심스테크

Dr.Tracking

SIMSTECH's 'Dr. Tracking' is a digital reusable surgical instruments management system that includes an entire business process, which automatically records usage history of a series of infection prevention processing tasks for each instrument, in order to ensure that patients in hospitals are safe from any possible medical infections.

‘Dr.Tracking’ ensures transparency that reusable surgical instruments required by all departments within a hospital can be delivered accurately and quickly at the right time and place with getting rid of any infection risk.

Under laws globally, it is a requirement that all reusable medical devices used on a patient are sterile.

All reusable medical devices must be traceable as to when, how, and by whom they were used. This is because if an infection occurs in a patient after surgery, the hospital must provide evidence that each device has undergone an appropriate sterilization process.

Searching through paper forms is a quite difficult task. Instead, ‘Dr.Tracking’ makes it possible to directly trace for individual medical devices through the entire reprocessing cycle starting from decontamination, cleaning, packaging, sterilization, storage, and up to return after surgical use.

‘Dr.Tracking’ enables complete traceability management of reusable medical devices, which results in increased work efficiency in the event of an emergency and ultimately regulatory compliance for medical infection prevention.

Technology & System

'Dr.traking' mainly consists of 3 following technologies and its systems

01

UDI (Unique Device Identifier) Marking System

In order to guarantee the traceability management of reusable medical devices, an efficient method to track individual medical devices is needed. Global medical device standard code (Unique Device Identifier) ​​regulations are strictly controlled by International Medical Device Regulatory Forum (IMDRF). In line with this, in Korea, in accordance with the Enforcement Rules of the Medical Device Act (Prime Minister Decree No. 1512), medical device standard codes are attached and integrated for each medical device class, starting from Stage 4 from July 1, 2019, and Stage 1 from July 1, 2022. Accordingly, ‘Dr.Tracking’, as a core technology, provides on-device Direct Part Marking (DPM) technology that meets standard code regulations and stores unique information on medical devices efficiently.

Data Matrix is ​​a type of barcode and is a two-dimensional matrix code that can store a large amount of data in a small space. Each medical device is engraved on its surface to identify unique information. Using the ECC200 2D code, the latest version of the Data Matrix standard that adopts the data restoration function, two types of data structures, square and rectangular, are applied depending on the size and shape of the medical device requiring engraving. The square type is applied to general medical devices, but the rectangular type is applied to medical devices for which square type marking is difficult due to their small size or circular structure.
UDI Direct Part Marking System

02

UDI (Unique Device Identifier) Analysis System

The technology, which can acquire and recognize unique information stored on individual reusable medical devices, enables automatic recording of usage history and tracking of real-time locations, results in maximized traceability efficiency. Accordingly, ‘Dr.Tracking’ provides a technology combining 2D Data Matrix and AI Computer Vision, which is not only easy to apply to all types of medical devices with high durability and low operating costs, but also to recognize large amounts of data at once.

A Machine Vision system is applied to recognize and process the Data Matrix information engraved on a large amount of individual medical devices as images at once. The Machine Vision system basically consists of an optical system that reads images and a system (PC, board, monitor) that stores and processes images transmitted from the optical system. Additionally, the optical system consists of a camera, lens, and lighting. The configuration and environmental settings of the optical system used in this study are as follows.
YOLO, the latest deep learning technology for AI Vision, is the main technology for analyzing the Data Matrix. YOLO uses the images read and stored through machine vision, then identifies actual location of objects called Data Matrix, and finally generates unique code for individual medical devices.

It is the most important success key factor that work efficiency in hospitals can be increased by maximizing the data throughput processed in limited time and space. Accordingly, ‘Dr.Tracking’ employs a such technology combining Data Matrix and AI Computer Vision, which simultaneously recognizes the unique information of large quantities (100 to 200) of reusable medical devices at once. Currently, No other competitors in the market have implemented the technology.

03

Surgical Instruments Management System – Software Platform

Recycling of reusable medical devices in hospitals generally follows the standard step-by-step process to comply with sterilization guidelines. The recycling work processes largely consists of seven steps: incoming (return), washing, packaging, sterilization, storage, outgoing (dispatch), and usage. ‘Dr.Tracking’ is a software platform that provides complete traceability to automatically create and store data at each stage of the recycling processes. Through the platform, workers at hospitals can check the flow status of all reusable medical devices through instant stored data inquiry anytime, anywhere, and can smoothly manage work at each stage.

Features

  1. Identification of reusable medical devices

    Assigning a unique identification code with 2D Data Matrix,
    each medical device can be identified and its location can be tracked in real time.

    01

  2. Real-time Emergency Tracking

    By tracking the patient-related usage history of each medical device,
    you can respond quickly if a infection problem arises.

    02

  3. Real-time Inventory Management

    Track and manage the inventory status of medical devices in real time.
    If necessary, order and stock them to prevent inventory shortages.

    03

  4. Maintenance management

    Track and Manage the maintenance status of each medical device.
    This maintains the performance of medical devices and ensures safety.

    04

  5. Notification and warning

    Provides notifications about important safety matters such as the expiration date of each medical device. This allows medical
    staff to respond to medical risks in a timely manner.

    05

  6. Reports and analysis

    Analyze usage history and maintenance-related data to identify opportunities
    for improving inventory efficiency and cost.

    06

Work Flow - Central Sterile Supply Department (CSSD)

Central Sterile Supply Department (CSSD), mainly in charge of recycling of reusable medical devices, generally follows the 7 standard stages complied with national sterilization guideline: incoming(return), washing, packaging, sterilization, storage, outgoing(dispatch), and usage.

Reusable medical devices returned to CCSSD are first washed, newly packaged as a set, and once sterilization suitable for the package property is completed, they are stored in a storage room or shipped to departments requesting for. The packages follow endless cycles, where they are shipped from CSSD and returned to CSSD again after being used at the requesting departments.

At this time, ‘Dr.Tracking’ automatically stores data at each stage of the recycling process. The information stored includes the actual completion time of individual device at each stage, the person in charge of processing, and patient-related information. Workers in hospitals can check the flow of all reusable medical devices and smoothly manage work at each stage by immediately searching stored data anytime and anywhere.

In order to accurately recognize individual medical devices at each stage, ‘Dr.Tracking’ utilizes a mixture of RFID and Data Matrix technologies.

01

RFID

A wireless communication is used to recognize information of sets that have already been packaged. A RFID tag is inserted when packaging a set. The individual medical devices composing of the set are registered when packaging is completed in the packaging stage. After then, information of the individual medical devices that make up the set can be automatically recognized through the set information. RFID is used to recognize set information during the sterilization, storage, and outgoing (dispatch) stages, where only the packaged sets are carried over.

02

Data Matrix

AI Computer Vision is used to recognize information engraved on the surface of individual medical devices. At the both of Incoming (return) and Packaging stages, where unpackaged trays are carried over, each individual medical device is recognized to accurately determine whether it is missing or not.

At the Incoming (return) stage, it is checked whether the medical devices are correctly returned or not. An immediate alarm is brought if any missing devices found.

At the Packaging stage, it is checked whether the medical devices are correctly composed or not. Likewise, an immediate alarm is brought if any missing devices composing of a set found.