2018/11/15

DGSHAPE Announces Surgical Instrument Reprocessing Solution

Hamamatsu, November 15, 2018 -

DGSHAPE Corporation, a wholly-owned subsidiary of Roland DG Corporation and a leading provider of digital fabrication tools, including 3D milling machines, 3D printers, and engraving machines, announced today the launch of Eirthemis, a complete surgical tool reprocessing and management system for healthcare facilities. The software solution is made up of three individual odules: “Eirthemis MD”, “Eirthemis KT” and “Eirthemis BI Manager”.

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Eirthemis applies the technology and know-how of “Digital Yatai” (* 1) used at Roland DG production sites to manage the usage history and maintenance records of surgical instruments in hospitals nationwide. This is a surgical instrument management solution developed in collaboration with Hamamatsu Medical University Hospital for the purpose of improving the efficiency of their surgical instrument reprocessing.

Information on the 3 individual software modules can be found here (content in Japanese).

  • Eirthemis MD(Master file Data base)
    • This is basic database software that enables the search and display of work instructions in digital format
  • Eirthemis KT(KumiTate)
    • Software that enables individual device management using 2D barcodes (Unique Device Identifiers)
  • Eirthemis BIManager(Business Intelligence Manager)
    • Software that displays various data obtained by operating Eirthemis MD / KT in visual graphs and charts
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 Current status of maintenance and management of surgical instruments in hospitals

Currently, maintenance and management of surgical instruments involves preparation of “surgery sets” - bundles of specific tools for a given medical procedure. However, there can be hundreds of “surgical sets” to prepare. In addition, there are many types of surgical instruments required for a “surgical set”, and most surgical instruments do not have a mark that identifies the instrument, such as model number or manufacturer. Therefore, the identification of surgical instruments relies on the operator's visual judgment. In addition, each surgical instrument has a detailed handling method, but work instructions are largely based on ambiguous paper manuals, and work quality is greatly influenced by the level of proficiency of the worker. As a result, there is a daily occurrence of “set mistakes” in which surgical instruments cannot be used normally due to “work quality variation” or “handling”, and the necessary surgical instruments are not prepared. If these events occur during surgery, it may lead to emergency cancellations and in the worst case a surgical site infection, so the preparation of the surgical set is very important for safe surgery. Most reprocessing departments require a learning period of at least two years to be able to know all the methods of identifying and handling equipment and to carry out all operations stably. Because there is little consistency in device management from location to location, there is no industry standard for reprocessing, the total number of instruments used in the hospital can be difficult to determine, and device usage history is poorly managed.

Eirthemis Trial Results

Eirthemis digitized paper work instructions in the department and allowed for the addition of detailed notes per surgical set. In order to comply with the worldwide UDI (Unique Device Identification) regulations, DGSHAPE brought in its MPX-95 impact printer to mark 2D barcodes on surgical instruments, and its MR-1 touchless scanner to identify the equipment and provide work instructions. The digitized work instructions have been devised to display how to handle surgical instruments. This makes it possible to build a work environment that is mistake-free, without depending on worker knowledge, displaying the work instructions necessary for selecting and setting equipment. In addition, when Eirthemis was introduced, all surgical instruments were marked so that existing inventory is calculated. As a result, it is possible to grasp the total number of surgical instruments in hospitals, which has been unclear until now, as well as the operation rate of surgical instruments and surgical sets through operation. By accumulating and analyzing data, inventory optimization and cost reduction effects can be expected such as eliminating the need for new equipment purchases, thereby lowering costs for the facility.

Eirthemis contributes to the realization of a work environment that does not depend on "tribal knowledge" for the management and maintenance of surgical instruments.

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The Eirthemis Story...

