Connectivity to Improve Patient Safety
January / February 2010
Connectivity to Improve Patient Safety
Making Medical Device “Plug-and-Play” Interoperability a Reality
In previous PSQH articles (2008, 2009) we have described the importance of medical device interoperability for improving patient safety, and have reported on the growing support of clinicians and healthcare delivery organizations to have access to this capability. For the past 5 years the Medical Device “Plug-and-Play” (MD PnP) Interoperability Program has been leading the evaluation and adoption of open standards and technology for medical device interoperability to support clinical innovation and improve patient safety. Now we are pleased to report that there has been significant national progress towards that goal.
Why is achieving medical device interoperability important? Improvements in patient safety, clinical care, and healthcare efficiency require systems solutions. Medical devices and information systems in high-acuity clinical environments must be easily integrated to enable the creation of smarter, error-resistant systems. The adoption of open standards for medical device interoperability will support:
- Complete, accurate electronic medical record systems (EMRS)
- Reduction of errors caused by manually entered data
- Facilitation of disaster preparedness: real-time inventory of hospital equipment in use and in national stockpiles
- Rapid deployment of devices in makeshift emergency care settings
- Medical device safety interlocks to produce error-resistant systems
- Clinical decision support systems and smart clinical alarms (with context-awareness)
- Support of remote healthcare delivery
- Automated system readiness assessment (prior to starting invasive clinical procedures)
- Reduction of cost of devices and device integration, and reduction of accelerating EMR-adoption costs
- Closed-loop control of therapeutic devices and safety interlocks (e.g. ventilation, medication and fluid delivery)
Getting there is not easy. There is an inherent “chicken and egg” problem. We cannot simply specify standards like “USB 2.0 compliance,” as we can when purchasing computers, because interoperability standards have not been adopted. Existing standards for non-high-acuity device communication are not likely to be capable of supporting the necessary clinical use cases or clinical workflow scenarios in high-acuity healthcare. Therefore, it is essential to assess candidate interface standards to inform the required changes in existing standards, and to develop additional standards if needed.
The paradox continues: Since development of the necessary open standards and technology requires significant resources, there has been reluctance to pursue these solutions without demonstration of clinical benefit. But the implementation of technology to integrate disparate medical devices and IT systems is a necessary step to demonstrate clinical benefit. A rational way to circumvent this impasse, and solve a few related problems, is to develop an open interoperability platform, to help define the safety and technology requirements of the new systems that will be built, and to better understand the safety and performance requirements of hardware and software in these new “systems of systems” environments. The complexity of this challenge requires that we work on all of these multiple facets simultaneously (standards, clinical pull, funding sources, use case demonstrations, open platform development), while also addressing regulatory concerns. These are the challenges that the MD PnP program has been addressing since 2004.
Image courtesy of Julian Goldman, MD
The MD PnP program is affiliated with Massachusetts General Hospital (MGH), CIMIT (Center for Integration of Medicine and Innovative Technology), and Partners HealthCare Information Systems, with additional direct support from TATRC (U.S. Army Telemedicine & Advanced Technology Research Center). Having evolved from the OR of the Future program at MGH, the MD PnP program remains clinically grounded, in contrast to “technology push” interoperability-related efforts. From its docking point within CIMIT, MD PnP has harnessed organizational skills in convening and facilitation to involve diverse stakeholder groups (clinicians, biomedical and clinical engineers, healthcare delivery organizations, regulatory agencies, medical device vendors, and standards development experts). The MD PnP program has built a geographically dispersed, interdisciplinary, multi-institutional team that is developing strategy and building blocks for device interoperability through collaborative projects. Since the program’s inception, more than 700 clinical and engineering experts, and representatives of more than 90 institutions that share a vision of medical device interoperability have participated in MD PnP activities.
