WO2015193664A1

WO2015193664A1 - Sterilisation/wash test indicator system and method of use thereof

Info

Publication number: WO2015193664A1
Application number: PCT/GB2015/051772
Authority: WO
Inventors: David Campbell
Original assignee: Albert Browne Limited
Priority date: 2014-06-20
Filing date: 2015-06-17
Publication date: 2015-12-23
Also published as: GB201410996D0

Abstract

A Sterilisation/wash test indicator system is provided for testing the effectiveness of a sterilisation and/ or wash procedure. The indicator system consists of or includes a test sample which is capable of undergoing a change during a sterilisation and/ or wash procedure to indicate whether the sterilisation/wash procedure has been effective. The test sample includes, is associated with or consists of a code. The code has two or more different conditions; at least a first condition existing prior to the sterilisation and/ or wash procedure, and at least a second condition existing after the sterilisation and/ or wash procedure. Data contained within and/ or encoded by the code in the at least first and second conditions being different.

Description

Sterilisation/Wash Test Indicator System and Method of Use Thereof

This invention relates to a sterilisation/ wash test indicator system and to a method of use thereof.

Although the following description refers almost exclusively to a sterilisation/wash test indicator system for use in certain specific sterilisation and/ or wash processes, it will be appreciated by persons skilled in the art that the present invention could be applied to any test or verification system used in any suitable sterilisation process, disinfection process, cleaning process, wash process and/ or the like that is available now or that becomes available in the future.

It is well known to use indicator devices to verify or test the efficiency of a sterilisation, disinfectant, cleaning and/ or washing process. One example of such an indicator device is in the form of a test strip with a sterilisation ink printed on the same which changes colour when a required sterilisation temperature or pH has been detected, such as for example when a required sterilisation temperature during a steam sterilisation process has been reached. An alternative indicator device is in the form of a wash process test strip which comprises a coloured test soil sample printed thereon. Removal of the coloured soil sample from the wash test strip indicates that a washing process has been effective. A further alternative indicator device is in the form of a process challenge device where sterilisation fluid, ink or a test strip is provided in a device having a tortuous route through which, for example, steam has to pass before it comes into contact with the sterilisation fluid, ink or test strip prior to a colour change being activated in the fluid, ink or test strip.

In use, all such known conventional indicator devices are typically located in the sterilisation, disinfectant, cleaning and/ or washing apparatus with other equipment being sterilised, disinfected, cleaned and/ or washed to determine if the sterilisation, disinfectant, cleaning and/ or washing process has been effective. A user typically visually detects a colour change of the sterilisation ink or removal of a test soil sample from the indicator device and then manually records the data on a data card and/or data file to confirm whether the process has been effective, and thus whether the equipment undergoing the process has passed or failed the test. This process of user visualisation and manual recording is time consuming and susceptible to user error. In addition, due to the time involved in manually recording the test data results, only limited test data is typically recorded for each cleaning process. This may result in problems for example, where equipment is being used for surgical procedures, and where detailed data relating to sterilisation or disinfection may need to be traced back to equipment used on a specific patient in the event of an infection being detected in the patient.

In an attempt to overcome these problems, it is known to use bar codes in conjunction with sterilisation/wash test apparatus that contain relevant information relating to the sterilisation process and/or tracking of the equipment being sterilised.

JP2010220970 discloses a non-discolouring bar code which has a discolouring sterilisation ink located over the top of the same. The bar code cannot be read before sterilisation due to it being hidden by the discolouring sterilisation ink, but after sterilisation the sterilisation ink is removed and the bar code can be viewed. The bar code itself remains in the same form both before and after the sterilisation process and only ever encodes a single data message.

JP2012068811 discloses the method of printing part of a bar code with sterilisation ink such that a) part of the bar code is not readable before sterilisation but is readable after sterilisation, or b) part of the bar code is readable before sterilisation but is not readable after sterilisation. A remaining part of the bar code is present both before and after the sterilisation process and remains unchanged during the sterilisation process. However, the bar code as a whole, is only readable either a) before sterilisation, or b) after sterilisation. Thus, the bar code in this disclosure has only a single full readable condition and is only capable of encoding a single data message.

