DE9421086U1 - System for monitoring the material flow during the processing of sterile goods - Google Patents

Description

The invention relates to a system for monitoring the material flow during the processing of sterile goods according to the preamble of claim 1.

Sterile goods are used in hospitals. Sterile goods is the collective term for medical devices, which are subjected to a suitable sterilization process controlled for effectiveness in a package. A packaging unit of sterile goods is referred to below as a sterilization unit.

Inadequate process conditions during the sterilization process endanger the hygienic safety of the sterile goods and thus the life and health of the patients treated with them.

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The nursing staff in the hospital or the hospital operator are obliged to handle the patient's "life and health" responsibly. In the event of a claim for recourse by an injured patient against the hospital or the responsible staff, the so-called reversal of the burden of proof comes into effect, i.e. the defendant must, among other things, prove that he used sterile goods that are hygienically safe for the procedure. As a result, the hospital operator and the hospital staff must use tools and procedures that enable them to prove beyond doubt that the sterile goods were processed in a perfectly hygienic manner.

Information on data with which the sterile goods should be marked can be found in DIN 58953, Part 9:

Sterilization containers must be labeled in such a way that it is clearly visible that the contents have been subjected to a sterilization process. For this purpose, the sterilization containers must be provided with a treatment indicator. It must be clear whether the sterilization containers were opened before the sterilized goods were used. In addition, the sterilization containers must be

a) with the content

b) with the sterilization date (day, month, year)

c) be marked with the name and signature of the packer.

All information must be clear and visible at a glance. In addition, the

expiry date resulting from the storage period.

According to the current state of the art, marking is usually done as follows:

As a treatment indicator, a paper label printed with indicator ink is inserted into the package or attached to the outside.

To indicate whether the package has been opened, the sterilization containers are sealed or lead-sealed, whereby the seals or lead-sealings are destroyed when the container is opened.

The contents of the sterilization containers are indicated by engraved labels attached to the outside. For paper or textile packaging, an adhesive strip is often attached and labeled with a felt-tip pen.

For example, the sterilization date is written by hand on a paper tag that is attached to the outside of the sterilization unit. This is usually the same tag that has the indicator ink on it. The date can also be stamped on a label using a labeling tool such as those used in department stores for price labeling.

The packer's signature is often placed on the paper label, which also bears the sterilization date, or reusable metal tags with the number of the respective packer are placed in the package.

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As proof of properly performed sterilization, the physical
Process data of sterilization currently either
using digital recording devices
(measurement data printer) or using analogue recording devices.
The recorded data includes the name of the selected sterilization program _f the
Sterilization date, possibly a batch number and as process data the processing times, temperatures and pressures.

In the most modern systems to date, after sterilization, a printer on the sterilizer issues packaging labels that contain the data "Sterilization date," "Sterilizer identification number," and "Batch number." These labels are attached to the sterilization units. The data recorded on them can, under certain circumstances, be transferred to the treatment protocol later. An expiration date can also be noted on the label. However, the same expiration period is always used to calculate the expiration date. Specific data such as type of packaging and storage conditions cannot be taken into account because the data processing facility in question has no reference to the respective sterile goods. These labels cannot be viewed as individual identification of the sterilization units either, because the sterilization units in a batch have the same label.

When used, the sterilization units are taken to the place of use, which is usually the operating room. Immediately before use, the packaging label is checked again. A treatment protocol is created to document the treatment of the patient. The manual

The data written on the sterilization unit or contained in the label are transferred by hand to the treatment record. The treatment record is kept for the entire period for which proof of hygienic safety can be required. This is usually thirty years.

If, after treatment, a patient requests proof from the hospital or the responsible staff that the sterile goods used for their treatment are hygienically safe, the treatment protocol is used and the sterilization batch number of the sterilization unit used is read. The physical process data recorded on the batch document corresponding to this number should be used to prove that the treatment aids from the sterilization unit in question were properly sterilized and thus hygienically safe. The methods of documentation described above and others known to date rely on handwritten records in many places and are therefore labor-intensive and unsafe, as labeling errors or manipulation are possible. This makes any proof of the hygienic safety of the sterile goods questionable.

