Systems and methods for traceability and sanitary compliance management of reusable medical devices and environmental reprocessing.

Abstract

A method for reusable medical device reprocessing compliance and a system for environmental or equipment hygiene standard compliance. For example, in this method, the reusable medical device is reprocessed using a reprocessing procedure before performing a second medical procedure and after performing a first medical procedure, and the reprocessing data is uploaded. In this method, the first medical procedure is performed using the reusable medical device, and the first medical procedure data is uploaded. The reusable medical device is interactively verified before performing the second medical procedure, including querying procedure details to provide instructions. The second medical procedure is performed using the reusable medical device, and the second medical procedure data is uploaded. An alert is automatically generated based on comparing the first medical procedure data, procedure details, second medical procedure data, and reprocessing data to hygiene standards. The alert indicates non-compliance with hygiene standards.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 034,616, filed on June 4, 2020, U.S. Provisional Patent Application No. 63 / 068,481, filed on August 21, 2020, and U.S. Provisional Patent Application No. 63 / 172,822, filed on April 9, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure generally relates to reusable medical devices and environments, and more specifically, to systems and methods for traceability and hygiene compliance management of the reprocessing of reusable medical devices and environments with respect to required laws, standards, guidelines, or internal standard operating procedure manuals.

Background Art

[0003] Traditional traceability systems are rooted in operating rooms / central sterilization departments where the decontamination of reusable medical devices is standardized and centralized. However, the number of reusable medical devices outside this environment is increasing, and the number of reprocessing systems and methods outside operating rooms / central sterilization departments is also increasing for the benefit of streamlining workflows within healthcare facilities. Furthermore, there is a growing need to manage the traceability of reprocessing and protection of environments, including medical treatment rooms, patient environments, bathrooms, hotel rooms, and public transport, as well as other facilities and environments that may be used to accommodate or treat patients, posing a risk of cross-contamination. The reprocessing of these reusable medical devices and environments must be managed in accordance with laws, standards, guidelines, or internal standard operating procedures to mitigate the risk of cross-contamination. Often, information regarding the reprocessing of reusable medical devices and the environment is stored in separate, complex, and difficult-to-manage paper-based systems that are frequently mismanaged and lost, leading to inefficiencies in providing effective traceability and compliance to laws, standards, guidelines, or internal standard operating procedures to adequately protect patients by providing the traceability evidence necessary to efficiently manage the risks and emergencies of cross-contamination. [Overview of the project]

[0004] Accordingly, according to one embodiment, a method for compliance with the reprocessing of reusable medical devices is provided. The method includes the following steps: providing a plurality of reusable medical devices; reprocessing the reusable medical devices using a reprocessing procedure after performing a first medical procedure and uploading the first medical procedure data of the first reusable medical device's first medical procedure reprocessing data; interactively verifying the reusable medical devices for a second medical procedure before performing a second medical procedure, which includes querying the procedure details of the second medical procedure and providing instructions based on the procedure details of the second medical procedure; performing the second medical procedure using the reusable medical devices and uploading the second medical procedure data of the second medical procedure; and automatically generating warnings based on a comparison of the first medical procedure data of the first medical procedure, the procedure details and second medical procedure data of the second medical procedure, and the reprocessing data with a plurality of hygiene standards, the warnings indicating non-compliance with at least one of the plurality of hygiene standards.

[0005] In other embodiments, a system is provided for compliance with environmental or equipment hygiene standards. The system includes a centralized application and one or more mobile devices. One or more mobile devices include performing the following steps: uploading reprocessing data to the centralized application, the reprocessing data relating to the environmental or equipment reprocessing procedure; uploading first action data for the first action relating to the environment or equipment to the centralized application; interactively verifying the environment for the second action before performing the second action. Interactive verification includes querying the action details for the second action and providing instructions based on the action details for the second action; uploading second action data for the second action relating to the environment or equipment to the centralized application. The centralized application automatically generates warnings based on comparing the first action data for the first action, the action details and second action data for the second action, and the reprocessing data with multiple hygiene standards. The warnings indicate non-compliance with at least one of the multiple hygiene standards.

[0006] In another embodiment, a method is provided for indicating compliance with the reprocessing of reusable medical devices to a patient. The method includes the following steps: after performing a first medical procedure, reprocessing the reusable medical device using a reprocessing procedure and uploading the first reprocessing data for the reusable medical device; interactively verifying the reusable medical device for the second medical procedure before performing a second medical procedure, and interactive verification includes querying the procedure details for the second medical procedure and providing instructions based on the procedure details for the second medical procedure; receiving a verification message confirming that the reusable medical device complies with hygiene standards; displaying the verification message to the patient; performing the second medical procedure using the reusable medical device and uploading the second medical procedure data for the second medical procedure; and automatically generating a warning based on a comparison of the first medical procedure data for the first medical procedure, the procedure details and second medical procedure data for the second medical procedure, and the reprocessing data with multiple hygiene standards, the warning indicating non-compliance with at least one of the multiple hygiene standards.

[0007] The advantages obtained by the systems and methods described herein are that the digitized and automated systems process data relating to both the reprocessing of reusable medical devices and / or the environment before use and patient treatment information for the acquisition and correlation of time series. Based on the above, the system compares hygiene regulations, standards, and guidelines with document compliance to provide traceability, and rapidly creates known risks of cross-contamination for analysis, assessment, and control to minimize the risk of patient infection that may be caused by reusable medical devices and environments that have not been reprocessed in accordance with hygiene regulations, standards, or guidelines.

[0008] The embodiments described above are merely illustrative. Other embodiments are within the scope of the disclosed subject matter.

[0009] To help understand the features of this disclosure, a detailed description may be given with reference to several embodiments shown in the accompanying drawings. However, it should be noted that the drawings show only specific embodiments and should not be considered limiting, as the scope of the disclosed subject matter also encompasses other embodiments. The drawings are not necessarily to scale and are generally focused on illustrating the features of specific embodiments. In the drawings, similar numbering is used to indicate similar parts across different figures. [Brief explanation of the drawing]

[0010] [Figure 1] This block diagram shows a system for traceability and sanitary compliance management of reusable medical devices and environmental reprocessing in accordance with necessary laws, standards, or guidelines, as described in one or more aspects of this specification.

[0011] [Figure 2A] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, including relevant high-level disinfection and reprocessing equipment cycle data, according to one or more embodiments described herein. [Figure 2B] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, including relevant high-level disinfection and reprocessing equipment cycle data, according to one or more embodiments described herein.

[0012] [Figure 3A] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein. [Figure 3B] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein.

[0013] [Figure 4A] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of mobile reusable medical devices, according to one or more embodiments described herein. [Figure 4B] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of mobile reusable medical devices, according to one or more embodiments described herein.

[0014] [Figure 5A] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of different types of mobile reusable medical devices in different environments, according to one or more embodiments described herein. [Figure 5B] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of different types of mobile reusable medical devices in different environments, according to one or more embodiments described herein.

[0015] [Figures 6A-6D] A graphical user interface for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein. [Figure 6E-6G] A graphical user interface for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein.

[0016] [Figure 7A-7C] A graphical user interface for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein. [Figures 7D-7G]A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein.

[0017] [Figures 8A-8C] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein. [Figure 8D-8G] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein.

