336 ) or positioned on one or more components contained within the kit  334  (e.g., the sterile water  336 , etc.). Additionally, marking the indicator element  304  using the token  326  within the kit  334  may indicate that the user marked the indicator element  304  at a time between opening and disposing the kit  334 . 
     In some embodiments, the token  326  may be associated with a particular patient care protocol performed. For example, the kit  334  may include a plurality of tokens  326  therein that correspond to different patient care protocols. As such, the token  326  may include text, graphics, color, etc., which may associate the token  326  with the particular patient care protocol. Also, the token  326  may be located in any number of suitable kits or locations, which may be accessed during and/or after performing the particular patient care protocols. 
     In some embodiments, a separate pre-insertion patent care package may be included in the kit  334  and include its own corresponding one or more tokens to indicate performance and/or compliance of one or more pre-insertion patient care protocols including one or more of cleaning the catheter, the meatus of the patient, or the inner thighs of the patient using wipes present in the pre-insertion patent care package prior to insertion of the catheter into the patient. These separate one or more tokens from the pre-insertion patent care package may be applied to the indicator element  304  in a selected location to indicate performance and/or compliance of the one or more pre-insertion patient care protocols. As such, marking the indicator element  304  using the token may indicate that a specific task was completed (e.g., verifying that a pre-insertion and/or post-insertion patient care protocol was performed). 
       FIGS. 4A-4D  are isometric views of indicator elements  404  that are distinct and separate from (e.g., not attached or otherwise incorporated into) a drainage bag  402 , according to various embodiments. The indicator element  404  shown in  FIGS. 4A-4D  may be used in any of the embodiments disclosed herein. 
     The indicator elements  404  may be used in a drainage bag system  400  that is substantially similar to the drainage bag system  100  shown in  FIG. 1A . For example, the drainage bag  402  may be configured to receive a fluid from a patient via a drainage tube  412 . The drainage bag system  400  may also include at least one indicator element  404  that is configured to indicate that a task related to the drainage bag system  100  was performed. For example, the indicator element  404  may include a compliance indicator element configured to verify compliance with one or more patient care protocols that are associated with the drainage bag system  400 . Each indicator element  404  may include a type identifier  420  and/or one or more indicator sites  422 . Each indicator element  404  may include a paper, plastic, other medium, or combinations thereof that includes the type identifier  420  and/or the indicator sites  422  thereon (e.g., printed thereon). 
     Referring to  FIG. 4A , the indicator element  404  may be configured to attach to one or more components of the drainage bag system  400 . For example, the indicator element  404  is attached to one or more components of the drainage bag system  400  that are distinct and separate from the drainage bag  402 , such as a drainage tube  412 . Alternatively, the one or more components of the drainage bag system  400  may include a portion of the drainage bag  402  that is distinct and separate from the front panel  406 , such as an inlet  410  of the drainage bag  402 , an outlet  416  of the drainage bag  402 , etc. The indicator element  404  may attach to the one or more components of the drainage bag system  400  using an adhesive, a string, an elastic band, a clamp, or another attachment method. For example, the indicator element  404  may include a hole  446  therein that receives the string, elastic band, or other attachment device. Alternatively, the hole  446  may receive the one or more components of the drainage bag system  400  (e.g., a portion of the drainage tube  412  may be positioned within the hole  446 ) or the hole  446  may be omitted. Similarly, the one or more components of the drainage bag system  400  may be configured to have the indicator element  404  attached thereto. For example, the one or more components of the drainage bag system  400  may comprises a stronger material or be thicker than similar portions of the drainage bag system  400 . 
     Referring to  FIG. 4B , the indicator element  404  may be configured to be attach to one or more medical devices proximate to the drainage bag system  400 . For example, the illustrated indicator element  404  is attached to an IV pole  444 . The indicator element  404  may attach to the one or more medical devices using any of the attachment method disclosed herein. 
     Referring to  FIG. 4C , the indicator element  404  may be configured to be attached to a bed  448 . For example, the indicator element  404  may be attached to the bed  448  on which a patient is positioned. The indicator element  404  may be attached to any portion of the bed  448 , such as a base of the bed  448 . The indicator element  404  may be attached to the bed  448  using any of the attachment methods disclosed herein. 
     Referring to  FIG. 4D , the indicator element  404  may be configured to be attached to a wall  450 . For example, the indicator element  404  may be attached to one of the walls  450  that encloses a room in which the drainage bag system  400  is positioned. The indicator element  404  may be attached to the wall  450  using any of the attachment techniques and/or devices disclosed herein. 
     In an embodiment, the indicator element  404  may distinct and separate from the drainage bag  402  to improve the visibility of the indicator element  404  from one or more locations. For example, the drainage bag  402  may be at least partially obscured from one or more locations (e.g., the door to the patient&#39;s room, the base of the bed  448 , etc.). As such, the indicator element  404  may be spaced from the drainage bag  402  and attached to a location that improves the visibility of the indicator element  404  from one or more locations, such as any of the locations disclosed herein or any other suitable location. 