A major disadvantage of the methods used to date for labeling goods is that the data is distributed across several data storage devices and confusion can occur when assigning them. In addition, creating each data storage device involves additional work and additional costs. A number of possible errors are listed below:

Possible errors at the packaging station:

The packer forgets to insert the indicator (the error is only apparent when the product is used).

The packer forgets to label the contents.

The packer forgets to write the sterilization date on the paper label or uses an incorrect date.

The packer forgets to affix his signature. Possible errors when operating the sterilizer:

The sterilization program must be selected by the sterilizer operator. The operator must decide which program is the right one based on the load. The operators are often overwhelmed, especially when the sterilizer is loaded with mixed loads. The operating room staff also often lack the ability to judge, even if the staff were to check the sterilization program used again based on a note that may be present.

If labels are issued by the sterilizer after sterilization, they must be attached to the treated sterilization units. This again presents the possibility of errors. Before the labels are issued, the number of labels to be printed must be entered on the sterilizer. If the number is entered incorrectly, either individual sterilization units cannot be labeled or excess labels can be misused. It is also possible to use the labels

to assign incorrectly, i.e. to stick labels from batch Y on batch X.

Possible errors during storage:

Since the documentation methods used to date do not usually include labelling of the storage location, there is a risk that the goods will be stored under conditions which do not guarantee the required shelf life.

Possible errors in the required recall action:

If the person in charge of the sterilization department subsequently discovers a malfunction in the sterilizer and therefore has to recall certain unusable sterilization units, he or she will have no reliable information about the type of goods, the number and whereabouts of the sterilization units in question, unless additional handwritten records are available, which are laborious to create and may be inaccurate. Since the malfunction of the sterilization process cannot be recognized either externally or by the indicator of the goods not recalled, these units may be used, thus endangering patients.

Possible errors during data transmission:

The transfer of all or individual data from the sterilization unit to the treatment protocol is done by hand, whereby transfer

errors are possible. Even in the event that
that certain data is stored by a sterilizer
printed label that can be pasted into the treatment protocol, the correct assignment may still be
doubtful, since the same label is also used by
another sterilization unit with a completely
other content, but that could be the case with the
was sterilized from the same batch.

The invention is based on the object of specifying a system of the type mentioned at the beginning, which enables complete documentation of the processing of sterile goods from packaging to consumption, so that proof of the hygienic safety of the sterile goods used can be provided.

This object is achieved according to the invention by the features specified in the characterizing part of claim 1.

With the system according to the invention, it is now possible to clearly assign a specific sterilization process, characterized by its physical data, to an individually identified sterilization unit. Furthermore, it is ensured that each sterilization unit is subjected to the sterilization process suitable for the respective sterilized goods.

Preferably, data is recorded on the data storage devices that can be connected to the sterilization units and the protocols in machine-readable form so that it does not have to be transferred by hand. This eliminates errors that can occur when data is transferred, including when data is manually entered into a data input device by an operator.

The individual identification of the sterilization units does not preclude several sterilization units from being combined into a batch before sterilization, for which a collective data carrier containing the data identifying the units is created in addition to the data carriers assigned to the individual units. For such a batch, only the data on the collective label needs to be entered or read in. This avoids the effort involved in entering or reading in each individual label.

For a batch, which does not necessarily have to consist of identical sterilization units, a batch record is created on which all sterilization units are listed in an identifiable manner, for example by assigning and recording a serial number for each sterilization unit.

Preferably, the data carriers that carry the data identifying the respective sterilization unit can be detachably connected to the sterilization units. For example, the data carriers can be designed as adhesive labels so that they can be easily attached to the sterilization units and then removed from them again in order to stick them on the treatment protocols, for example. This avoids the need for handwritten transfer with the possible errors that this can lead to.

If necessary, data carriers can also be used that contain two sections, each of which contains identical data sets. One of the sections remains with the consumer, for example it is stuck onto the treatment protocol, while the other section remains on the sterilization unit. This also makes it possible to monitor the return of reusable sterile goods, such as surgical instruments.