[0018] [Figure 9A-9B2] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein. [Figures 9C-9F] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein. [Figure 9G] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein.

[0019] [Figure 10A] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein. [Figure 10B] A graphical user interface of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices according to one or more aspects described herein.

[0020] [Figure 11] This is a flowchart of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices, according to one or more embodiments described herein.

[0021] Corresponding reference letters indicate the corresponding parts through several figures. The examples described herein illustrate several embodiments, but should not be construed as limiting the scope. [Modes for carrying out the invention]

[0022] This disclosure relates to a technology for traceability and hygiene compliance management for the reprocessing of different types of reusable medical devices. Advantageously, the technology enables the linking and aggregation of patient treatment and reprocessing data for reusable medical devices or environments, allowing hospitals and other institutions to improve control over infection prevention processes, procedures, means, and responses. Dashboards and reports can be presented to manage the reprocessing of mobile or stationary reusable medical devices.

[0023] The technologies presented herein, in part, provide documented evidence of the level / type of reprocessing of reusable medical devices and information on how one or more reusable medical devices were used at that time in order to support the need for facility audits, provide transparency and awareness, and provide correlative documented evidence of compliance with management hygiene laws, standards or guidelines to embody patient protection in order to mitigate the risk of cross-contamination.

[0024] In summary, this disclosure provides a traceability system that can support reusable medical devices located outside the centralized operating room environment, enabling more efficient workflows within healthcare facilities. Current technology allows for the reprocessing of these reusable medical devices to be controlled in accordance with patient safety laws, standards, and guidelines. The systems and methods presented herein combine information regarding the reprocessing of reusable medical devices with information regarding their use in patient treatment to provide effective traceability and compliance with laws, standards, and guidelines for adequate patient protection, providing the traceability evidence necessary to manage the risks and breakthroughs of cross-contamination. Furthermore, the technology provides traceability for the reprocessing and use of medical treatment rooms, medical patient environments, and other facilities and environments that may be used to accommodate or treat patients at risk of cross-contamination.

[0025] Although this disclosure describes a specific embodiment, for example, a patient in a healthcare setting, the techniques described are equally applicable to other medical or healthcare settings. The techniques presented herein concern the management of sanitary and regulatory requirements, whether related to medical care or not, regardless of whether those requirements are laws, standards, guidelines, or internal standard operating procedures valid in the described environment.

[0026] Furthermore, while specific examples are given with respect to reusable medical devices, this disclosure is intended to apply the same principles and techniques to environments such as rooms and other locations, and the examples given can be applied to such environments. Similarly, examples directed towards the reprocessing of reusable medical devices can also be applied to reprocessing or decontamination in environmental transformations, for example, to mitigate the risk of cross-contamination between users.

[0027] As a concrete example of the problems solved by this technology, the probe may be used in HIV-positive patients for intraoperative liver biopsy, and the probe's next job may be abdominal scans of healthy, risk-free pregnant women in their sixth month of pregnancy. By using this technology, the probe will be prepared for the exposure risk of the patients it will be used in, namely healthy pregnant women in closed-skin abdominal examinations. Advantageously, this technology ensures that the use of the probe complies with sanitary standards and achieves the goal of reprocessing the ultrasound probe following significant exposure to the environment, in accordance with significant reprocessing requirements, before use in healthy women with intact skin.

[0028] Furthermore, regarding environmental reprocessing, the following examples can be achieved using this technology: Operating rooms may be changed between surgeries in compliance with hygiene standards. Patient rooms may be changed in accordance with hygiene standards in response to patient deaths, and these changes may often be increased depending on the pathogen profile of past patients. Time-based reprocessing can be achieved in compliance with hygiene standards; for example, hospital bathrooms may have a hygiene requirement of reprocessing every 15 minutes, and patient rooms may require deep cleaning every two days depending on the type of environment, pathogen risk profile, and exposure risk profile. Other examples include wiping bed rails X times a day, cleaning floors X times a day, changing dental rooms for each patient, changing the environment for terminally ill patients, changing the CT scan environment for COVID patients, etc. These standard operating procedures may be specified as applicable hygiene standards and may be tracked and scanned.

[0029] (Typical example of a system) Figure 1 is a schematic block diagram showing a system 100 for traceability and hygiene compliance management of reusable medical devices 101, such as ultrasound probes, blood pressure monitors, CT scanners, or other similar devices commonly found in medical facilities such as hospitals, primary caregiver companies, or other care facilities. Other non-limiting examples of reusable medical devices include, but are not limited to, ophthalmic devices such as gamma probes, tonometers and throcytes, Doppler ultrasound probes, transesophageal echocardiography (TOE or TEE) probes, and dental devices. Furthermore, this technology can be used for disinfection of hospital facilities and spaces, dental facilities and spaces, ophthalmic and other medical specialties in both hospital and clinic environments, as well as elderly care facilities, hospices, and emergency vehicles.

[0030] Other reusable medical devices that can be used with this technology are listed in Table 1 below.

[0031] [Table 1]

[0032] Figure 1 provides a generalized example of System 100, but those skilled in the art will readily understand that the concepts described herein apply to any number of different configurations for reprocessing reusable medical devices or environments. In particular, in some examples within the scope of this disclosure, multiple reprocessing devices may be located in a fixed reprocessing room or area. In other examples, the reprocessing devices are portable and can be moved from room to room. Data entry for reprocessing may include manually entered automated reprocessing device cycle data of reprocessing operations, either directly integrated into the system or to document other systems or means for reprocessing reusable medical devices or environments. In other embodiments, multiple scanning devices may be used by staff or clinicians to track the use of reusable medical devices and / or environments in or for patient treatment, with data being uploaded immediately or in batch mode some time after a number of procedures have been performed.

[0033] In the embodiment shown in Figure 1, the system 100 includes at least one usage scanning device 101 used to track the usage details of one or more reusable medical devices 102 and runs a mobile application. The system 100 includes one or more reprocessing devices 103 used to reprocess the reusable medical devices 102. In other examples, the technology may be embodied as a system or procedure method. For example, the reprocessing device 103 may be an automated ultrasonic probe sterilization device such as a Trophon EPR or Trophon 2 device available from Nanosonics Limited in Australia. The reprocessing device 103 may be connected via a hospital network. In such a case, the reusable medical device 102 may be an ultrasonic probe with an RFID or other identification tag, and the reprocessing data referred to herein, along with patient treatment information, treatment hygiene classification information, etc., is uploaded directly from the reprocessing device 103 to the system application. In other examples, the reusable medical device 102 may be one or more endoscopes, MRI machines, CT machines, dental machines, ophthalmic machines, etc.

[0034] In some examples, the scanning device 101 may be a tablet, smartphone, smartwatch, dedicated handheld input device, or any other type of device available to track and track the details of the use of one or more reusable medical devices. In other examples, various types of reusable medical devices may be reprocessed in a number of different types of reprocessing systems, methods, devices, technologies, or facilities, and information about the reprocessing may be loaded directly into the application by the reprocessing device or the use scanning device.

