Congratulations to our Best Paper Award Nominees!
The Best Paper Award will be announced on Tuesday morning, May 19th
Levels of Conceptual Interoperability Model for Healthcare
- Michael Robkin - Anakena Solutions Inc. & MDPNP. org
- Sandy Weininger - U.S. Food and Drug Administration & Center for Devices and Radiological Health
- Benjamin Preciado - Anakena Solutions Inc. & MDPNP. org
- Julian Goldman - Massachusetts General Hospital
The Medical Device and Healthcare Information Technology (HIT) industries have not achieved safe PNP cross-manufacturer (heterogeneous) interoperability although it has been achieved decades ago in other safety critical industries. We believe that the Levels of Conceptual Interoperability Model (LCIM)  offers an essential account of the disparity and thereby offers insight for how to achieve safe PNP cross-manufacturer interoperability in HIT. The LCIM is a conceptual framework for interoperability first developed for military simulation and modeling. We have expanded its scope and detail while applying it to medical devices. Our results show that safe interoperability minimally requires system components that are aligned about a conceptual model (i.e. manufacturers are operating at level 6). Furthermore, such devices can be assured to be safely interoperable cross-manufacturer only if different manufacturers share the conceptual model embodied by the communicating devices. We identify some root causes preventing this realization.
Towards a Logic-Based Extension of a Relational Software Tool for Coherent Technical Documentation of Medical Devices
- Tobias Lueddemann - Technical University of Munich
- Jonas Schiebl - Technical University of Munich
- Daniel Roppenecker - Technical University of Munich
- Franziska Klein - Technical University of Munich
- Tim C Lueth - Technical University of Munich
This work presents a novel software tool for generation of coherent technical documentation. It is based on a relational database system serving as knowledge base incorporating information from the medical device directive and various harmonized standards such as ISO 14971. In order to achieve increased consistency among sections of documentation for medical devices a concept for formal description of technical documentation and an additional logic-based system is presented.
Product Safety Program Planning - From Prescriptive to Hazard-Based Safety
- Oscar Overton, Jr. - Lexmark International, Inc.
The goal of a product safety program is to eliminate mishaps. To accomplish this goal we must design to eliminate energy hazards or reduce the probability of uncontrolled energy release to zero. In reality, neither of these ideals can be realized. Therefore, it is incumbent on product safety engineering to identify the energy sources, determine the energy transfer mechanisms, and establish adequate control, thereby minimizing the risk of a mishap. To be most effective, this effort cannot be ad hoc, but it must be accomplished in a planned process. Unfortunately, because of the nature of prescriptive standards, this ad hoc approach is more the rule than the exception. The advent of hazard-based safety standards reveals that a planned product safety program is essential. This paper presents the rudiments of a Product Safety Planning Program. It explains the basics of a risk assessment process and presents a product safety program outline that can be tailored to each product development project.