Abstract:
A device, system, and method of ensuring hand hygiene compliance is provided including a device for dispensing hygiene maintenance material that also monitors a detection zone to determine if an individual is present. The device, system, and method provide reminders and tracking of use of the dispensing device and the relation of that use compared to a desired use profile.

Description:
BACKGROUND AND SUMMARY OF THE DISCLOSURE 
       [0001]    The present disclosure relates to a dispenser of hand hygiene maintenance material. More specifically, the present disclosure relates to a dispenser of hand hygiene maintenance material that provides reminders and tracking of use of the dispenser and the relation of that use compared to a desired use pattern. 
         [0002]    Healthcare-associated infections remain one of the most significant sources of morbidity and mortality among hospital patients worldwide. In the United States there are an estimated 1.7 million healthcare-associated infections in hospitals resulting in approximately 80-100,000 deaths each year adding $4.5 to $5.7 billion to patient care costs. (Jarvis W R. Selected aspects of the socioeconomic impact of nosocomial infections: morbidity, mortality, cost and prevention. Infect Control Hospital Epidemiology, 1996:August 17(8):552-557). Transmission of healthcare-associated pathogens most often occurs via the contaminated hands of health care workers due to failure to use proper hand washing technique or failure to hand wash altogether before every patient contact. Compliance rates for basic hand washing techniques have been cited between about 25-50%. Failure to remember to comply with hand washing protocol prior to every patient contact is probably the most significant factor for low compliance rates. Other factors including understaffing and overcrowding further exacerbate this problem. 
         [0003]    Recognizing a worldwide need to improve hand washing in health care facilities the World Health Organization (WHO) launched its “Guidelines on Hand Hygiene in Health Care (Advanced Draft) in October 2005. These global consensus guidelines reinforce the need for multidimensional strategies as the most effective approach to promote hand hygiene. Key elements include adoption of alcohol-based hand rub as the primary method for hand hygiene and the use of performance indicators to assess the compliance with hand washing policies. Presently, the only routine monitoring of compliance involves direct visual observation of hand hygiene by hospital personnel. In the CDC&#39;s monograph (MMWR. Oct. 25, 2002. 51(RR16); 1-44) many recommendations are indicated. These include: 1) to develop a device to facilitate the use and optimal application of hand hygiene agents, 2) to monitor hand hygiene adherence by ward or service staff and 3) to provide feedback to personnel regarding staff performance using the new device. 
         [0004]    One study by Pittet et al (Pittet D, Hugonnet S et al. Effectiveness of a hospital-wide program to improve compliance with hand hygiene. Lancet, 2000; 356:1307-1312) showed a definite association between improved hand hygiene compliance and a decreased incidence of hospital acquired nosocomial infections, including methicillin-resistant staphylococcus aureus (MRSA) infections. Another study by Pittet et al (Pittet D, Simon A et al. Hand hygiene among physicians: performance, beliefs and perceptions Ann Intern Med 2004; 148w) found that easy access to alcohol-based hand rub was an independent predictor of improved hand hygiene compliance. In addition, 8 out of 9 hospital-based studies from 1977-2000 clearly demonstrate a temporal relationship between improved hand hygiene and reduced nosocomial infection rates, especially MRSA. 
         [0005]    Another very recent incentive to reduce hospital-acquired infections was a new rule imposed by Medicare on Oct. 1, 2008 which stated their refusal to pay hospitals for catheter-associated urinary tract and vascular catheter-associated infections. It is likely that private insurance companies will soon put this same rule into effect. Both types of infections could be reduced by adequate hand washing technique. (O&#39;Grady N P, Alexander M et al. Guidelines for the prevention of intravascular catheter-related infections. Pediatr 2002:ppe51) and could save hospitals millions of dollars in reimbursements. 
         [0006]    Visitors who do not use adequate hand washing techniques and then have direct contact with patients are another possible source of hospital acquired infections. This potential problem needs to be addressed and resolved as well. 