In recent years, many medical institutions in Japan and overseas have faced challenges such as management of surgical instrument usage history (traceability management) and improvement of maintenance work quality and efficiency. The movement of regulatory authorities to identify the distribution route of surgical instruments and to thoroughly manage the use history in hospitals is also emerging worldwide. In the United States, the UDI regulation that mandates the display of a unique identifier on the main body of surgical instruments has been enforced in stages since September 2014 for all surgical instruments. In the US, UDI labeling will be mandatory for all surgical instruments and devices by 2022, and surgical instruments and instruments that do not have labels will no longer be available for distribution. In Europe, the obligatory decision was made in 2017, and the labeling of all surgical instruments and devices is required by 2027. In Asian countries including Japan, labeling is expected to be mandatory within a few years.

In the future, surgical instrument maintenance and usage records will become mandatory, and the spread of systems for managing surgical instruments is expected to expand worldwide.

Roland DG released the MPX-90M, the world's first marking device for two-dimensional dot-pin type barcodes on surgical instruments.The MPX-95 was released in 2016 as a successor unit, and is the perfect device for medical institutions and surgical instrument manufacturers to mark their tools. Whereas the MPX manages device marking, procedures such as disassembly, cleaning, set assembly, and sterilization of surgical instruments and equipment after surgery remain personally dependent on the experience of the operator. Applying the work support system of “Digital Yatai” completes the system and automates the process of tool reprocessing and management.

 

Future Development

Eirthemis is best for medium-sized hospitals with 300-500 beds.

For now, sales of Eirthemis systems are limited to Japan. Other markets are under consideration for future expansion. 

Why "Eirthemis"?

Eirthemis is a combination of Eir (Norse goddess of great medical skill and healing) and Themis (Greek goddess of “law and order”) to create a new medical process control brand combing healing and order.

Created from the desire to contribute to the construction of a stable work environment by assisting work in the medical field in order to practice “imagining the future life through innovation”, which is our corporate philosophy. 

About DGSHAPE

DGSHAPE Corporation designs and manufactures hardware and software solutions for entrepreneurs who want to fulfill their dreams of creating something new to Shape the Future. We cater to multiple industries including: medical, manufacturing, and retail. We help innovators unlock their dreams by removing barriers to creation: through intuitive technology that simplifies the user experience: interface, software, and maintenance, multi-axis rotary milling technologies, and Internet of Things (IoT) analytical platforms. Everything we do is motivated by creating tools for the next great history-maker to Shape Ideas, make innovation, and make life better.  

To learn more about DGSHAPE Corporation, please visit www.dgshape.com 

About Roland DG Corporation

Roland DG Corporation is the world's leading provider of digital printing solutions. The company's inkjet printers, printer/cutters and cutting machines are widely used to create a broad range of promotional items including banners, signs, vehicle graphics, stickers and labels, and to provide customization services for apparel and personal items like smartphone cases. Recently, Roland DG has embarked on a promising new retail frontier by capitalizing on individuals' increasing desire to create their own, uniquely designed and decorated items. The company’s COTO business division has developed proprietary design and print management software which enables customers to design their own gifts, apparel and treasured mementos, and to enjoy an unforgettable creative experience.

For more information, please visit www.rolanddg.com.

(*1)About Digital Yatai

This is a digital cell (single person) production system originally developed by Roland DG Corporation, which is used for machine assembly at our factory. While checking the digital manual displayed on the PC's display, the operator takes out the parts from the carousel that automatically supplies the necessary items for each process, and selects the designated power tool to assemble the product. The system is designed to automate assembly and remove human error while also conducting quality inspections in each process. It is characterized by supporting human memory and attention through the use of digital technology, and simultaneously achieving high quality and high productivity. The work log data for each stand is stored on the server, so that site managers can grasp the work progress and link to improvement activities through data analysis. Another great feature is that the entire factory can be controlled optimally.

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Contact for press

DGSHAPE Corporation Marketing Department

1-6-4 Shintoda, Kita-ku, Hamamatsu, Shizuoka Prefecture 431-2103

Japan TEL: +81 053-482-7069

E-Mail:dgs-marketing@dgshape.com

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Customer Inquiries

DGSHAPE Corporation New Business Planning Office

1-6-4 Shintoda, Kita-ku, Hamamatsu, Shizuoka Prefecture 431-2103

Japan TEL: +81 053-424-6062

E-Mail:eirthemis@dgshape.com

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