WO2021001485A1

WO2021001485A1 - Hygiene detection device and use thereof for monitoring hygiene compliance

Info

Publication number: WO2021001485A1
Application number: PCT/EP2020/068693
Authority: WO
Inventors: Robin M BANNISTER; Gregory A STOLOFF
Original assignee: Biocopea Limited
Priority date: 2019-07-02
Filing date: 2020-07-02
Publication date: 2021-01-07

Abstract

The present specification discloses hygiene detection devices and methods and uses for such devices in monitoring hygiene compliance, hygiene monitoring systems and methods and uses of such systems.

Description

HYGIENE DETECTION DEVICE AND USE THEREOF FOR MONITORING HYGIENE COMPLIANCE

[001] This application claims the benefit of priority and is entitled to the filing date pursuant to 35 U.S.C. § 119(e) of U.S. Provisional Patent Application 62/869,927, filed July 2, 2019, the content of which is hereby incorporated by reference in its entirety.

[002] Healthcare-associated infections (HAI), also referred to as nosocomial infections, is a major problem for patient safety, affecting 5% to 15% of hospitalized patients and 9% to 37% of those admitted to intensive care units. Unrelated to a patient's initial hospital admission diagnosis, HAI results in prolonged hospital stay, long-term disability, increased resistance of microorganisms to antimicrobials, massive additional financial burden, high costs for patients and their families, and excess deaths. It is estimated that each year in United States, over about 2 million hospitalized patients are affected by HAI, with about 99 000 deaths being attributed to these nosocomial infections. The annual economic impact of HAI in the U.S. ranges from $4.5 billion to $11 billion. Similarly, in Europe, approximately 5 million patients are affected by HAI each year, resulting in about 135,000 deaths and an economic burden of€13 billion to€24 billion. The HAI burden is greatly increased in high-risk patients such as those admitted to ICUs. Prevalence rates of infection acquired in ICUs vary from 9-37% in the U.S. and 9.7-31.8% in Europe, with crude mortality rates ranging from 12% to 80%.

[003] More than 50% of all HAIs can be directly related to the transmission of harmful microorganisms by healthcare providers who have not properly washed their hands. To address this issue, the Centers for Disease Control and Prevention (CDC) as well as other regulatory agencies recommend hand washing before and after each patient encounter. Unfortunately, reports indicate that healthcare workers adhere to hand washing guidelines less than 70% of the time. Healthcare workers have reported several factors that can negatively impact their adherence with recommended hygiene practices including: 1) washing agents cause dryness, irritation and cracking to skin; 2) wash stations were inconveniently located; 3) lack of soap, paper towels or other cleaning supplies; 4) insufficient time to properly wash hands due to understaffing or overcrowding; 5) unfamiliar or disagree with recommend hygiene guidelines/protocols; 6) forgetfulness; 7) failure to realize how infrequent or inadequate worker complied with recommended hygiene practices; 8) low risk of acquiring infection from patients; 9) incomplete understanding of benefits of personal hygiene; and 10) patient needs taking priority.

[004] Similar concerns exist in other industries, such as those relating to the processing and preparation of food. For example, the CDC estimates that each year food-borne microbial diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States. To address this issue, the U.S. Food and Drug Administration's Food Code (the "Food Code") provides guidelines for preparing food and preventing food-borne illness. Retail outlets such as restaurants and grocery stores and other institutions such as nursing homes are subject to the Food Code. In addition to requiring employees to wash their hands, the Food Code requires their employer to monitor the employees' hand washing. However, despite such extensive efforts to ensure hygiene compliance, the CDC estimated that improper hand washing was a contributing factor in over a third of the outbreaks. [005] Numerous strategies have been attempted to increase hygiene compliance as a preventative measure to HAIs and food-borne microbial diseases, but all have been largely unsuccessful. One major disadvantage of these strategies is expense and complex technologies employed. For example, many strategies require installation and use of sophisticated electronic monitoring technology to monitor and enforce hygiene compliance. Another disadvantage is that many of these strategies only allows for after- the-fact analysis; there is no real-time monitoring systems that enable instantaneous assessment of compliance. Furthermore, these strategies are essentially trust-based systems where personnel are entrusted to properly comply with recommended hygiene practices. Thus, unless personnel are actively supervised, there is usually no way to determine whether proper hygiene procedures have been followed. Furthermore, even if personnel do comply, there is no way to easily determine whether they have followed a prescribed government- and/or industry-approved regimen to ensure proper compliance.

[006] Thus, there is an unmet need in the art for providing new detection devices for hygiene compliance as well as methods, uses and systems for monitoring and promoting proper hygiene practices. According the present specification discloses such devices, methods, uses and systems for monitoring hygiene compliance.

SUMMARY

[007] Aspects of the present specification disclose a hygiene detection device. One configuration, the disclosed hygiene detection device can comprise a base and a hydrochromic pigment layer comprising one or more hydrochromic pigments. The disclosed hygiene detection device can further comprise an adhesive layer, a sealing layer, an absorbent layer, a securing component, or any combination thereof. In another configuration, the disclosed hygiene detection device can comprise a base and an absorbent layer comprising one or more hydrochromic pigments. In this configuration, the disclosed hygiene detection device can further comprise an adhesive layer, a sealing layer, a securing component, or any combination thereof. In yet another configuration, the disclosed hygiene detection device can comprise a base that serves as both a solid support and an absorbent and comprising one or more hydrochromic pigments. In this configuration, the disclosed hygiene detection device can further comprise an adhesive layer, a sealing layer, a securing component, or any combination thereof. In an aspect of this configuration, the disclosed hygiene detection device comprise a base that serves as both a solid support and an absorbent and comprising one or more hydrochromic pigments, and an adhesive layer.

[008] Other aspects of the present specification disclose a securing component comprising a hygiene detection device disclosed herein. The securing component can be a band that can be secured to an individual. In aspects of this configuration, a band is composed of a flexible material and can be fitted around a wrist of an individual or a finger of an individual. In other aspects of this configuration, a band is composed of a rigid material and can be fitted around a wrist of an individual or a finger of an individual. [009] Other aspects of the present specification disclose a method of monitoring hygiene compliance. The disclosed method includes the step of detecting a change in a hygiene detection device or hygiene monitoring system disclosed herein on an individual that was, or thought to have, washed on a skin surface with a washing agent. The disclosed method can also comprise applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device or hygiene monitoring system disclosed herein of the individual.

[010] Other aspects of the present specification disclose use of a hygiene detection device or hygiene monitoring system disclosed herein for monitoring hygiene compliance.

[011] Other aspects of the present specification disclose a hygiene detection device or hygiene monitoring system disclosed herein for use in monitoring hygiene compliance.

BREIF DESCRIPTION OF THE DRAWINGS

[012] FIG. 1A-0 show the organization of the different layers in the various configurations of the hygiene detection device disclosed herein with FIG. 1A shows a device disclosed herein comprising a base and a hydrochromic pigment layer; FIG. 1 B shows a device disclosed herein comprising a base, a hydrochromic pigment layer and an adhesive layer; FIG. 1 C shows the device of FIG. 1 B where a sealing layer is inserted in between the base and hydrochromic pigment layer; FIG. 1 D shows the device of FIG. 1 B where a sealing layer is places on top of the hydrochromic pigment layer; FIG. 1 E shows the device of FIG. 1 B where a sealing layer is inserted in between the adhesive and base layers; FIG. 1 F shows a device disclosed herein comprising a base, a hydrochromic pigment layer, and an absorbent layer; FIG. 1 G shows a device disclosed herein comprising a base, a hydrochromic pigment layer, an absorbent layer, and an adhesive layer; FIG. 1 H shows the device of FIG. 1G where a sealing layer is inserted in between the base and hydrochromic pigment layer; FIG. 11 shows the device of FIG. 1 G where a sealing layer is places on top of the absorbent layer; FIG. 1J shows the device of FIG. 1G where a sealing layer is inserted in between the absorbent and hydrochromic pigment layers; FIG. 1 K shows a device disclosed herein comprising a base, a hydrochromic pigment layer, and an absorbent layer; FIG. 1 L shows a device disclosed herein comprising a base, a hydrochromic pigment layer, an absorbent layer, and an adhesive layer; FIG. 1 M shows the device of FIG. 1 L where a sealing layer is inserted in between the base and absorbent layer; FIG. 1 N shows the device of FIG. 1 L where a sealing layer is places on top of the hydrochromic pigment layer; and FIG. 10 shows the device of FIG. 1 L where a sealing layer is inserted in between the hydrochromic pigment and absorbent layers.

[013] FIG. 2A-I show the organization of the different layers in the various configurations of the hygiene detection device disclosed herein when using a combined absorbent and hydrochromic pigment layer or a combined base, absorbent and hydrochromic pigment layer. FIG. 2A shows a device disclosed herein comprising a base, an absorbent layer comprising a hydrochromic pigment (a combined absorbent and hydrochromic pigment layer); FIG. 2B shows a device disclosed herein comprising a base, a combined absorbent and hydrochromic pigment layer and an adhesive layer; FIG. 2C shows the device of FIG. 2B where a sealing layer is inserted in between the base and combined absorbent and hydrochromic pigment layer; FIG. 2D shows the device of FIG. 2B where a sealing layer is place on top of the combined absorbent and hydrochromic pigment layer; FIG. 2E shows the device of FIG. 2B where a sealing layer is inserted in between the base and adhesive layers; FIG. 2F shows a device disclosed herein comprising a base comprising a hydrochromic pigment which also serves as an absorbent layer (a combined base, absorbent and hydrochromic pigment layer); FIG. 2G shows a device disclosed herein comprising a combined base, absorbent and hydrochromic pigment layer and an adhesive layer; FIG. 2H shows the device of FIG. 2G where a sealing layer is place on top of the combined base, absorbent and hydrochromic pigment layer; FIG. 21 shows the device of FIG. 2G where a sealing layer is inserted in between the combined base, absorbent and hydrochromic pigment layer and the adhesive layer.

[014] FIG. 3A-E show the organization of the different layers in a hygiene detection device disclosed herein with pore/well arrangement. FIG. 3A shows a device disclosed herein where the top layer comprises one or more pores that expose the layers lying underneath this porous layer to the environment; FIG. 3B shows a device disclosed herein where one of the layers in made with wells, the wells being“filled” with at least a hydrochromic pigments; FIG. 3C shows a device of FIG. 3B where wells (or pores) are depressed below the surface of a layer with openings; FIG. 3D shows a device of FIG. 3B where a sealing layer is applied over the wells; and FIG. 3E shows a device of FIG. 3B where an absorbent layer is applied over the wells.

