WO2008034913A2

WO2008034913A2 - Medical devices with access control

Info

Publication number: WO2008034913A2
Application number: PCT/EP2007/060128
Authority: WO
Inventors: Johan KÄLLSTRAND
Original assignee: Sensodetect Ab
Priority date: 2006-09-22
Filing date: 2007-09-24
Publication date: 2008-03-27
Also published as: WO2008034913A3

Abstract

A medical system is disclosed comprising a data carrier having at least one authorization data element stored thereon and at least one medical device comprising a locking assembly for selectively activating said medical system, wherein said locking assembly comprises a reading unit for communicating with said data carrier and reading said at least one authorization data element stored thereon, and wherein said data carrier is 'devised for providing said at least one authorization data element to said reading unit, and at least a first memory element, said memory having stored thereon at least one access granting data element, a matching unit- arranged for comparing an authorization data element read from said data carrier with an access granting data element from said first memory element, and arranged to grant activating said medical system upon a positive match thereof.

Description

A medical system having improved patient safety

Field of the Invention

This invention pertains in general to the field of medical systems, and more particularly to medical systems comprising at least one medical device that is in need of being protected from misuse, such as disposables, sterile medical systems, or medical systems needing continuous update .

Background of the Invention

Single-use medical devices (SUDs) , for example intravenous catheters, tracheotomy tubes or single-use laparoscopic dissection devices are used in vast amounts within the medical community. SUDs are for instance provided sterile in a suitable packaging which is opened just prior to use, thus ensuring that sterile devices are used for medical procedures.

However, reusing such devices that are intended for single use is widely used to cut costs within the medical community. Most often, such reuse is not intended from the manufacturer of the SUDs, e.g. due to product liability reasons, and such reuse could lead to adverse health effects for patients, e.g. due to cross-contamination . This issue is supported in the literature by several studies that trace high bacterial counts in reused SUDs, see for instance Heeg P, Roth K, Reichl R, Cogdill CP, Bond WW: "Decontaminated single-use devices: an oxymoron that may be placing patients at risk for cross-contamination . ", Infection control and hospital epidemiology : the official journal of the Society of Hospital Epidemiologists of America, 2001 Sep, 22 ( 9) : 542-9; Roth K, Heeg P, Reichl R.: "Specific hygiene issues relating to reprocessing and reuse of single-use devices for laparoscopic surgery.", Surg Endosc. 2002 JuI, 16 (7) : 1091-7; or Da Silva MV, Martinez MB, Andreoli Pinto Tde J. : "Microbiological evaluation of reused catheter guides in a Brazilian hospital.", PDA J Pharm Sci Technol . 2006 Nov-Dec, 60 ( 6) : 356-65. Moreover, durability of materials of SUDs is limited, which furthermore could put the patient's health at stake when SUDs are re-used, see e.g. da Silva MV, Ribeiro Ade F, Pinto Tde J.: "Safety evaluation of single-use medical devices after submission to simulated reutilization", Int. Journal of Association of Official Analytical Chemists International, 2005 May-Jun; 88 (3) : 823-9.

Hence, there is a need for re-use control in medical systems used for medical procedures. The ability to control SUDs might prevent time of ward and suffering and even reduce risk of death due to severe infections. In the long term, a more sophisticated and controlled use of SUDs might save not only lives, but also money because hospitalization might be reduced as a result of less infections and complications.

In addition, as medical systems gets more technically advanced and/or comprise a plurality of interlaced parts, a huge demand is set on the user's skill and experience. In this respect equipment could be used in a manner not intended, willingly or un-willmgly . To prevent misuse and/or mal use a need for integrated authorization of the system may be considered necessary.

Thus, there is a need for a new or at least improved system, device, or method of providing selected access to a medical system.

Furthermore, continuous scientific updating and increased usability for some medical systems, e.g. systems for objective diagnostics decision support within psychiatry, would be made easier if a disposable comprising completing and updated information was put forth.

Hence, an improved medical system would be advantageous, and in particular a medical system allowing for increased flexibility, cost-effectiveness, patient safety and/or medical diagnosis or medical treatment standard of a patient would be advantageous. Summary of the Invention

Accordingly, embodiments of the present invention preferably seeks to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a medical system, a method, a signal, a computer- program product, a medical workstation, and a graphical user interface, according to the appended patent claims. According to a first aspect of the invention, a medical system is provided, which comprises at least one medical device comprising a data carrier having at least one authorization data element stored thereon, and a locking assembly for selectively activating the medical system, wherein the locking assembly comprises a reading unit for communicating with the data carrier and reading the at least one authorization data element stored thereon, and wherein the data carrier is devised for providing the at least one authorization data element to the reading unit, and at least a first memory element, the memory having stored thereon at least one access granting data element, a matching unit arranged for comparing an authorization data element read from the data carrier with an access granting data element from the first memory element, and arranged to grant activating the medical system upon a positive match thereof.