         [0007]    The device of the present disclosure records hand hygiene compliance for all individuals who enter a monitored room. The recorded data can then be utilized to track compliance of a particular unit/ward to allow targeted training to improve compliance on that unit/ward. Immediate follow up data can then be supplied about the efficiency of the training It can also track data at night and on weekends, when the presently used visual observation is not routinely used. 
         [0008]    According to a first embodiment, the present disclosure includes a hygiene compliance device including a housing; a hygiene maintenance material holder located within the housing; an interface member coupled to the housing that, when activated by a user, causes distribution of hygiene maintenance material from within the hygiene maintenance material holder to the user; an interface member sensor coupled to the housing that detects activation of the interface member; a signal emitter coupled to the housing; a signal sensor coupled to the housing that cooperates with the signal emitter to detect the presence of a person in a detection zone; a circuit board located within the housing and coupled to the signal emitter, the signal sensor, and the interface member sensor, the circuit board including a processor; and a data storage unit located within the housing and electrically coupled to the processor. The data storage unit has instructions thereon that, when interpreted by the processor cause the processor to perform the steps of: issuing commands to the signal emitter to emit a signal; receiving data from the signal sensor; processing the data received from the signal sensor to determine if an individual is located within a detection zone of the sensor; detecting activation of the interface member sensor; determining if the interface member sensor is activated within a first preset time of a detection of an individual within the detection zone; and choosing between and executing one of: logging a compliant event by saving a record to the data storage unit if the interface member is activated within the first preset time of the detection of the individual in the detection zone; and issuing an alert detectable by the individual if the interface member is not activated within the first preset time of the detection of the individual in the detection zone. 
         [0009]    According to a second embodiment, a method of monitoring hygiene compliance including the steps of: providing a hygiene compliance device to a hygiene sensitive location; providing for communication between the hygiene compliance device and a network; providing an adjustable signal emitter in the hygiene compliance device to monitor an ingress/egress point to the hygiene sensitive location; the hygiene compliance device further having a processor and a data storage unit. The data storage unit has instructions thereon, that when interpreted by the processor, cause the processor to perform the steps of: issuing commands to the signal emitter to emit a signal; receiving data indicative of the presence or lack of presence of an individual proximate the monitored ingress/egress point; processing the data received to determine if an individual is located within a detection zone of the sensor; detecting dispensing of hygiene compliance material from the hygiene compliance device; determining if the hygiene maintenance material is dispensed within a first preset time of a detection of an individual proximate the detection zone; and choosing between and executing one of: logging a compliant event by saving a record to the data storage unit if the interface member is activated within the first preset time of the detection of the individual in the detection zone; and issuing an alert detectable by the individual if the interface member is not activated within the first preset time of the detection of the individual in the detection zone. 
         [0010]    Additional features of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description of the illustrative embodiment exemplifying the best mode as presently perceived. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIGS. 1   a &amp; b  are perspective views of a hygiene maintenance device of the present disclosure; 
           [0012]      FIG. 2  is a schematic of computing systems in communication with the hygiene maintenance device of  FIG. 1 ; 
           [0013]      FIGS. 3   a - f  are overhead schematic views of embodiments of room setups using the hygiene maintenance device of  FIG. 1 ; 
           [0014]      FIG. 4  is a schematic diagram of the inputs and outputs for a microprocessor and a circuit board of the hygiene maintenance device of  FIG. 1 ; 
           [0015]      FIG. 5   a &amp; b  are a decision tree showing the functional process followed by the hygiene maintenance device of  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION 
       [0016]    The embodiments of the disclosure described herein are not intended to be exhaustive or to limit the invention to precise forms disclosed. Rather, the embodiment selected for description have been chosen to enable one skilled in the art to practice the disclosure. 
         [0017]      FIG. 1  shows hygiene maintenance device  10 . Hygiene maintenance device  10  is shown as a dispenser of soap or hand rub such as an antiseptic hand rub. Device  10  provides an auditory and visual reminder to use it, an alcohol (or otherwise) based hand rub and a compliance monitoring system all in one unit. 