[015] FIG. 4A-D show the organization of the different layers in a hygiene detection device disclosed herein, with FIG. 4A shows a device disclosed herein comprising a base, a hydrochromic pigment layer and a sealing layer where the hydrochromic pigment layer is located in between the base and a sealing layer, with the base on the bottom and the sealing layer on top; FIG. 4B shows a variation of the layer arrangement depicted in FIG, 4A where the sealing layer has openings which provide exposure of the hydrochromic pigment layer to the outside environment; FIG. 4C shows that a device disclosed herein comprising two bases and a hydrochromic pigment layer where the hydrochromic pigment layer is located in between the base layers; and FIG. 4D shows a variation of the layer arrangement depicted in FIG, 4C where the top base has openings which provide exposure of the hydrochromic pigment layer to the outside environment.

[016] FIG. 5A-F show three general types of indicator visualizations of a hygiene detection device disclosed herein, with FIG. 5A shows one embodiment of a device disclosed herein in dry state where the hydrochromic pigment layer is opaque and masks the symbol lying underneath; FIG. 5B, shows the device of FIG. 5A in the wet state o where the hydrochromic pigment layer becomes transparent or translucent revealing a symbol as an indicator; FIG. 5C shows another embodiment of a device disclosed herein in dry state where the hydrochromic pigment layer is opaque and masks the symbol lying underneath; FIG. 5D, shows the device of FIG. 5C in the wet state o where the hydrochromic pigment layer becomes transparent or translucent revealing a symbol as an indicator; FIG. 5E shows another embodiment of a device disclosed herein in dry state where the hydrochromic pigment layer is opaque and masks the symbol lying underneath; and FIG. 5F, shows the device of FIG. 5E in the wet state o where the hydrochromic pigment layer becomes transparent or translucent revealing a symbol as an indicator.

DETAILED DESCRIPTION

[017] A hygiene detection device disclosed herein detects whether a skin surface of an individual was washed with a washing agent. In some embodiments, a disclosed hygiene detection device conveys a binary signal which indicates whether a skin surface of an individual was exposed to conditions complying with proper hygiene compliance. For example, a hygiene detection device disclosed herein will display one signal when exposed to conditions indicating an individual appropriately used a washing agent, thereby indicating that the individual washed his skin surface correctly. Alternatively, a hygiene detection device disclosed herein will display a different signal when no exposure to washing conditions occurred, thereby indicating that the individual failed to wash his skin surface correctly.

[018] A hygiene detection device is employed with a method for monitoring hygiene compliance. Such a disclosed method comprises detecting a change in a hygiene detection device disclosed herein of an individual that was, or thought to have, washed on a skin surface with a washing agent. Thus, hygiene compliance is monitored based on an appropriate indication in a hygiene detection device disclosed herein that a skin surface was properly washed.

[019] A hygiene monitoring system comprises a hygiene detection device disclosed herein and a washing agent. The disclosed system monitors hygiene compliance by detecting when a surface was, or thought to have been, washed with a washing agent based on an appropriate indication in a hygiene detection device disclosed herein.

[020] The disclosed device, methods and systems enable the public to assess in real-time whether a person has complied with public health and safety standards, thereby making the consumer/patient the auditor of hygiene compliance. A resulting advantage is the ability to monitor hygiene compliance in a more cost effective and frequent manner than current systems and methods, which can involve expensive and bulky equipment.

[021] In some embodiments, a hygiene detection device disclosed herein is designed to be placed on a skin surface of an individual. Typically, placement will be on the back of one or both hands although any location that ensures sufficient exposure to a washing condition is suitable. In some embodiments, a hygiene detection device disclosed herein is integrated into a securing component that is worn by an individual, typically in the vicinity of a skin surface where monitoring is desired. For example, a ring comprising a hygiene detection device disclosed herein worn on a finger of an individual or a wrist band comprising a hygiene detection device disclosed herein worn on a wrist of an individual.

[022] In some embodiments, a disclosed hygiene detection device comprises a base and a hydrochromic pigment layer, and can further comprise an adhesive layer, a sealing layer, an absorbent layer, a securing component, or any combination thereof. In some embodiments, a disclosed hygiene detection device comprises a base comprising one or more hydrochromic pigments and an adhesive layer, the base also serving as an absorbent layer.

[023] Aspect of the present specification disclose a base. A base serves as a solid support for a hygiene detection device disclosed herein. A base can be made from a wide variety of materials including paper, fabric, plastic, and metal. A base disclosed herein can be of any size and shape although a size and shape that fits comfortably on the bank of a hand, or within a securing component, but is easily observable by another person is preferred. For example, and simple geometry like polygon including a triangle, square, rectangle or star, or a circle, or oval that is about 1 cm to 4 cm at its widest point is preferred. Non-limiting examples of a base include material composed of a natural textile material, a synthetic textile material, a plastic, metal, or any combination thereof. A natural textile material includes, without limitation, a plant-based textile material, an animal-based textile material, or any combination thereof. A plant-based textile material includes, without limitation, textile fibers obtained from abaca, acetate, bamboo, banana, coir, cotton, flax, hemp, jute, kapok, kenaf, lyocell, modal, piha, raffia, ramie, rayon, sisal soy protein, or any combination thereof. An animal-based textile material includes, without limitation, textile fibers obtained from alpaca, angora, byssus, camel, cashmere, chiengora, lamb, llama, mohair wool, qiviut, rabbit, sheep, silk, vicuna, yak, or any combination thereof. A synthetic textile material includes, without limitation, acrylic, azlon, kevlar, modacrylic, nomex, nylon, polybenzimidazole, polychloroprene, polyester, polyethylene, polyolefin, polypropylene, polyurethane, saran, spandex, spunlace, vinylon, or any combination thereof. A plastic includes, without limitation, acrylic plastics, polyester plastics, silicone plastics, polyurethane plastics, halogenated plastics, or any combination thereof.

[024] A base disclosed herein can be composed of a uniform color, or have a symbol printed on it. The color used for a base can be any color as long as it is visually distinct from the color of the hydrochromic pigments used in a hygiene detection device disclosed herein. A symbol can be a pattern, word, logo, brand name, or any other design. Like a base color, the color used for a symbol can be any color as long as it is visually distinct from the color of the hydrochromic pigments used in in a hygiene detection device disclosed herein. A color, whether used for a base or a symbol, typically comprises a color pigments from the visual spectrum of light, e.g. , about 400 nm to about 700 nm. In other embodiments, a color can comprise infra-red (IR) base pigments, ultra-violet (UV) based pigments, or other pigments that not readily observable by a human eye without use of an appropriate light source, e.g. , a IR-light source or a UV-light source. In some embodiments, a base disclosed herein is a distinct layer from an absorbent layer disclosed herein. In some embodiments, a base serves as both a solid support and an absorbent layer disclosed herein.

[025] As a solid support, other layers can be applied to a base disclosed herein to form a hygiene detection device disclosed herein. In one embodiment, a hygiene detection device disclosed herein comprises a base and a hydrochromic pigment layer manufactured in a manner that exposes the hydrochromic pigment layer to the environment (FIG. 1 A). In another embodiment, a hygiene detection device disclosed herein comprises a base, a hydrochromic pigment layer and an adhesive layer manufactured in a manner that the base is in between the other two layers with the adhesive layer applied on one side of the base and designed to be placed in contact with a skin surface of an individual and the hydrochromic pigment layer applied to the other side of the base and designed to be exposed to the environment. In this configuration, the adhesive layer can be designated as the“bottom” layer, the hydrochromic pigment layer designated as the“top” layer and the base designated as the“middle” layer, sandwiched in between the adhesive and pigment layers (FIG. 1 B). In yet another embodiment, a hygiene detection device disclosed herein comprises a base, a hydrochromic pigment layer, a sealing layer and an adhesive layer manufactured in a manner that the sealing layer is applied to one side of the base, the hydrochromic pigment layer applied to the sealing layer and designed to be exposed to the environment, and the adhesive layer applied to the other side of the base and designed to be placed in contact with a skin surface of an individual. In this configuration, the adhesive layer can be designated as the“bottom” layer, followed by the base, and then the sealing layer and finally the hydrochromic pigment layer designated as the“top” layer; the base and sealing layers can be designated as“middle” layers, sandwiched in between the adhesive and pigment layers (FIG. 1 C). In another embodiment, a sealing layer can be place on top of the hydrochromic pigment layer (FIG. 1 D). In yet another embodiment, a sealing layer can be place in between the adhesive and base layers (FIG. 1 E).

[026] A hygiene detection device disclosed herein can also comprises a base, a hydrochromic pigment layer, and an absorbent layer manufactured in a manner that both the hydrochromic pigment layer and the absorbent layer are applied to one side of the base. In one configuration, the base can be designated as the “bottom” layer, followed by the hydrochromic pigment layer and finally the absorbent layer designated as the “top” layer; the hydrochromic pigment layer can be designated as “middle” layer, sandwiched in between the base and absorbent layer (FIG. 1 F). In an embodiment, a hygiene detection device disclosed herein comprises a base, a hydrochromic pigment layer, an absorbent layer and an adhesive layer manufactured in a manner that the hydrochromic pigment layer is applied to one side of the base, the absorbent layer applied to the hydrochromic pigment layer and designed to be exposed to the environment, and the adhesive layer applied to the other side of the base and designed to be placed in contact with a skin surface of an individual. In this configuration, the adhesive layer can be designated as the“bottom” layer, followed by the base, and then the hydrochromic pigment layer and finally the absorbent layer designated as the “top” layer; the base and hydrochromic pigment layers can be designated as“middle” layers, sandwiched in between the adhesive and absorbent layers (FIG. 1G). In a further embodiment, a sealing layer can be inserted in between the base and hydrochromic pigment layer (FIG. 1 H). In another embodiment, a sealing layer can be placed on top of the absorbent layer (FIG. 11). In yet another embodiment, a sealing layer can be place in between the absorbent and hydrochromic pigment layers (FIG. 1 J).

