Today’s medical devices and biomedical/clinical engineering (CE) departments are increasingly dependent upon a health system’s IT infrastructure and expertise. Take, for example, the direct input of live patient monitoring data into the electronic medical record (EMR), wireless surveillance monitoring technology, and multi-platform clinical communication systems. These scenarios are forcing health system executives to rethink their strategies for leveraging IT convergence to improve outcomes. Key questions such as these often rise to the surface:
• What are the risks in maintaining separate IT and CE strategies and departments?
• What are the opportunities and risks in formal integration of IT and CE departments?
• If the decision is made to support departmental integration, what are the key organizational and development needs to support financial and clinical outcomes? Is the health system prepared to handle regulatory implications?
Why now? One driving factor for this convergence is an increased dependency of medical devices on IP-based networks, especially with the emergence of wireless patient monitors, and the increased occurrence of patient monitoring data feeding directly into the EMR.
Also looming large on the minds of the both IT and CE teams are data and device security concerns, with the most notable coming in the form of an FDA warning regarding Hospira LifeCare infusion pumps.
Addressing a need for guidance on risk management policies and producers for integrating medical devices into dynamic IT environments, the International Electrotechnical Commission, established IEC 80001-1, a framework upon which health systems can base their risk management approach. In addition, in response to today’s security breaches and threats from hackers, the Association for the Advancement of Medical Instrumentation (AAMI) issued a technical information report, AAMI TIR57, which shares principles for medical device security and risk management..
Convergence, the migration of medical and IT devices onto a single network infrastructure, can result in cost savings, less complex implementations, and the consolidation of support staff in recognition of the IT-centric component of medical device systems. Convergence also supports alignment of IT infrastructure and CE strategic plans that leverage project management resources and ensure correct prioritization of resources to support clinical team needs. For instance, joint strategic plans would reduce the likelihood that new implementations (computing or medical technology) negatively affect the performance of existing systems.
IT and CE convergence can lead to increased awareness and overall experience within an IT organization of general medical device connectivity concerns, which ultimately accelerates the organization’s ability to accommodate remote/home monitoring technologies, which are key to a population health/shared risk strategy. The unique skillsets of both departments, for instance Biomedical engineers and IT engineers, must be fully leveraged for a successful convergence.
Common challenges when undergoing IT and CE convergence:
• Increasing dependence on IP-based networks
Growing reliance on IP-based networks places a heavier burden on reliability, scalability, and business continuance (high availability and disaster recovery) planning and investment. The cost and physical design to accommodate and support two separate and distinct networks introduces significant risk and impact to patient care operations.
Solution: Solutions that are interoperable and potentially leverage the same infrastructure elements such as WiFi or route/switch layer will maximize investments, reduce facility (i.e. HVAC, electrical, data center, technology rooms) requirements, and improve availability.
IT and CE can work together to evaluate technologies that can work together and in instances where compatibility may be a challenge due to regulatory compliance collaborate with the vendors on a converged strategy. Organizations should evaluate shared resource models to position skilled resources where they serve the most value. The industry shouldn’t expect a certified Biomedical Engineer to have a deep understanding of traditional IP-based networks and nor the reverse for a certified Network engineer. Developing a collaborative program to not only design/support the now but build for the future will ensure a connected care environment will meet and exceed the demand of clinical technologies and users who depend on them.
• Increased demands on the CIO and IT leadership
Integration of Clinical Engineering under the CIO has inherent risks that can be mitigated by CIO, IT leadership, and informatics leadership education.
Solution: In addition to a greater involvement of the CIO in discussions about CE priorities and infrastructure needs, clinical leadership and Director of Clinical Engineering should also provide a clear set of priorities and needs to IT leadership to ensure that clinical outcomes are achieved. Lastly, integration of these functions exposes the CIO to vendor management challenges that may differ from traditional IT hardware vendor relationships in their depth of clinical alignment, longevity and vendor leverage.
• Shared Governance and Accountability
IT and informatics leadership may lack direct involvement with prior clinical engineering projects (and vice versa), and therefore need to be engaged collaboratively early and often to ensure that clinical engineering needs do not receive lower priorities due solely to awareness and hierarchical structure.
Solution: As clinical devices and technologies continue to converge and rely more heavily on IT infrastructure, it is critical that Clinical Informatics, IT and CE organizations stay in synch. Decision making for selection of new clinical devices and other CE projects needs to be a shared interest between IT, CE and clinical leadership. IT needs to be apprised of a device’s use in the clinical environment and the long-term roadmap for use. Similarly, it is the responsibility of Clinical Informatics leadership to ensure CE and IT are aware of any changes to care delivery that can impact decision making or project implementation considerations. Similarly, critical clinical initiatives require shared accountability to ensure achievement of desired goals. Consider efforts to reduce alarm fatigue on in-patient units. Aligned transformation initiatives require considerable collaboration between Clinical Informatics, Clinical Engineering and IT to achieve the intended outcomes.
• Vendor leverage
A common challenge faced by our clients historically can be categorized as “vendor leverage” over IT and CE roadmaps. Strategic vendors (IT infrastructure, patient monitoring systems) often attempt to force infrastructure decisions that simplify the vendors’ own requirements for support or reduce their own risk. However, the impact on the health system may be significant, leading to divergence, additional cost and barriers to consolidated strategic planning.
Solution: Any vendor infrastructure recommendations need to be researched, challenged, and evaluated relative to the advantages of converged architecture. By integrating IT and CE organizations and strategic roadmaps, health systems can leverage the full breadth of internal expertise to improve leverage and prevent the “silo” effect that vendors so often use to their own advantage.
Tim Needham is the Executive Director of Healthcare Solutions and Corey M. Gaarde is Director of Healthcare Design and Transformation at the Burwood Group.
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