According to a second one aspect of the invention, a method is provided for securing usage of a medical system according to the first aspect of the invention. The method comprises comparing an authorization data element read from a data carrier with an access granting data element from a first memory element, and activating the medical system upon a positive match thereof.

According to a further aspect of the invention, a computer program for processing by a computer comprised in a medical system of the first aspect of the invention is provided. The computer program comprises a code segment for comparing an authorization data element read from a data carrier with an access granting data element from a first memory element, and activating the medical system upon a positive match thereof.

Further embodiments of the invention are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention are as for the first aspect mutatis mutandis.

Some embodiments of the invention provide for prohibiting usage of medical equipment for non-authorized personnel.

Some embodiments of the invention provide for ensuring that disposables within surgical care are only used one time and thereby minimizing risks of re-usage and ensuring a sterile environment. Some embodiments of the invention provide for use of diagnostic assessment tools for which it is applicable to pay on a per diagnosis basis, which may reduce the investment cost for the customer and enabling continuous revenues and product development possibilities for the manufacturer.

Some embodiments of the invention provide solutions for a time limited usage of software which the user only needs to use for a restricted period of time and thus wants to pay only for the time of use. Some embodiments of the invention provide for the possibility for developing countries health care facilities to get a more proper sterile clinical environment by activating certain medical equipment with one-time valid codes for usage of sterile parts. Some embodiments provide for improved patient safety.

Some embodiments of the invention provide for reduced overall costs for medical treatments.

Some embodiments of the invention provide for improved patient treatment as a state-of-the-art treatment is ensured.

Some embodiments of the invention provide for a medical system whose functions are non-accessible until an authorization is provided to the system, whereby misuse of the medical systems and medical equipment depending of the overall configuration of said system is prevented.

It should be emphasized that the term "comprises/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

Brief Description of the Drawings

These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which

Fig. 1 is a schematic illustration of a control device, which includes an interface 102, a micro-processor 104 and data storage memories 106; Fig. 2 is schematic flowchart showing consecutive steps of a method, which includes entering authorization code 204, checking the code's validity 206, activating a medical equipment 208, performing a medical procedure session 210, and deletion of the used embedded pre- programmed activation code 212;

Fig. 3 is a schematic illustration of an embodiment comprising a reading device;

Fig. 4 is a schematic illustration of a medical system that comprises a fan assembly; Fig. 5 is a schematic illustration of an embodiment comprising a fluid reservoir; and

Fig. 6 is a schematic illustration of an embodiment comprising a bar code reader.

Description of embodiments

Specific embodiments of the invention now will be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

Several embodiments of the present invention are disclosed below. These embodiments provide patient safety by use of an information data containing unit, like a barcode, e.g. related to a disposable or single-use medical device of a medical system for use in a medical procedure, and a reading unit for reading and using this information data, wherein the reading unit is hosted on a mother system or host apparatus in communication with or within the medical system. The reading unit, or a control unit in communication thereto, is arranged to selectively control the use of the medical device in the medical system for the medical procedure, based on the information data related to the disposable or single-use medical device. In addition, a certification status of staff using the medical system or the medical device may be verified by means of suitable identification units or devices, such as ID cards, smart cards, biometric data verification units, etc.

In addition, restrictions implied by the control of the medical device in the medical system may be overridden. The medical system may comprise an override unit arranged to grant activating of the medical system upon a negative match of authorization data element read from a data carrier with an access granting data element stored in the medical system or device. For instance an override may be allowed a predefined number of times. However, when this number is exceeded, it may in certain embodiments not be possible to use the apparatus any more until suitable measures are taken, e.g. new, sterile, disposable or single-use medical device of a medical system for use in a medical procedure are provided, and/or a service is ordered from the manufacturer. In this manner, the medical system may be used again for the intended use in the desired medical procedure.

This principle will be elucidated below with reference to some embodiments.