If the data carriers for the sterilization units and the protocols are created using electronic data processing devices, it is advantageous if the operator identifies himself at the respective device by entering a personal identification number, whereby the personal identification number is noted on the data carrier or the protocol. This also makes it possible to identify the persons responsible for packaging or sterilizing an individually identifiable sterilization unit.

Preferably, when a sterilized sterilization unit is delivered to a consumer, the data on the data carrier is recorded again and stored together with the data identifying the consumer and the circumstances of delivery. This also makes it possible to determine the route of an individual sterilization unit to the respective consumer. In addition, it is possible to use this data for warehousing and inventory monitoring. Finally, the expiration date of the respective sterilization unit can be monitored at this time and the sterilization unit can be prevented from being issued if this expiration date has already passed.

The system according to the invention therefore makes it possible to mark each sterilization unit individually and unmistakably, to document all the data required for patient-related proof of the safe processing, storage and intended use of sterile goods, to control the sterilization process depending on the load and to monitor the material flow of the sterile goods.

The packing station and the warehouse can have their own data processing facilities. However, the data input and output facilities of the

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Packing station and warehouse are connected to the data processing facility at the sterilization station, so that data can be exchanged immediately and the data does not have to be read in again each time you move from one station to another.

Preferably, the data input devices have means for entering personal identification data so that operators at the packing station and/or the sterilization station and/or the warehouse can identify themselves by entering a personal identifier. For example, such a device can have a card reader for entering an identification card.

Preferably, the data input devices each have a data reading device for machine-readable data, for example a barcode reading device or a magnetic stripe reader, so that transmission errors that can occur when entering data manually are avoided.

The data output device of the packing station is preferably equipped with a label printer for printing adhesive labels. These expediently comprise a carrier layer provided with a first adhesive layer and a data carrier layer which is releasably adhered to the carrier layer by means of a second adhesive layer, wherein the adhesive strength of the second adhesive layer on the carrier layer is expediently less than the adhesive strength of the first adhesive layer on an adhesive surface of the sterilization container. This means that the adhesive labels can be stuck onto the sterilization containers in the packing station. At the consumer's site, the data carrier layers are then peeled off and, for example, stuck onto a treatment protocol.

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The first data carrier can carry a treatment indicator responding to a sterilization process in a manner known per se. Furthermore, the data carrier can be connected to the sterile goods container in such a way that it can only be detached from the sterile goods container after it has been opened.

Further features and advantages of the invention emerge from the following description, which explains the invention with the attached drawing using an exemplary embodiment. They show:

Figure 1 is a schematic representation of the packing station and the documentation carried out in the packing station,

Figure 2 is a schematic representation of the steri

lysing station and the documentation carried out therein,

Figure 3 a schematic representation of the bearing

for sterilization units and the operations associated with their dispensing and

Figure 4 is a schematic representation of the Do

Documentation of sterile supplies in an operating room.

Figure 1 shows a packaging station with a packing table 10 on which a sterilization unit, generally designated 12, is located. This consists of a sterile goods container 14 and the sterile goods contained therein. On the packing table 10 there is also a label printer 16 with an input keyboard 18, a barcode reader pen 20 and a label dispenser 22. To the right of the packing table 10 there is a transport trolley 24 on which a multi-

number of sterilization units 12 are collected into a batch.

The packer of a sterilization unit 12 usually also carries out the labeling. Before requesting labels, the packer must identify himself using a personal code number that authorizes him to use the label printer 16. For this purpose, he has an ID card 26 that has his personal code number 28 printed on it as a barcode. This is read into the label printer 16 using the reading pen 20. Alternatively, the packer can also enter his code number using the keyboard 18 on the label printer.

The packer selects the product-specific label by entering the article number of the sterile goods in question on the label printer 16 or by reading it from an article number directory 3 0 in which the article numbers are recorded in the form of barcodes.

The label printer 16 prints a packaging label 32 for each sterilization unit 12, which is stuck onto the sterile goods container 14.

