Physiologic monitoring devices are so ubiquitous in hospitals that it’s difficult to recall a time without them.
The success of integrating this technology into patient care as a regular part of the clinical record was driven by evolving clinical standards, a desire on the part of hospitals to improve patient safety, and in part by the HITECH Act of 2009 and its associated Meaningful Use (MU) requirements, which accelerated electronic health record (her) adoption and revolutionized charting and documentation of vital signs.
The next great sea change is the seamless integration of continuous, high-fidelity data from physiologic monitors and historical, low-fidelity data extracted from EHRs. Data seamlessly integrated from EHRs, vital signs and other medical device can enhance clinical decision support and patient-safety initiatives while also improving the efficacy of clinical workflows.
This is not a concept for the future. Continuous clinical surveillance, advanced analytics and timely intervention based upon changing and evolving trends in a patient’s condition is attainable right now. For many hospitals and health systems, this represents less a net-new technology investment than how to piece together existing infrastructure and components.
Implications of Real-Time Intervention
The capture of so much data from so many device types that normally exist throughout the spectrum of care within most major hospital systems presents a few challenges. How do you seamlessly combine continuous data (physiologic devices) with historical data (EHRs)? How do you uncover actionable data from the vast ocean of data collected from each patient?
Data derived from medical devices can be employed for decision making, both as part of the standard patient care management process of charting and bedside management, as well as in more acute care of patients. One such type of data that are used for more real-time intervention are alarm signals derived from medical devices based on measured limit threshold breaches. The communication of such alarm signals in large quantities to already overloaded staff can have a critical negative impact on patient safety. Thus, it is important to understand the implications of requirements on data delivery latency, response, sensitivity, specificity, and integrity.
Middleware can be leveraged to pull data from physiologic or other medical devices and combine it with historical data in the patient record to create a more holistic and complete picture of the current patient state. The capabilities of various middleware solutions overlap, but there are basic architectural and regulatory accommodations that must be considered that extend beyond software or physical access to the datau.
FDA clearances. The ability to retrieve data at variable rates requires technical capability on the part of the middleware vendor, but it also requires quality and regulatory capabilities in the form of submitting for and receiving appropriate U.S. Food and Drug Administration (FDA) clearances.
The ability to extract data and translate it to a system of record (i.e., EHR) is part of what the FDA considers to be a medical device data system (MDDS). The FDA requires that MDDS solutions carry an FDA Class I status for general documentation. Alarm signal generation and transmission as part of active patient monitoring is beyond the scope of standard MDDS capabilities. According to the rule, if an MDDS is used beyond its intended use, this shifts the burden for oversight and compliance onto hospitals, requiring the hospital to test and demonstrate efficacy of the system, effectively classifying the hospital system as a medical device manufacturer.
A Class II clearance with indications for use supporting active patient monitoring and alarm communication can be achieved by a middleware vendor that demonstrates from a risk perspective that it has successfully mitigated the hazards of the data (relative to assured delivery, latency, data integrity) for use in live interventions, which would be consistent with alarm communication or creation of new alarm signals or notifications from raw data collected from medical devices.
For a middleware vendor to claim clearance for active patient monitoring, they must have all the checks and balances in place to ensure the receipt and delivery of all active patient data for intervention purposes from collection point to delivery point. These technical capabilities include:
Assured delivery of data. To support active patient monitoring and verified delivery of data, the communication pathway from the bedside medical device to the recipient must guarantee delivery of the data within a specified time frame. In order to guarantee delivery, the system must continuously monitor that communication pathway and report if and when data are impeded or otherwise delayed beyond a maximum acceptable limit on latency and throughput.
Two-way communication of data. This capability ensures that data delivery and verification does not impede or otherwise interfere with the medical device operation. This is of particular importance when exploring external control of medical devices or when alarm data are communicated per active patient monitoring.
Ensuring data integrity. In middleware systems cleared for active patient monitoring, the ability to transform the data is possible. Algorithms for performing transformations, calculation of tertiary results, and otherwise interpreting data must pass muster and be validated for all intended operational scenarios of the medical device, including failure modes. Data security, hostile attacks on data, medical device, and denial of service, and ransomware all have the potential to impact data integrity and these requirements must be identified and detailed through specific scenarios and validated through testing.
Conclusion
For hospitals and health systems, especially those that are breaking ground on a net-new medical device integration program, the formidable task list that comes with any MDI initiative requires the input and expertise of a project team, which ideally, should be comprised of leadership from myriad departments, including IT, networking, facilities, clinical staff, and biomedical engineering.
This team will be responsible for every phase of deployment—acquisition, rollout, implementation and transition to live operations. The team will determine the hospital’s objectives and integration goals, as well as the devices, device types, business and clinical requirements, risk management concerns, patient safety goals, and costs.
This reinforces the need to have a comprehensive and forward-looking approach to selecting an MDI and middleware provider that can support the technical and clinical needs of your healthcare organization both in terms of the immediate needs associated with an EHR implementation, as well as enabling real-time patient surveillance and intervention to improve patient safety and overall quality of care.
John Zaleski, PhD, CAP, CPHIMS, is Executive Vice President and Chief Analytics Officer at Bernoulli, a leader in real-time connected healthcare. He can be reached at jzaleski@bernoullihealth.com.