[027] In an alternative configuration, the base can be designated as the“bottom” layer, followed by the absorbent layer and finally the hydrochromic pigment layer designated as the“top” layer; the absorbent layer can be designated as“middle” layer, sandwiched in between the base and pigment layers (FIG. 1 K). In one embodiment, a hygiene detection device disclosed herein comprises a base, a hydrochromic pigment layer, an absorbent layer and an adhesive layer manufactured in a manner that the absorbent layer is applied to one side of the base, the hydrochromic pigment layer applied to the absorbent layer and designed to be exposed to the environment, and the adhesive layer applied to the other side of the base and designed to be placed in contact with a skin surface of an individual. In this configuration, the adhesive layer can be designated as the“bottom” layer, followed by the base, and then the absorbent layer and finally the hydrochromic pigment layer designated as the“top” layer; the base and adhesive layers can be designated as“middle” layers, sandwiched in between the adhesive and pigment layers (FIG. 1 L). In a further embodiment, a sealing layer can be inserted in between the base and absorbent layer (FIG. 1 M). In another embodiment, a sealing layer can be place on top of the hydrochromic pigment layer (FIG. 1 N). In yet another embodiment, a sealing layer can be place in between the hydrochromic pigment and absorbent layers (FIG. 10).

[028] A hygiene detection device disclosed herein can also comprises a base, an absorbent layer comprising a hydrochromic pigment (a combined absorbent and hydrochromic pigment layer), manufactured in a manner that both the combined absorbent and a hydrochromic pigment layer is applied to one side of the base. In one configuration, the base can be designated as the“bottom” layer, followed by the combined absorbent and hydrochromic pigment layer designated as the“top” layer (FIG. 2A). In one embodiment, a hygiene detection device disclosed herein comprises a base, a combined absorbent and hydrochromic pigment layer and an adhesive layer manufactured in a manner that the combined absorbent and hydrochromic pigment layer is applied to one side of the base and designed to be exposed to the environment, and the adhesive layer applied to the other side of the base and designed to be placed in contact with a skin surface of an individual. In this configuration, the adhesive layer can be designated as the “bottom” layer, followed by the base, and then the combined absorbent and hydrochromic pigment layer designated as the“top” layer; the base can be designated as the“middle” layer, sandwiched in between the adhesive and combined absorbent and hydrochromic pigment layer (FIG. 2B). In a further embodiment, a sealing layer can be inserted in between the base and combined absorbent and hydrochromic pigment layer (FIG. 2C). In another embodiment, a sealing layer can be place on top of the combined absorbent and hydrochromic pigment layer (FIG. 2D). In yet another embodiment, a sealing layer can be place in between the base and adhesive layers (FIG. 2E).

[029] A hygiene detection device disclosed herein can also comprises a base comprising a hydrochromic pigment, the base also serving as an absorbent layer disclosed herein (FIG. 2F). In one embodiment, a hygiene detection device disclosed herein comprises a base comprising one or more hydrochromic pigments, the base serving both as a solid support and an absorbent layer, and an adhesive layer manufactured in a manner that the combined base, absorbent and hydrochromic pigment layer is designed to be exposed to the environment and adhesive layer applied to one side of the combined base/absorbent layer comprising one or more hydrochromic pigments and designed to be placed in contact with a skin surface of an individual. In this configuration, the adhesive layer can be designated as the“bottom” layer, followed by the combined base/absorbent layer comprising one or more hydrochromic pigments designated as the“top” layer (FIG. 2G). In a further embodiment, a sealing layer can be applied to the top of the combined base/absorbent layer comprising one or more hydrochromic pigments (FIG. 2H). In another embodiment, a sealing layer can be place in between the combined base/absorbent layer comprising one or more hydrochromic pigments and the adhesive layer (FIG. 21).

[030] A hygiene detection device disclosed herein can be constructed so that the layered arrangements disclosed herein make up the entire device. For example, a sheet comprising one of the layered arrangements described in FIGS. 1 -2 can be made and then a punch used to create a patch that can be affixed to a body part of a person, for example the back of the hand.

[031] Alternatively, a hygiene detection device disclosed herein can be made where the hydrochromic pigment layer is assessable only through openings which provide exposure to the outside environment. As shown in FIG. 3A, a hygiene detection device disclosed herein can be made where the top layer comprises one or more pores that expose the layers lying underneath this porous layer to the environment. In one embodiment, the porous layer is a sealing layer with openings to create the pores. In another embodiment, the porous layer is an absorbent layer to create the pores. As shown in FIG. 3B, a hygiene detection device disclosed herein can be made where one of the layers in made with wells, the wells being“filled” with at least a hydrochromic pigments. In one embodiment, the layer containing the wells is composed of material used to a sealing layer. In another embodiment, the layer containing the wells is composed of material used to make an absorbent layer or a base. In a preferred arrangement, a hygiene detection device disclosed herein comprises a base with wells on a top surface, the wells comprising hydrochromic pigments and an adhesive layer on the bottom surface. While FIG. 3B illustrates wells containing a base and hydrochromic pigment layers, the wells can be made to include any one of a hydrochromic pigment layer, a base, an absorbent layer, a sealing layer, a combined absorbent and hydrochromic pigment layer, a combined base, absorbent and hydrochromic pigment layer, or any combination thereof. For example, wells disclosed herein may include any of the layered arrangements shown in FIGS. 1 -2 (except that the adhesive layer would not be part of the well construction. As shown in FIG. 3C, the wells (or pores) can be depressed below the surface of the layer with openings. Such depression creates a reservoir where moisture, e.g. , from a wetting or washing agent, e.g., water or liquid washing agent, can collect thereby prolonging the exposure of hydrochromic pigments to the moisture in order to extend the time period the hydrochromic pigments remain in a moisture-exposed state, e.g., a translucent or transparent state.

[032] As shown in FIG. 3A-E, a hygiene detection device disclosed herein with openings can further comprise on an adhesive layer, an absorbent layer, a sealing layer, or any combination thereof. An adhesive layer is typically applied the surface of a hygiene detection device opposite to the surface comprising the openings (FIG. 3A-E). The sealing and/or absorbent layers are typically applied the same surface of a hygiene detection device that have the openings in order to protect the hydrochromic pigments and assist in the controlled loss of moisture to better control the time period the hydrochromic pigments remain in a moisture-exposed state, e.g. , a translucent or transparent state (FIG. 3D-E).

[033] FIG. 4A-D show further organizational arrangements of the different layers in a hygiene detection device disclosed herein. FIG. 4A shows that a hygiene detection device disclosed herein can comprises a base, a hydrochromic pigment layer and a sealing layer where the hydrochromic pigment layer is located in between the base and a sealing layer, with the base on the bottom and the sealing layer on top. In this arrangement, however, the hydrochromic pigment layer extends for only a portion of the hygiene detection device, with the other portions comprising only the base and sealing layer. FIG. 4B shows a variation of this arrangement where the sealing layer has openings which provide exposure of the hydrochromic pigment layer to the outside environment. FIG. 4C shows that a hygiene detection device disclosed herein can comprises two bases and a hydrochromic pigment layer where the hydrochromic pigment layer is located in between the base layers. In this arrangement, however, the hydrochromic pigment layer extends for only a portion of the hygiene detection device, with the other portions comprising only the bases which merge to become one layer. FIG. 4D shows a variation of this arrangement where the top base has openings which provide exposure of the hydrochromic pigment layer to the outside environment. An adhesive layer can further comprise a hygiene detection device. An adhesive layer is typically applied the surface of a hygiene detection device opposite to the surface comprising the openings (FIG. 4A-D).

[034] In one embodiment, a hygiene detection device disclosed herein comprises depressions/openings which exposure a hydrochromic pigment layer to the outside environment while maintaining a hydrochromic pigment layer in a moisture-exposed state, e.g., a translucent or transparent state until a certain period of time has elapsed. In aspects of this embodiment, depressions/openings disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 60 seconds, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In other aspects of this embodiment, depressions/openings disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes. In yet other aspects of this embodiment, depressions/openings disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , translucent or transparent state until after, e.g. , at most 5 seconds, at most 10 seconds, at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 60 seconds, at most 2 minutes, at most 3 minutes, at most 4 minutes, or at most 5 minutes. In still other aspects of this embodiment, depressions/openings disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 45 seconds, about 10 seconds to about 60 seconds, about 30 seconds to about 45 seconds, about 30 seconds to about 60 seconds, about 1 minute to about 2 minutes, about 1 minute to about 3 minutes, about 1 minute to about 4 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 3 minutes, about 2 minutes to about 4 minutes, about 2 minutes to about 5 minutes, about 3 minutes to about 4 minutes, about 3 minutes to about 5 minutes, or about 4 minutes to about 5 minutes. [035] Aspect of the present specification disclose one or more hydrochromic pigments. Hydrochromic pigment is one that changes color or produces a color change when exposed to moisture, e.g., from a wetting or washing agent, e.g., water or liquid washing agent. A wetting agent includes an substance that can elicit a color change in a hydrochromic pigment and includes, without limitation, or any liquid having solvent properties, such as, e.g., water, an alcohol or other organic liquid as well as colloidal mixture comprising a liquid such as, e.g., an aerosol, an emulsion, a foam, a gel or a sol. The color change of a hydrochromic pigment can be reversible or non-reversible. For example, one or more hydrochromic pigments can comprise one or more reversible hydrochromic pigments that forms an opaque layer when dry, becomes transparent or translucent when wet, and as the layer dries, the one or more hydrochromic pigments returns to their opaque state. Non-limiting examples of hydrochromic pigments include polydiacetylene-based hydrochromic pigments such as, e.g., polydiacetylene-based hydrochromic pigments based on a diacetylenic lipid such as, e.g., 10,12-pentacosadiynoic acid (PCDA), 10,12- tricosadiynoic acid (TCDA), and 8,10-heneicosadiynoic acid (HCPA). Such polydiacetylene-based hydrochromic pigments can be functionalized with amine, imidazolium and/or cesium carboxylate groups. Commercially available hydrochromic pigments are manufactured by, e.g., Good Life Innovations Ltd (Special FX Creative), Unit 15, Newhaven Enterprise Centre, Denton Island, Newhaven, East Sussex, BN9 9BA, United Kingdom.

[036] In some embodiments, one or more hydrochromic pigments are incorporated or integrated into another layer or components comprising a hygiene detection device disclosed herein. For example, one or more hydrochromic pigments can be integrated into a base or an absorbent layer disclosed herein. In aspects of these embodiments, one or more hydrochromic pigments are incorporated or integrated or integrated into a base, and as such, creating a base comprising one or more hydrochromic pigments. In other aspects of these embodiments, one or more hydrochromic pigments are incorporated or integrated or integrated into an absorbent layer, and as such, creating an absorbent layer comprising one or more hydrochromic pigments. In some embodiments, one or more hydrochromic pigments disclosed herein are applied to another layer or component by painting. In some embodiments, one or more hydrochromic pigments disclosed herein are applied to another layer or component by print screening.

[037] In some embodiments, one or more hydrochromic pigments is present as a hydrochromic pigment layer distinct from all other layers and components comprising a hygiene detection device disclosed herein. For example, one or more hydrochromic pigments can be present as a hydrochromic pigment layer distinct a base or an absorbent layer disclosed herein. In some embodiments, a hydrochromic pigment layer disclosed herein is applied to another layer or component by painting. In some embodiments, a hydrochromic pigment layer disclosed herein is applied to another layer or component by print screening.

[038] In application with a disclosed hygiene detection device, when dry, one or more hydrochromic pigments are opaque and obscures the base which will be a different color than the one or more hydrochromic pigments and/or have a symbol. When the device is exposed to moisture, e.g., from a wetting or washing agent, e.g., water or liquid washing agent, one or more hydrochromic pigments becomes transparent or translucent revealing the color of the base and/or symbol printed on it. As the disclosed hygiene detection device dries, one or more hydrochromic pigments becomes opaque once again, covering up the base color and/or printed symbol. In this way, a person observing an individual wearing a hygiene detection device disclosed herein will be able to determine whether the individual recently washed his hands by whether the base color and/or printed symbol is observable.

[039] In some embodiments, the type of wetting agent used has an influence on the degree of change of one or more hydrochromic pigments disclosed herein undergoes upon exposure. For example, exposure to moisture, e.g., from a wetting or washing agent, e.g. , water or liquid washing agent, can result in a more complete transition of one or more hydrochromic pigments to a transparent or translucent state resulting in a more intense color appearance, e.g. , a vivid or bright color. As another example, exposure to moisture from an alcohol-based wetting agent can result in a less complete transition of one or more hydrochromic pigments to a transparent or translucent state resulting in a less intense color appearance, e.g. , a pastel or muted color. This allows an observer to visually assess the type of washing agent used.

[040] For example, FIG 5A-B show a hygiene detection device disclosed herein where the indicator is a symbol. FIG. 5A shows the dry state of the device where a hydrochromic pigment layer comprising one or more hydrochromic pigments is opaque and masks the symbol lying underneath. As shown in FIG. 5B, upon exposure to moisture, e.g. , from a wetting or washing agent, e.g. , water or liquid washing agent, the hydrochromic pigment layer comprising one or more hydrochromic pigments becomes transparent or translucent revealing a symbol as an indicator that the skin surface was appropriately cleaned or disinfected. In another embodiment, as shown in FIG. 5C-D, in the dry state the hydrochromic pigment layer comprising one or more hydrochromic pigments is opaque and masks the color lying underneath. As shown in FIG. 5B, upon exposure to moisture, e.g. , from a wetting or washing agent, e.g. , water or liquid washing agent, a hydrochromic pigment layer comprising one or more hydrochromic pigments becomes transparent or translucent revealing a color as an indicator that the skin surface was appropriately cleaned or disinfected. FIG. 5E-F are similar to the hygiene detection device of FIG 5C-D except that the hydrochromic pigment layer comprising one or more hydrochromic pigments is covered by an additional layer having openings which provide exposure of the hydrochromic pigment layer to the outside environment.

[041] As evaporation of moisture, e.g. , from a wetting or washing agent, e.g., water or liquid washing agent, is a mechanism to change a hydrochromic pigment, especially a reversible hydrochromic pigment, back to its original opaque state, controlling the rate of moisture evaporation controls the duration a hydrochromic pigment layer remains transparent or translucent. One way in which evaporation rate can be controlled is by controlling how much hydrochromic pigment is contained within a hydrochromic pigment layer or another layer like a base or absorbent layer, such as, e.g. , controlling the amount of hydrochromic pigment contained in a hydrochromic pigment layer or incorporated into another layer comprising a hygiene detection device disclosed herein; or controlling the thickness of the layer comprising one or more hydrochromic pigments. Generally speaking, the larger the amount of hydrochromic pigment contained in a hydrochromic pigment layer or incorporated into another layer comprising a hygiene detection device disclosed herein, the longer the duration in time that a layer comprising a hydrochromic pigment remains in a moisture-exposed state, e.g. , a translucent or transparent state. Similarly, the thicker a layer is which comprises one or more hydrochromic pigments, the longer the duration in time that a layer comprising one or more hydrochromic pigments remains in a moisture-exposed state, e.g., a translucent or transparent state.

[042] In one embodiment, thickness of a layer comprising one or more hydrochromic pigments maintains a hydrochromic pigment in a moisture-exposed state, e.g. , a translucent or transparent state until a certain period of time has elapsed. In aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments maintains a hydrochromic pigment in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 60 seconds, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments maintains a hydrochromic pigment in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes. In yet other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments maintains a hydrochromic pigment in a moisture- exposed state, e.g., a translucent or transparent state until after, e.g., at most 5 seconds, at most 10 seconds, at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 60 seconds, at most 2 minutes, at most 3 minutes, at most 4 minutes, or at most 5 minutes. In still other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments maintains a hydrochromic pigment in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 45 seconds, about 10 seconds to about 60 seconds, about 30 seconds to about 45 seconds, about 30 seconds to about 60 seconds, about 1 minute to about 2 minutes, about 1 minute to about 3 minutes, about 1 minute to about 4 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 3 minutes, about 2 minutes to about 4 minutes, about 2 minutes to about 5 minutes, about 3 minutes to about 4 minutes, about 3 minutes to about 5 minutes, or about 4 minutes to about 5 minutes.

[043] As discussed above, another way in which the evaporation rate of moisture on a hygiene detection device can be controlled is through the use of reservoirs to store moisture, e.g. , from a wetting or washing agent, e.g., water or liquid washing agent, in order to prolong a moisture-exposed state, e.g. , a translucent or transparent state of the hydrochromic pigments. As discussed below, yet another way in which the evaporation rate of moisture on a hygiene detection device can be controlled is through the use of a sealing and/or absorbent layer to control a moisture-exposed state, e.g., a translucent or transparent state of the hydrochromic pigments. Thus, the evaporation rate of moisture, e.g. , from a wetting or washing agent, e.g. , water or liquid washing agent, on a hygiene detection device can be controlled is through the use of specific hydrochromic pigments, the amount of hydrochromic pigments, thickness of a layer comprising one or more hydrochromic pigments, the use of reservoirs, the use of a sealing layer, and the use of an absorbent layer.

[044] Aspect of the present specification disclose an adhesive layer. An adhesive layer comprises an adhesive used to ensure that a hygiene detection device disclosed herein is properly secured to a skin surface of an individual or other surface substrate. In one embodiment, an adhesive is a medical grade adhesive. In one embodiment, an adhesive is a hypoallergenic adhesive. In one embodiment, an adhesive has anti-microbial properties or includes an anti-microbial agent. In one embodiment, an adhesive is a hypoallergenic, medical grade adhesive. In one embodiment, an adhesive is a medical grade adhesive having anti-microbial properties or includes an anti-microbial agent. In one embodiment, an adhesive is a hypoallergenic, medical grade adhesive having anti-microbial properties or includes an anti-microbial agent. Anti-microbial is any substance that can kill a microorganism or inhibit or reduce growth of a microorganism and includes, without limitation, an anti-bacterial agent, an anti-fungal agent, an anti-viral agent, and an anti-parasitic agent. For example, an adhesive can be a medical grade acrylate adhesive or a medical grade silicone adhesive which, optionally, are hypoallergenic and antimicrobial. In some embodiments, an adhesive layer disclosed herein is a single-sided adhesive layer where the adhesive side is used to affix a hygiene detection device disclosed herein to a skin surface of an individual or other surface substrate. In some embodiments, an adhesive layer disclosed herein is a double-sided adhesive layer where one side is affixed to a hygiene detection device disclosed herein and the other side is used to affix the hygiene detection device to a skin surface of an individual or other surface substrate. In these embodiments, the side of a single-sided or double-sided adhesive layer disclosed herein used to affix a hygiene detection device disclosed herein to a skin surface of an individual or other surface substrate includes a protective covering that shields or otherwise prevents the adhesive present on the second side of the double-sided adhesive tape from debris, inappropriate affixing or other events fouling or otherwise making the adhesive inoperable for its intended use.

[045] Aspects of the present specification disclose a securing component. A securing component ensure that a hygiene detection device disclosed herein is properly secured to a skin surface of an individual or other surface substrate. In some embodiments, a securing component comprises a hook- and-loop fastener where a hook component is affixed to a hygiene detection device disclosed herein and a loop component is used to affix the hygiene detection device to an individual or other surface substrate. In some embodiments, a securing component comprises a hook-and-loop fastener where a loop component is affixed to a hygiene detection device disclosed herein and a hook component is used to affix the hygiene detection device to an individual or other surface substrate. In some embodiments, a securing component is an adhesive layer disclosed herein.

[046] In some embodiments, a securing component comprises a hygiene detection device disclosed herein and is used to secure the device to an individual. In some embodiments, a securing component is a band. In aspects of these embodiments, a securing component comprising a hygiene detection device disclosed herein is a band is composed of a flexible material, for example a fabric or flexible plastic material, that is used to secured the device to an individual ( e.g . , a wrist, a finger, or other skin surface area for which hygiene monitoring is desired), l.e. , a wrist band or a ring. In other aspects of these embodiments, a securing component comprising a hygiene detection device disclosed herein is a band is composed of a rigid material, for example a hard plastic material or metal material, that is used to secured the device to an individual (e.g. , wrist, a finger, or other skin surface area for which hygiene monitoring is desired), l.e., a wrist band or a ring. A hygiene detection device disclosed herein can be affixed to a band disclosed herein using a hook-and-loop fastener disclosed herein, an adhesive layer disclosed herein, or via a device holder where a hygiene detection device disclosed herein is inserted into a sleeve that affixes the device to the band while exposing one or more hydrochromic pigments to the environment.

[047] Aspect of the present specification disclose a sealing layer. A sealing layer is used to enhance the integrity and stability of a hydrochromic pigment layer disclosed herein. While providing structural support and protection, a sealing layer is sufficiently porous to allow passage of enough moisture, e.g. , from a wetting or washing agent, e.g., water or liquid washing agent, to adequately expose a hydrochromic pigment layer and cause a change in the state of the hydrochromic pigments, e.g., from opaque to translucent or transparent. A sealing layer disclosed herein can be place below or above a hydrochromic pigment layer. In one embodiment, a sealing layer disclosed herein can also serve as a base disclosed herein. Non-limiting examples of a sealing layer include material composed of polyethylene, polyester, polyurethane, polyolefin, polypropylene, Nylon, Rayon woven or nonwoven, Spunlace nonwoven, polyvinyl chloride, elastic polymer, thermoplastic elastomer, or any combination thereof.