It can also be entered on the label printer 16 that a whole series of individual packaging labels 3 2 belong together to form a series. A series is usually the sum of all sterilization units 12 that belong together to form a batch load. For this series, the label printer 16 automatically issues a collective label 34 after all packaging labels 3 2 have been issued, which is assigned to the series and is attached, for example, to the batch trolley 24. A collective label 34 always represents only one series of packaging labels 32 of a uniform type of sterile goods. If the batch load consists of a mixture of several types of goods, a corresponding number of

34 collection labels are created, but they still belong together in a series. The collection labels that belong together are numbered and the total number of collection labels belonging to the series is printed on each collection label .

The label printer 16 contains the following data in its data memory:

The identification (code number) of the authorized packers.

Sterile goods type-specific data that is assigned to the respective article number, such as article name, permissible expiry period, name or function of the consumer of the respective article and number of the intended storage location for the respective article.

Non-sterile goods-specific data such as identification number of the label printer, name of the packaging department and packaging date.

Calculated data such as expiration date, which is determined from the packaging date plus the expiration period specific to the sterile goods type, serial number of each packaging label 32, start and end number of the serial numbers of all packaging labels 32 of a goods type belonging to the series and number of the respective collective label 34 as well as total number of collective labels 34 of a series.

The serial number for each package label 3 2 consists of the identification number of the label printer and a number that is continuously incremented by the label printer.

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number. The serial number must always contain the identification number of the label printer, since several printers can work in parallel and they do not have to be connected to each other, so that if a serial number is assigned that does not contain the label printer number, the same number would be assigned multiple times. This would mean that individual identification of each sterilization unit would no longer be guaranteed.

The label printer 16 prints an article number, the serial number of the sterilization unit including the identification number of the label printer, the expiration date and the storage location in an encrypted barcode on the packaging labels 3 2. The name of the packaging department, the name of the packer, the name or function of the consumer, the article description and the packaging date are printed in plain text.

The label printer prints the article number, the start and end number of the serial numbers of all packaging labels 32 of a sterile goods type belonging to the series, including the identification number of the label printer, the number of the respective collective label and the total number of collective labels in a series, the expiration date and the storage location in the form of a barcode on the collective labels 34. The article description and the name of the packer are also printed in plain text.

The packaging labels 32 can also be printed with an indicator color in a suitable place (not shown) that changes color when exposed to steam. This makes it clear whether a sterilization unit has already been sterilized or not.

The packaging label 32 remains on the respective sterilization unit until it is used. The labels 32

are double-adhesive and resistant to the conditions encountered during sterilization.

The collective label 34 is also steam-resistant and remains on the sterilizer with the corresponding batch load until the data is transferred by a barcode reader as described below. However, it can also continue to be used as a data carrier until the sterile goods are issued or even until the consumer, if the batch load is not divided on the way there.

Figure 2 shows a sterilization station with a sterilizer 36. This contains a sterilization chamber that can be closed by a door 38 and into which the transport trolley 24 with the sterilization units 12 can be pushed. Furthermore, the sterilizer 36 comprises a control part 40 with a data input device 42, a data output device 44 and a data processing device 46 connected to both, which will also be referred to below as a documentation computer. The data input device 42 comprises a keyboard (not shown in detail) and a barcode reader pen 48. The documentation computer 46 could of course also be a separate unit that is in the data network with the control part 40 of the sterilizer 36.

The documentation computer contains in a data storage device at least the identification (code numbers) of the authorized operators for the sterilizer, the assignment of the article numbers of the various types of sterile goods to the respective sterilization programs with which the types of sterile goods can be properly treated, the name of the sterilization department and the identification number of the sterilizer. The latter is important if several sterilizers are working in parallel.

The code number of the respective operating person is entered into the documentation computer 46. This person must identify himself using a personal code number which authorizes him to use the sterilizer 3 6. In this case, a barcode ID is read using the barcode reader 48 in a similar way to the packaging station. Alternatively, the operator can also enter his code number using the keyboard of the input device on the sterilizer 3 6.