It is to be noted that for conventional bar codes to be machine readable, the entire bar code has to be present for the encoded data to be obtained therefrom. Thus, bar codes can only be read one way (i.e. have only one message contained therein) and the entire bar code must be present for the code or the message to be deciphered by the reading apparatus. A partial bar code does not represent an encoded data message. The use of conventional bar codes in sterilisation and/or wash test processes is therefore relatively limiting as only a single message can be encoded by the code and the code is only machine readable in one sterilisation condition.

It is therefore an aim of the present invention to provide an alternative sterilisation/ wash test indicator system that overcomes the abovementioned problems.

It is a further aim of the present invention to provide an alternative method of using a sterilisation/wash test indicator system.

According to a first aspect of the present invention there is provided a sterilisation/wash test indicator system for testing the effectiveness of a sterilisation and/or wash procedure, said indicator system consisting of or including a test sample which is capable of undergoing a change during a sterilisation and/or wash procedure to indicate whether the sterilisation/wash procedure has been effective, the test sample includes, is associated with or consists of a code, characterised in that the code has two or more different conditions; at least a first condition existing prior to the sterilisation and/ or wash procedure, and at least a second condition existing after the sterilisation and/ or wash procedure, data contained within and/ or encoded by the code in the at least first and second conditions being different. Thus, the present invention provides a sterilisation/wash test indicator system that provides a different code, data or encodes a different message, information content or encoded data in two or more different sterilisation conditions. This increases the possible amount of data that can be associated with the test sample and allows improved automated data capture at different stages of a sterilisation and/ or a wash procedure.

Preferably the code, and further preferably a whole or complete code, is visible to the eye of a user and/ or to machine or electronic code readable apparatus in the two or more different conditions. This is in contrast to some prior art techniques where a complete code is only visible in a pre- sterilisation condition or a post sterilisation condition.

Preferably the data or encoded data contained within the code or the code itself is readable, decipherable, machine readable and/or machine decipherable in all or each of the two or more different conditions. Thus, although at least part of the code may increase or decrease in size (i.e. part of it becomes visible or invisible), data content, design, shape and/or the like between the different conditions, the code is readable/decipherable/encodes a different machine readable message in each of the different conditions. This is in contrast to the prior art where part of a bar code becomes visible or invisible during a sterilisation process but the bar code can only be machine readable/ encode data when the entire bar code is present in one condition or sterilisation/wash state.

In one embodiment the entire, or substantially the entire, code or data encoded by the code is visible, decipherable and/ or readable in each of the different conditions.

In one embodiment the data content contained or encoded by the code in each of the different conditions has a different or substantially different meaning, message content, data content and/or the like. The code of the present invention on, with or in association with the sterilisation/wash test indicator system provides a plurality of advantages. The code can typically be electronically read using code reading means in the different conditions, thereby allowing a significantly greater amount of data to be associated with the indicator system than is currently possible or feasible with some conventional test data result recording techniques. For example, data can be encoded in the code and can be read or visualised both before, during and/or after a sterilisation or wash test procedure. This could have significant benefits in fields such as for example, surgical equipment sterilisation procedures or hospital equipment tracking procedures, whereby an item of surgical equipment can have data stored and recorded via the code which may include details such as which patient the equipment has been used on, what procedures were used with the equipment, when the procedure took place, the surgeon undertaking the procedure, what other equipment went through the same test procedure with it and/or the like. Electronic reading or machine reading of the code is likely to be more accurate in determining a pass or fail of a test process or conveying information compared to conventional user visualisation. In addition, the speed at which a pass or fail can be recorded for a test process and/or test data can be transferred onto an electroninc database is significantly increased.

Preferably a change in condition of the code and/or the test sample only takes place when a sterilisation and/or wash procedure has been effective and/or has reached one or more pre-determined threshold conditions or values.

In one example the test sample is a test soil sample.

Preferably a change in condition of the code and/or the test sample only takes place over or following a pre-determined time period during or after a sterilisation and/ or wash procedure has taken place. Preferably the change in the condition of the code and/ or test sample has to be a significant change, such as for example significant enough to bring about a change in the data content encoded by the code. This can include any change, removal of at least part of the code and/ or addition to the code that is capable of being measured, recorded, electronically read by read apparatus, visualised and/ or the like.