[048] In one embodiment, a sealing layer disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until a certain period of time has elapsed. In aspects of this embodiment, a sealing layer disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 60 seconds, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In other aspects of this embodiment, a sealing layer disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes. In yet other aspects of this embodiment, a sealing layer disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., at most 5 seconds, at most 10 seconds, at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 60 seconds, at most 2 minutes, at most 3 minutes, at most 4 minutes, or at most 5 minutes. In still other aspects of this embodiment, a sealing layer disclosed herein maintains a hydrochromic pigment layer in a moisture-exposed state, e.g., a translucent or transparent state until after, e.g., about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 45 seconds, about 10 seconds to about 60 seconds, about 30 seconds to about 45 seconds, about 30 seconds to about 60 seconds, about 1 minute to about 2 minutes, about 1 minute to about 3 minutes, about 1 minute to about 4 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 3 minutes, about 2 minutes to about 4 minutes, about 2 minutes to about 5 minutes, about 3 minutes to about 4 minutes, about 3 minutes to about 5 minutes, or about 4 minutes to about 5 minutes.

[049] A sealing layer disclosed herein can also include as adhesive layer as disclosed herein. Commercially suitable sealing layer with adhesive layer include Medical Tape 9833, Medical Tape 9834, and Medical Tape 9836 (medical grade acrylate adhesive on polyurethane backing; 3M Medical Specialties, St. Paul, MN); Medical Tape 9948 (medical grade acrylate adhesive on thermoplastic elastomer backing; 3M Medical Specialties, St. Paul, MN); Medical Tape 1522 (medical grade acrylate adhesive on polyethylene backing; 3M Medical Specialties, St. Paul, MN); and Medical Tape 9917 (medical grade acrylate adhesive on Spunlace nonwoven backing; 3M Medical Specialties, St. Paul, MN).

[050] Aspect of the present specification disclose an absorbent layer. An absorbent layer is used as a reservoir by retaining a sufficient amount of moisture, e.g. , from a wetting or washing agent, e.g. , water or liquid washing agent, to maintain a hydrochromic pigment layer in a moisture-exposed state, e.g., a translucent or transparent state. As such, an absorbent layer is used to help control the time period a hydrochromic pigment layer is exposed to moisture. An absorbent layer is sufficiently porous to allow passage of enough moisture to adequately expose a hydrochromic pigment layer and cause a change in the state of the hydrochromic pigments, e.g., from opaque to translucent or transparent. Non-limiting examples of an absorbent layer include material composed of a natural textile material disclosed herein, a synthetic textile material disclosed herein, a plastic disclosed herein, or any combination thereof. In some embodiments, an absorbent layer is a distinct layer from a base disclosed herein. In some embodiments, an absorbent layer also serves as a base disclosed herein.

[051] An absorbent layer disclosed herein can be place below or above a hydrochromic pigment layer. In addition, as discussed above, an absorbent layer can comprise a hydrochromic pigment, thereby providing the properties of both an absorbent layer and a hydrochromic pigment layer, but as one integrated layer. In another embodiment, an absorbent layer disclosed herein can also serve as a base disclosed herein. In a further embodiment, an absorbent layer can comprise a hydrochromic pigment and serve as a base disclosed herein, thereby providing the properties of an absorbent layer, a hydrochromic pigment layer and as a base, but as one integrated layer.

[052] In one embodiment, an absorbent layer disclosed herein maintains one or more hydrochromic pigments in a moisture-exposed state, e.g., a translucent or transparent state until a certain period of time has elapsed. In aspects of this embodiment, an absorbent layer disclosed herein maintains one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 60 seconds, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In other aspects of this embodiment, an absorbent layer disclosed herein maintains one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes. In yet other aspects of this embodiment, an absorbent layer disclosed herein maintains one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , at most 5 seconds, at most 10 seconds, at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 60 seconds, at most 2 minutes, at most 3 minutes, at most 4 minutes, or at most 5 minutes. In still other aspects of this embodiment, an absorbent layer disclosed herein maintains one or more hydrochromic pigments in a moisture-exposed state, e.g., a translucent or transparent state until after, e.g. , about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 45 seconds, about 10 seconds to about 60 seconds, about 30 seconds to about 45 seconds, about 30 seconds to about 60 seconds, about 1 minute to about 2 minutes, about 1 minute to about 3 minutes, about 1 minute to about 4 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 3 minutes, about 2 minutes to about 4 minutes, about 2 minutes to about 5 minutes, about 3 minutes to about 4 minutes, about 3 minutes to about 5 minutes, or about 4 minutes to about 5 minutes.

[053] In one embodiment, thickness of a layer comprising one or more hydrochromic pigments, a sealing and/or absorbent layer and/or depressions/openings which exposure one or more hydrochromic pigments to the outside environment all help maintain one or more hydrochromic pigments in a moisture- exposed state, e.g., a translucent or transparent state until a certain period of time has elapsed. In aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments, a sealing and/or absorbent layer, and/or depressions/openings disclosed herein maintain one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , about 5 seconds, about 10 seconds, about 15 seconds, about 30 seconds, about 45 seconds, about 60 seconds, about 2 minutes, about 3 minutes, about 4 minutes, or about 5 minutes. In other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments, a sealing and/or absorbent layer, and/or depressions/openings disclosed herein maintain one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , at least 5 seconds, at least 10 seconds, at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 60 seconds, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes. In yet other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments, a sealing and/or absorbent layer, and/or depressions/openings disclosed herein maintain one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g. , at most 5 seconds, at most 10 seconds, at most 15 seconds, at most 30 seconds, at most 45 seconds, at most 60 seconds, at most 2 minutes, at most 3 minutes, at most 4 minutes, or at most 5 minutes. In still other aspects of this embodiment, thickness of a layer comprising one or more hydrochromic pigments, a sealing and/or absorbent layer, and/or depressions/openings disclosed herein maintain one or more hydrochromic pigments in a moisture-exposed state, e.g. , a translucent or transparent state until after, e.g., about 5 seconds to about 10 seconds, about 5 seconds to about 15 seconds, about 5 seconds to about 30 seconds, about 5 seconds to about 45 seconds, about 5 seconds to about 60 seconds, about 10 seconds to about 15 seconds, about 10 seconds to about 30 seconds, about 10 seconds to about 45 seconds, about 10 seconds to about 60 seconds, about 30 seconds to about 45 seconds, about 30 seconds to about 60 seconds, about 1 minute to about 2 minutes, about 1 minute to about 3 minutes, about 1 minute to about 4 minutes, about 1 minute to about 5 minutes, about 2 minutes to about 3 minutes, about 2 minutes to about 4 minutes, about 2 minutes to about 5 minutes, about 3 minutes to about 4 minutes, about 3 minutes to about 5 minutes, or about 4 minutes to about 5 minutes.

[054] Aspects of the present specification disclose a method for monitoring hygiene compliance. A disclosed method can comprises detecting a change in a hygiene detection device disclosed herein on a skin surface of an individual that was, or thought to have been, washed with a washing agent. A disclosed method can comprises applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device disclosed herein on a skin surface of the individual. In some embodiments, an individual can a healthcare worker, including a physician, a nurse, an attendant or an aid as well as a patient or other individual being taken care of by a healthcare worker. In some embodiments, an individual is a family member or house guest.

[055] The present specification discloses, in part, hygiene compliance. Hygiene relates to conditions or practices conducive to maintaining health and preventing disease, and includes, without limitation, personal hygiene, residential hygiene, commercial hygiene, and industrial hygiene. Hygiene compliance relates to an action, state, or fact of observing or satisfying a rule or standard pertaining to the conditions or practices conducive to maintaining health and preventing disease. Standards for hygiene compliance are promulgated by many public health and regulatory agencies including, without exception, World Health Organization (WHO), the CDC, as well as other regulatory agencies around the world.

[056] The present specification discloses, in part, a washing agent. A washing agent refers to a substance used in establishing and/or maintaining hygiene, and includes, without limitation, a personal washing agent, a residential washing agent, a commercial washing agent and an industrial washing agent. A washing agent can establish and/or maintain hygiene by, e.g. , reducing the number of microorganisms present on an object. A washing agent disclosed herein can be a broad-spectrum antimicrobial/antiseptic, fast-acting, and/or persistent. A washing agent may be in the form of a solid (i.e. , bar of soap, surgical prep sponge), powder, liquid, cream, spray, gel, or the like. A washing agent disclosed herein includes, without limitation, water, a detergent, a soap, a cleaner, a bleach, a disinfectant, or a sterilizing agent.

[057] A washing agent can be prepared in a wide variety of ways, including, e.g. , a surfactant-based composition, an alcohol-based composition, an antimicrobial composition, an antiseptic composition, or any combination thereof. A surfactant-based composition refers to a preparation composed of both hydrophilic and lipophilic components and can be divided into four groups: anionic, cationic, amphoteric, and nonionic detergents. A surfactant-based composition includes, e.g. , a detergent or a soap. An alcohol-based composition refers to a preparation comprising an alcohol, typically in an amount of about 50% to about 100%. Examples of commonly used alcohols include, without limitation, ethanol, isopropanol, n-propanol, or any combination thereof. An alcohol-based composition includes, e.g., an alcohol-based hand rub. An antimicrobial composition refers to a preparation comprising a washing agent and an antimicrobial agent. An antimicrobial composition includes, e.g., an antimicrobial hand wash, an antimicrobial hand rub, and a waterless antimicrobial composition. An antiseptic composition refers to a preparation comprising a washing agent and an antiseptic agent. An antiseptic composition includes, e.g., an antiseptic hand wash, an antiseptic hand rub, and a waterless antiseptic composition. An antiseptic agent includes, without limitation, an alcohol, chlorhexidine, chlorine, hexachlorophene, iodine, chloroxylenol (PCMX), a quaternary ammonium compound, and triclosan.

[058] The present specification discloses, in part, washed or washing. Washed or washing refers to treating a skin surface with a washing agent disclosed herein.

