I really couldn't fit the actual title of this event into the title field of my blog software, so I had to wing it. The actual name is:

The Improving Patient Safety through Medical Device Interoperability and High Confidence Software joint workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug and Plan (MD PnP) Interoperability.

The meeting started this morning at the Cambridge Hyatt hotel. There are a total of 130 attendees at this meeting, with an interesting mix of vendors, providers, academics and regulators.

John Parrish MD, Director of CIMIT, welcomed everyone, noting the importance of interoperability on improving patient safety. “The attendees at this event are ‘make it happen’ folks, so this could be a turning point in our mission.”

Insup Lee PhD, U of Penn and co-chair was next up. Lee noted that this is the first medical device connectivity event to provide a forum to exchange new research and development results by the emerging community of researchers, developers, regulators, users and manufacturers involved in HCMDSS and MD PnP.

Any event like this has a history. Previous meetings – 2 HCMDSS meetings, Nov 2004; 59 attendees; goal: identify crucial medical device software and systems issues and stake holders that will help shape research needs agenda for a larger workshop in 2005.

Past activities of HCMDSS has been based on 3 observations:

  1. The Federal government recognizes that the rapidly increasing software complexity of medical devices makes the development of high integrity medical device software and systems a crucial issue in public health.
  2. Software for future medical devices cannot be developed using existing design and productivity technologies.
  3. The increasingly heterogeneous nature of medical device design requires the need to identify emerging technical and scientific issues in
    medical devices and to identify obstacles to the development and certification of medical device software and systems.

The meeting in 2004 targeted 8 topics:

  • Enabling Technologies for Future Medical Devices
    • Implantable regulatory devices, networked biosensors, telesurgery, robotic surgery
  • Foundations for Integration of Medical Device Systems/Models
    • Component-based foundations for accelerated design and verifiable system integration
  • System of systems (including models, medical devices, care-givers, patients)
  • Distributed Control & Sensing of Networked Medical Device Systems
    • Robust, verifiable, fault-tolerant control of uncertain, multi-modal systems
  • Patient Modeling & Simulation
    • Large scale, high fidelity organ and patient models for design and testing
  • Embedded, Real-Time, Networked System Infrastructures for MDSS
    • Architecture, platform, middleware, resource management, QoS (Quality of Service), PnP (Plug-and-Play) of MDSS
  • High Confidence Medical Device Software Development & Assurance
    • Care-giver requirements solicitation and capture, design and implementation V&V (Verification and Validation)
    • Heterogeneity in environment, architecture, platform in medical devices
  • Medical Practice-driven Models and Requirements
    • User-centered design, risk understanding, and use/misuse modeling in medical practice
  • Certification of MDSS
    • Quantifiable incremental certification of MDSS, role of design tools
    • COTS, non-determinisitic and self-adaptive medical device systems

The next milestone was a meeting in June 2005, which had 99 attendees. There was an open call for contributions, and 40 papers were accepted. The motivation for this meeting was to improve the development, certification and operation of medical device software and systems that will result in better and more cost effective medical care.

The meeting’s objective was to identify short term and long term technology challenges faced by medical device manufacturers and regulators. Specific goals were to identify research challenges and emerging issues. A comprehensive report on research needs and recommended roadmap were completed.

Six 6 working groups were created:
1. Foundations for Integration of MDSS (Medical Devices Software and Systems)
2. Distributed Control and Sensing in Networked Medical Device Systems
3. Patient Modeling and Simulation
4. Real-Time, Embedded, Networked System Infrastructures for MDSS
5. High-Confidence Medical Device Software Development & Assurance and Medical Practice-driven Models
6. Validation and Certification of MDSS

This meeting brings together the HCMDSS and MD PnP communities of medical device specialists from the clinical environment, industry, research labs, academia, and government.

The other co-chair, Julian Goldman MD is the director of the Medical Device Plug and Play program at CIMIT. Goldman noted that at a previous meeting in 2004 they asked the question, “is this the right time to re-consider medical device interoperability? And, if so, what can be learned from prior mis-steps?"

Pictured right is a representation of the social network of the attendees at the 2004 meeting, as created by June Holley.

Here’s what they learned when pursuing interoperability:

  • Must be clinical-requirements based
  • Regulatory obstacles were perceived
  • Legal concerns were deal-breakers
  • What is the business case?
  • No widely adopted standards
  • In summary: Interoperability requires more than standards

They learned at the meeting that key needs must be addressed, like:

  • Must be clinical requirements based
  • Regulatory obstacles were perceived
  • Legal concerns on the part of providers and vendors
  • What is the business case?
  • No widely adopted standards
  • In summary, interoperability requires a lot more than standards

So, why are we here today? Is it the abilithy to plug any device into any other and transfer data? Standardization on USB and WiFi? Remote control of medical devices?

Ultimately interoperability is about empowerment of the user/customer. Look at consumer electronics world, especially digital photography, PC peripherals, and USB - all examples of consumer electronics interoperability. Health care providers need similar empowerment. It will allow clinicians and biomedical engineers to leverage medical devices and IT systems to solve clinical problems, improve patient safety, and improve efficiency.

The role of medical device devices in health care automation efforts is undeniable. Diagnosis and treatment are usually performed with medical devices - they are the "sharp end" of patient care. Medical devices are responsible for the integrity of data, and are the actuators that deliver energy and IV medications.

Comprehensive integration of devices and data from clinical and environmental systems, using the latest computer-science methodologies, will prevent errors and inefficiencies across the continuum of care. Medical device connectivity is critical for complete and accurate EMRS. What also remains is the ability to "close the loop" in many medical device use scenarios. What is needed are smart alarms that include event awareness, decision support to guide diagnosis and therapy, and workflow support to improve productivity and patient satisfaction.

The adopt of medical device interoperability will support:

  1. Clinical decision support systems
  2. Smart clinical alarms
  3. Medical device safety interlocks
  4. Closed-loop control of ventilation, medication and fluid delivery
  5. Support of remote health care delivery (home, battlefield, e-ICU)
  6. Automated system readiness assessment (prior to starting invasive clinical procedures)
  7. Complete, accurate electronic medical records
  8. Increased quality and completeness of national research databases
  9. Facilitation of disaster preparedness: real-time inventory of hospital equipment in-use and national stockpiles, and rapid deployment of devices in makeshift emergency care settings
  10. Understanding key issues at the heart of Biomedical Engineering (BME)-IT “convergence”

Goldman closed with the rhetorical question, “If not now, when?”

You can read subsequent posts about the conference here: