Interoperability standards for medical device integration in the OR and issues relating to international approval procedures

Part 1: The Digital Operating Room

by Heinz U. Lemke

The advances in medical technology, specifically information technology (IT), in the last quarter of the 20th Century have produced extraordinary changes in the way medicine, and in particular surgery, is practiced. These advances have not been without certain drawbacks and shortcomings including escalating healthcare costs and the challenge to handle the complexity of these technologies.

It has been challenging to cost-justify many of the new technological and system advances, associated interventional procedures and the corresponding redesign of healthcare infrastructures, for example, for the Operating Room (OR). The development and dissemination of these technologies have become central issues in the debate over healthcare reform and healthcare finance.

In particular, a number of major technical and organizational challenges are being faced in the attempt to improve the safety and effectiveness of connectivity/interoperability for the diverse array of medical devices and information technology that proliferates in the OR environments today. These have been clearly identified in recent years, for example by J. M. Goldman, MD, (Director, CIMIT Program on Interoperability, and Medical Device “Plug-and-Play” Interoperability Program), as challenges in their MD PnP Program [1]: 1) Proprietary medical device systems; long capital equipment cycles (12 years!); 2) Limited comprehensive, vetted user requirements (clinically/safety based); 3) Absence of proven standards matched to clinical requirements; 4) Tendency to silo standards that would limit interoperability across continuum of care; 5) Limited funding for development; 6) Limited recognition of complexity of challenges in IT-BME convergence and lack of system integrators to build the middleware; 7) Legal (liability) concerns, and; 8) Regulatory pathway questions.

2005+: Maturity level 1
The first stage of development (maturity level 1) may be characterized by the vendor specific integration of technologies. The critical feature of this stage is considered to be the development of integrated device control. Additional technologies include HD video and digital image acquisition and processing, boom-mounted devices, automatic reporting.

2010+: Maturity level 2
The second stage of development (maturity level 2) may be characterized by peri-operative processes optimization. The two critical feature of this stage are considered to be the development of pre- operative image integration and navigated control. Additional technologies include basic DICOM in surgery, intra-operative image acquisition, modeling and simulation; and intelligent cameras.

2015+: Maturity level 3
The third stage of development (maturity level 3) may be characterized by intra-operative process optimization. The two critical features of this stage are considered to be the development of a workflow management (TIMMS) engine and full DICOM in surgery. Additional technologies include DOR process redesign with EMR and signal integration, basic IHE integration profiles for surgery, Smart walls including n-dimensional visualization, and basic model guided intervention.

2020+: Maturity level 4
The fourth stage of development (maturity level 4) may be characterized by vendor independent integration of technologies. The critical features of this stage are considered to be the development of hospital/enterprise wide interoperability and patient-specific models. Additional technologies include knowledge and decision management, clinical quantitative and statistical assessment, and IHE integration profiles for surgery, pathology and interventional procedures generally.

2025+: Maturity level 5
The fifth stage of development (maturity level 5) may be characterized by intelligent infrastructure and processes. The critical feature of this stage is considered to be the development of surgical cockpit systems and Medical TIMMS architecture. Additional technologies include real-time access to peer-to- peer surgical process repositories, intelligent real-time data mining, full voice/gesture control, real-time CAD integration, and intelligent (situation aware) robotic devices.

Digital operating room maturity levels.
Digital operating room maturity levels.

A glimpse of what may be ahead in the OR and predicted in [3] is provided by an interesting example of a surgical workflow management system which includes a Surgical Procedure Manager (SPM) already in clinical use at the International Development Reference Centre (IRDC) in Leipzig [12]. First experiences with this system show that this type of knowledge-based system in the OR can improve efficiency of the interventional processes. It may, however, induce the surgeon to rely excessively on the “intelligence” of the machine to provide the “right” information on patient and processes at the right place, at the right time and to the right person in the OR. Trust in this form of “intelligence” and in the right record keeping and subsequent management of interventional process information for patient outcome evaluation, are new dimensions of concern when machine intelligence moves into therapeutic activities within the context of a digital OR. Important aspects of these dramatically evolving ICT based methodologies and tools are new requirements for:

1. DOR IT architectures providing the right basis for enabling a higher quality of therapeutic interventions by means of interoperability features, for example, real time integration of information in patient-related data structures and therapeutic processes through computer assisted workflow, knowledge and decision management (see also section 2 below).

2. Standards which take account of the specific requirements for surgical/interventional workflows, devices and systems. Examples are DICOM in Surgery and IHE Surgery (see also section 3 below).

3. Methods and tools for supporting approval procedures on an international level, for example, device/systems classification, clinical and non-clinical testing for safety, high confidence medical device software and systems through appropriate modeling and simulation, etc. (see also section 4 below).

[1] Goldman JM (2007): The OR of the Future: Current activities and Health IT implications, HIMSS07 New Orleans.
[2], accessed August 2014
[3] Lemke HU, Berliner L (2011): DOR Maturity Levels (2005-2025 and beyond): Evolutionary growth path. International Journal of CARS, Vol 6, Suppl 1, Springer Verlag, Heidelberg, Germany
[5] The FDA (CDRH) Workshop on Medical Device Interoperability: achieving safety and effectiveness, Co-Sponsored by The Continua Health Alliance and The Center For Integration Of Medicine & Innovative Technology (CIMIT), Medical Device “Plug-and-Play” Interoperability Program (MD PnP), January 25-27, 2010

We encourage contributions to forthcoming parts (email; edited by Heinz Lemke):

2) DOR IT architectures for interoperability
3) DOR standards
3.1) DICOM in Surgery
3.2) IHE Surgery
4) International approval issues
4.1) FDA (USA)
4.2) PMDA (Japan)
5) Conclusion

Heinz U. Lemke, PhD is a professor of Computer Science at the Technical University of Berlin since 1974, where he teaches and supervises research on the theme of Technical Informatics in Biomedicine. Since 1983 Heinz Lemke is the organizer of the congress series Computer Assisted Radiology and Surgery (CARS), editor-in-chief of the CARS Proceedings of the International Journal of CARS and executive director of the International Foundation of CARS.

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