[0035] Referring further to Figure 1, the system 100 described herein includes a server-based application 104 that receives data from a scanning device 101 and a reprocessing device 103, enabling any number of users 106 to manage the traceability and hygiene compliance of reusable medical devices 102. Reusable medical devices 102 may include RFID tags or barcodes, unique alphanumeric identification codes or other such identification information that can be scanned by or manually entered into the scanning device 101. The centralized server application 104 may also provide an application programming interface (API), which is described in more detail below. In other embodiments (not shown), instead of an ultrasound probe or similar “dam” device, the reusable medical devices 102 may themselves be smart devices equipped with a processor and WiFi® capabilities for directly uploading information to the scanning device 101 or the application 104.

[0036] The scanning device 101 may, in one example, be based on a commercially available Android® or other smartphone equipped with a preloaded mobile application for scanning tags or codes 108, a dedicated QR code® scanner, and a radio frequency identification (RFID) scanner. In such a case, the mobile application 104 would provide a user interface (not shown) that enables healthcare professionals to obtain details of acceptance numbers for medical devices, procedures, patients, and point of care. The scanning device 102 may include a USB® charging cable and other accessories.

[0037] A mobile application running on the scanning device 101 can acquire various data about one or more reusable medical devices 102. For example, the scanning device 101 can acquire various data including, but not limited to, medical device data via RF tags; sterilization status of medical devices; treatment classification by manual selection using standards and guidelines such as the Spalding classification; procedure acceptance number; patient identifier. Passive tags such as RFID can carry small amounts of information that can be used to store such data.

[0038] As will be explained in more detail below, this technology is applicable to management by providing a mobile or portable reusable medical device and environment reprocessing compliance workflow across all areas of the healthcare environment, including hospitals, clinics, and patients, by offering end-to-end traceability between reprocessing equipment / environment, reprocessing, and patient treatment, thereby reducing the risk of cross-contamination, reducing hospital-acquired infections, and protecting facilities from financial and reputational risks due to non-compliance with hygiene standards. The mobile device incorporates ongoing reprocessing compliance training, and the application will output prompts and warnings as the user completes the workflow.

[0039] Figures 2A–5B provide some embodiments or scenarios of the present disclosure.

[0040] (Scenario A: High-level disinfection and reprocessing cycle data) (Summary) In Figures 2A and 2B, the exemplary method 200 is used in a centralized application that combines at least one high-level disinfection device and associated reprocessing cycle data, a mobile device used for clinician collection procedures (i.e., reusable medical device usage data), and reprocessing and usage data to generate a set of compliance dashboards that enable the facility to demonstrate compliance with hygiene standards, guidelines, standard operating procedures (SOPs), and instructions for use (IFUs).

[0041] For example, Method 200 uses a mobile electronic device that can connect to a network using direct connection, Wi-Fi®, or telecommunications (e.g., 4G®) to transmit reusable medical device-specific identification information, reprocessing information of reusable medical devices from high-level disinfection and reprocessing equipment, usage information of reusable medical devices, patient and / or procedure identification information, and date and time information to a centralized application that aggregates, processes, and presents evidence-based tracking and traceability information related to the hygiene practices of reusable medical devices, including notifications of hygiene activities that present risks to patients as indicated by control laws, standards, guidelines, and product usage instructions (IFUs), and the notifications include: • Unique reusable medical device ID, including RFID, barcode, or other numbering systems. Reprocessing data for reusable medical devices, including evidence of the operator who performed the reprocessing, the serial number of the reprocessing equipment, evidence of the reprocessing agent and / or evidence data of the reprocessing equipment and the date and time of the reprocessing process. Medical device usage data, which may include information on the hygiene category of the procedure, information on the clinician or operator of the medical device in use, and the date and time of use. • Patient and / or procedure identification data, which may include information that would enable the reprocessing and utilization dataset of reusable medical devices to be linked to the patient's medical record system or personal record system for hygienic traceability purposes.

[0042] (Scenario A: Flowchart (Figures 2A and 2B)) Figures 2A and 2B illustrate exemplary methods 200 for reprocessing traceability and sanitary compliance management. In one embodiment, block 210, the method performs traceability and documentation steps for reprocessing compliance to sanitary laws, guidelines, standards or internal standard operating procedures (SOPs) for mobile reusable medical devices (e.g., ultrasound probes) with respect to patient treatment use.

[0043] For example, in block 212, the method performs the step of directly collecting reprocessing data for mobile reusable medical devices from a reprocessing facility. By obtaining medical procedure data, it becomes possible to process and curate the data so that the appropriate information is stored in a database (server application, etc.) for later detection of infection. Reprocessing information is collected as each medical device is reprocessed. During reprocessing, the scanning device can continuously reeducate clinical users in the necessary hygiene standards by specifying, for example, high-level disinfection (HLD) or low-level disinfection (LLD), and notifying the user if the device has not been reprocessed as required for use before a particular patient's procedure. In one particular example, if a user refuses to perform HLD and attempts to ignore the appropriate disinfection procedure, and the device resets to think that a procedure requiring LLD has been performed, the system can log this information. As an advantage, method 200 allows supervisor notification, for example, if documentation during a procedure is outside the scope of guidelines, enabling rapid course correction or risk management. Reprocessing information can be uploaded to an application. In one example, two different datasets, i) medical procedure data and ii) device reprocessing data, can be uploaded to the application. In another example, clinician input indicates the level of disinfection or sterilization of reusable medical devices or environments. This data may be uploaded in real time or in a batch procedure. If uploaded in a batch procedure, the current system can mine the data to find reprocessing errors that could lead to a warning that a particular patient may have been exposed to improperly reprocessed equipment. In such embodiments, uploading reprocessing information involves batch uploads, and correlating the information involves ordering treatment history and reprocessing events to find failed or inadequate reprocessing cycles.

[0044] Next, in block 214, method 200 performs the step of collecting patient / procedure use information for each use of a reusable medical device using a scanning device. Once collected, in block 216, method 200 performs the step of uploading the reprocessing and use data for each reusable medical device to a centralized application. After the data has been uploaded, in block 218, method 200 performs the step of aggregating and processing the reprocessing and use data for reusable medical devices. For example, medical procedure information and reprocessing information may be correlated to determine whether a reprocessing cycle for a particular medical device was failed or insufficient, and such data can be used to track potential infections. In other examples, the system supports reporting key performance indicators (KPIs), and specific corrective actions may be taken depending on the range of acceptable indicators. For example, a failed or insufficient reprocessing cycle may include a reprocessing cycle that was insufficient to reprocess a particular medical device considering the specific medical procedure information. In a specific example, correlating the information may include contact tracing of multiple patients exposed to a particular medical device for which the reprocessing cycle failed or was insufficient. In yet another example, correlating information includes mapping specific levels of sterilization of medical equipment along with each medical procedure.

[0045] Furthermore, the system and related methods can be used in many ways that are within the spirit of this disclosure. For example, patient information can be uploaded at any time, and correlations can be rerun to take the new data into consideration. As another example, the correct reprocessing procedure may depend not only on previously performed medical procedures but also on the patient's condition. If a patient is later found to be positive for COVID-19 or other tests, the system can retrospectively rerun the correlations to find equipment that was not properly reprocessed in light of these new facts. The batch upload data described above can be correlated by identifying the time series of events, ensuring that all protocols were followed, finding missing disinfection cycles, etc. In such cases, more generally, the method may include uploading updated patient information indicating that at least one patient found in the patient information of the medical procedure information has been in a condition requiring a different level of reprocessing of the medical device, and that the medical procedure information should be updated based on the updated patient information.

