On June 9 and 10, 2021, the PoCSpec project team met for the final multi-day working meeting, as the project will end on June 30, 2021. In addition to a review of what has been achieved, the next steps to be taken were also discussed, since editorial work still has to be carried out before the DevSpecs and ModSpecs developed by the project can be published as part of the ISO/IEEE 11073 SDC series of standards, and the further standardization process has to be accompanied until adoption. This work will be carried out under the umbrella of OR.NET e.V. and further supported by the project partners.
In the last two weeks PoCSpec was on the “big stage”: From 25 – 28.05.2021 the joint international meeting of HL7 and the IEEE 11073 Point-of-Care Devices working group was on the agenda. We presented the current status of our draft standards and discussed it with the experts from all over the world. On June 01 and 02, 2021, the focus was on implementations. At the third SDC/SDPi Plug-a-thon of IHE Deutschland e.V., the interoperability of the available software libraries was tested and further improved. These libraries are currently being used for prototype implementations, such as our Device Specializations. Implementations of the first market-ready devices were also involved. Further information can be found at https://confluence.hl7.org/x/EKefBg.
Embedded in an initiative launched by OR.NET e.V., some members of the PoCSpec project are currently participating in a working group that is working on the clarification of approval-relevant issues in connection with networked systems. Following initial individual contacts with test centers and notified bodies, contact has now been established with the IG-NB (Software Working Group). The IG-NB is an association of notified bodies for medical devices, forming a community of interest. The aim of IG-NB is to develop common positions, to coordinate the interests of the German Notified Bodies and to better enforce them vis-à-vis industry and authorities. Currently, the IG-NB has ten Notified Bodies for medical devices as members. The IG-NB is organized by the Verband der TÜV e.V. (Vd TÜV) in terms of organization.
In the first joint meeting, the activities of OR.NET e.V. were presented with regard to openly networked medical devices, SDC Conformance Principles and the MOVE test platform. After the different information and positions were initially exchanged in the further meetings, the current discussion now focuses on the following questions:
- How does one manage to generate trustworthy test tools?
- How does the exchange of certificates work?
- How does ensemble formation work?
- How can the influence on risk management and usability be presented?
- Where does the responsibility of the manufacturer or certification end?
- Where does the responsibility of the operator begin?
In order to be able to offer manufacturers and test bodies a guide in the future, a guidance document is to be jointly developed. A first rough draft is available. This document is to be developed in smaller working groups and later published and maintained under the direction of OR.NET e.V..
The association “OR.NET e.V.: Safe Dynamic Networking in Operating Rooms and Clinics,” which emerged from the BMBF project of the same name, has published a technical report describing principles for medical device approval based on the SDC “Participant Key Purpose” standards on which PoCSpec’s work is based:
Several PoCSpec project participants, including Björn Andersen, Martin Kasparick, Anton Keller, Lorenz Rosenau and Stefan Schlichting, were involved in the preparation of this document.
On October 14th and 15th, the PoCSpec partners met again for a two-day web conference to work together on the SDC draft standards. The main topics included the modeling of an argon source in high frequence surgery, the modeling of foot switches and the description of the endoscopic camera and the endoscopic light source. In addition, the good news could be announced that the extension of the project until June 30, 2021, requested by the partners, has been approved by the funding authority.
We welcome Richard Wolf GmbH as a new partner in the PoCSpec project that further strengthens our expertise in the field of endoscopy.
We are pleased that Todd Cooper (San Diego, USA), an internationally very experienced medical device standardization expert, is now taking part in the PoCSpec project to ensure close coordination with the IEEE standardization processes. Welcome to the PoCSpec team!
Special times call for special measures: Due to the travel restrictions of the COVID 19 pandemic, the PoCSpec partners met on April 1st and 2nd as part of a two-day web conference to continue working on the SDC draft standards for HF surgery and endoscopy work and plan the further course of the project.
On January 21 and 22, 2020, the PoCSpec partners met in the premises of Erbe Elektromedizin in Tübingen to continue working together on the SDC draft standards for HF surgery and endoscopy. The status of the device models achieved so far was discussed with the technical experts, open questions were clarified and the next steps on the way to a complete draft standard were agreed.
During the 6th PoCSpec project meeting, which took place on 3-4 December 2019 in the premises of Dräger in Lübeck, a joint working session was held with representatives of the BMBF-funded project “MoVE” (Modular Validation Environment for Medical Device Networks). Both projects are concerned with the manufacturer-independent, dynamic integration of medical devices based on the ISO/IEEE 11073 SDC standard series, but with different emphases: PoCSpec develops device profiles for the fields of endoscopy and HF surgery, while MoVE develops validators and addresses the issue of medical device certification of dynamically networked devices. During the working session it was clarified which requirements the PoCSpec device profiles have to fulfill from the perspective of a later approval of the devices.
The PoCSpec project team has presented the status of the project on 25 September 2019 during a separate session at BMT 2019 in Frankfurt/Main.
After a brief overview lecture by project coordinator Dr. Marco Eichelberg (OFFIS), Björn Andersen (IMI, University of Lübeck) reported about “ISO / IEEE 11073 Service-oriented Device Connectivity (SDC) for Point-of-Care Medical Device Interoperability”. Jan Schlamelcher (OFFIS) presented “Methods and Tools for Developing SDC Device Specializations”. Anton Keller (AESCULAP), Head of DKE Working Group UK 812.2 “Electromedical Equipment – Therapy, Surgery”, reported on the prospects of “Cross-Vendor Medical Device Interoperability for High Frequency Surgical Systems” and Stefan Klöckner (Olympus Winter & Ibe), head of DKE Working Group UK 812.4 “Electromedical Equipment – Electrooptical Devices” concluded the session with a lecture on “Cross-Vendor Medical Device Interoperability for Endoscopic Camera / Visual Systems”.
BMT 2019 (“Biomedical Technology”) was organised as a three-country conference D-A-CH by the German Society for Biomedical Engineering (DGBMT) within VDE, the Austrian Society for Biomedical Engineering (ÖGBMT) and the Swiss Society for Biomedical Engineering (SGBT).
The international IEEE experts in the field of point-of-care medical device interoperability met from May 6th to May 10th 2019 in Montréal, Canada, in conjunction with the HL7 International Conference & Working Group Meeting. Anton Keller (Aesculap), Martin Kasparick (University of Rostock) and Stefan Schlichting (Dräger, associated partner) represented the PoCSpec project, supported by additional project partners attending via web conference. Our team presented the current project progress on Device Specialisations for IEEE 11073 Service-oriented Device Connectivity (SDC) based networked surgical devices and received very positive feedback
The second PoCSpec project meeting on 26 and 27 February 2019 at the KARL STORZ Visitor Center in Tuttlingen aimed to promote a common knowledge of all project participants. Tutorials and practical “hands-on” exercises on endoscopy, HF surgery and IEEE 11073 SDC provided the basis for an intensive exchange between the 25 participants.
The project “PoCSpec – Modular Specializations for Point of Care Medical Devices” has started with a two-day kick-off meeting at the OFFIS Institute for Information Technology on 9 and 10 January 2019.