Preferably measurement or detection of a change, significant change or difference in the test sample condition during or following a sterilisation and/ or wash test procedure is considered to represent a test "pass" or an effective procedure in one example.

However, it will be appreciated that measurement or detection of a significant change or difference in the test sample condition during or following a sterilisation and/ or wash test procedure could be considered to represent an ineffective procedure or a "fail" for the procedure.

Preferably the change in the test soil sample condition only takes place once one or more pre-determined conditions or values have been met during the sterilisation and/or wash procedure. For example, the one or more predetermined conditions or values may include any or any combination of a required temperature being reached, a required pH being reached, required environmental conditions being reached, a soil sample or obscuring material has been removed or washed off and/ or the like.

The test sample or code can be in any suitable form and can include or consist of any or any combination of one or more 2-Dimensional codes, colour codes, data encoded codes, Quick Response (QR) type codes, bar type codes, binary code, digital code, mathematical code and/ or the like.

In one embodiment the test sample itself is in the form of the code. Thus, for example, rather than printing a test sample on a test strip using sterilisation ink that changes colour during a sterilisation procedure, the code could be printed using sterilisation ink that changes colour during a sterilisation procedure. In one embodiment the code and/or the test sample is printed and/or formed using a sterilisation ink or fluid; test soil means, ink or fluid; disinfection means, ink or fluid; and/or cleaning ink, fluid, means and/or the like.

Reference to test soil means, ink or fluid relates to a material that is used to provide a test soil sample for subsequent removal by a sterilisation and/ or wash test procedure.

In one embodiment the code could be printed, formed and/or otherwise applied on indicator system apparatus so that in the first condition, at least part of the code is hidden or substantially hidden from view prior to the sterilisation and/or wash procedure taking place but the first condition code encodes first readable data content or a message, to a second condition, wherein the entire or substantially the entire code becomes visible, decipherable and/ or readable during or after the sterilisation and/ or wash procedure has taken place and encodes second readable data content or a message, the second readable data content or message being different to the first readable data content or message.

Preferably the first condition indicates a starting position of a procedure, an ineffective test procedure and/or a failed test procedure, and the at least second condition indicates a partial or complete finishing position of a procedure, an effective test procedure and/ or a passed test procedure.

In one embodiment more than two conditions can exist for the code. A third and/or further conditions can represent partial sterilisation and/or wash procedures, represent one or more pre-determined conditions have been met before, during or after a procedure and/ or the like.

In one embodiment the code could be printed and/or formed on test apparatus so that it moves from the first condition, wherein the code is in a first form, to the least a second condition, wherein the code is in a second different form during and/or following a test procedure. The change in form from the first condition to the second conditions could be as a result of a colour change of a whole or part of the code, a change in the physical form or layout of a whole or part of the code, a change in chemical form or layout of a whole or part of the code and/ or the like.

In one embodiment the code could be arranged to move from the first condition to a second condition and/or at least a third condition. For example, the code could start off in a first condition, such as being of a first colour prior to the start of test procedure. The code could move or change to a second condition, such as a second colour if the test procedure has been effective and could, for example, indicate a "pass" condition of the test procedure. Alternatively, the code could move or change to a third condition, such as a third colour if the test procedure has been ineffective and could, for example, indicate a "fail" condition of the test procedure.

In one embodiment the code could be formed or printed as one or more layers of a plurality of layers to form the test sample. For example, the test sample could include a plurality of partially or substantially wholly overlapping layers. The code could be provided in or form one or more of said overlapping layers. A change and/or removal of one or more of these layers could result in at least part of the code being revealed having previously being hidden, or the code becomes hidden when previously it was visible, it could result in a colour change in the code, a change in the physical form of the code and/or the like. For example, a test soil sample component could be provided over at least part of the code to hide the same, and removal of the test soil sample component could reveal the code following a successful wash procedure. It is to be noted that in accordance with the present invention the code encodes different data or a different message depending on whether the test soil sample is present or not. The data encoded in both conditions is typically a complete data code. In one embodiment the test sample can include at least a first upper layer comprising or consisting of a test soil sample and at least a second lower layer comprising or consisting of a code.