       FIG. 5  is a side view of a drainage bag system  500  including a drainage bag  502  and a plurality of packages  524  (e.g., the package  124 ,  124 ′ shown in  FIGS. 1C-1D ) removably attached together, according to an embodiment. The plurality of packages  524  may be used with any of the embodiments disclosed herein. 
     The drainage bag  502  may be the same as or similar to the drainage bags  102 ,  202 ,  302 ,  402  shown in  FIGS. 1A, 2-4A . For example, the drainage bag  502  may include at least one indicator element  504  configured to verify completion of a task related to the drainage bag system  500 . In the illustrated embodiment, the indicator element  504  includes a type identifier  520  and one or more indicator sites  522 . The indicator sites  522  may at least partially form a calendar  523 . Each of the one or more indicator sites  522  may include a blank or unfilled location that is configured to be marked by a user. For example, the one or more indicator sites  522  may be marked by a user before, during, or after one or more patient care protocols have been performed. In the illustrated embodiment, the indicator element  504  may include a compliance indicator sites that may verify compliance with one or more patient care protocols that occur twice a day (e.g., every 12 hours). 
     In an embodiment, the drainage bag  502  may be configured to be attached to an IV pole  544 . For example, the drainage bag  502  may include a hook  552  that attaches to the IV pole  544 . Connecting the drainage bag  502  to the IV pole  544  or another similar device may increase the visibility of the indicator element  504 . However, the drainage bag  502  may be attached to devices other than the IV pole  544  that are proximate the patient. For example, the drainage bag  502  may be attached to the patient, a bed, a wheelchair, a medical device, a wall, or any other suitable device. 
     The plurality of packages  524  may be removably attached together (e.g., directly or indirectly). In the illustrated embodiment, the plurality of packages  524  are indirectly attached together used a retention device  554 . The retention device  554  may be attached to the IV pole  544  (e.g., include a hook, hole, etc.). The retention device  554  may include any device that is configured to carry the plurality of packages  524  and permit the packages  524  to be removed therefrom. For example, the retention device  554  may include a rigid, semi-rigid, or flexible material. Each of the plurality of packages  524  may be attached to the retention device  554  using adhesives (e.g., both weak and strong adhesives), clamps, or any other attachment technique. In an embodiment, each of the plurality of packages  524  may be removably attached to the retention device  554 , thereby allowing each of the plurality of packages  524  to be selectively detached from the retention device  554  and from each other. For example, in the illustrated embodiment, the retention device  554  may define a plurality of holes  556  that can receive the plurality of packages  524 . In another embodiment, the plurality of packages  524  may be attached to the retention device  554  using a weak adhesive or other reversible attachment technique. In another embodiment, each of the plurality of packages  524  may more strongly attached (e.g., using a strong adhesive, a staple, etc.) to the retention device  554 . For example, in such an embodiment, detaching one of the plurality of packages  524  from the rest of the packages  524  also requires separating some of the retention device  554  from the rest of the retention device  554 . As such, the retention device  554  may include a plurality of perforations or other mechanism that permits a portion of the retention device  554  to be separated from the rest of the retention device  554 . 
     In an embodiment, the plurality of packages  524  may be directly removably attached together. For example, the plurality of packages  524  are removably attached together using an adhesive that is strong enough to hold the plurality of packages  524  together, but weak enough to allow each of the plurality of packages  524  to be detached without damaging the any of the plurality of packages  524 . In another embodiment, each of the plurality of packages  524  may be bonded together. In such an example, the boundary between each of the plurality of packages  524  may include a plurality of perforations that allow a user to easily separate one package  524  from an immediately adjacent package  524 . In an embodiment, the plurality of packages  524  may be removably attached to each other and to the retention device  554 . 
     The plurality of packages  524  may be configured to verify compliance with one or more patient care protocols. For example, detaching one of the plurality of packages  524  from the rest of the plurality of packages  524  may indicate that one or more patient care protocols associated with the packages  524  has been performed. A compliance officer (e.g., a supervisor, responsible physician, etc.) may view the plurality of packages  524  and see that at least one package  524  is missing, thereby indicating that the one or more patient care protocols associated with the package  524  were performed. 
     In an embodiment, the plurality of packages  524  may be used in conjunction with the indicator element  504  of the drainage bag  502 . For example, each of the plurality of packages  524  may include at least one token associated therewith (e.g., attached thereto, incorporated therewith, or positioned therein). In some embodiments, the token may only be accessed after the package  524  is detached from the rest of the plurality of packages  524 . As such, the plurality of packages  524  may form a second means of indicating compliance with the one or more patient care protocols. 
     While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.