         [0018]    Device  10  is wall mounted or on an independent portable stand close to the entrance to a patient&#39;s room. Device  10  includes housing  12 , sanitizer container  14 , battery holders  16 , batteries  17 , circuit board  20 , speaker  22 , status LED  24 , and fault LED  26 . 
         [0019]    Housing  12  is substantially similar to soap/alcohol dispensers known in the art. Housing  12  includes a front half  28  pivotally coupled to a back half  30 . Front half  28  includes window  32 , dispensing handle  34 , and LED windows  36 ,  38 . Front half  28  pivots relative to back half  30  to allow access to the interior of housing  12  for servicing of device  10 , including fixing malfunctions, refilling/replacing sanitizer container  14 , and replacing batteries  17 . Window  32  allows a user to see therethrough to see sanitizer container  14 . Dispensing handle  34  is pressed by a user&#39;s hand to cause dispensing of sanitizer from device  10 . Alternatively, handle  34  is hingedly coupled to back half  30 . LED windows  36 ,  38  align with LED&#39;s  24 ,  26  when front half  28  is in a closed position to allow a user to view light produced by LED&#39;s  24 ,  26  through LED windows  36 ,  38 , respectively. 
         [0020]    Back half  30  includes sanitizer container mount  42 , sanitizer container  14 , battery holders  16 , circuit board  20 , speaker  22 , LED&#39;s  24 ,  26 , sensor/emitter  44 , and speaker port  40 . Sanitizer mount  42  provides a quick disconnect mount that readily receives and releases sanitizer container  14  while providing a leak-free connection for sanitizer container  14  that allows dispensing of the contents of sanitizer container  14 . Sanitizer container  14  is either a disposable or refillable container of the sanitizer to be dispensed by device  10 . Battery holders  16  hold batteries  17  and are electrically coupled to circuit board  20 . Circuit board  20  includes a processor  46  thereon as well as a plurality of input/output/power ports. The input/output/power ports are coupled to portions for detection (such as sensor/emitter  44 ), for providing alerts (such as LED&#39;s  24 ,  26 , speaker  22 ), for powering the device (such as battery holders  16  and batteries  17 ), for determining the amount of sanitizer remaining in sanitizer container  14 , for communicating with other devices, and for saving data. Speaker  22  is coupled to circuit board  20  and provides audible commands or alerts, or information generally. Status LED  24  provides an indication of the operational status of hygiene maintenance device  10 . Status LED  24  can operate in a plurality of ways. Such ways include providing a solid-on state and various combinations of flashes to indicate various operational states, or by producing various colors to indicate various operational states. Similarly, fault LED  26  provides an indication of operational faults or low battery/power (or loss of power). LED  26  can communicate this in any of the ways described with respect to status LED  24 . Sensor/emitter  44  is located at the top of back half  30  and is illustratively an infrared motion sensor/emitter. Sensor/emitter  44  therefore emits an infrared signal and then senses the signal that is reflected by the surroundings back to sensor/emitter  44 . More specifically, sensor/emitter  44  utilizes infrared sensing technology across a narrow spectrum (multiple “rays”) to detect an object moving through its field. The sensor chosen for this prototype is “tuned” more specifically towards the heat signature of a person to limit detection of a moving door or moving piece of equipment. Optionally, a second electrically coupled sensor/emitter  44  is also used. Speaker port  40  aligns with speaker  22  to readily allow sounds to emanate therefrom. 