[0046] After aggregation, in block 220, Method 200 performs the step of presenting reprocessing compliance data and a dashboard (compliance with hygiene standards, guidelines, standard operating procedures, and user manuals). Also in block 222, Method 200 performs the step of presenting an assessment of hygiene practices for each classification of reusable medical devices and procedures. In addition to reports and dashboards, in block 224, Method 200 performs the step of notifying or warning of risks based on the assessment of hygiene practices evaluated against the management hygiene laws, standards, or guidelines. Furthermore, in block 226, Method 200 performs the step of notifying or warning of equipment status (e.g., availability). Furthermore, in block 228, Method 200 performs the step of persistently tracking data for traceability and risk management purposes.

[0047] Again, different actions may be taken based on data collected by the system and using the methods described. For example, a patient may be contact-traced or inquired about for further testing. In other examples, reusable medical devices may be excluded from service and scheduled for immediate reprocessing according to the correct protocol. In specific cases, if a high level of disinfection is required before reusing a reusable medical device, and only a low level of disinfection is performed, the system can track which reusable medical devices have not been properly disinfected.

[0048] (Scenario B: Mobile Reusable Medical Device Traceability System) (Summary) In Figures 3A and 3B, exemplary method 300 provides a mobile, reusable medical device traceability system that is isolated from specific disinfection equipment and can capture data from many reprocessing devices and manual reprocessing systems / processes (for example, for use in hospitals, clinics, dental offices, optometry practices, and other medical settings).

[0049] For example, Method 300 uses a mobile electronic device that can connect to a network using direct connection, Wi-Fi®, or telecommunications (e.g., 4G®) to transmit reusable medical device-specific identification information, reprocessing information, usage information, patient and / or procedure identification information, and date and time information to a centralized application that aggregates, processes, and presents evidence-based tracking and traceability information related to the hygiene practices of the reusable medical device, including notifications of hygiene activities that present risks to the patient as indicated by control laws, standards, guidelines, and product IFUs, and the notifications include: • Unique reusable medical device ID, including RFID, barcode, or other numbering systems. Reprocessing data for reusable medical devices, including evidence of the operator who performed the reprocessing, the reprocessing agent, and / or evidence data of the reprocessing equipment, and the date and time of the reprocessing process. Medical device usage data, which may include information on the hygiene category of the procedure, information on the clinician or operator of the medical device in use, and the date and time of use. • Patient and / or procedure identification data, which may include information that would enable the reprocessing and utilization dataset of reusable medical devices to be linked to the patient's medical record system or personal record system for hygienic traceability purposes.

[0050] (Scenario B: Flowchart (Figures 3A and 3B)) The flowcharts in Figures 3A and 3B illustrate an example of Scenario B.

[0051] For example, in block 310, method 300 provides steps for traceability and documentation of reprocessing compliance to hygiene laws, guidelines, standards or internal standard operating procedures for different mobile reusable medical devices in different environments (e.g., hospital, clinical, dental, optometrist).

[0052] In one embodiment, in block 312, Method 300 performs the step of collecting reprocessing data for mobile reusable medical devices directly from a reprocessing facility or manually (e.g., using a manual input device). Next, in block 314, Method 300 performs the step of collecting patient / procedure use information for each mobile reusable medical device. After collecting the data, in block 316, Method 300 performs the step of uploading the reprocessing and use data for each mobile reusable medical device to a centralized application. After uploading the data, in block 318, Method 300 performs the step of aggregating and processing the reprocessing and use data for mobile reusable medical devices. Next, in block 320, Method 300 performs the step of presenting reprocessing compliance data and mobile reusable device traceability data. In block 322, Method 300 also performs the step of presenting an assessment of hygiene practices for each classification of reusable medical devices and procedures. Next, in block 324, method 300 performs a step of notifying or warning of risks based on an assessment of hygiene practices evaluated against management hygiene laws, standards, or guidelines. Furthermore, in block 326, method 300 performs a step of notifying or warning of equipment status (e.g., availability). Furthermore, in block 328, method 300 performs a step of persistently tracking data for traceability and risk management purposes.

[0053] (Scenario C: Fixed, reusable medical device) (Summary) The following examples illustrate additional functions for fixed, reusable medical devices and the replacement of rooms for these devices (including, but not limited to, MRI machines, CT machines, and the rooms and environments in which they are fixed).

[0054] For example, Method 400 uses a mobile electronic device that can connect to a network using direct connection, Wi-Fi®, or telecommunications (e.g., 4G®) to transmit to a centralized application that aggregates, processes, and presents reusable medical device-specific identification information, specific room or location information, reprocessing information for reusable medical devices and rooms or locations, usage information for reusable medical devices, patient and / or procedure identification information and date and time information, evidence-based tracking and traceability information related to hygiene practices of the reusable medical devices and associated rooms or locations, and notifications of hygiene activities that present risks to patients as indicated by control laws, standards, guidelines, and product IFUs, and notifications of the availability of the equipment and / or rooms after reprocessing is complete, the notifications including: • Unique reusable medical device ID, including RFID, barcode, or other numbering systems. • A unique room or location ID, including RFID, barcode, or numbering systems. • Reprocessing data for reusable medical devices and rooms or locations, including evidence of the operator who performed the reprocessing, the reprocessing agent, and / or evidence data of the reprocessing equipment, and the date and time of the reprocessing process. • Patient and / or procedure identification data, which may include information that would enable the reprocessing and utilization dataset of reusable medical devices to be linked to the patient's medical record system or personal record system for hygienic traceability purposes.

[0055] (Scenario C: Flowchart (Figures 4A and 4B)) The flowcharts in Figures 4A and 4B illustrate an example of Scenario C.

[0056] For example, in block 410, method 400 provides steps for traceability and documentation of reprocessing compliance with sanitary laws, guidelines, standards or internal standard operating procedures for fixed reusable medical devices of different types and associated environments (MRI, CT equipment and other such rooms and environments).

[0057] In one embodiment, in block 412, Method 400 performs the step of collecting reprocessing data for fixed reusable medical devices and / or environments, either directly or manually (e.g., using a scanning device or by manual input). Furthermore, in block 414, Method 400 performs the step of collecting patient / treatment use information for each of the fixed reusable medical devices. After collection, in block 416, Method 400 performs the step of uploading the respective reprocessing and use data for the fixed reusable medical devices and / or environments to a centralized application. Next, in block 418, Method 400 performs the step of aggregating and processing the respective reprocessing and use data for the fixed reusable medical devices and / or environments. Next, in block 420, Method 400 performs the step of presenting reprocessing compliance data and fixed reusable device traceability data. Next, in block 422, Method 400 performs the step of presenting an evaluation of the respective hygiene practices for the fixed medical devices / rooms. Furthermore, in block 424, method 400 performs a step of notifying or warning of risks based on an assessment of hygiene practices evaluated against the Controlling Hygiene Law, Standard or Guidelines. Next, in block 426, method 400 performs a step of notifying or warning of the status of fixed medical devices or rooms (e.g., availability). Furthermore, in block 428, method 400 performs a step of persistently tracking data for traceability and risk management purposes.