Some embodiments of the present invention comprise a system for secure storage of the mentioned codes in an apparatus, an interface for entering such codes, a Match/no-Match circuit enabling the user to use the system for a session or an amount of time regulated in the specific key code, and a real - time clock regulating the time the host apparatus might be used. A device - below referred to as the interface - for reading a unique code which connects the user of the intellectual property method or the apparatus, where the code can be text , numbers, barcode, RFs or another code. Some embodiments of the present invention comprise an intermediate control system device which has an interface by which an authorization code is entered, a validity control of the entered code by means of a Match/no-Match circuit and a communication interface between the device and the host product, e.g. medical equipment.

Upon usage, the host product may require entering an authorization code through the interface. The interface may for instance compromise of a bar-code reader, a smart card reader, a RF-tag reader, a keyboard, a cellular device or any other type of technology capable of transferring an authorization code to a computer readable configuration. By means of a Match/no-Match procedure between the entered authorization code and pre-programmed embedded activation codes, a validation control may be performed in some embodiments. The pre-programmed embedded activation codes are stored in at least one set of data storage within the device. The data storage is in an embodiment designed as an erasable hardware memory unit. For each session performed by the host product a matched, corresponding activation code is erased from the data storage memory. Hence, un-authorized use of the host product is prohibited as a further use of an earlier used activation code is unsuccessful .

Authorization codes may be provided to the users verbally via telephone, fax, or in paper form or via computer networks in the form of barcodes or any other suitable codes. Authorization codes may be provided as single codes, series of codes, or a plurality of arbitrary codes, each of these codes corresponding to a preprogrammed embedded activation code for allowing usage of a medical system for a medical procedure by means of matched authorization.

Two sets of data storage memories may be provided in some embodiments. The second data storage memory holds information data of settings for the host product in order to be correctly configured in accordance to an activation code. Hence, there is a relation between these two data storages as one setting in the later storage corresponds to a plurality of activation codes in the first storage memory. For this second data storage no information is erased upon finishing of a performed session. By entering or providing a unique activation code, which may be provided as barcodes, RF tags, numbers or texts or other codes, that corresponds to a pre-stored embedded code within the host apparatus to be activated for usage through an interface, a one-time session and/or time limited usage of the host apparatus and/or use of a restricted service may be enabled.

When a code has been used for a session, if it is a one-time session code, or for its corresponding amount of time, if it is a time limited usage code, it is deleted from the pre-stored database, and thus no longer available for subsequent activations of the host system, i.e. a medical system for performing a medical procedure. For instance, a limited number of activation codes are provided within the medical system, e.g. on an integrated chip or memory, and erased upon usage. Additional activation codes may be supplied or provided to the medical system for activation at periodic services of the medical system, or check-ups which e.g. are conducted by vendor authorized technicians .

Physicians may not be restricted in their effort in rescuing lives. Therefore, medical systems of some embodiments of the present invention may be provided with an emergency mode, which may be available upon activation with one or several manual override codes chosen from a plurality of codes. A restricted number of emergency override codes may be available. Emergency override may also be coupled to a requirement of documenting the use of the medical system in the emergency mode. When manual override codes are consumed, new emergency override codes may be activated, e.g. by a service technician of a manufacturer of the medical system.

Some embodiments are described below for ascertaining patient safety in a multi-unit medical system.

In order to perform a complex medical task, for example advanced surgery, it is crucial that disposables and components necessary for the operation fulfill the highest standards possible, including sterility, not being too old and being used by certified staff. This implies that some disposables necessary for an operation should be previously never-used, for instance in order to eliminate risks of infection, and/or to ensure that the mechanical properties of the disposable are not reduced in a way that may jeopardize a patient's health.

An embodiment of the present invention, as illustrated in Figure 3, may comprise a reading device 300 that is used to check all components necessary for the operation. This reading device must be passed in order to start an operation, i.e. the reading device verifies and approves the medical devices and optionally certifies the users thereof.

In an embodiment, the medical procedure is an operation, the medical system is part of an operation theatre, comprising anesthesia and surgrcal machines etc.

In an embodiment the reading device comprises a barcode reader 301 to read information data from at least a part or all components of the medical system 3 before the medical procedure performed by means of the medical system. For instance, for a surgical operation this may comprise reading the barcodes of one or more, such as a plurality, e.g. ten, disposables that can only be used one time. Barcodes are verified against barcodes stored in a memory of the reading device. Barcodes may be read manually or automatically, provided by suitable arrangement of the reading device 300 devised for that purpose.