         [0021]    Whereas one embodiment of the device is described above, various alternatives are envisioned. More specifically, whereas the sensor/emitter  44  is described as a motion sensor device, other embodiments are envisioned such as those using a light gate, RFID, ultrasound, a thermal sensor, or any other suitable sensor known in the art. Furthermore, whereas sensor/emitter  44  is described as being integrated with hygiene maintenance device  10 , embodiments are envisioned where sensor/emitter  44  is separate from hygiene maintenance device  10  and is able to be positioned remotely from hygiene maintenance device  10 . Sensor/emitter  44  can have a fixed aim or can be adjustable such that the coverage thereof can be adjusted once installed. Each of the detection methods provide opportunities to customize the detection profiles (the conditions under which a detection of a user is considered to have been triggered). The detection profiles can either be fixed as a factory setting or can be adjustable by an installer or other individual to customize hygiene maintenance device  10  to suit its particular application setting. 
         [0022]    Additionally, LED&#39;s  24 ,  26  and speaker  22  can provide different ways of signaling that a detection has been made. As previously noted, LED&#39;s  24 ,  26  can provide solid on or off settings, as well as flash patterns, and differing colors to indicate various things. Similarly, audible alerts provided via speaker  22  can be provided in the form of tones, music, or voice prompts. Additionally, multiple alerts can be provided and the timing of such alerts relative to other events can either be a factory setting or adjustable by an installer or user. 
         [0023]    The embodiment of  FIG. 1  shows batteries  17  and battery holders  16 . Alternatively or additionally, power can be provided via a traditional AC plug or a power cord that couples to a PC (USB or otherwise). Thus, batteries  17  can be either a primary or a secondary (backup) power source. 
         [0024]    Circuit board  20 ,  FIG. 4 , is coupled to storage component  50  and includes communications components  52  thereon. Storage components  50  store the programming used to operate hygiene maintenance device  10  and store configuration settings. Storage components  50  also store operational data indicative of how hygiene maintenance device  10  has been used or unused and data relating to compliance with a proscribed use protocol. Embodiments are envisioned where device  10  includes removable memory such as a memory card/stick or jump drive for storing data. Such embodiments optionally operate without an infrastructure for networked monitoring. In still another embodiment, processor  46  detects the connection of a jump drive (or thumb drive) connected via a USB port or otherwise and automatically uploads stored data thereto. Such embodiment would additionally operate without the need for a dedicated computer or network infrastructure. 
         [0025]    Communications components  52  allow data to be transferred between hygiene maintenance device  10  and other computing devices, such as a central computer coupled to a plurality of hygiene maintenance devices  10 . Use of communications components  52  allows data to be saved to or pulled from storage components  50 . Communication components  52  include components for wired or wireless networking, or for direct coupling to a computer. The wired components are those for connection to a LAN or Ethernet based system (such as an RJ-45 interface). Wireless networking components are those for traditional Wi-Fi or a wireless MESH network (WMN) operating according to the Zigbee standard or otherwise. Direct coupling components are those suitable for providing USB, Serial, firewire, or other known transmission interfaces. Device  10  can communicate directly to another computer via the direct connection for purposes of downloading stored data or changing the program presets. (i.e. a user can connect to an individual device via a USB cable connected to their laptop or portable computer.) Such embodiments optionally operate without an infrastructure for networked monitoring 
         [0026]    Device  10  further includes switch  48  that is coupled to or integral with dispensing handle  34 . Switch  48  is a limit switch, a micro switch, a position switch, or any other suitable switch. Switch  48  allows detection of the use of dispensing handle  34  and thus the dispensing of sanitizer. Software also receives input from switch  48  to count the number of times dispensing handle  34  is pressed and uses information regarding the last refill/replacement of sanitizer container  14  to produce an approximation on the amount of sanitizer remaining in sanitizer container  14 . Accordingly, appropriate staff can be alerted when sanitizer container  14  is running low on sanitizer. 