[059] The present specification discloses, in part, a skin surface. For example, a skin surface includes without limitation, a hand, an arm, a face, a scalp, a neck, a foot, a leg, a chest, a back or a buttock.

[060] The present specification discloses, in part, hand washing. Hand washing, also known to as hand hygiene, refers to treating one or both hands of an individual with a hand washing agent designed to clean, disinfect, or sterilize the skin of the hands. For example, the hands of an individual can be washed by applying soap and water to all surfaces of the hand, by applying only hand washing agent to all surfaces of the hand, by dipping hands into a hand washing agent or by using friction-generating activities to scrub the skin surface of the hands.

[061] The present specification discloses, in part, detecting a change in a hygiene detection device disclosed herein. Detection is typically done by simple observation of an individual, either the individual who performed the washing of a skin surface, or another individual. Alternatively, more sophisticated detection systems can be used. For example, if the color or symbol being detected is applied using infrared material, then an IR-reading sensor can be used to detect a change in a hygiene detection device.

[062] Aspects of the present specification can be described as follows:

1. A hygiene detection device comprising a base and a hydrochromic pigment layer comprising one or more hydrochromic pigments.

2. The hygiene detection device according to embodiment 1 , wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

3. The hygiene detection device according to embodiment 1 or 2, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

4. The hygiene detection device according to embodiment 2 or 3, wherein the color of the base is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment. The hygiene detection device according to any one of embodiments 2-4, wherein the color of the symbol is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment. The hygiene detection device according to any one of embodiments 1 -5, further comprising an adhesive layer.

The hygiene detection device according to embodiment 6, wherein the base is in between the hydrochromic pigment layer and the adhesive layer.

The hygiene detection device according to any one of embodiments 1 -7, further comprising a sealing layer.

The hygiene detection device according to embodiment 6, wherein the sealing layer is on top of the hydrochromic pigment layer.

The hygiene detection device according to embodiment 6, wherein the sealing layer is in between the base and the hydrochromic pigment layer.

The hygiene detection device according to embodiment 8, the base and the sealing layer are the same material.

The hygiene detection device according to any one of embodiments 1 -1 1 , further comprising an adsorbent layer.

The hygiene detection device according to embodiment 12, wherein the hygiene detection device is arranged as follows: a) the adhesive layer, the base, the absorbent layer, the hydrochromic pigment layer, the sealing layer; or b) the adhesive layer, the base, the sealing layer, the hydrochromic pigment layer, the absorbent layer; or c) the adhesive layer, the base, the hydrochromic pigment layer, the sealing layer, the absorbent layer; or d) the adhesive layer, the base, the hydrochromic pigment layer, the absorbent layer, the sealing layer.

The hygiene detection device according to embodiment 12, wherein the base and the adsorbent layer are the same material.

The hygiene detection device according to embodiment 12 or 14, wherein the base and the adsorbent layer are integrated into a single layer.

The hygiene detection device according to embodiment 15, wherein the hygiene detection device is arranged as follows: a) the adhesive layer, the integrated base and absorbent layer, and the hydrochromic pigment layer; or b) the adhesive layer, the integrated base and absorbent layer, the sealing layer, and the hydrochromic pigment layer; or c) the adhesive layer, the integrated base and absorbent layer, the hydrochromic pigment layer and the sealing layer.

The hygiene detection device according to any one of embodiments 1 -16, wherein the hygiene detection device further comprises a layer with openings located on the top surface.

The hygiene detection device according to embodiment 17, wherein the openings are pores.

The hygiene detection device according to embodiment 17, wherein the openings are wells comprising a reservoir.

A hygiene detection device comprising a base and an absorbent layer comprising one or more hydrochromic pigments.

The hygiene detection device according to embodiment 20, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture. The hygiene detection device according to embodiment 20 or 21 , wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 20 or 21 , wherein the color of the base is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 21 -23, wherein the color of the symbol is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment. The hygiene detection device according to any one of embodiments 20-24, further comprising an adhesive layer.

The hygiene detection device according to embodiment 25, wherein the base is in between the absorbent layer and the adhesive layer.

The hygiene detection device according to any one of embodiments 20-26, further comprising a sealing layer.

The hygiene detection device according to embodiment 27, wherein the sealing layer is on top of the absorbent layer.

The hygiene detection device according to embodiment 27, wherein the sealing layer is in between the base and the absorbent layer.

The hygiene detection device according to embodiment 29, the base and the sealing layer are the same material.

The hygiene detection device according to any one of embodiments 20-30, wherein the hygiene detection device further comprises a layer with openings located on the top surface.

The hygiene detection device according to embodiment 31 , wherein the openings are pores.

The hygiene detection device according to embodiment 31 , wherein the openings are wells comprising a reservoir.

A hygiene detection device comprising a base that serves as both a solid support and an absorbent and comprising one or more hydrochromic pigments.

The hygiene detection device according to embodiment 34, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 34 or 35, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 34 or 36, wherein the color of the base is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 35-37, wherein the color of the symbol is a pigment from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment. The hygiene detection device according to any one of embodiments 34-38, further comprising an adhesive layer.

The hygiene detection device according to any one of embodiments 34-39, further comprising a sealing layer.

The hygiene detection device according to embodiment 40, wherein the sealing layer is on top of the absorbent layer. 42. The hygiene detection device according to any one of embodiments 34-41 , wherein the hygiene detection device further comprises a layer with openings located on the top surface.

43. The hygiene detection device according to embodiment 42, wherein the openings are pores.

44. The hygiene detection device according to embodiment 42, wherein the openings are wells comprising a reservoir.

45. A hygiene detection device disclosed herein comprises a base, the base comprising wells on a top surface, the wells comprising hydrochromic pigments, and an adhesive layer, the adhesive layer located on a bottom surface of the base.

46. The hygiene detection device according to embodiment 45, wherein the wells further comprise a reservoir.

47. Use of a hygiene detection device as defined in embodiments 1 -46 to monitor hygiene compliance.

48. A hygiene detection device as defined in embodiments 1 -46 for use in monitoring hygiene compliance.

49. The use according to embodiment 47 or 48, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

50. A method of monitoring hygiene compliance comprising detecting a change in a hygiene detection device as defined in embodiments 1 -46 on a skin surface of an individual that was, or thought to have been, washed with a washing agent

51 . A method of monitoring hygiene compliance comprising applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device as defined in embodiments 1 -46 on a skin surface of the individual.

52. The method according to embodiment 50 or 51 , wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

53. A system comprises a hygiene detection device as defined in embodiments 1 -46 and a washing

agent.

[063] Aspects of the present specification can be described as follows:

1 . A hygiene detection device comprising a base, an absorbent layer and one or more hydrochromic pigments.

2. The hygiene detection device according to embodiment 1 , wherein the base and the adsorbent layer are the same material.

3. The hygiene detection device according to embodiment 1 or 2, wherein the base and the adsorbent layer are integrated into a single layer.

4. The hygiene detection device according to any one of embodiments 1 -3, wherein the one or more hydrochromic pigments are integrated into the adsorbent layer as a single layer.

5. The hygiene detection device according to any one of embodiments 1 -3, wherein the one or more hydrochromic pigments are present as a hydrochromic pigment layer distinct from the base and the adsorbent layer.

6. The hygiene detection device according to any one of embodiments 1 -5, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture. The hygiene detection device according to claim 6, wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 1 -7, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 8, wherein the color of the symbol is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 1 -9, wherein the hygiene detection device is arranged as follows: a) the base, the absorbent layer, and the one or more hydrochromic pigments integrated into a single layer; b) the base and the absorbent layer integrated into a single layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer; or c) the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer.

The hygiene detection device according to any one of embodiments 1 -9, further comprising an adhesive layer.

The hygiene detection device according to embodiment 1 1 , wherein the hygiene detection device is arranged as follows: a) the adhesive layer, and the base, the absorbent layer, and the one or more hydrochromic pigments integrated into a single layer; b) the adhesive layer, the base and the absorbent layer integrated into a single layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer, or c) the adhesive layer, the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer.

The hygiene detection device according to any one of embodiments 1 -1 1 , further comprising a sealing layer.

The hygiene detection device according to embodiment 12, wherein the hygiene detection device is arranged as follows: a) the adhesive layer, and the base, the absorbent layer, the one or more hydrochromic pigments integrated into a single layer, and the sealing layer; b) the adhesive layer, the base and the absorbent layer integrated into a single layer, the one or more hydrochromic pigments present as a hydrochromic pigment layer, and the sealing layer; or c) the adhesive layer, the base, the absorbent layer, the one or more hydrochromic pigments present as a hydrochromic pigment layer, and the sealing layer.

The hygiene detection device according to any one of embodiments 1 -13, wherein the hygiene detection device further comprises a layer with openings located on a top surface.

The hygiene detection device according to embodiment 14, wherein the openings are pores.

The hygiene detection device according to embodiment 14 or 15, wherein the openings are wells comprising a reservoir.

A hygiene detection device comprising a base, an absorbent layer and one or more hydrochromic pigments, wherein the base, the absorbent layer, and the one or more hydrochromic pigments are integrated into a single layer.

The hygiene detection device according to embodiment 17, further comprising an adhesive layer. A hygiene detection device comprising an adhesive layer, a base, an absorbent layer and one or more hydrochromic pigments, wherein the base, the absorbent layer, and the one or more hydrochromic pigments are integrated into a single layer.

The hygiene detection device according to any one of embodiments 17-19, wherein the base and the adsorbent layer are the same material.

The hygiene detection device according to any one of embodiments 17-20, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture. The hygiene detection device according to embodiment 21 , wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 17-22, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 22, wherein the color of the symbol from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to embodiment 25, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 25 or 26, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 26 or 27, wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to embodiment 27 or 28, wherein the color of the symbol is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 25-29, further comprising an adhesive layer.

The hygiene detection device according to any one of embodiments 25-30, further comprising a sealing layer.

The hygiene detection device according to embodiment 31 , wherein the sealing layer is on top of the absorbent layer.

The hygiene detection device according to any one of embodiments 25-33, wherein the hygiene detection device further comprises a layer with openings located on a top surface.

The hygiene detection device according to embodiment 33, wherein the openings are pores.

The hygiene detection device according to embodiment 33 or 34, wherein the openings are wells comprising a reservoir.

Use of a hygiene detection device as defined in any one of embodiments 1 -35 to monitor hygiene compliance.