[0058] (Scenario D: Room sanitation reprocessing) (Summary) The following examples illustrate additional features of extensions indicating sanitary reprocessing and replacement of patient rooms (including hospital rooms and locations, as well as other publicly used rooms such as hotel rooms and public restrooms).

[0059] For example, Method 400 uses a mobile electronic device capable of connecting to a network using direct connection, Wi-Fi®, or telecommunications (e.g., 4G®) to transmit room or location-specific identification information, room or location reprocessing information, reusable medical device usage information, patient or user information, and date / time information to a centralized application that aggregates, processes, and presents notifications of hygiene activities that present risks to patients or users, indicated by control laws, standards, guidelines, infection control requirements, and / or room availability after reprocessing is complete, and the notifications include: • Unique room or location ID, including RFID, barcode, or other numbering systems. • Evidence of the operator or cleaner who performed the reprocessing, the reprocessing agent, and / or evidence data of the reprocessing equipment, as well as reprocessing data for the room or location, including the date and time of the reprocessing process. • Usage data for a room or location, which may include information regarding the date and time of use. Patient and / or user identification data, including information that enables the use of datasets to be linked to the patient's medical record system or personal record system for hygiene traceability purposes. If the infection status of the patient or user is known, the patient or user data would include the patient's known specifications or risk assessment indicators.

[0060] (Scenario D: Flowchart (Figures 5A and 5B)) The flowcharts in Figures 5A and 5B illustrate an example of Scenario D.

[0061] For example, in block 510, method 500 provides steps for traceability and documentation of reprocessing compliance with sanitation laws, guidelines, standards or internal standard operating procedures for rooms / locations including hospitals / clinics / other medical offices, bathrooms, hotel rooms, waiting rooms, etc.

[0062] In one embodiment, in block 512, Method 500 performs the step of collecting room, room usage, and room rotation data (e.g., using a mobile scanning device or by manual input). Furthermore, in block 514, Method 500 performs the step of collecting hygiene, user, patient, and treatment information for each room (relevant only if the room was used for treatment). After collection, in block 516, Method 500 performs the step of uploading the data for each room or location to a centralized application. Next, in block 518, Method 500 performs the step of aggregating and processing the reprocessing and usage data for each room / location. Next, in block 520, Method 500 performs the step of presenting evidence-based tracking and hygiene compliance information for each room / location. Subsequently, in block 522, Method 500 performs the step of presenting an assessment of hygiene practices for each room / location equipped with reusable medical devices. Furthermore, in block 524, Method 500 performs a step of notifying or warning of risks by evaluating hygiene practices in each room / location against the Management Hygiene Law, Standard or Guideline. Furthermore, in block 526, Method 500 performs a step of notifying or warning of room conditions (e.g., vacancy status, problems, etc.). Furthermore, in block 528, Method 500 performs a step of permanently tracking data for traceability and risk management purposes.

[0063] While the systems and methods described above have been applied to reusable medical devices and reprocessing in all the examples above, the same concepts can be applied to tracking the necessary reagents or chemicals required by medical devices. For example, if it is later discovered that a particular chemical used in reprocessing is contaminated or expired, this additional information can be entered into the system, the correlation can be re-executed to find the affected reusable medical devices and patient records, and corrective actions and warnings can be generated as needed.

[0064] Other examples relate to changes in treatment standards. For instance, if a record plan is deemed inadequate for infection control, information on new requirements for disinfection procedures can be updated, and all non-compliant reusable medical devices can be identified and scheduled for reprocessing under the modified treatment standards.

[0065] The technologies described above are suitable for use in hospitals, clinics, dental offices, and facilities performing ultrasonic procedures, CAT scans, and other treatments. While the term "reusable medical device" is used throughout, it can be used more broadly to describe rooms containing instruments or equipment, each element of which requires its own reprocessing standards. Different rooms may also be designated with different treatment standards depending on whether they are located in a contaminated or clean area, in relation to specific issues such as coronavirus or other infectious diseases.

[0066] In addition to correlations for identifying corrective actions and generating warnings, a reporting function is proposed that enables KPI scanning, baseline establishment, performance determination for locations such as hospitals, and verification of best practices. For example, data uploaded from multiple hospitals can be correlated to identify, for instance, incorrect disinfection counts and provide an automated weekly score for that hospital or facility.

[0067] Other devices, including stethoscopes, blood pressure sensors, and thermometers, are ready for use with this system and can be tagged and tracked using the system.

[0068] Furthermore, any of the techniques described herein can be applied to the disinfection of emergency vehicles, including but not limited to ambulances. For example, the use of validated cleaning agents and other materials may be used to scan emergency vehicles.

[0069] Figures 6A–6G are graphical user interfaces 600A–600G for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices. In particular, Figures 6A–6G show an example of logging noncritical procedures. As illustrated, logging noncritical procedures requires that the user provide information about the procedure, which is obtained by scanning the accession code of the procedure, scanning the code that identifies the reusable medical device, and verifying the information logged. In particular, the collected information indicates that low-level disinfection was performed, and the Spalding classification of the procedure indicates contact with healthy skin.

[0070] Figures 7A–7G are graphical user interfaces 700A–700G for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices. In particular, Figures 7A–7G show an example of recording a semi-critical procedure. In this example, additional information is needed to verify the semi-critical procedure. Specifically, the collected information indicates that low-level disinfection was performed, the Spalding classification of the procedure indicates contact with mucous membranes or intact skin, and leads to prompting the user to enter an employee ID to confirm critical notes regarding probe adjustment shown in Figure 7B1. In other embodiments, a number of different queries may be performed by the user interface to collect other information regarding the semi-critical procedure.

[0071] Figures 8A to 8G are graphical user interfaces 800A to 800G for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices. In particular, Figures 8A to 8G show an example of recording a critical procedure that has been highly disinfected with a probe cover (sterile sheath). In this example, additional information is needed to verify the critical procedure. Specifically, the collected information indicates that high-level disinfection was performed. The Spalding classification of the procedure indicates contact with sterile tissue and leads to further questions. First, the user interface in Figure 8B1 inquires about the use of a sterile sheath, and if the answer is "Yes," proceeds to Figure 8C. In other embodiments, a number of different inquiries may be made by the user interface to gather other information regarding the critical procedure.

[0072] Figures 9A–9G are graphical user interfaces 900A–900G for a traceability and hygiene compliance management system for the reprocessing of reusable medical devices. In particular, Figures 9A–9G show an example of recording a critical procedure that has been highly disinfected without a probe cover (sterile sheath). In this example, additional information is needed to verify the critical procedure. Specifically, the collected information indicates that a high level of disinfection was performed, and the Spalding classification of the procedure indicates contact with sterile tissue, leading to further questions. First, the user interface in Figure 9B1 queries about the use of a sterile sheath, and if the answer is "No", it proceeds to Figure 9B2, which prompts the user to enter an employee ID to confirm that important notes regarding probe preparation shown in Figure 9B2 are indicated. In other embodiments, a number of different queries may be made by the user interface to collect other information regarding the critical procedure.