Furthermore, the data printed on the packaging labels 32 and/or the collective labels 34 are read in using the barcode reader 48. The number of sterilization units per type of goods can be determined from the data read in from the packaging labels or from the difference between the start and end number of the serial numbers on the collective labels. Since an assignment of certain types of sterile goods to certain sterilization programs is programmed in the documentation computer 46, the documentation computer 46 can automatically select and start the correct sterilization program. If different types of goods are put together to form a batch for which no suitable sterilization program is available, a corresponding error message is displayed. During sterilization, the data generated include the name of the selected sterilization program, the sterilization date, the batch number and process data such as process times, temperatures and pressures.

The documentation computer 46 assigns the data taken over via the barcode reader 48 or entered into the documentation computer 46 in another way to the data already present in the memory and to the data generated during sterilization. At the end of the sterilization process, these data are output in the form of a batch document 50.

In addition to the usual data identifying the batches (program name, batch number, date) and process data (process times, temperatures, pressures), the batch document 50 also contains the data identifying all sterilization units used in the relevant process for later traceability. These are the article numbers, the number of pieces per type of goods (article) as well as the serial number, the expiration date and the location number of each sterilization unit.

The batch document 50 must be checked by the person responsible for sterilization to ensure that the process data is correct and must be signed or authenticated with a unique stamp before the sterilization units are used. If the operator notices any irregularities, he or she must block the use of the sterilization units in question. Based on the data on the batch document 50, the operator can identify the number, storage location and serial number of each individual sterilization unit and is thus able to find and retrieve them.

Batch document 50 is kept for the entire period for which proof of hygienic safety can be required. This period is usually thirty years.

After successfully completing the sterilization, the sterilization units are unloaded and placed in the appropriate storage locations of a sterile goods warehouse 52 (Figure 3). In the documentation computer 46, the delivery of the unloaded goods is recorded as an entry into the sterile goods warehouse 52. If necessary, the identity of the persons carrying out the unloading can be determined on this occasion in the same way as for the responsible

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persons at the packaging station and the sterilization station as already described.

A data input device 54 and a data display device 56 are provided in the sterile goods storage area 52, which are connected to the documentation computer 46 of the sterilization station. The data input device 54 is shown as a barcode reader with a reading pen 58. Of course, other means for data input can also be provided, for example a magnetic stripe reader or the like.

Before leaving the sterile goods storage area 52, the packaging label 32 of each sterilization unit is read using the reading pen 58. If not individual sterilization units 12 but a complete, undivided batch is dispensed, it is advantageous to read the collective label(s) 34 at the sterile goods dispensing point 60.

The documentation computer 4 6 uses the read-in data to immediately check the expiration date and compares it with the stored expiration period. If it has expired, an error message is displayed on the data display device 56 at the sterile goods dispenser 60. The sterilization unit in question may then no longer be issued.

Due to the fact that the identifying data of each sterilization unit 12 are recorded in the documentation computer 4 6 at the time of entry into the sterile goods warehouse 52 and also at the time of exit, it is possible to carry out a permanent inventory balance. The current inventory and the movements in the warehouse can be printed out on the documentation computer 4 6.

If several sterilizers 36 are working in parallel, it is necessary for correct inventory balancing that all sterilizers are connected to a data network with a documentation computer that records the sterilization units coming from all sterilizers as they enter the sterile goods warehouse 52.

The majority of sterile goods are required in operating rooms. In Figure 4, one such room is indicated by an operating table 62. When or after opening a sterile goods container 14, the packaging label 32 is removed from the sterile goods container 14 and stuck onto an operation protocol 64. If, after a treatment or surgical procedure, a patient requests proof from the hospital or the responsible staff that the treatment or surgical agents used on him are hygienically safe, the treatment protocol 64 is used. The serial number of the packaging label 32 of the sterilization unit 12 used during the treatment is read.