A hygiene detection device as defined in any one of embodiments 1 -35 for use in monitoring hygiene compliance. 38. The use according to embodiment 36 or 37, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

39. A method of monitoring hygiene compliance comprising detecting a change in a hygiene detection device as defined in any one of embodiments 1 -35 on a skin surface of an individual that was, or thought to have been, washed with a washing agent

40. A method of monitoring hygiene compliance comprising applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device as defined in any one of embodiments 1 -35 on a skin surface of the individual.

41 . The method according to embodiment 39 or 40, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

42. A system comprises a hygiene detection device as defined in any one of embodiments 1 -35 and a washing agent.

[064] Aspects of the present specification can be described as follows:

1 . A hygiene detection device comprising a base and one or more hydrochromic pigments.

2. The hygiene detection device according to embodiment 1 , wherein the base is composed of paper, fabric, plastic, or metal.

3. The hygiene detection device according to embodiment 1 or 2, wherein the base is composed of an adsorbent material.

4. The hygiene detection device according to embodiment 1 or 2, further comprising an adsorbent layer.

5. The hygiene detection device according to any one of embodiments 1 -4, wherein the one or more hydrochromic pigments are integrated into the base layer as a single layer.

6. The hygiene detection device according to any one of embodiments 1 -4, wherein the one or more hydrochromic pigments are present as a hydrochromic pigment layer distinct from the base.

7. The hygiene detection device according to any one of embodiments 1 -6, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

8. The hygiene detection device according to embodiment 7, wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

9. The hygiene detection device according to any one of embodiments 1 -8, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

10. The hygiene detection device according to embodiment 9, wherein the color of the symbol is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

1 1 . The hygiene detection device according to any one of embodiments 1 -10, wherein the hygiene detection device is arranged as follows: a) the base composed of absorbent material and the one or more hydrochromic pigments integrated into a single layer; b) the base composed of absorbent material, and the one or more hydrochromic pigments present as a hydrochromic pigment layer; or c) the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer. The hygiene detection device according to any one of embodiments 1 -1 1 , further comprising an adhesive layer.

The hygiene detection device according to embodiment 12, wherein the hygiene detection device is arranged as follows: a) the adhesive layer, and the base composed of absorbent material and the one or more hydrochromic pigments integrated into a single layer; b) the adhesive layer, the base composed of absorbent material, and the one or more hydrochromic pigments present as a hydrochromic pigment layer; or c) the adhesive layer, the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer.

The hygiene detection device according to any one of embodiments 1 -1 1 , further comprising a securing component.

The hygiene detection device according to embodiment 14, further comprising the securing component comprises a hook and loop fastener.

The hygiene detection device according to embodiment 14 or 15, wherein the securing component further comprises a band configured to be attached to an individual.

The hygiene detection device according to embodiment 14, the securing component comprises adhesive layer.

The hygiene detection device according to any one of embodiments 14-17, wherein the hygiene detection device is arranged as follows: a) the securing component, and the base composed of absorbent material and the one or more hydrochromic pigments integrated into a single layer; b) the securing component, the base composed of absorbent material, and the one or more hydrochromic pigments present as a hydrochromic pigment layer; or c) the securing component, the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer.

The hygiene detection device according to any one of embodiments 1 -18, further comprising a sealing layer.

The hygiene detection device according to any one of embodiments 1 -19, wherein the hygiene detection device further comprises a layer with openings located on a top surface.

The hygiene detection device according to embodiment 20, wherein the openings are pores.

The hygiene detection device according to embodiment 20 or 21 , wherein the openings are wells comprising a reservoir.

The hygiene detection device according to embodiment 23, further comprising an adhesive layer. The hygiene detection device according to embodiment 23, further comprising a securing component. The hygiene detection device according to embodiment 25, further comprising the securing component comprises a hook and loop fastener.

The hygiene detection device according to embodiment 25 or 26, wherein the securing component further comprises a band configured to be attached to an individual.

The hygiene detection device according to embodiment 25, the securing component comprises adhesive layer. A hygiene detection device comprising a base that serves as both a solid support and an absorbent and comprising one or more hydrochromic pigments.

The hygiene detection device according to embodiment 29, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 29 or 30, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

The hygiene detection device according to embodiment 30 or 31 , wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to embodiment 31 or 32, wherein the color of the symbol is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

The hygiene detection device according to any one of embodiments 29-33, further comprising an adhesive layer.

The hygiene detection device according to any one of embodiments 29-33, further comprising a securing component.

The hygiene detection device according to embodiment 35, further comprising the securing component comprises a hook and loop fastener.

The hygiene detection device according to embodiment 35 or 36, wherein the securing component further comprises a band configured to be attached to an individual.

The hygiene detection device according to embodiment 35, the securing component comprises adhesive layer.

The hygiene detection device according to any one of embodiments 29-38, further comprising a sealing layer.

The hygiene detection device according to any one of embodiments 29-39, wherein the hygiene detection device further comprises a layer with openings located on a top surface.

The hygiene detection device according to embodiment 40, wherein the openings are pores.

The hygiene detection device according to embodiment 40 or 41 , wherein the openings are wells comprising a reservoir.

Use of a hygiene detection device as defined in any one of embodiments 1 -42 to monitor hygiene compliance.

A hygiene detection device as defined in any one of embodiments 1 -42 for use in monitoring hygiene compliance.

The use according to embodiment 43 or 44, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

A method of monitoring hygiene compliance comprising detecting a change in a hygiene detection device as defined in any one of embodiments 1 -42 on a skin surface of an individual that was, or thought to have been, washed with a washing agent

A method of monitoring hygiene compliance comprising applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device as defined in any one of embodiments 1 -42 on a skin surface of the individual. 48. The method according to embodiment 46 or 47, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

49. A system comprises a hygiene detection device as defined in any one of embodiments 1 -42 and a washing agent.

43. A hygiene detection device comprising a securing component and a hygiene detection device as defined in any one of embodiments 1 -13, 23, 24, or 29-34.

44. The hygiene detection device according to embodiment 43, wherein the securing component further comprises a band configured to be attached to an individual.

45. The hygiene detection device according to embodiment 43, wherein the securing component is a flexible wrist band, flexible ring, a rigid wrist band, or a rigid ring.

46. Use of a hygiene detection device as defined in any one of embodiments 1 -45 to monitor hygiene compliance.

47. A hygiene detection device as defined in any one of embodiments 1 -45 for use in monitoring hygiene compliance.

48. The use according to embodiment 46 or 47, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

49. A method of monitoring hygiene compliance comprising detecting a change in a hygiene detection device as defined in any one of embodiments 1 -45 of an individual that was, or was thought to have, washed with a washing agent

50. A method of monitoring hygiene compliance comprising applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device as defined in any one of embodiments 1 -45 of the individual.

51 . The method according to embodiment 49 or 50, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

52. A system comprises a hygiene detection device as defined in any one of embodiments 1 -45 and a washing agent.

EXAMPLES

[065] The following non-limiting examples are provided for illustrative purposes only in order to facilitate a more complete understanding of representative embodiments now contemplated. These examples should not be construed to limit any of the embodiments described in the present specification, including those pertaining to the devices, methods, systems and uses disclosed herein.

Example 1

Hygiene Detection Device

[066] A hygiene detection device is manufactured by taking a sheet of blue-colored plastic and applying a hydrochromic paint on one side of the plastic sheet and affixing one side of a double-sided adhesive tape on the opposite side of the plastic sheet. The second side of the double-sided adhesive tape includes a protective covering that shields or otherwise prevents the adhesive present on the second side of the double-sided adhesive tape from debris, inappropriate affixing or other events fouling or otherwise making the adhesive inoperable for its intended use. The manufacture sheet thus comprises a top hydrochromic pigment layer and a bottom adhesive layer with a base sandwiched in between the top hydrochromic pigment layer and the bottom adhesive layer. These sheets can then be cut to any desired shape to produce smaller pieces that can easily fit onto the back of a hand, such as a circle, oval, triangle, square or rectangle to produce a final hygiene detection device. To affix a hygiene detection device to an individual, the protective covering is simply peeled off to expose the adhesive present on the second side of the double-sided adhesive tape and secures the device by pressing the exposed adhesive to a skin area on the back of a hand of an individual.

Example 2

Hygiene Detection Device

[067] A hygiene detection device is manufactured by taking blue-colored fabric and applying a hydrochromic paint on one side of the fabric. Due to the porous nature of the fabric, the hydrochromic paint is absorbed into the fabric. A double-sided adhesive tape is affixed onto the side of the fabric opposite to the side that the hydrochromic paint was applied. The second side of the double-sided adhesive tape includes a protective covering that shields or otherwise prevents the adhesive present on the second side of the double-sided adhesive tape from debris, inappropriate affixing or other events fouling or otherwise making the adhesive inoperable for its intended use. The manufacture sheet thus comprises a base that also serves as an absorbent layer with one or more hydrochromic pigments integrated into the base. The fabric can then be cut to any desired shape to produce smaller pieces that can easily fit onto the back of a hand, such as a circle, oval, triangle, square or rectangle to produce a final hygiene detection device. To affix a hygiene detection device to an individual, the protective covering is simply peeled off to expose the adhesive present on the second side of the double-sided adhesive tape and secures the device by pressing the exposed adhesive to a skin area on the back of a hand of an individual.

Example 3

Hygiene Detection Device

[068] A flexible wrist band made from plastic or a paper material coated in a plastic material and includes a holder. A hygiene detection device is manufactured according to Example 1 or 2, and is configured to be insertable into the holder of the flexible wrist band. In use, an individual will insert the hygiene detection device into the holder of the flexible wrist band and then attach the flexible wrist band to a wrist. Alternatively, an individual can attach the flexible wrist band to a wrist and then insert the hygiene detection device into the holder of the flexible wrist band. When desired, the hygiene detection device can be replaced by removing it from the holder and a new hygiene detection device inserted into the holder. Example 4

Hygiene Detection Device

[069] A hygiene detection device is manufactured according to Example 1 or 2, except that a hook component of a hook-and-loop fastener is affixed to second side of the double-sided adhesive tape, although in other embodiments, the loop component can be used instead of the hook component. A loop component of the hook-and-loop fastener is affixed to a substrate where the hygiene detection device is desired to be secured. To affix a hygiene detection device to a substrate, the hook component is simply pressing onto the loop component.

Example 5

Hygiene Detection Device

[070] A hygiene detection device is manufactured according to Example 1 or 2, except that instead of using a double-sided adhesive tape, a hook component of a hook-and-loop fastener is affixed to the side opposite to the side that the hydrochromic paint was applied, although in other embodiments, the loop component can be used instead of the hook component. A loop component of the hook-and-loop fastener is affixed to a substrate where the hygiene detection device is desired to be secured. To affix a hygiene detection device to a substrate, the hook component is simply pressing onto the loop component.