[0073] Figures 10A and 10B are graphical user interfaces 1000A-1000G of a traceability and hygiene compliance management system for the reprocessing of reusable medical devices. In particular, Figures 10A-10G show examples of different warnings generated by the system, with Figure 10A being the left side of the graphical interface table and Figure 10B being the right side of the graphical interface table. As shown in Figures 10A and 10B, notifications are generated based on information collected regarding procedures, disinfection, and patients. For example, the fourth procedure listed is a critical procedure that failed with probe serial number USP015. In one embodiment, the notification triggers information that causes the probe to be reprocessed so that it can be used for further procedures.

[0074] Figure 11 is a flowchart summarizing the traceability method 1100 according to many embodiments of this disclosure. In one or more embodiments, the system verifies safe reuse against hygiene standards for reusable medical devices and environments, and advantageously, the system reduces the risk of cross-contamination of patients through risk event warning notifications, evidence-based safe use indications for devices and environments, and data leading to insights into infection prevention measures implemented in the medical environment and devices, provides evidence-based reprocessing documentation, and links evidence-based reprocessing to patient treatment to support risk mitigation. Specifically, in block 1110, method 1100 considers hygiene standards such as Spalding classification guidelines. In block 1120, method 1100 performs verification of the reprocessing method. In block 1130, method 1100 ensures reprocessing requirements for reusable medical devices or environments. In block 1140, method 1100 verifies this information to provide traceability as described above. In block 1150, method 1100 links to patient treatment.

[0075] Therefore, from a medical device perspective, as shown in Figures 1-11, this technology allows point-of-care clinicians / cleaning technicians to advantageously identify patient procedure identifiers for linking reusable medical device unique IDs used in the classification of medical procedures or environment types, procedure or environment unique IDs, reprocessing actions performed before the procedure (including active agents or consumables used in the reprocessing process, critical parameters, contact time, and other validations), and reprocessing events of reusable medical devices to specific patients, and to calculate responses to compliance according to management hygiene standards and guidelines. From a hygiene compliance perspective, the integrated approach of this technology enables progress that goes beyond the limitations of conventional technologies that do not consolidate procedure and reprocessing information into specific actions taken to reduce cross-contamination, etc.

[0076] For example, if the reduction in logs resulting from reprocessing events is insufficient to meet the classification of this reusable medical device and procedure or the hygiene standards for the medical environment, the systems in Figures 1-11 are beneficial in alerting clinicians / cleaning technicians before performing any procedures or environments before making the environment available to the next person, and reminding them to meet the hygiene standards and guidelines that define the jurisdiction, equipment and procedure classifications.

[0077] Furthermore, if clinicians / cleaning technicians wish to accept this risk, they will need to record employee IDs and proceed with recording this non-compliance event. Conveniently, as illustrated in Figures 1–11, the non-compliance event will automatically trigger a real-time notification of the non-compliance to supervisors to limit exposure risk and assist in reprocessing compliance workflow management. The automated alert can be used to stop the circulation of medical devices to prevent cross-contamination.

[0078] Furthermore, when clinicians / cleaning technicians log compliance events, the system favorably collects, links, and stores verified medical device reprocessing cycles and events to provide documentary evidence, in addition to logic, to ensure workflow compliance and accuracy for clinicians and cleaning technicians, thereby improving patient safety.

[0079] In one or more embodiments, as described above with respect to Figures 1-11, the logged information is collected via a series of mobile devices and, optionally, from the reprocessing medical device itself, and this information is transmitted to a cloud-based application operated to provide infection prevention risk management reports, compliance reports for reprocessing, asset utilization and management reports, reprocessing reports, reprocessing personnel reports, digital logbooks, and other information to support best patient care. For example, the centralized database described above would hold information uploaded from all reprocessing devices and point-of-care devices.

[0080] Furthermore, the techniques shown in Figures 1-11 enable environmental reprocessing to provide evidence of reprocessing workflow compliance and essential pathogen log removal, as required by the selection of environment type, known contamination risk, reprocessing action, active agents used, cleaning technician ID, and location ID. Before and after environmental reprocessing, cleaning technicians will scan for active agents, take time-stamped photographs to confirm contact time, and perform surface exposure or other scans to indicate a reduction in pathogen logs.

[0081] As a further explanation of the technological advantages shown in Figures 1-11, the discussion begins with the classification of patient procedures or the risk of environmental contamination, then triangulates the requirements of standards and guidelines, reusable equipment / environment, and the requirements for reducing reprocessing logs, to provide verified evidence to ensure that the reprocessing workflow for reusable medical devices or environments is managed in accordance with control methods, standards, guidelines, and manufacturer instructions to ensure patient protection.

[0082] The specific advantages realized by the technologies shown in Figures 1-11 include:

[0083] The system may maintain a database of hygiene standards and guidelines, divided into specific details of procedures and environmental classification requirements;

[0084] The system may maintain a database of reusable medical devices, separate specific manufacturing requirements for reprocessing, storage, and use for each device, and separate systems for linking the use of these reusable medical devices to patient treatment and reprocessing events;

[0085] The system may have a database of the medical environment and specific reprocessing requirements, a method for acquiring, verifying, and storing reprocessing events, and linking them to patient treatment and reprocessing events;

[0086] The system may maintain a database of reprocessing medical devices, separate these purposes, reusable device compatibility, log deletion functions, and have a method for retrieving, verifying, storing, and linking reprocessing cycles to patient treatment;

[0087] This system may have a database of environmental reprocessing agents, activities, and processes, and a method for retrieving, verifying, and storing reprocessing data and linking it to specific environmental and patient treatments;

[0088] The system may guide clinicians / cleaning technicians at point of care (POC) and within the environment through compliant reprocessing procedures for specific reusable medical devices / environments, procedure / environment classifications, and patient procedures / use methods, helping to reduce non-compliance by clinicians and cleaning agents, thereby reducing the risk of patient cross-contamination, by obtaining verified evidence of compliance to reduce pathogen logs to meet hygiene standards and guidelines for facility locations and activity routes through real-time alerts and notifications via workflow management;

[0089] This complex task will be accomplished by identifying the jurisdiction of standards and guidelines, the reusable medical devices used or the environment to be reprocessed, the classification of procedure hygiene requirements or environmental contamination risks, highly specific instructions from reusable medical device manufacturers for reprocessing or reprocessing requirements for specific environments, and date / time / operator / chemical / verification data for reprocessing events. Using complex algorithms, the AP system will instruct clinicians and cleaning technicians through the reprocessing compliance workflow to verify the necessary pathogen log reduction requirements for safely performing patient procedures or reusing environments, warn them of non-compliant activities, and alert supervisors and managers of risk events confirmed by approval from clinicians or cleaning technicians or by system failure. Note that the reprocessing requirements for the environment example are the opposite of those for reusable medical devices, in that the need for environmental reprocessing depends on the risk of previous human contamination, and for reusable medical devices, it will depend on the exposure risk to the patient on whom the device is used. For example, consider a vascular access scenario in which airborne bacteria fall onto the surface of the device, enter the bloodstream through contact, and cause a septic reaction.

[0090] A further advantage lies in patient acceptance. In one example of this technology, clinicians can display the sanitary status of reusable medical devices to patients before use. By reviewing the sanitary data, patients can digitally accept the use of the device, significantly improving the patient-caregiver relationship.