In one embodiment the indicator system apparatus includes a substrate or support means/device on or in which the test sample or code is provided or associated, directly or indirectiy, with. The substrate or support means could include any or any combination of a test strip, a tortuous path device, a process challenge device and/ or the like.

In one embo<iiment the code is applied, printed and/or formed direcdy on the substrate or support means.

In one embodiment the code is applied, printed and/or formed on a substrate or support means which is then located in a process challenge device, tortuous path device and/ or the like.

In one embodiment the code is applied, printed and/ or formed indirectly on a substrate or support means. For example, one or more base or lower layers could be applied to a substrate or support means prior to application of a code thereto.

Although the indicator system apparatus is referred to as sterilisation/ wash test indicator system apparatus, it will be appreciated by persons skilled in the art that the apparatus of the present invention could be any or any combination of sterilisation test apparatus, wash test apparatus, disinfectant test apparatus, cleaning test apparatus and/or the like.

Although the apparatus of the present invention is referred to as being used in a sterilisation/wash test procedure or process, it will be appreciated by persons skilled in the art that the procedure or process referred to could be any or any combination of sterilisation procedure, wash procedure, disinfectant procedure, cleaning procedure and/ or the like. Although the ink, fluid or means referred to in this application is often termed a sterilisation ink, sterilisation fluid, test soil ink or test soil means, it will be appreciated by persons skilled in the art that the ink, fluid or means referred to could be any or any combination of one or more inks, fluids or means that is/ are used to detect the effectiveness of a sterilisation process, disinfectant process, wash process, cleaning process and/or the like. The term sterilisation ink or fluid, disinfectant ink or fluid, wash ink or fluid, cleaning ink or fluid is typically a term used to define an ink or fluid that changes colour, condition or appearance when one or more certain predetermined conditions are met during a sterilisation procedure, disinfectant procedure, washing procedure, cleaning procedure and/ or the like.

In one example a combination of two or more different inks, fluids and/or test soil means could be provided to create the test sample and/or the code. For example, two different types of sterilisation inks could be provided which could result in an apparent change in condition, physical form and/ or visual appearance of the code following a sterilisation procedure.

In one example, a combination of one or more sterilisation inks or fluids and one or more non-sterilisation inks or fluids could be used to form the code, test soil means and/or test sample. Thus, in this example, the non- sterilisation inks may remain the same or substantially the same, not undergo a change or not be removed during or following a sterilisation and/or wash procedure.

Test soil means could include any or any combination of one or more proteins, carbohydrates, lipids and/or the like. The test soil means can be any means which represents a substance that a sterilisation or wash procedure is trying to remove.

Preferably the test ink, test fluid or test means that is used to form the test sample is operable over a temperature range of -200°C to +300°C under specific conditions and/ or specific temperatures. The change in condition of the test sample or code that takes place during a sterilisation/ wash procedure can be any or any combination of a physical change, a visual change, an optical change, a colour change, a biological change, a chemical change, an enzymatic change, a change in the physical layout of the code and/ or the like.

The data contained or encoded in the code could be any or any combination of suitable data, such as for example, information relating to a sterilisation/ wash test procedure, information relating to one or more items or equipment on which the code is to be associated with, identification data, authorisation data, details relating to an organisation associated with the equipment in some way and/or the one or more users undertaking the sterilisation/wash test procedure, the date and/or time on which a sterilisation/ wash test procedure took place, whether the procedure was recorded as a "pass" or "fail", details of the one or more patients on which the equipment has been used on or is to be used on, details of the medical practitioner using the equipment, the location of the equipment and/or sterilisation/wash test procedure, details on whether further test apparatus needs to be ordered and/ or the like.

A non-exhaustive list of the sterilisation/wash test procedures which the system apparatus and/or code of the present invention could be used with includes any or any combination of sterilisation procedures, such as for example, steam sterilisation, dry heat sterilisation, low temperature steam formaldehyde (LTSF), Ethyleneoxide (EO), Gamma Irradiation, hydrogen peroxide vapour, hydrogen peroxide glass plasma, High Level disinfectant process, liquid sterilisation process, any or any combination of process challenge formats, such as tortuous path devices, soil sample wash test devices and/or the like. Different test fluids, test inks, test means and/or the like would typically be required depending on the type of procedure being undertaken. The change and/ or removal of the test sample may also differ depending on the type of procedure being undertaken. According to a second aspect of the present invention there is provided a code formed from or including test indication/verification means, test ink, test fluid, sterilisation ink, sterilisation fluid, test soil means, test soil fluid, cleaning fluid or ink, wash fluid or ink, disinfectant fluid or ink and/or the like, said code capable of moving between or having two or more different conditions in use, at least some of the data contained within or encoded by the code in the two or more different codes being different

According to a third aspect of the present invention there is provided a test sample in the form of or including a code, said code capable of moving between or encoding two or more different conditions in use.