From the stored batch documents 50 of the sterilizer(s) 3 6, the one on which the relevant serial number is recorded is selected. By evaluating the physical process data also recorded on this batch document 50, the correct sterilization and thus the hygienic safety of the treatment agents from the relevant sterilization unit 12 can be proven.

This means that every sterilization unit can be traced back from use on the patient to processing. This gives the hospital the opportunity to protect itself against unjustified claims for damages due to errors in the processing of sterile goods.

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When using the method and system according to the invention, errors are still conceivable, but the number of possible errors is significantly reduced and the detection of possible errors is made easier. For example, the packer can forget to stick a label on the sterilization unit. However, this error is already recognized when the data is read into the sterilizer 3 6. On the other hand, the packer cannot forget to apply the treatment indicator, the content marking, the date information and his signature, since these markings are either already specified in the label or are printed on the label before it is issued.

At the sterilization station, the operator could forget to read individual package labels 32. However, this error cannot occur if collective labels are used, since each collective label indicates how many collective labels the series consists of. The sterilizer displays an error if not all of the package labels have been read.

The system according to the invention eliminates errors such as the wrong selection of the sterilization program, incorrect information about the number of sterilization units and the assignment of labels to goods from the wrong batch.

Due to the fact that the correct storage location can be read on each packaging label 3 2, incorrect storage is very unlikely.

Since each sterilization unit is individually marked and recorded on the batch document 50 and since its whereabouts (storage location or consumer) are also recorded, each individual sterilization unit 12 can be located. Gaps in the records regarding the number of sterilizations

lysing units are practically impossible. This ensures that all sterilization units that need to be returned can be recorded during recall operations.

The above description shows that the system according to the invention ensures practically complete documentation of the sterile goods from processing to the consumer. Suitable measures can also be taken to ensure that the return of reusable sterile goods such as clothing or medical instruments is also documented, so that the cycle of the sterile goods is closed.

Claims (8)

Expectations 1. System for monitoring the material flow during the processing of sterile goods, comprising a packing station for packaging the items to be sterilized. Goods in a sterile goods container (14), a sterilization station with a sterilizer (36) for sterilizing the sterile goods and a warehouse (52) for storing and dispensing the sterilization unit (12) consisting of the sterile goods and the sterile goods container (14), characterized in that the packing station has a data input device (10, 20) for recording data characterizing the sterilization unit (12) and a data output device for recording data characterizing the sterilization unit on a data carrier (32) that can be attached to the sterilization unit (12), that the sterilizer (36) is connected to a data processing device (46) that has a data input device (42, 48) for recording at least part of the data characterizing the sterilization unit (12) and a data output device (44) that records data characterizing the sterilization unit (12) and the records data relating to the sterilization process on a second data carrier (50), and that in the storage (52) at least one data input device (54, 58) for capturing data recorded on the first and/or the second data carrier and a data display device (56) for displaying control data is provided. 2. System according to claim 1, characterized in that the data input and output device (16) of the packing station and/or the data input and data display device (54, 58; 56) of the warehouse (52) are connected to the data processing : ir it :.: processing facility (46) of the sterilization station are in the data network. 3. System according to claim 1 or 2, characterized in that the data input devices (18; 42; 54) have means for entering personal identification data. 4. System according to one of claims 1 to 3, characterized in that the data input devices each have a data reading device (20; 48; 58) for machine-readable data. 5. System according to one of claims 1 to 4, characterized in that the data output device (22) of the packing station is a label printer. 6. System according to claim 5, characterized in that the first data carriers (32) are adhesive labels comprising a carrier layer provided with a first adhesive layer and a data carrier layer which is releasably adhered to the carrier layer by means of a second adhesive layer. 7. System according to claim 6, characterized in that the adhesive strength of the second adhesive layer on the carrier layer is lower than the adhesive strength of the first adhesive layer on an adhesive surface of the sterile goods container (14). 8. System according to one of claims 1 to 7, characterized in that the sterilizer (36) is designed such that, depending on data which are read from the data carrier (32) attached to the sterilization unit (12) and entered into the sterilizer (36) via the data input device (42, 48), a a suitable sterilization method is selected for this sterilization unit (12).