Example 6

Hygiene Detection Device

[071] A flexible wrist band made from plastic or a paper material coated in a plastic material and includes a loop component of a hook-and-loop fastener. A hygiene detection device is manufactured according to Example 4 or 5, and is configured to be attached to the loop component present on the flexible wrist band. In use, an individual will attach the hygiene detection device to the loop component on the flexible wrist band and then attach the flexible wrist band to a wrist. Alternatively, an individual can attach the flexible wrist band to a wrist and then attach the hygiene detection device to the loop component on the flexible wrist band. When desired, the hygiene detection device can be replaced by removing it from the loop component and a new hygiene detection device attached to the loop component.

Example 7

Method of Cleaning Hands

[072] A healthcare provider working in an office suite is tasked to take the vital signs of each patient as a preliminary examination before a healthcare physician examines the patient. Before entering an examination room to take the signs of the next patient, the healthcare provider washes her hands with a disinfectant. The healthcare worker has affixed a hygiene detection device disclosed herein to the back of her left hand. After rubbing the disinfectant all over her hands and fingers for at least 20-30 seconds, including underneath the fingernails, a blue color appears on the device due to the hydrochromic pigment layer being exposed to the water or alcohol. The blue color remains after rinsing her hands thoroughly with water but will eventually fade away after 2-3 minutes as the hydrochromic pigment layer dries. Upon entering the examination room the patient sees that the blue color on the device located on the healthcare provider’s left hand and can make a note that her hands were properly washed (the patient knows this as there are signs posted in the examination room stating that all staff examining the patient must have blue indicator color on the device located on the back of the left hand upon entering the room).

[073] In closing, it is to be understood that, although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. The specific embodiments are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular compound, composition, article, apparatus, methodology, protocol, and/or reagent, etc., described herein, unless expressly stated as such. In addition, those of ordinary skill in the art will recognize that certain changes, modifications, permutations, alterations, additions, subtractions and sub-combinations thereof can be made in accordance with the teachings herein without departing from the spirit of the present specification. It is therefore intended that the scope of the invention is not to be limited by this detailed description. Furthermore, it is intended that the following appended claims and claims hereafter introduced are interpreted to include all such changes, modifications, permutations, alterations, additions, subtractions, and sub-combinations as are within their true spirit and scope.

[074] Certain embodiments of the present invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the present invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above- described embodiments in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[075] Groupings of alternative embodiments, elements, or steps of the present invention are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified, thus fulfilling the written description of all Markush groups used in the appended claims.

[076] Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.

[077] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. For instance, as mass spectrometry instruments can vary slightly in determining the mass of a given analyte, the term "about" in the context of the mass of an ion or the mass/charge ratio of an ion refers to +/-0.50 atomic mass unit. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[078] Notwithstanding that the numerical ranges and values setting forth the broad scope of the invention are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein.

[079] Use of the terms“may” or“can” in reference to an embodiment or aspect of an embodiment also carries with it the alternative meaning of “may not” or“cannot.” As such, if the present specification discloses that an embodiment or an aspect of an embodiment may be or can be included as part of the inventive subject matter, then the negative limitation or exclusionary proviso is also explicitly meant, meaning that an embodiment or an aspect of an embodiment may not be or cannot be included as part of the inventive subject matter. In a similar manner, use of the term “optionally” in reference to an embodiment or aspect of an embodiment means that such embodiment or aspect of the embodiment may be included as part of the inventive subject matter or may not be included as part of the inventive subject matter. Whether such a negative limitation or exclusionary proviso applies will be based on whether the negative limitation or exclusionary proviso is recited in the claimed subject matter.

[080] The terms“a,”“an,”“the” and similar references used in the context of describing the present invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, ordinal indicators - such as, e.g.,“first,”“second,”“third,” etc. - for identified elements are used to distinguish between the elements, and do not indicate or imply a required or limited number of such elements, and do not indicate a particular position or order of such elements unless otherwise specifically stated. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the present invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[081] When used in the claims, whether as filed or added per amendment, the open-ended transitional term“comprising”, variations thereof such as, e.g., “comprise” and “comprises”, and equivalent open- ended transitional phrases thereof like“including,”“containing” and“having”, encompass all the expressly recited elements, limitations, steps, integers, and/or features alone or in combination with unrecited subject matter; the named elements, limitations, steps, integers, and/or features are essential, but other unnamed elements, limitations, steps, integers, and/or features may be added and still form a construct within the scope of the claim. Specific embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrases “consisting of or“consisting essentially of (or variations thereof such as, e.g.,“consist of,“consists of,“consist essentially of, and“consists essentially of) in lieu of or as an amendment for“comprising.” When used in the claims, whether as filed or added per amendment, the closed-ended transitional phrase“consisting of excludes any element, limitation, step, integer, or feature not expressly recited in the claims. The closed-ended transitional phrase“consisting essentially of limits the scope of a claim to the expressly recited elements, limitations, steps, integers, and/or features and any other elements, limitations, steps, integers, and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Thus, the meaning of the open- ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and/or features as well as any optional, additional unspecified ones. The meaning of the closed-ended transitional phrase“consisting of is being defined as only including those elements, limitations, steps, integers, and/or features specifically recited in the claim, whereas the meaning of the closed-ended transitional phrase “consisting essentially of is being defined as only including those elements, limitations, steps, integers, and/or features specifically recited in the claim and those elements, limitations, steps, integers, and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Therefore, the open-ended transitional phrase “comprising” (and equivalent open-ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases“consisting of or “consisting essentially of.” As such, the embodiments described herein or so claimed with the phrase “comprising” expressly and unambiguously provide description, enablement, and support for the phrases “consisting essentially of and“consisting of.”

[082] All patents, patent publications, and other references cited and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the present invention. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard is or should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicant and do not constitute any admission as to the correctness of the dates or contents of these documents.

[083] Lastly, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention, which is defined solely by the claims. Accordingly, the present invention is not limited to that precisely as shown and described.

Claims

2. The hygiene detection device according to claim 1 , wherein the base is composed of paper, fabric, plastic, or metal.

3. The hygiene detection device according to claim 1 or 2, wherein the base is composed of an adsorbent material.

4. The hygiene detection device according to claim 1 or 2, further comprising an adsorbent layer.

5. The hygiene detection device according to any one of claims 1 -4, wherein the one or more hydrochromic pigments are incorporated or integrated into the base layer as a single layer.

6. The hygiene detection device according to any one of claims 1 -4, wherein the one or more hydrochromic pigments are present as a hydrochromic pigment layer distinct from the base.

7. The hygiene detection device according to any one of claims 1 -6, wherein the base is a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

8. The hygiene detection device according to claim 7, wherein the color of the base is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

9. The hygiene detection device according to any one of claims 1 -8, wherein the base comprises a symbol, the symbol being a color different than the color of the one or more hydrochromic pigments when exposed to moisture.

10. The hygiene detection device according to claim 9, wherein the color of the symbol is from the visible spectrum of light, an infrared pigment, or an ultraviolet pigment.

1 1 . The hygiene detection device according to any one of claims 1 -10, wherein the hygiene detection device is arranged as follows:

a. the base composed of absorbent material and comprises the one or more hydrochromic pigments incorporated or integrated into a single layer,

b. the base composed of absorbent material, and the one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base, or

c. the base, the absorbent layer, and the hydrochromic pigment layer one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base and the absorbent layer.

12. The hygiene detection device according to any one of claims 1 -1 1 , further comprising an adhesive layer.

13. The hygiene detection device according to claim 12, wherein the hygiene detection device is arranged as follows:

a. the adhesive layer, and the base composed of absorbent material, the base comprising the one or more hydrochromic pigments incorporated or integrated into a single layer,

b. the adhesive layer, the base composed of absorbent material, the one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base and the adhesive layer, or

c. the adhesive layer, the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base, the absorbent layer and the adhesive layer.

14. The hygiene detection device according to any one of claims 1 -1 1 , further comprising a securing component.

15. The hygiene detection device according to claim 14, further comprising the securing component comprises a hook-and-loop fastener.

16. The hygiene detection device according to claim 14 or 15, wherein the securing component further comprises a band configured to be attached to an individual.

17. The hygiene detection device according to claim 14, the securing component comprises adhesive layer.

18. The hygiene detection device according to any one of claims 14-17, wherein the hygiene detection device is arranged as follows:

a. the securing component, and the base composed of absorbent material and comprising the one or more hydrochromic pigments integrated into a single layer,

b. the securing component, the base composed of absorbent material, and the one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base and the securing component, or

c. the securing component, the base, the absorbent layer, and the one or more hydrochromic pigments present as a hydrochromic pigment layer distinct from the base, the absorbent layer and the securing component.

19. The hygiene detection device according to any one of claims 1 -18, further comprising a sealing layer.

20. The hygiene detection device according to any one of claims 1 -19, wherein the hygiene detection device further comprises a layer with openings located on a top surface.

21 . The hygiene detection device according to claim 20, wherein the openings are pores.

22. The hygiene detection device according to claim 20 or 21 , wherein the openings are wells comprising a reservoir.

23. A hygiene detection device comprising a securing component and a hygiene detection device as defined in any one of claims 1 -13.

24. The hygiene detection device according to claim 23, wherein the securing component further comprises a band configured to be attached to an individual.

25. The hygiene detection device according to claim 23, wherein the securing component is a flexible wrist band, flexible ring, a rigid wrist band, or a rigid ring.

26. Use of a hygiene detection device as defined in any one of claims 1 -25 to monitor hygiene compliance.

27. A hygiene detection device as defined in any one of claims 1 -25 for use in monitoring hygiene compliance.

28. The use according to claim 26 or 27, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

29. A method of monitoring hygiene compliance comprising detecting a change in a hygiene detection device as defined in any one of claims 1 -25 of an individual that was, or was thought to have, washed with a washing agent

30. A method of monitoring hygiene compliance comprising applying a washing agent to a skin surface of an individual; and detecting a change in a hygiene detection device as defined in any one of claims 1 - 25 of the individual.

31 . The method according to claim 29 or 30, wherein the washing agent is a personal washing agent, a residential washing agent, a commercial washing agent, or an industrial washing agent.

32. A system comprises a hygiene detection device as defined in any one of claims 1 -25 and a washing agent.