According to a fourth aspect of the present invention there is provided a method of using, making and/ or printing sterilisation/ wash indicator system apparatus that includes or consists of a code, said code capable of moving between or having two or more different conditions in use, at least some of the data contained within or encoded by the code in the two or more different codes being different

According to a fifth aspect of the present invention there is provided a method of using, making and/or printing a code formed from test indication/verification means, test ink, test fluid, sterilisation ink, sterilisation fluid, test soil means, test soil fluid, cleaning fluid or ink, wash fluid or ink, disinfectant fluid or ink and/ or the like, said code capable of moving between or having two or more different conditions in use, at least some of the data contained within or encoded by the code in the two or more different codes being different

According to a sixth aspect of the present invention there is provided a method of using, making and/ or printing a test sample in the form of or including a code, said code capable of moving between or having two or more different conditions in use, at least some of the data contained within or encoded by the code in the two or more different codes being different The code could be made and/ or printed at a first location and used at said first location. Alternatively, the code could be made and/ or printed at a first location and used at at least a second location, and preferably the at least second location is substantially remote from said first location.

According to a seventh aspect of the present invention there is provided code reading apparatus for reading a code formed from test indication/verification means, test ink, test fluid, sterilisation ink, a sterilisation fluid, test soil means, test soil fluid and/ or the like.

In one embodiment the code reading apparatus includes any or any combination of image recording device, camera, colour or optical density measurement device, iPhone, mobile phone, palm computer, microprocessing device with image capturing capabilities and/ or the like.

According to an eighth aspect of the present invention there is provided a method of using and/or making reading apparatus for reading a code formed from test indication/ erification means, test ink, test fluid, sterilisation ink, a sterilisation fluid, test soil means, test soil fluid and/ or the like.

In one embodiment the data captured from the code can be stored in the reading apparatus and/or communicated to a further device and/or a remote device.

The data captured is typically stored in a database or data filed. The database can be located or stored on a computer system, mobile phone, palm computer, micro-processing means, storage device, remote storage device, remote server and/ or the like.

Communication between the reading apparatus and one or more computer system can via wired or wireless means, such as via WIFI, the internet, radio frequency signals and/or the like. Embodiments of the present invention will now be described with reference to the accompanying figures, wherein:

Figures la and lb show a QR type of code used on a test soil strip in a first condition prior to a sterilisation procedure, and in a second condition after a sterilisation procedure where a physical change in the two dimensional layout of the code has taken place according to an embodiment of the present invention respectively; and

Figures 2a and 2b show a wash test strip showing a simplified code in a first condition prior to a wash procedure, and in a second condition after a wash procedure has successfully been undertaken according to an embodiment of the present invention respectively.

Referring to figures la- lb there is illustrated sterilisation/ wash test indicator system apparatus that incorporates or consists of a test sample in the form of a code similar to a QR code.

A QR code as described herein is a type of bar code that is a machine readable optical label and which typically contains information relating to the item to which the label is attached to in use. However, a QR type of code of the present invention is different to conventional QR codes in that although it looks similar visually, it can be machine readable when the code is in different forms or conditions. A QR code as used herein incorporates four standardized encoding modes (numeric, alphanumeric, byte/binary, and kanji) to efficiently store data thereon. The code typically consists of black square dots arranged in a square grid on a white background, which can be read by an imaging device, such as a camera, and processed using Reed-Solomon error correction until the image can be interpreted. The data is then extracted from the patterns of dots present in both horizontal and vertical components of the image. Although QR codes have conventionally been used for the purposes of product tracking, item identification, time tracking, document management and general marketing, to the applicant's best knowledge it has not previously been used in the field of sterilisation/ wash test procedures to stteamline and improve the accuracy of the data recording and data storage associated with such procedures. Furthermore, QR codes are typically formed from conventional printing inks, and the use of sterilisation inks, sterilisation fluids, disinfectant inks, disinfectant fluids, cleaning inks, cleaning fluids, test soil sample means and/ or the like to form a QR code is, to the best of the applicant's knowledge, also not known. Furthermore, conventional QR codes can typically only be machine read when in a single complete form and it is not known to provide a QR type of code that can change in condition to result in a change in the data it encodes as in the present invention.