         [0027]    Device  10  operates to monitor ingress and egress from a hygiene sensitive area. If the sensor/emitter  44  detects a user passing within its sensing range, and if a sanitizer is not dispensed within a specified period of time, a voice alarm in English (and/or in other appropriate languages) with an adjustable, time-cycled volume control says “You must cleanse hands.” Alternatively, an audible tone is presented instead. In addition, a visual alarm is activated. If the sanitizer is not dispensed after 2 warnings, a “non-compliant event” is recorded and stored. All “compliant events” are recorded and stored as well. Logs of events are stored in the storage components. The logs are stored as .csv, .txt, or other file types as desired. Furthermore, the logs provide records of each event including the unique ID of hygiene maintenance device  10 , date and time of the event, whether an audible alert was presented, whether detection sensor detected an individual, whether the detection resulted in a compliant or non-compliant sanitizer use, approximate sanitizer remaining in sanitizer container  14 , and any other data deemed useful by the operator. 
         [0028]    Device  10  continuously monitors compliance and transmits the logged information via the communication components to local and/or central computers so compliance rates can be monitored for a particular room, a particular unit/ward, and/or the whole hospital on a regular basis.  FIG. 2  shows an example setup for the network setup. Device  10  communicates in any of the above described ways to network  200 . Server  210  is coupled to network  200 . Various other computers access server  210  either in real-time or at a later time to access the compliance and operational data. Unit nurses&#39; station computer  220  is primarily used to monitor operational status of devices  10 . Faults in device  10  and low sanitizer warnings are provided to computer  220  to inform of the need for maintenance of device  10 . However, compliance data, real time or historical, can also be provided to computer  220  if desired. Real time compliance data can be useful for prompting staff to encourage compliance or to educate non-healthcare workers (such as visitors) regarding hygiene requirements. Infection control computer  230  is provided as a device to access, synthesize, and produce reports regarding the compliance data. The programming of infection control computer  230  can include programs that are set to monitor data in server  210  for certain conditions and generate remedial protocols or note particularly well performing areas. Infection control computer  230  generally allows for manipulation of the data of server  210 . 
         [0029]    The definition for a compliant event can be adjusted and dictated by the owner of device  10 . One protocol for determining the compliant/non-compliant status of an event is shown in  FIG. 5 . The processor runs the program and sits in detect mode  500  waiting for an activation. The processor activates the system when sensor/emitter  44  detects the presence of an individual within its capture zone, step  501 . This results in the activation of LED  24  by the processor, step  502 . The processor then waits a delay time, step  503 . The delay time is adjustable and can be customized on a site, ward, room, or other basis. An exemplary delay time is provided as one second. The processor then checks to see if switch  48  has been triggered, step  504 . If switch  48  has been triggered, then the processor turns off the visual alert, step  505  and stores the event in the event log as a compliant event without alert, step  506 . The processor then returns to detect mode  500 . 
         [0030]    If switch  48  has not been triggered, then the processor sounds an audible alert, step  507 . The processor then waits a delay time, step  508 . The processor then again checks to see if switch  48  has been triggered, step  509 . If switch  48  has been triggered, then the processor turns off the visual alert, step  517  and stores the event in the event log as a compliant event with first audible alert, step  518 . 
         [0031]    If switch  48  has not been triggered at the point of step  507 , then the processor sounds a second audible alert, step  510 . The processor then waits a delay time, step  511 . The processor then again checks to see if switch  48  has been triggered, step  512 . If switch  48  has been triggered, then the processor turns off the visual alert, step  513  and stores the event in the event log as a compliant event with a second audible alert, step  514 . The processor then returns to detect mode  500 . 
         [0032]    If switch  48  has not been triggered at the point of step  512 , then the processor turns off the visual alert, step  515  and stores the event in the event log as a non-compliant event, step  516 . The processor then returns to detect mode  500 . 
         [0033]    When compliance rates are below appropriate levels in a certain area, additional training is instituted in those units and follow-up compliance rates are then monitored. The device also has a visual alarm, LED  26 , indicating a low level of sanitizer so that the unit can be refilled or indicating if there is a malfunction detected. An auditory alarm will sound, via speaker  22 , if the sanitizer is not replaced in a specified amount of time or if the malfunction is not fixed. 
         [0034]    Similarly, in embodiments where device  10  uses AC power from a wall outlet an alarm sounds if device  10  becomes unplugged. 