MD PnP program activities have included (1)convening five plenary meetings and many smaller workgroups to bring stakeholders together for information exchange and discussion of issues related to adopting medical device interoperability, (2) developing a methodology for defining clinical requirements, eliciting and collecting high-level clinical scenarios that would benefit from medical device interoperability, and making these use cases available to collaborative projects, (3)developing the MD PnP Lab (in Cambridge, MA) as a vendor-neutral “sandbox” for interoperability and standards conformance testing, collaborative development of use case demonstrations, and development of sharable tools and resources for medical device interoperability work, (4)facilitating medical societies and healthcare delivery organizations to endorse and demand medical device interoperability, (5)developing scientific exhibits to show how interoperability could improve patient safety in typical clinical scenarios, and demonstrating these at national conferences, (6)working with academia, industry, and federal agencies on projects to ensure safe implementation of device interoperability and to instantiate the concepts, and (7)keeping medical devices in the picture for the national health IT agenda.
Over the past 5 years, the focus and work of the MD PnP program has evolved into five interdependent and synergistic themes, being pursued in parallel:
- Standards Development
- Open Platform Development
- Clinical and Engineering Requirements for Device Interoperability
- Facilitated Collaboration
- Regulatory Pathway
Standards Development
The MD PnP program has been contributing leadership, clinical requirements, and technical expertise to standards development organizations that are developing interoperability-enabling standards (e.g. ASTM International, ISO, and IEEE). Most recently, we contributed content to the ASTM ICE standard (see below) and to Technical Note 905 for the HITSP (Healthcare Information Technology Standards Panel) Common Device Connectivity Extension/Gap, which seeks to define requirements for more tightly integrating medical devices into EMRS.
ICE Standard. Establishing a high-acuity standards framework began with a standard for an “Integrated Clinical Environment” (ICE) to define the requirements for interoperability to successfully improve patient safety and clinical workflow. A multi-institutional writing group convened by ASTM International with MD PnP leadership — including engineers and standards experts — drafted Part I of the multi-part ICE standard that embodies the elements of the overall technology ecosystem to safely implement networked medical device systems. This draft was submitted by ASTM as a New Work Item Proposal to the IEC/ISO international standards development organizations in late 2007. It received a tie vote in ISO, which was insufficient for adoption as a New Work Item.
Comments (over 120) submitted during the ISO/IEC review process revealed strong support from clinical institutions, gaps in the technical and clinical content, and specious criticism from organizations with proprietary interests. An FDA-hosted meeting with regulatory, technical, and standards experts was instrumental in allaying misconceptions and enhancing mutual understanding, to the benefit of the ICE standard. Submitted comments were systematically reviewed and addressed by ASTM, resulting in a greatly improved draft standard: “Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE).” Part I was re-scoped and re-named “General requirements and conceptual model,” and it delineates more specific ICE parts (to be written). ICE Part I was published by ASTM as F2761-2009 in December 2009, and is available on the ASTM website.
Open Platform Development
To date we have used the MD PnP Lab to develop demonstration implementations of clinical use cases in which integrating the clinical environment will improve patient safety; these use case implementations have been shown at major clinical and health IT conferences. Now we must build an open interoperability platform and define safety and technology requirements for the interoperability systems that will be built (these can be considered “systems of systems”). This must be a comprehensive platform — analogous to the Internet — that will allow the global community to build innovative clinical applications on top of it. With CIMIT funding we have been working on the first instantiation of an open mobile platform for clinical delivery of evolving MD PnP functionality. This hardware and software platform is intended to support iterative development of MD PnP standards (e.g. ICE) and related technologies for external collaboration.
Use Case Implementation. Our first use case demonstration, presented at the 2007 American Society of Anesthesiologists (ASA) meeting and the 2007 CIMIT Innovation Congress, showed how automatic synchronization of x-ray exposure with ventilation could enable clear images to be obtained without the need to turn off the ventilator — a straightforward application of integrated medical devices that is still not commercially available 10 years after the technical solution was demonstrated and published. Our second demonstration addressed a patient safety issue that has been the cause of many adverse events; we showed an error-resistant patient-controlled analgesia (PCA) medication delivery system with safety interlocks to prevent overdose, based on PCA / monitor interoperability — this scientific exhibit was recognized with a first place award at the 2008 ASA annual meeting.