When the barcodes read from the disposables matches barcodes in the memory, the disposables are verified and the medical system 3 may be authorized for the medical procedure, such as the surgical procedure. Matched barcodes are erased from the memory 302 thereafter, and in this manner these deleted barcodes cannot be used again for authorizing a subsequent medical procedure, such as the surgical procedure. For instance, for an open chest surgical procedure, a number of sterile disposables, such as tubes, knives etc. may first be registered before activating a heart lung machine. The registering may be done automatically by means of wireless communication of the reading device with RF tags in the disposables, e.g. when these are installed in a heart lung machine used for the open chest surgical procedure .

This verification operation may in certain embodiments comprise two steps, namely the first step may be a match/no match operation of data read from one or more disposables with the data stored in the reading device's memory, as described above. A second step may be performed on a second parameter, e.g. a check if a given disposable's expiry date is passed. This date check may be performed by means of a timer unit 303.

For some extra-demanding surgical operations this may comprise checking the identity and/or certification of a user, e.g. by means of a biometric characteristic, as for instance one or more fingerprints of the physician with a specific fingerprint reader to test if he or she is certified for performing the medical procedure intended to be performed by means of the medical system. This check may be performed by means of a verification unit 304 of the medical system 3.

The final result is a convenient system to ascertain patient security in a multi- approach: checking if the disposables are right for the equipment, checking if they are within their respective expiry dates and finally, if needed, to check if one or several persons in the staff are certified for performing the medical procedure.

Some embodiments are described below for controlling infection-preventing elements in the medical community.

In order to make it possible for the medical community to keep a clean internal milieu, and in order to counteract potentially life-threatening states by reducing risks of infections and spread of a variety of diseases, some embodiments of the present the invention provide an efficient tool, as will be clear from the following description of some embodiments.

In an embodiment of the invention, as illustrated in Figure 4, a medical system 4 comprises a fan assembly 400. The fan assembly 400 comprises a disposable filter unit 404 that is arranged to filter air to or from a room, e.g. an operation theatre, an intensive care unit, or an infectious disease control unit. The disposable filter unit 404 has a certain maximum time of operation until the end of which filtering is ensured satisfactory. At the end of the maximum time of operation, the disposable filter 404 has to be replaced with a new one.

In this embodiment, the medical system 4 is the fan assembly 400 comprising a fan unit 401 and the medical device is the disposable filter unit of the fan assembly.

The fan assembly of the medical system may comprise a timer unit, e.g. integrated on the disposable filter unit. The fan assembly may receive or read information data related to the operation time of the filter unit. The filter unit may for instance provide data related to the maximum operation time, as well as the current operation time during which the filter unit has been used hitherto, and/or an expiry date of the filter. The fan assembly may send a status signal through an interface 405 to medical staff or technical staff. The status signal may be based on a comparison of the maximum operation time and the current operation time of a specific disposable filter unit, or a comparison of the current date and the expiration date of the specific disposable filter unit. Such a signal may be used for identifying and/or indicating different ranges of patient safety. For instance a) a safe range, b) a warning range with reduced patient safety, c) a critical range, e.g. with risk for patient injury, harm, damage, contamination etc. For instance these ranges could be indicated in a color coded way by warning lights or on a screen having a graphical user interface.

In an example, the safe range may be indicated when the current operation time is considerably lower than the maximum operation time of the filter unit, e.g. indicated by a green diode indicator. The warning range may be indicated, when the current operation time comes close to the maximum operation time, which may be indicated to order a new replacement filter, e.g. by a yellow diode indicator. The critical range may be indicated when the current operation time has exceeded the maximum operation time, or the filter passed its expiry date, e.g. by a red diode indicator . Additionally, such a system may combine a sensor unit 402 restricting the fan only to function with a certain kind of filter part installed, e.g. from specific manufacturers in order to optimize performance. In addition to a sensor unit 402 or as an alternative, an air flow test unit 403 to test air flow through the filter 404 may be included in the medical system 4, which is also a feature that ascertains optimal performance of the medical system 4. This would taken together lead to a highest possible level of safety for the patient, and also for the staff, by reducing risks of infections and minimizing spread of diseases.

Some embodiments are described below for controlling a status of fluids and reducing risks of using old, expired or non usable or non effective products.

One field of application for some embodiments of the present invention is to ensure for the medical community that a fluid packaged in a disposable of some kind, for example a reservoir containing contrast fluid, drip or any other fluid that might be used in the medical community, could not be used after its expiry date.