Referring to figures la-lb, there is illustrated a sterilisation test strip 2 formed from a substrate 3 that has a test sample printed thereon in the form of a QR type of code 4.

The QR code 4 is printed using a combination of different sterilisation inks according to one embodiment of the present invention. A first sterilisation ink used in this example is of a type that changes colour from black to red when the temperature of the ink reaches 100°C or more. A second sterilisation ink used in this example is of a type that is black at room temperature and is removed, dissolved or becomes colourless when the temperature of the ink reaches 100°C or more. Figure 2a illustrates the test strip prior to a sterilisation procedure, wherein both inks of the QR code are in a first visible condition and the data encoded by the code is in a first machine readable and visible form providing a first data message. Figure 2b illustrates the test strip after the sterilisation procedure, wherein the QR code is in a second condition and the data encoded by the code is in a second machine readable and visible form providing a second data message. At least part of the data encoded by the codes in the first and second conditions is different and thus the first and second messages contained within the complete codes in the first and second conditions are also different The first ink remains but the second ink has been removed or is now substantially invisible to QR reading apparatus, thereby changing the physical form, condition or appearance of the QR code. This change in physical form of the QR code in one example can be read and/ or recorded as a pass by the reading apparatus, together with reading and/ or recordal of all other information contained in the remaining QR code.

Referring to figures 2a and 2b, a test strip 2 is provided with a test soil sample in the form of a simplified code for the purpose of ease of illustration. In figure 2a, the visible code comprises two circles 6 and two triangles 8 printed in a first sterilisation ink which is black in colour in a first condition prior to a sterilisation process. A second sterilisation ink is also used to print two adjacent triangles 10, 12 either side of triangle 8 which, if visible, would form a square shape when combined with triangle 8. Adjacent triangle codes 10, 12 are shown in dotted lines as the second sterilisation ink is yellow in colour and is therefore not machine readable in the first condition shown in figure 2a and not typically visible to the naked eye of a user. Thus, in the first condition shown in figure 2a, an electronic code reader would read the code as being two circles 6 and two triangles 8 and this encodes a first data message. Following a successful sterilisation process, the second sterilisation ink moves from a yellow colour to a red colour and the first sterilisation ink moves from a black colour to a red colour. This results in the code now consisting of two squares 14 and two circles 6 and is therefore a change in condition that is different to the code condition shown in figure 2a prior to sterilisation. An electronic code reader would read the code as being two squares and two circles and this encodes a second data message that is different to the first data message. Thus, there are two complete machine readable codes present in both the first and second conditions and each code condition encodes data that is different to each other.

Claims

1. Sterilisation/wash test indicator system for testing the effectiveness of a sterilisation and/or wash procedure, said indicator system consisting of or including a test sample which is capable of undergoing a change during a sterilisation and/ or wash procedure to indicate whether the sterilisation/ wash procedure has been effective, the test sample includes, is associated with or consists of a code, characterised in that the code has two or more different conditions; at least a first condition existing prior to the sterilisation and/or wash procedure, and at least a second condition existing after the sterilisation and/or wash procedure, data contained within and/or encoded by the code in the at least first and second conditions being different.

2. A system according to claim 1 wherein the code is visible, readable and/or decipherable to an eye of a user and/or to a machine or electronic code readable apparatus in the two or more different conditions.

3. A system according to claim 1 wherein a change in condition of the code between the two or more different conditions only takes place when a sterilisation and/ or wash procedure has been effective, when one or more pre-determined threshold conditions or values have been reached, or following a pre-determined time period during or after a sterilisation and/ or wash procedure has taken place.