The initial prototype implementation of the mobile platform is based on the PCA use case and provides the preliminary foundation for an open research platform that could support evaluations by the FDA of MD PnP systems and serve as a generic platform that could be shared with other organizations developing, for example, open medical device interface adapters and an ICE Part I reference architecture. Over several iterations, our multi-institutional development team (engineers from three universities in three countries: the University of Pennsylvania, the University of Waterloo, Canada, and the University of Applied Science, Wiener-Neustadt, Austria), implemented a “medical network” capability and developed “device interface boards” to provide an initial model of what could be used for an open ICE platform; this implementation was exhibited at HIMSS08 (Healthcare Information & Management Systems Society). For HIMSS09 the team developed a tabletop version of the system with enhanced and miniaturized PnP adapters, and added a basic “black box data recorder” capability (also required by ICE).
In scientific exhibits at HIMSS08, HIMSS09, 2008 CIMIT Innovation Congress, and ATA09 (American Telemedicine Association), we demonstrated how continuous monitoring of the patient’s SpO2 and respiratory rate could detect the onset of respiratory depression, and how integration of the PCA pump and monitors can automatically stop the infusion, lock out further doses, and activate the nurse call system. The exhibit demonstrated that the plug-and-play capability to easily swap different monitors to assess respiratory function could increase the reliability of problem detection (increase sensitivity) while reducing false alarms. The exhibit attracted considerable interest from medical device companies and other visitors.
Clinical and Engineering Requirements for Device Interoperability
The need to start with clinical requirements was identified early by all stakeholder groups as critical to the creation of a clinically valid standardization framework. To gather these clinical requirements, we have held focus group sessions at medical and engineering society meetings; participants have included anesthesiologists (Society for Technology in Anesthesia, and ASA), surgeons (Society of American Gastrointestinal Endoscopic Surgeons), and clinical and biomedical engineers (Association of Advanced Medical Instrumentation). Each of these groups brought unique perspectives on what interoperability of medical devices could contribute to patient safety and workflow efficiency, and on how the “ideal” system should look and behave.
The raw input from focus group sessions was organized into defined clinical scenarios or “use cases,” which were presented back to earlier domain experts for refinement. Several clinical scenarios were incorporated into the ICE Part I standard, and a team of MD PnP collaborators (called the ICE-PAC) has been performing detailed workflow analysis of these use cases and analyzing the ability of the IEEE 11073 set of standards to meet these requirements. Collaborators working on ICE-related development projects (see Facilitated Collaboration below) have an ongoing need for additional high-level clinical scenarios to be developed into detailed clinical workflows and then into requirements.
Society endorsements. Beginning in March 2007, the need for medical device interoperability has been endorsed by seven clinical societies to date—the Anesthesia Patient Safety Foundation, the American Society of Anesthesiologists, the Society of American Gastrointestinal Endoscopic Surgeons, the World Federation of Societies of Anaesthesiologists, the Society for Technology in Anesthesia, and most recently the American Medical Association and the Massachusetts Medical Society:
RESOLVED, That our American Medical Association (AMA) believes that intercommunication and interoperability of electronic medical devices could lead to important advances in patient safety and patient care, and that the standards and protocols to allow such seamless intercommunication should be developed fully with these advances in mind. Our AMA also recognizes that, as in all technological advances, interoperability poses safety and medico-legal challenges as well. The development of standards and production of interoperable equipment protocols should strike the proper balance to achieve optimum patient safety, efficiency, and outcome benefit while preserving incentives to ensure continuing innovation.