In this embodiment, a medical system 5 is equipped with a timing device 501 that may be battery operated, a user-interface 502, a tap 503 and a digital-mechanical lock 504 for the mentioned tap, see Figure 5. The timing device 501 may be programmed by the manufacturer of the medical system 5 for a specific fluid, and through the user- interface 502 the user is informed about the status of the fluid. When the fluid is well before its expiry date, the interface 502 signals this to the user, for instance with a green diode. When the expiry date is closer, this may be signaled by a yellow diode, and when the expiry date is passed, the digital-mechanical tap-lock is activated. Thus it is impossible to harm a patient by using expired fluids in his or her treatment. Also here, like in the other embodiments, different ranges of operation may be provided. For instance if a contrast fluid has a shelf life of ten years before expiration, a warning may be issued after 10 years, but activation may still be permitted for another couple of months. When the expiration date has been exceeded considerably, e.g. by a year, use of the contrast fluid may be prohibited. Manual overrides in special circumstances may be provided, e.g. for emergency cases.

Some embodiments are described below for medical systems, for which continuous development, updating and user-manufacturer interaction is of major importance.

In some embodiments of the invention, medical systems on the market are improved, for which a continuous updating is of extraordinary importance for its operator/operators in order to use the mentioned medical system properly. For instance, a high level of expertise may be reguired in order to use the medical system to its full potential, possibly already at an early stage of the system's development. Providing an advantageous level of expertise to such medical systems may be achieved and better controlled by using certain embodiments of the present invention . In an embodiment, a medical device of the medical system, or a unit in communication with the medical device, may comprise a time-restriction unit, which ensures that the user takes continuous service, updating and external control, and/or a disposable-restriction unit, which restricts the number of disposables and thus enables the manufacturer to exert an influence on the use of the system. In addition to the time-restriction unit, and/or the disposable-restriction unit a user verification unit may further increase patient safety in some embodiments. The user verification unit ensures that only certified users may activate a medical device and use the medical system. One field of use of some embodiments may be apparatuses for diagnostic tests, for example within neurology and psychiatry, for which continuous growth of disease-specific patterns in the research laboratory of the manufacturer is at hand. In order to update the equipment, and thus to maximize its area of usage, and improving the probability of a correct diagnosis of a patient, an embodiment of the invention is arranged to make a constant interaction and dialogue between a user of the medical system and its manufacturer not only preferred but necessary.

In order to use the equipment in emergency cases it may be possible to override the mentioned restrictions in order to help the patient. This override however would only be possible to be activated a restricted number of times, as for instance approximately five times before an override is no longer authorized by the medical system or medical device .

It is known that within the medical community in general the need of precise and efficient physiological diagnostic tools is urgent, even more so within the field of clinical psychiatry and neurology.

In an electrophysiological diagnostic decision support system developed and constructed by SchizoDetect AB, measuring electrophysiological brain patterns from a patient elicited by certain sound stimuli and comparing the outcome (that is a group of brain patterns) with schizophrenic and non- schizophrenic pre-defined patterns, and thus serving as a diagnostic decision support for the clinical staff regarding brain stem disorders, such as schizophrenia, some embodiments of the present invention are well suited. This is for instance due to the fact that the medical community has in some countries reimbursement systems that are based on a pay per diagnosis. Such a system is disclosed in WO2006/062480 of the same applicant as the present application, which is incorporated herein by reference in its entirety.

Some embodiments, such as based on such a medical system as disclosed in WO2006/062480, may comprise a smart card containing specific operation data for the medical system.

The medical system may be an objective diagnostic decision support (ODDS) system for the medical community. This smart card may have stored thereon active parts for the ODDS system, such as algorithms therefor allowing a diagnosis of a patient, and it is not possible to use the ODDS system meaningfully for the clinician if not the smart card is used to update and complete operative parameters of the ODDS system, such as code segments, algorithms, measurement and/or trigger intervals, and/or diagnostic apparatus criteria, and so forth. Thus, this embodiment uses the smart card, or a comparable information storage medium, as an active part in the ODDS system, which optimizes the usability for the medical community and furthermore may reduce initial investment as the smart card could be paid for instead.

In such embodiments system execution data may be stored on and provided from a memory of the smart card. The system execution data may comprise data necessary to run a medical system at least partly. For instance, the system execution data that is stored in the memory on the smart card may comprise code sections of software run on the medical system. For instance a medical workstation may comprise initially only a loader code segment for loading the code sections into the system from the execution data from the smart card.

