Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/70—Cleaning devices specially adapted for surgical instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
  • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
  • A61B1/121—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use
  • A61B1/123—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning post-use using washing machines
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/70—Cleaning devices specially adapted for surgical instruments
  • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/70—Cleaning devices specially adapted for surgical instruments
  • A61B2090/702—Devices for testing the cleaning process, e.g. test soils

Definitions

• the invention relates to a method for monitoring a reprocessing device for endoscopes, in particular a cleaning and / or Desinfiziervoriques, wherein over a plurality of processing operations of at least one endoscope in at least one processing device one or more process parameters and a time of the respective preparation process logs and in association with the respective treatment process get saved.
• the invention further relates to a corresponding system for monitoring a reprocessing device for endoscopes, comprising at least one processing device and at least one evaluation device.
• the treatment usually includes both washing, disinfecting and drying the endoscopes.
• the disinfection goes over
• the ETD3 has extensive sensor technology and logging functions. Thus, in addition to corresponding time stamps, the amount of the various treatment agents, that is to say water metering, detergent dosing and chemical dosing, is recorded and recorded for the preparation processes, in each case using impeller flowmeters.
• the ETD3 also features automatic transponder-based detection of compatible endoscopes via the Olympus EndolD system. Among other things, this system records the serial number of the reprocessing device, the type and serial number of the reprocessed endoscope, the name of the operator who started the reprocessing process, and other process parameters.
• the Endol D system allows, after recognizing the endoscope to be reprocessed Automatically set process parameters for the endoscope automatically.
• the ETD3 also has leak detection.
• a report can be generated after the reprocessing process as to whether all process parameters of the reprocessing process were correct, ie within calibrated or predefined parameter ranges, and that sufficient reprocessing results have been achieved.
• This report can be printed out or transmitted directly to an endoscope information management system, for example via an ISDN or LAN connection.
• the ETD3 offers the possibility of remote maintenance.
• the present invention has the object to improve the monitoring of reprocessing devices for endoscopes and endoscopes.
• This object is achieved by a method for monitoring a reprocessing device for endoscopes, in particular a cleaning and / or disinfecting device, wherein a plurality of reprocessing operations of at least one endoscope in at least one processing device one or more process parameters and a time of the respective preparation process are logged and stored in association with the respective preparation process, which is further developed in that a trend analysis of the at least one logged process parameter is performed in the evaluation device via at least one logged process parameter.
• a trend is understood to mean temporal development, but also abnormalities that depend on other process parameters, for example occur more frequently in individual reprocessing programs or in the case of certain operators.
• maintenance can be scheduled, ie on-site maintenance or possibly remote maintenance.
• the training needs of employees can be better coordinated.
• a conditioner indicator is, for example, a serial number of the conditioner, an operator indicator whose name or person identification number, a preparation program indicator, for example, a program name or designation or number designating the preparation program, an endoscope indicator, a type designation and / or a serial number of an endoscope, a preparation indicator such as a chemical name or a chemical identifier. If several of these process parameters are logged and analyzed, this increases the process reliability, quality and efficiency of the endoscope reprocessing.
• sub-process relevant process parameters are logged with respect to the individual sub-processes, in particular a sub-operation identifier, duration of the processing sub-process and / or dosing of one or more during the sub-process to be dispensed conditioning, then is a Close-meshed and specific trend analysis possible.
• Sub-processes include, for example, pre-washings, washes, disinfectants, rinses, drying cycles and the like. a. understood, each of which is carried out with its own process parameters. In this way, maintenance-relevant abnormalities in individual sub-processes can be identified and remedied.
• the temporal trend analysis typically relates to the dosage of the disinfecting chemical or disinfecting chemicals or other treating agents.
• the chemical dose may more or less continuously decrease or increase within the allowed range.
• Each individual dosage and the resulting disinfection result are therefore compliant with specifications and inconspicuous.
• a need for maintenance has so far only been determined when this trend has continued and the dosage has actually moved out of the area compliant with the regulations.
• a trend analysis according to the invention reveals the prevailing trend, so that countermeasures can be taken in a maintenance before the disinfection result becomes inadequate or, conversely, more disinfectant chemicals are consumed than necessary.
• An application example of this is the monitoring of the calibra- ration of dosing devices in a treatment device.
• the deviation of a dosing amount from the desired dosing amount for a particular dosing device can be analyzed as a function of the size of the desired dosing amount. If this difference increases or decreases as the desired metered quantity increases, the calibration of the metering device must be adjusted.
• a logged process parameter in particular a metered quantity or a process duration, develops such that this process parameter leaves a calibrated range or a tolerance range as the trend continues.
• a maintenance requirement of the processing device is advantageously signaled before a logged process parameter leaves the calibrated range or tolerance range if the trend analysis yields such a trend.
• a training requirement of an operator is signaled when the trend analysis reveals that the frequency of the occurrence of malfunctions, incorrect operation and / or error messages to other operators is increased in the operator.
• a pressure loss and / or a pressure loss rate is an important, the trend analysis of accessible, process parameters.