4. A system according to claim 1 wherein measurement or detection of a change, significant change or difference in the test sample condition during or following a sterilisation and/or wash test procedure can represent a test "pass" and/ or an effective procedure, or a test "fail" and/ or ineffective procedure.

5. A system according to claim 3 wherein the one or more predetermined threshold conditions or values include any or any combination of a required temperature being reached, a required pH being reached, required environmental conditions being reached, or a soil sample or obscuring material has been removed or washed off.

6. A system according to claim 1 wherein the test sample includes or consists of any or any combination of one or more 2-dimensional codes, colour codes, data encoded codes, Quick Response (QR) type code, bar type code, binary code, digital code or mathematical code.

7. A system according to claim 1 wherein the code and/or the test sample is printed and/ or formed using one or more sterilisation inks or fluids; test soil means, ink or fluid; disinfection means, ink or fluid; and/ or cleaning means, ink or fluid.

8. A system according to claim 1 wherein in the first condition, at least part of the code is hidden or substantially hidden from view, is undecipherable and/or unreadable prior to the sterilisation and/or wash procedure taking place but the first condition code encodes a first readable data content or message, and in the second condition, the entire or substantially the entire code is visible, decipherable and/or readable during or after the sterilisation and/or wash procedure has taken place and the second condition code encodes a second readable data content or message, the second readable data content or message being different to the first readable data content or message.

9. A system according to claim 1 wherein the first condition indicates a starting position of a procedure, an effective test procedure and/or a failed test procedure, and the at least second condition indicates a partial or complete finishing position of a procedure, an effective test procedure and/ or a passed test procedure.

10. A system according to claim 1 wherein a third and/or further conditions exist for the code.

11. A system according to claim 1 wherein the change in the code from the first condition to the second condition is as a result of a colour change or a whole or part of the code, a change in a physical form of a whole or part of the code, a change in a chemical form of a whole or part of the code, an optical change, a biological change, an enzymatic change and/or a visual change.

12. A system according to claim 1 wherein the test sample includes a first upper layer comprising or consisting of a test soil sample and at least a second lower layer comprising or consisting of the code.

13. A system according to claim 1 wherein the apparatus includes a substrate or support means on or in which the test sample or code is provided or associated directly or indirectly with.

14. A system according to claim 13 wherein the substrate or support means includes any or any combination of a test strip, a tortuous path device, or a process challenge device.

15. A system according to claim 12 wherein the test soil sample includes any or any combination of one or more proteins, carbohydrates and/ or lipids.

16. A system according to claim 1 an ink, fluid or test means that is used to form the test sample is operable over a temperature range of - 200°C to +300°C.

17. A system according to claim 1 wherein the data contained in or encoded by the code can be any or any combination of information relating to a sterilisation/wash test procedure, information relating to one or more items or equipment on which the code is to be associated with, identification data, authorisation data, details relating to an organisation associated with the equipment in some way and/ or the users undertaking the sterilisation/wash test procedure, the date and/or time of the sterilisation/wash test procedure, whether the procedure was recorded as a "pass" or "fail", details of the one or more patients on which the equipment has been used on or is to be used on, details of the medical practitioner using the equipment, the location of the equipment and/or sterilisation/ wash test procedure, or details on whether further test apparatus needs to be ordered.

18. A system according to claim 1 wherein the sterilisation and/or wash test procedure is any of steam sterilisation, dry heat sterilisation, low temperature steam formaldehyde (LTSF), Ethyleneoxide (EO), Gamma Irradiation, hydrogen peroxide vapour, hydrogen peroxide glass plasma, High Level disinfectant process, liquid sterilisation process, any or any combination of process challenge formats.

19. A method of using a sterilisation/wash test indicator system for testing the effectiveness of a sterilisation and/ or wash procedure, said method including the steps of:

providing a test sample which is capable of undergoing a change during a sterilisation and/ or wash procedure to indicate whether the sterilisation/ wash procedure has been effective, the test sample includes, is associated with or consists of a code,

putting the test sample through a sterilisation/wash procedure, characterised in that the code has two or more different conditions; at least a first condition existing prior to the sterilisation and/or wash procedure, and at least a second condition existing after the sterilisation and/or wash procedure, data contained within and/or encoded by the code in the at least first and second conditions being different.