[0091] In summary, as is generally stated, in one embodiment, a method for compliance (e.g., compliance workflow management) of reprocessing of reusable medical devices and a system for implementing the method are described herein. For example, the method includes the steps of: reprocessing the reusable medical device before performing a second medical procedure and after performing a first medical procedure using a reprocessing procedure, and uploading the reprocessing data for the first reusable medical device. The sanitary status of the reusable medical device is verified before use on a patient to protect the patient from cross-contamination. Reprocessing includes the use of reprocessing equipment such as disinfection of an ultrasound probe, and systems and facilities such as wiping, immersion / spraying with compliant chemicals applied using chemicals, as well as manual methods for using such systems and facilities verified by the method and system. Reprocessing may also include using a process consistent with the manufacturer's instructions. Performing a second medical procedure using a reusable medical device from among several reusable medical devices and uploading the first medical procedure data for the first medical procedure. Interactively verifying the reusable medical device for the second medical procedure before performing the second medical procedure. Interactive verification includes querying the procedure details of the second medical procedure and providing instructions based on those details. It involves performing the second medical procedure using reusable medical devices and uploading the second medical procedure data. It automatically generates alerts based on comparing the first medical procedure data, the procedure details and second medical procedure data, and the reprocessing data with multiple hygiene standards, with the alerts indicating non-compliance with at least one of the hygiene standards.

[0092] In one example, a warning informing a clinician that a reusable medical device does not meet standards is generated for the clinician before they use the reusable medical device. In another example, if a clinician accepts the risk of non-compliance, this logs the risk event and notifies administrators in real time for prompt risk assessment and course correction. For example, a warning may be based on the identified sanitary conditions of the reusable medical device and details of the second action. Furthermore, a warning may be based on a violation of the manufacturer's instructions (for example, an ultrasound device may be reusable according to sanitary standards after passing through a high-temperature steamer, but this damages the device and goes against the manufacturer's instructions for use, thus triggering a warning).

[0093] In one embodiment, the method further includes determining at least one other medical procedure performed using a reusable medical device and generating an alert identifying that at least one other medical procedure poses a risk of cross-contamination. In another embodiment, one or more mobile devices are used to upload data to a centralized application, which automatically generates the alert. In a further embodiment, the method further includes analyzing data from past medical procedures and multiple reusable medical devices to determine a reprocessing compliance baseline, including past compliance levels for one or more criteria, and generating an alert based on the determination that future medical procedures and reprocessing data for multiple reusable medical devices deviate from past compliance levels. For example, the use of wipes, chemical sprays, chemical soaks, etc., is verified based on compliance with relevant hygiene standards. Such a method may be verified by reviewing when and how the method was performed and its relevant documentation.

[0094] In one embodiment, the method further includes analyzing control methods, standards, guidelines, and instructions for use regarding the use of reusable medical devices to determine a baseline for reprocessing compliance. In other embodiments, reprocessing further includes a reprocessing device that automatically uploads reprocessing data. In further embodiments, reprocessing further includes a reusable medical device that automatically uploads reprocessing data.

[0095] In one example, the reusable medical device automatically uploads first and second treatment data. In another example, the method further includes determining the risk from the first patient to the second patient, for example, due to cross-contamination. In yet another example, the reusable medical device is a mobile reusable medical device.

[0096] In other embodiments, the method and system demonstrates to the patient reprocessing compliance and / or environmental compliance (to relevant hygiene standards) of a reusable medical device. The method and system protect patients in a healthcare environment who, despite their independent health status, may be exposed to the risk of cross-contamination, in order to manage workflow compliance to better protect patients from cross-contamination. The method includes the following steps: Reprocessing a reusable medical device after performing a first medical procedure using a reprocessing procedure and uploading the first reprocessing data for the reusable medical device. Interactively verifying the reusable medical device for the second medical procedure before performing the second medical procedure, and interactive verification includes querying for procedure details of the second medical procedure and providing instructions based on the procedure details of the second medical procedure. Receiving a verification message confirming that the reusable medical device complies with hygiene standards. Displaying the verification message to the patient. Performing the second medical procedure using the reusable medical device and uploading the second medical procedure data for the second medical procedure. The system automatically generates warnings based on a comparison of the first medical procedure data for the first medical procedure, the procedure details and second medical procedure data for the second medical procedure, and reprocessing data with multiple hygiene standards. The warnings indicate non-compliance with at least one of the multiple hygiene standards.

[0097] This specification describes embodiments with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments. It will be understood that each block in the flowcharts and / or block diagrams, as well as combinations of blocks in the flowcharts and / or block diagrams, can be implemented by computer-readable program instructions.

[0098] These computer-readable program instructions may provide processors for general-purpose computers, dedicated computers, or other programmable data processing equipment for generating machines such that instructions executed via a computer processor or other programmable data processing create means for performing functions / actions specified in flowcharts and / or block diagram blocks or blocks. These computer-readable program instructions may also be stored in computer-readable storage media so that computers, programmable data processing equipment, and / or other devices function in a particular way such that the computer-readable storage medium on which the instructions are stored contains products that include instructions performing modes of functions / actions specified in flowcharts and / or block diagram blocks.

[0099] Computer-readable program instructions can also be loaded onto a computer, other programmable equipment, or other device to generate a process performed on a computer, other programmable equipment, or other device, in which a series of operational steps are executed on the computer, other programmable equipment, or other device, so that the instructions executed on the computer perform the functions / operations specified in the blocks of the flowchart and / or block diagram.