Healthcare Delivery Organizations. As a result of collaboration with the MD PnP program, Kaiser Permanente in 2006 began to include limited requirements for medical device interoperability in vendor contracts. Under the leadership of the MD PnP program, two additional major Healthcare Delivery Organizations (HDOs) — MGH / Partners HealthCare and Johns Hopkins Medicine — became actively engaged in this effort in 2008 with the goal of expanding and strengthening the original language to make it clear that customers want this capability and expect vendors to cooperate in making it happen. In October 2008 these institutions issued a nationwide Call to Action to HDOs to improve patient safety by recommending that medical device interoperability requirements be included as an essential element in vendor selection criteria and procurement processes. This collaboration produced sample RFP and contracting language that is being shared with other institutions as well as device manufacturers (MD FIRE: Medical Device Free Interoperability Requirements for the Enterprise) and is available through our program website. MD FIRE was presented in a March 2009 webcast at the VHA (Volunteer Hospital Association), heard by more than 140 hospitals. Recently, the U.K. National Health Service has used the MD FIRE document for HIT system requirements.
Facilitated Collaboration
Convening diverse stakeholders and maintaining their engagement has been a key focus of the MD PnP program and is a good fit with the mission of our home in CIMIT. To date we have convened five plenary meetings (with TATRC, CIMIT, NSF, and FDA sponsorship) to bring stakeholders together for information exchange and discussion of issues related to achieving medical device interoperability. The kick-off meeting in May 2004 solidified interest and support across stakeholder groups to pursue standards for medical device interoperability. The FDA hosted the second meeting in November 2004, so that regulatory issues could be more thoroughly explored with increased FDA participation. At a third plenary meeting in June 2005 stakeholders began to frame the issues around eliciting and defining clinical requirements for interoperability, and they identified useful functionality for a shared “sandbox” laboratory for prototype development and testing against proposed standards.
A Joint HCMDSS (High Confidence Medical Devices, Software, and Systems)/MD PnP Workshop held in June 2007, which added academic embedded-systems experts to interact with stakeholders, attracted 145 attendees. This workshop brought together two highly synergistic research communities (MD PnP and HCMDSS), included a panel of federal agencies interested in interoperability (NIST (National Institute of Standards & Technology), NSF, NIH, TATRC, FDA), and had as the opening keynote speaker Dr. Robert Kolodner, then National Coordinator for Health IT, generating a more solid connection with the national health IT agenda.
The program has convened smaller working group meetings to develop program strategy, to work on methodology, to develop MD PnP demonstrations, and to draft the ICE standard. In July 2009 the MD PnP program convened 40 invited participants from organizations that are working collaboratively on funded projects to research development and safety issues in implementation of safe and effective networks of integrated medical devices (systems of systems). In addition to meetings, our website (http://www.mdpnp.org/) provides extensive information about the program, including streaming video of the talks from the May 2004, June 2005, and June 2007 meetings. We have been gratified that medical device interoperability has become part of the national HIT dialogue.
The interest of DoD in advancing medical device interoperability has been demonstrated by six awarded small business research grants for device interoperability-related development, including ICE Manager capabilities and ICE Supervisor functionality for trauma assistance. These projects are producing products and technology that will inform the future development and architecture of an open ICE development platform, as well as subsequent parts of the ICE standard.
In addition, collaborative work that is currently underway with two university computer science and engineering groups (University of Pennsylvania and University of Illinois at Urbana-Champaign) is expected to inform both the ICE standard and the ICE development platform. For example, a graduate student from Urbana-Champaign spent the summer of 2008 as an intern at the FDA, working with senior technical staff involved in the MD PnP program. He focused on safety modeling and analysis for interoperable medical device systems.
ICE-PIC. Over the 2 years since our last major plenary meeting in June 2007, the MD PnP program has formed collaborations with academic groups funded by NSF and with companies funded by DoD small business research grants to work on projects related to medical device interoperability and to the ICE standard in particular. Collaborative relationships with federal agencies have grown, and now include TATRC, FDA, NSF, NIST, and the Veterans Administration. There has been extensive work on developing the ICE standard, and the ICE-PAC gap analysis is underway, including participation by several device manufacturers. In order to facilitate synergistic progress and accelerate our mutual objectives, the MD PnP program organized a 2-day workshop of these collaborators (called the ICE-PIC — ICE Platform Integration Collaboration) in July 2009.