• a leak test of the endoscopes is carried out before starting the endoscope preparation. For this purpose, a slight overpressure is generated and the pressure drop is checked in a certain period of time. If the pressure loss is above a defined threshold of a low and allowable pressure loss, the endoscope is reported as leaking and the reprocessing is not started. This prevents that During treatment, moisture enters sensitive parts of the endoscope. Without trend analysis, a leak is always assigned to the endoscope and thus leaks in the area of the treatment device are not reliably detected. Furthermore, aging of both the endoscope and the processing device is only recognized when the triggering threshold is reached, so that processing is then no longer possible.
• the trend analysis of the leak test via the pressure loss or the pressure loss velocity makes it possible, for example by correlation with the endoscope indicator, to determine whether a change over the trend period behavior of the treatment device or its leak tester or the endoscope can be assigned. An endoscope that approaches a corrective amount of leakage may then be displayed for repair. By contrast, independent of the endoscopes increase the pressure loss, however, a problem of the leak tester of the treatment device can be detected in good time and communicated, for example, stored in the service memory of the processing device for a service technician.
• the system is designed and set up to carry out a method according to the invention described above.
• FIG. 1 shows a system 10 according to the invention for monitoring a reprocessing device 12 for endoscopes, which comprises an evaluation device 14 in addition to the reprocessing device 12.
• the conditioning device 12 and the evaluation device 14 are connected to one another via a data connection 16, for example an ISDN connection or LAN connection.
• a data connection 16 for example an ISDN connection or LAN connection.
• the evaluation device 14 can be used for remote maintenance of the processing device 12, and the processing device 12 can transmit logging data to the evaluation device 14.
• the processing device 12 can be, for example, the automatic processing device ETD3 of the applicant.
• the evaluation device 14 may also be integrated in the processing device 12. Nevertheless, a data connection 16 to an external evaluation device 14 may also be present in this case.
• the treatment device 12 is used to clean and disinfect endoscopes after their use.
• the treatment device 12 passes through a plurality of processing part processes, such as pre-wash, wash, disinfection, rinse and drying cycle.
• Other aisles may also be included, such as diagnostic procedures for the endoscopes, e.g. B. a leak test.
• the processing device 1 2 is designed with its sensors to record various process parameters, such as the identity of the operator, the identity of the reprocessed endoscopes as well as part process times, total duration, amounts of metered-in treatment agents, such as water, chemicals, detergents, etc., and this Protocol to the evaluation device 14 to transmit.
• the evaluation device 14 is designed to use this data to create a trend analysis over a plurality of reprocessing processes in order to be able to identify, for example, maintenance requirements for the machine or training requirements for operators at an early stage.
• Fig. 2 shows a trend analysis of a metering parameter, namely the time course over a total of 27 preparation processes of the dosage of peracetic acid (PAA).
• the data points 21 each correspond to a preparation process.
• the parameter Vp AA denotes the amount of PAA actually delivered during a treatment process or a disinfection sub-operation of a treatment process.
• the course of time is entered on the x-axis.
• the permissible range for the data points 21 is delimited by an upper limit 26 and a lower limit 28. Measurements outside of this range lead to error messages and inadequate disinfection results.
• the trend analysis shows that first the measured values 21 are in a middle range of the permissible range without a critical trend being recognizable.
• the (linear) trend 20 is not critical in this case.
• FIG. 3 shows a different kind of trend analysis, namely a person-related trend analysis.
• persons A to I how many incorrect operations or what an erroneous operating rate these operators A to I have caused.
• the number of incorrect operations or misuse rates is so low that it falls within the zero training range, so there is no need for training for these persons.
• Two persons, namely F and I have such high numbers or rates of incorrect operation 30, 32 that they have a high and urgent training requirement of category 2. These people need to be trained promptly.
• Another person G has a slightly increased number or rate of incorrect operations 34, so that it must be considered in this person, if there is further training needs is. This person G falls in the lower part of area 1 of the training needs.
• the error rate can also be shown in a further trend analysis for individual persons versus time, so that it can be determined, if necessary, for which new training sessions should be scheduled for these persons due to their worsening operating error rates. This way the training needs for a whole staff can be coordi- nated.
• the number of error messages and other possibly personal identifiers may also be analyzed.
• FIG. 4 a further trend analysis according to the invention is shown graphically.
• the lower, shown coarse coordinate system represents the real delivered PAA quantity Vp AA against a program-appropriate PAA quantity Vp AA .
• different programs or partial programs are on the x-axis, ie the axis for Vp AA d Pi, P 2 and P3 shown in each of which a different Licher quantity required for PAA, ie in each case different Dosiermengen are delivered.
• the required dosing amount in program P1 is low, in program P2 medium high and in program P 3 high. It may also be the number of one, two or three endoscopes to be reprocessed in the processor 12, thereby scaling the need for PAA accordingly.
• the reference numeral 40 denotes a desired calibration, which connects the setpoint values linearly with one another.
• the actual delivered quantity V P R AA would thus be equal to the target quantity Vp AA for the individual programs Pi, P 2 and P3.
• Each individual data sequence 21, 21 ', 21" thus essentially corresponds to a temporal trend analysis shown in FIG.
• the data points 21, 21 'and 21 can each be summarized in one point or distribution to correctly determine the calibration
• a temporal analysis of the change in the calibration may also be made.
• measures may be taken to remedy this misalignment, for example, in the context of remote maintenance or on-site Maintenance.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Physics & Mathematics (AREA)
• Radiology & Medical Imaging (AREA)
• Optics & Photonics (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Endoscopes (AREA)

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• 2013
  • 2013-03-26 DE DE102013205296.0A patent/DE102013205296A1/de not_active Ceased
• 2014
  • 2014-03-10 CN CN201480018181.9A patent/CN105120735A/zh active Pending
  • 2014-03-10 JP JP2016504510A patent/JP2016520344A/ja active Pending
  • 2014-03-10 WO PCT/EP2014/000606 patent/WO2014154327A1/de not_active Ceased
  • 2014-03-10 EP EP14709882.6A patent/EP2978362B1/de active Active
• 2015
  • 2015-09-24 US US14/863,826 patent/US9993301B2/en active Active

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