In this manner, also partial functionalities of a medical system may be released for use. Code segments for certain functions may be provided on the smart card. This embodiment may reduce an initial investment into a medical system that is gradually enhanced with further functionality by means of the system execution data loadable from the memory of the smart card.

In addition or alternatively, a medical device or equipment may be activateable for restricted amounts of time; it may be activated for short-time use by authorization codes, e.g. provided as barcodes or on a smartcard. This gives the possibility to use the equipment a defined time, for example one day, week, or a month. In this manner a manufacturer or distributor of a medical device or system may be economically better off as the equipment may be offered to a larger range of clients between the equipment is moved for temporary use enabled by means of the activation data provided. Alternatively, the equipment may be stationary and different users may use it, activated by means of embodiments of the present invention. This provides a feasible way for a user to gain access to expensive equipment in a cost-effective way, as the equipment has not to be bought, saving heavy investments and only pay for a time of active usage of the medical equipment.

Thus, some embodiments of the present invention provide for a flexible, effective and well-functioning patient safety increasing system for medical systems. To offer flexible per usage activation to the medical community may in addition be a cost reducing and effective way for the user to try and to evaluate new methods, and to minimize investment risk. Furthermore, certain producers of medical devices or medical systems, such as inventors and small science-based companies, might be able to offer their product or service at an early phase of the product or service being developed, and thus being able to get revenues and feedback, or just valuable feedback, on the equipment at an early phase, by using embodiments of the present invention, while still control over the medical device is maintained and patient safety ensured during such early development and/or evaluation phases of medical devices . When having a time limited activateable use of medical equipment, it may be ensured that the latest version, developments, or research results are implemented in the equipment. For instance during regular services of the equipment, both the codes for activation may be updated and the technical functionality of the equipment, e.g. by dynamically downloading a new software and/or upgrading a hardware of the equipment. In this manner a reliable stat- of-the-art medical procedure may be performed with the medical equipment at all times.

Payment control of the use of medical devices may be a secondary effect of some embodiments of the present invention .

A medical treatment session using an embodiment of the present invention will now be described in more detail, and in particular a treatment session at clinical psychiatry or neurology. However, it will be appreciated that the invention is not limited to this application but may be applied to many other systems, as for instance the above described.

Schematically the device 100 has an interface 102 for entering an authorization code into the device. The device comprises a microprocessor 104 and at least one data storage memory 106. Communication with the host product is provided for.

The interface 102 may compromise of a bar-code reader, a smart card reader, a RF-tag reader, a keyboard or any other type of technology capable of transferring an authorization code to a computer readable configuration. In an embodiment of the invention according to Fig.2 a flowchart 200 discloses the out lines of an embodiment of the invention. The procedure starts at 202, the next step 204 invokes an interaction with the user as an authorization code using an interface is entered to the devices short term memory.

After the device has received the code a Match/no- Match is performed 206 between pre-programmed embedded codes and the entered code. With a negative outcome the session is prohibited and the short term memory is erased and the procedure is returned to 202. With a positive outcome from the Match/no-Match the device is unlocked and either a session based setting or time based setting is activated upon the embedded code 208. After the elected setting is transferred to the equipment the session is performed 210. Upon finishing of the performed session the corresponding pre-programmed embedded activation code within the device is erased 212 to prevent further un^¬ authorized use. Shortly thereafter the procedure returns to the start 202 awaiting the next session or power down.

The session based settings in 208 may be a number of approved sessions. The amount could be one, two or more individual sessions. The time based settings are configured as time limited with no restriction on amount of usage. The time interval may be for example, one week, one month or one quarter of a year.

In one of the embodiment of the invention the interface for the authorization code is a barcode reader, such as illustrated in Figure 6. Corresponding patient data sheets 602 may comprise a unique barcode 603 that is pre^¬ printed by the manufacturer of the host product. The position of the barcode may be on the back 606 of the patient data sheet. In this manner, a user may still advantageously write on the front 605 of the patient data sheet 602 or read data therefrom, while providing the barcode 603 to a suitably arranged barcode reader 601 in the medical device 600 of the medical system, here in form o fan ODDS system 6.

Upon reading the barcode 603 and a positive match, an activation of the device 600 may be made. Hence e.g. time based settings of the apparatus, e.g. unlimited usage of the device 600 for a limited period of time, may be provided.

The patient data sheet 602 may be an active document allowing making notations for each session preformed. The customer might in a flexible way be provided with patient data sheets 602 with barcodes 602 that suits his or her needs. A bar code 603 may allow for specific medical procedures to be activated, which are related to a specific type of patient data sheet 602, for instance for diagnosis of specific brainstem diseases, such as schizophrenia.