[0100] The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments. In this regard, each block in a flowchart or block diagram may represent a module, segment, or part of an instruction containing one or more executable instructions for performing a specified logical function. In some alternative implementations, the functions described in a block may differ from the order shown in the figure. For example, depending on the functions involved, two blocks shown consecutively may actually be executed substantially simultaneously, or the blocks may be executed in reverse order. It should also be noted that each block in a block diagram and / or flowchart, and any combination of blocks in a block diagram and / or flowchart, can be implemented by a dedicated hardware-based system that performs a given function or operation, or by executing a combination of dedicated hardware and computer instructions. [Configuration 1] A method for compliance management of the reprocessing of reusable medical devices, Before performing the second medical procedure and after performing the first medical procedure, the reusable medical device is reprocessed using a reprocessing procedure, and the first reprocessing data of the reusable medical device and the first medical procedure is uploaded. Before performing the second medical procedure, interactively verify a reusable medical device for the second medical procedure, wherein the interactive verification includes querying the procedure details of the second medical procedure and providing instructions based on the procedure details of the second medical procedure. Performing the second medical procedure using the reusable medical device, uploading the data for the second medical procedure, and Automatically generate a warning based on comparing the first medical procedure data of the first medical procedure, the procedure details and second medical procedure data of the second medical procedure, and reprocessing and process data with a plurality of hygiene standards, wherein the warning indicates a non-compliance with at least one of the plurality of hygiene standards. A method that includes doing so. [Configuration 2] The method according to configuration 1, further comprising identifying at least one other medical procedure performed using the reusable medical device and generating a warning that identifies at least one other medical procedure as having a risk of cross-contamination. [Configuration 3] The method according to Configuration 1, wherein one or more mobile devices are used to upload data to a centralized application, and the centralized application or the mobile devices automatically generate the warning. [Structure 4] The method according to Configuration 1, comprising reprocessing data of the plurality of reusable devices to analyze past medical procedures and identify a reprocessing compliance baseline, wherein the reprocessing compliance baseline includes past compliance levels of one or more criteria, and further comprising identifying future medical procedures for the plurality of reusable medical devices and generating the warning based on reprocessing data of the plurality of reusable medical devices that deviate from the past compliance levels. [Composition 5] The method according to Configuration 1, further comprising analyzing control methods, standards, guidelines, and directives for the use of reusable medical devices to identify a reprocessing compliance baseline. [Composition 6] The method according to configuration 1, further comprising a reprocessing device that automatically uploads the reprocessed data. [Composition 7] The method according to configuration 1, further comprising automatically uploading the reprocessed data. [Structure 8] The method according to Configuration 1, wherein performing the first and second procedures further includes uploading the first and second procedure data. [Composition 9] The first treatment data includes first patient data, and the second treatment data includes second patient data. The method further includes identifying the risk from the first patient in the first patient data to the second patient in the second patient data due to cross-contamination. The method described in Configuration 1. [Configuration 10] The method according to configuration 1, wherein the reusable medical device includes a mobile reusable medical device. [Composition 11] A system for compliance with environmental or equipment hygiene standards, Centralized applications and, Including one or more mobile devices, The aforementioned one or more mobile devices are The reprocessing data is uploaded to the centralized application, and the reprocessing data relates to the reprocessing procedure of the environment or the equipment. The first action data of the first action relating to the environment or the equipment is uploaded to the centralized application. Before performing the second action, the environment for the second action is interactively verified, and such interactive verification includes querying the details of the second action and providing instructions based on the details of the second action. The second treatment data relating to the environment or the equipment is uploaded to the centralized application. The centralized application automatically generates warnings based on comparing the first treatment data of the first treatment, the treatment details and second treatment data of the second treatment, and the reprocessing data with multiple hygiene standards, the warnings indicating non-compliance with at least one of the multiple hygiene standards. system. [Composition 12] The aforementioned environment is the system described in configuration 11, including emergency vehicles. [Composition 13] The centralized application further identifies at least one other action performed using the environment or the equipment and generates a warning identifying at least one other action as having a risk of cross-contamination, according to the system in configuration 11. [Composition 14] The centralized application further analyzes the control methods, standards, guidelines, and control orders for the use of the environment or equipment that identify the reprocessing compliance baseline, as described in Configuration 11. [Composition 15] The centralized application is the system described in configuration 11, which automatically receives the treatment data. [Composition 16] The centralized application relates to the system according to configuration 11, which associates past treatment data with identifying individuals who are exposed to a sanitary risk due to non-compliance with at least one of several sanitary standards.

Claims

1. A computer-based method for compliance management of the reprocessing of reusable medical devices, A reusable medical device is used during a first medical procedure, reprocessed using a first reprocessing procedure, and before the reusable medical device is used in a second medical procedure. To acquire first reprocessing data of the reusable medical device via the graphical user interface of the scanning device, The scanning device is used to scan a tag attached to the reusable medical device, wherein the tag identifies the reusable medical device. To query the details of the second medical procedure via the graphical user interface of the scanning device, The scanning device automatically analyzes the first reprocessing data and the details of the second medical procedure against at least one hygiene standard. The scanning device is used to automatically transmit a warning based on an analysis of the first reprocessing data and the details of the second medical procedure against the at least one hygiene standard, wherein the warning indicates a non-compliance with at least one hygiene standard. Based on the aforementioned warning, update the device status corresponding to the tag in the central database, the update including an indication that the reusable medical device has been removed from service, Methods that include...

2. The method according to claim 1, further comprising identifying at least one other medical procedure performed using the reusable medical device and generating a warning that identifies at least one other medical procedure as having a risk of cross-contamination.

3. The method according to claim 1, wherein one or more mobile devices are used to upload the first reprocessing data and the procedure details of the second medical procedure to a centralized application, and the centralized application or the one or more mobile devices automatically generate the warning.

4. To identify a reprocessing compliance baseline by analyzing past medical treatment and reprocessing data of multiple reusable medical devices, wherein the reprocessing compliance baseline includes past compliance levels of one or more criteria. To generate warnings based on future medical procedures and identifying reprocessing data for the multiple reusable medical devices that deviate from the aforementioned past compliance levels, The method according to claim 1, further comprising:

5. The method according to claim 1, further comprising analyzing control methods, standards, guidelines and directives for the use of reusable medical devices to identify a reprocessing compliance baseline.

6. The method according to claim 1, further comprising a reprocessing device that automatically uploads the first reprocessed data.

7. The method according to claim 1, further comprising automatically uploading the first reprocessed data.

8. The method according to claim 1, wherein performing the first medical procedure further includes uploading the first medical procedure data.

9. The scanning device automatically analyzes first medical procedure data, wherein the first medical procedure data includes first patient data. To identify the risk from the first patient in the first patient data to the second patient in the second patient data due to cross-contamination, The method according to claim 1, further comprising:

10. The method according to claim 4, wherein the plurality of reusable medical devices include a mobile reusable medical device.

11. A system for compliance with environmental or reusable medical device hygiene standards, Centralized applications and, Including one or more mobile devices, The aforementioned one or more mobile devices are Uploading reprocessing data to the centralized application via a network, wherein the reprocessing data relates to the environment after the first medical procedure is performed or to the reprocessing procedure of the reusable medical device. The procedure details of the second medical procedure can be viewed via a graphical user interface before the second medical procedure is performed. To transmit instructions based on the details of the second medical procedure via the graphical user interface, Uploading the second medical procedure data relating to the environment or the reusable medical device to the centralized application via the aforementioned network, It is configured to perform, The centralized application automatically sends a warning based on comparing the procedure details and the second medical procedure data of the second medical procedure, as well as the reprocessing data, with a plurality of hygiene standards, the warning indicating a non-compliance with at least one of the plurality of hygiene standards. system.

12. The system according to claim 11, wherein the environment includes an emergency vehicle.

13. The system according to claim 11, wherein the centralized application further identifies at least one other procedure performed using the environment or the reusable medical device and generates a warning identifying at least one other procedure as having a risk of cross-contamination.

14. The system according to claim 11, wherein the centralized application further analyzes the management methods, standards, guidelines and regulations for the use of the environment or the reusable medical device to identify a reprocessing compliance baseline.

15. The centralized application automatically receives the second medical treatment data, according to claim 11.

16. The system according to claim 11, wherein the centralized application associates past treatment data with identifying individuals who are exposed to a sanitary risk due to non-compliance with at least one of several sanitary standards.

17. Based on the aforementioned warning, the reusable medical device shall be reprocessed using the second reprocessing procedure, The second reprocessing procedure is determined to comply with at least one of the hygiene standards, In accordance with the determination that the second reprocessing procedure complies with at least one of the hygiene standards, the reusable medical device is put into service, The method of claim 1, further comprising:

18. The method according to claim 17, wherein the second reprocessing step is determined based on the details of the second medical procedure.

19. The system according to claim 11, wherein obtaining the details of the second medical procedure is performed by the user.

20. The system according to claim 11, wherein the reprocessing data includes the disinfection or sterilization status of the environment or the reusable medical device after the first reprocessing procedure of the environment or the reusable medical device has been performed.

Images