The 40 invited participants represented four universities, three healthcare delivery systems, nine companies, and three federal agencies. They included clinical users, biomedical engineers, information systems engineers, federal regulators, program managers, medical device manufacturers, and standards experts. They presented their project work, shared their vision and ideas, and worked together on a plan for future collaborative activities to advance the ICE standard and development of an open ICE research platform. Several members of this group are participating in the further development of the ICE standard.
Regulatory Pathway
An early premise of the MD PnP program has been that the goal of medical device interoperability standardization can only be achieved by working closely with the FDA, and this has been the approach to date. The mutual objective of the FDA and the MD PnP program leaders is to identify a regulatory pathway that will support the MD PnP concept, i.e. which will support safe integration of devices and not require re-validation or re-clearance of the entire system as each new independently validated device is added to the MD PnP network. Over the past 4 years we have studied and elaborated the issues and concerns surfaced by medical device interoperability stakeholders, and have increased the community’s understanding of them. We are continuing to pursue opportunities to work with the FDA in standards development activities, in discussions of the solution pathway offered by ICE, and on projects with our collaborators involving safety studies.
MD PnP is collaborating with the FDA and the Continua Health Alliance to co-sponsor and plan a workshop on medical device interoperability to be held at FDA in January 2010. This workshop, which is expected to attract 200 participants, will focus on recent and future efforts to establish safe and effective medical device interoperability and the probable impact on regulations and policies. The workshop will include device industry, clinical, academic, and FDA perspectives, and is intended to enable FDA to collect community input to develop regulatory guidance for interoperability for healthcare. (Workshop information at http://mdpnp.org/FDA_Interop_Workshop.php)
What Is Needed for Success?
In order to develop and achieve adoption of a standardization framework for medical device interoperability that has the support and buy-in of all stakeholders, we need clinically meaningful use cases and requirements, published open interoperability standards to enable meaningful use cases, an open development platform to provide enabling technology, reference implementations of the standards and related system architecture, profiles or guidelines to describe how to use the standards to achieve interoperability, a vendor-neutral compliance testing and evaluation environment, interoperability and conformance testing tools, strongly articulated user demand, a staged implementation plan that recognizes the need to accommodate legacy systems, and an appropriate regulatory pathway.
As an independent, vendor-neutral program, the MD PnP program is acting as the catalyst to bring the full spectrum of stakeholders together to achieve the goal of medical device interoperability. Over the past 5 years, we have provided a focal point for this effort, and today we are seeing the results of the hard work of the many individuals and groups working collaboratively to make medical device interoperability a reality. Ultimately, the national health IT agenda led by the White House and the ONC needs to make medical devices an explicit focus of the interoperability mantra. That would likely provide the tipping point for achieving success.
WANT TO LEARN MORE?
Go to http://www.mdpnp.org
Susan Whitehead is the program manager of the Medical Device Plug-and-Play (MD PnP) Interoperability program at CIMIT (Center for Integration of Medicine and Innovative Technology), a consortium based at Partners HealthCare in Boston. She coordinates collaborations, communications, and projects for the interdisciplinary, multi-institutional MD PnP program, which includes a growing network of more than 700 individuals and 90 institutions. Whitehead may be contacted at swhitehead@partners.org.
Julian Goldman is the medical director of Partners HealthCare Biomedical Engineering, director of the program on interoperability at CIMIT (Center for Integration of Medicine and Innovative Technology), and a practicing anesthesiologist in the Massachusetts General Hospital (MGH) “OR of the Future.” He is the director of the Medical Device Plug-and-Play (MD PnP) Interoperability Program, which he founded in 2004 to lead the adoption of open standards and technology for networking medical devices to support high-acuity clinical solutions for improving patient safety and healthcare efficiency. Goldman may be contacted at www.jgoldman.info.
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