In more detail, the ODDS system 6 is firstly prepared for usage. As already mentioned, the ODDS system is used to detect abnormal activity in the brainstem of a human subject in order to gain information regarding diseases affecting the brainstem, for example certain psychiatric diseases, to improve the diagnostic process, such as disclosed in WO2006/062480. To avoid misusage and/or unintended use of the ODDS system, control of each patient measurement is necessary. This is made possible by use of embodiments of the present invention.

The ODDSS measurement system is switched on. Embedded inside the system are certain numbers of pre-programmed bar codes, which are only known to the ODDS system manufacturer, and which allow activation of the ODDS system for a medical procedure. The pre-programmed bar codes are stored on a chip inside the ODDSS and may be erased if the system is opened by a non-certified service person, thus minimizing the risk of misuse of the equipment. In order to use the ODDS system for its purpose - recording brainstem activity elicited by certain sounds in order to establish a decision support for schizophrenia in a subject - the test leader must put a valid barcode in place above the integrated bar code reader (IBCR) . For instance, a patient analysis sheet 602 is placed above the IBCR by the test leader. Then the code of the barcode 603 on the back of the patient analysis sheet 602 may be approved, for instance by activation of a run test key 607. As shown in Figure 6, the host apparatus 600 has a paper holder, e.g. in A4 format, in which the patient data sheet (that is only valid for a single diagnosis session of one patient) is kept during usage of the system. The barcode 603 on the backside 606 of the paper is read by an integrated barcode reader 601 and matched to the embedded pre-stored code database within the host apparatus 600. If the barcode 603 matches with a code in the pre-stored database within the system 6, the system 6 is opened for usage .

Upon positive verification of the codes, the run test key 607 might be pushed again to induce an ODDS session. By this procedure the system 6 is unlocked and can be used for one diagnostic session, meaning the use of the apparatus on one human subject.

When the session is finalized, the barcode 603 just verified is erased from the memory of the apparatus 600 and cannot be used again before entering a new valid barcode. Thus the barcode that just was used is now a non-valid barcode. Each patient data sheet is provided with a unique bar code 603 in order to enable this functionality.

A key-feature of some embodiments of the present invention is that it does not rely on any telephone nor internet based technology, a feature which is important for many diagnostic procedures due to risks of vulnerability of malfunctioning and information leakage of such systems. A vast majority of payment solutions today rely on such vulnerable technologies. The minimal need of complex information technology structure is furthermore a factor that makes embodiments of the present invention well suited for developing countries.

Due to the medical system control that is provideable by means of some embodiments of the present invention, the producer of the equipment may minimize purchase costs of the equipment and puts the majority of margins on the customers running expenses. For instance, the medical facilities using the ODDS system might freely decide to what extent they want to use their equipment, and pay in precise relation to grade of usage. This gives the opportunity to small clinics and poor medical facilities to purchase the otherwise expensive equipment, and thus improve diagnostic quality for a minimum of investment.

Users are provided with a reliable way of using their equipment in a manner that is neither network nor internet depending (and thus very stable compared to such alternatives) , and furthermore leads to a highly flexible way of usage. A billing procedure may be made highly effective and secure because customers freely decide how many key activation codes to buy and can form an economic organization efficient usage-payment balance.

When a patient shall be investigated, e.g. with the SchizoDetect diagnostic system, a specific patient data sheet containing a unique barcode which - when read through the barcode reader and matched with pre-stored codes - opens the system for one session or time- limited usage must be entered. Codes are deleted after usage.

The manufacturer of a product or the inventor of a method could easily get revenues on a flexible per- diagnosis or per-time-unit basis by decreasing the investment cost and putting a bigger proportion of the costs on the per-use or per-time-unit of usage side.

Also, the manufacturer may have the certainty that its medical equipment is always up-to-date, e.g. when new software is downloaded each time new codes are loaded into the equipment.

By means of a one time code within the host product, the host product will be able to be used for example one diagnostic session in the case of medical diagnostic purposes or one well defined programming task in the case of software solutions, or for a restricted amount of time regulated by a real time clock, depending on the character of the code.

Embodiments of the invention may be combined with a suitable payment system, as e.g. disclosed in WO2007/067655, which is incorporated herein by reference in its entirety. In summary, embodiments of the invention radically improves patient safety and provides payment options for users of a broad variety of medical products and services, and furthermore drastically rationalizes billing procedures within a vast amount of areas. The advantages include economical benefits for both customer and producer through increased effectiveness, safer payment procedures by eliminating network, telemetric and internet dependent components and finally for the medical community benefits for the patients through a more secure usage of disposables .

The present invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above, performing the method by hardware or software, may be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.

Claims

1. A medical system comprising at least one medical device comprising a data carrier having at least one authorization data element stored thereon, and a locking assembly for selectively activating said medical system, wherein said locking assembly comprises a reading unit for communicating with said data carrier and reading said at least one authorization data element stored thereon, and wherein said data carrier is devised for providing said at least one authorization data element to said reading unit, and at least a first memory element, said memory having stored thereon at least one access granting data element, a matching unit arranged for comparing an authorization data element read from said data carrier with an access granting data element from said first memory element, and arranged to grant activating said medical system upon a positive match thereof.

2. The medical system according to claim 1, wherein said data carrier of said medical device is a barcode and said reading unit is a barcode reader.

3. The medical system according to claim 1, wherein said data carrier of said medical device is an RF-tag and said reading unit is an RF-tag reader.

4. The medical system according to claim 1, wherein said data carrier of said medical device is a smart card and said reading unit is a smart card reader.

5. The medical system according to any preceding claim, wherein said medical device is disposable or a single-use medical device.

6. The medical system according to claim 1, further comprising an identification unit for verifying a certification status of staff using said medical system or said medical device, such as ID cards, smart cards, biometric data verification units.

7. The medical system according to claim 1, further comprising an override unit arranged to grant activating of said medical system upon a negative match of said authorization data element read from said data carrier with said access granting data element, as an override.

8. The medical system according to claim 7, wherein said override unit is arranged to allow said override a predefined number of times.

9. The medical system according to claim 1, wherein said at least one access granting data element is at least one authorization code.

10. The medical system according to claim 9, wherein said matching unit is arranged to grant activating said medical system for a medical procedure session or an amount of time.

11. The medical system according to claim 9, wherein said medical device comprises a control system device which has an interface for entering an authorization code as said access granting data element.

12. The medical system according to claim 1, wherein said first memory element is arranged to delete said matched authorization data element upon said positive match .

13. The medical system according to claim 1, further comprising a second memory element holding information data of settings for configuring the medical system upon a positive match.

14. The medical system according to claim 1, wherein said medical device is an infection-preventing element, such as a surgical filter unit.

15. The medical system according to claim 1, wherein said at least one medical device comprises a plurality of medical devices, and wherein said medical system is a surgical system.

16. The medical system according to claim 1, wherein said medical device is a disposable device having packaged a fluid therein, which has an expiry date.

17. The medical system according to claim 1, wherein said medical system is updateable.

18. The medical system according to claim 17, wherein said medical system or said medical device or a unit in communication with said medical device comprises a time- restriction unit, and/or a disposable-restriction unit for restricting the number of disposables, and/or a user verification unit for ensuring that only certified users may activate said medical device and use said medical system.

19. The medical system according to claim 18, wherein said medical system is a diagnostic system.

20. The medical system according to claim 19, wherein said diagnostic system is configured for diagnostic tests within neurology and/or psychiatry.

21. The medical system according to claim 20, wherein said diagnostic system is an electrophysiological diagnostic decision support system devised for measuring electrophysiological brain patterns from a patient elicited by certain sound stimuli and comparing the outcome predefined patterns, and thus serving as a diagnostic decision support for clinical staff regarding brain stem disorders.

22. The medical system according to claim 21, wherein said medical system comprises a smart card containing specific operation data for the medical system.

23. The medical system according to claim 21, wherein said data carrier is a patient analysis sheet.

24. The medical system according to claim 23, wherein said patient analysis sheet comprises a barcode.

25. The medical system according to claim 24, wherein said barcode is arranged on the back of said patient analysis sheet for automatic reading by an integrated barcode reader.

26. A method securing usage of a medical system according to claim 1, comprising comparing an authorization data element read from a data carrier with an access granting data element from a first memory element, and activating said medical system upon a positive match thereof .

27. A computer program for processing by a computer comprised in a medical system of claim 1, the computer program comprising a code segment for comparing an authorization data element read from a data carrier with an access granting data element from a first memory element, and activating said medical system upon a positive match thereof.

28. The computer program of claim 27 enabling carrying out of a method according to claim 26.

29. A computer-readable medium having embodied thereon the computer program of claims 27 or 28.