         [0035]    Initially, close to the time of implementation, there would be expected to be a number of alarms triggered. However, these alarm instances would be expected to decrease as the task became a learned behavior. It would also ensure that this reminder remained present if compliance rates decreased due to factors such as new personnel or times of understaffing or overcrowding. 
         [0036]    As evidenced by the above described example protocol, detection of a user initiates the protocol. Accordingly, accurate and reliable detection of the user is needed. Accordingly, the positioning of sensor/emitter  44  can affect the operation of the system. Positioning of sensor/emitter  44  is determined by taking the layout of the monitored area into account.  FIGS. 3   a - f  show various positioning options usable with various area layouts. 
         [0037]      FIG. 3   a  shows a room layout without impediments or interior walls near the ingress/egress door of the room. Device  10  is placed proximate the door on a wall that is 90-degrees relative to the door to the room. Sensor/emitter  44  is provided as a two-part sensor/emitter  44  that provides two beams in the detection zone. The two beams optionally allow directionality to be discerned for a user that traverses the detection zone. In sum, hygiene maintenance device  10  is positioned such that anyone entering or leaving the room necessarily enters the detection zone. The arrangement shown in  FIG. 3   a  shows an arrangement using an IR, ultrasonic, light gate, motion, thermal, or RFID detection method. Sensor/emitter  44  is optionally configured to provide a distance parameter such that movement beyond a defined distance is not captured. This prevents general movement within the room but away from the door from triggering the device.  FIG. 3   d  shows similar hygiene maintenance device  10  positioning with a differing angle adjustment of sensor/emitter  44 . 
         [0038]      FIG. 3   b  shows a positioning suitable most readily for RFID detection method. Device  10  is located proximate the door on the same wall as the door. (It should be appreciated that “door” is being used as a generic term for an egress point. Furthermore, while placement of device  10  on walls is discussed, embodiments are envisioned where device  10  is on a moveable stand but oriented relative to an egress point consistently with the provided examples herein.) While  FIG. 3   b  is described as being most readily suitable for RFID, the adjustable nature of sensor/emitter  44  provides that the other detection methods may also be usable with such placement.  FIG. 3   d  shows device  10  having similar placement, with sensor/emitter  44  being adjusted to define different detection zones. Somewhat similarly,  FIG. 3   f  shows similar positioning of hygiene maintenance device  10  that uses remote sensor/emitter  44 . These remote sensor/emitter  44  are wired or wirelessly coupled to hygiene maintenance device  10 . As shown in  FIG. 3   f , the use of remote sensor/emitter  44  allows multiple positions for hygiene maintenance device  10 . (While  FIG. 3   f  shows multiple hygiene maintenance device  10 , only one would need to be coupled to remote sensor/emitter  44 .) 
         [0039]      FIG. 3   c  shows a positioning suitable when the ingress/egress point includes an internal hallway. Remote sensor/emitter  44  is positioned to create a detection zone across the hallway. The embodiments of  FIGS. 3   a - f  are exemplary and not intended to be exhaustive. 
         [0040]    Besides hospitals and other medical environments, device  10 , in various forms, could have applicability for nursing homes, food-handling areas including restaurants, schools, child care facilities and any other areas where hand hygiene is important for infection control. It may also be applicable in some “clean room” manufacturing environments. 
         [0041]    Additionally, devices  10  will have the ability to adjust the voice alarm volume with an internal 24 hour clock so that the voice alarm volume can be lowered or silenced as desired, such as at night for patient comfort. Via the network or direct connectivity, devices  10  can be volume adjusted on the room, ward, hospital, or other level. This 24 hour clock will also be helpful in determining compliance rates during different time periods. The unit further has a visual alarm to indicate when the device is running low on hand rub and an auditory alarm if dispenser is not refilled in a specified period of time or there is a unit malfunction. 
         [0042]    Although the invention has been described in detail with reference to certain preferred embodiments, variations and modifications exist within the spirit and scope of the invention as described and defined in the following claims.