The Internet of Medical Things | FMCNA

EVIDENCE BASED INSIGHT

The Internet of Medical Things: Actionable Information from Machines and Devices

September 21, 2020 • 7 min read

DAVID THOMPSON, DO • ROBERT J. KOSSMANN, MD, FACP, FASN

As more kidney patients move to home dialysis and devices become increasingly sophisticated, remote monitoring is an ever-more important component of patient care. Fresenius Medical Care North America (FMCNA) is successfully leveraging the internet of medical things (IoMT) to help patients, care teams, and providers gather and transmit treatment data. FMCNA is also exploring wearable devices and other technologies that use sophisticated sensing and artificial intelligence to deliver clinical insights, predict a range of acute issues, and improve patient well-being. 

Advances in medical technology are transforming care. As lifesustaining devices are deployed in an increasingly diverse range of environments—from patient home to the critical care bedside— the ability to sense changes in both patient physiology and device performance, communicate those changes, and actively respond in increasingly sophisticated ways is becoming critical. An internet of medical things (IoMT) is foundational for the connected devices, sensors, and monitoring systems that are already improving patient care and patient outcomes and will be central to advances in medical devices, care delivery, and ultimately success in emerging value-based care environments. 

In the area of kidney care, the IoMT is already demonstrating value, especially for patients receiving dialysis at home. As in many other societies around the world, there is a renewed focus in the United States on expanding use of home-based dialysis— either peritoneal dialysis (PD) or home hemodialysis. For example, the Advancing American Kidney Health initiative launched by the White House in 2019 has an explicit goal of increasing the percentage of new end-stage kidney disease patients receiving dialysis at home (or receiving a transplant) to 80 percent by 2025. Such a dramatic change requires expanded capability to monitor peritoneal cyclers (the devices that pump dialysate into and out of the peritoneal cavities of PD patients, often at night while patients are sleeping) and hemodialysis machines (the complex devices that directly remove wastes and fl uid from the bloodstreams of hemodialysis patients) as well as patient response to the treatments provided by these devices. 

MONITORING CARE VIA HUBS 

Fresenius Kidney Care (FKC), the dialysis services business segment of Fresenius Medical Care North America (FMCNA), has been able to leverage an IoMT to provide remote monitoring of patients by its clinical staff who support FKC home patients across the country. Both the Liberty Select cycler and the NxStage dialysis machine (and its integrated Nx2Me connected health platform) are connected devices that transmit patient data and machine data so that home therapy nurses can monitor their patients’ treatments, physicians can track patient progress and adjust treatments when needed, and patients can communicate with their care team.

FKC’s IoMT platform includes three integrated applications collectively called theHub. PatientHub, CareTeamHub, and ProviderHub enable patients, care teams, and providers, respectively, to monitor devices and patient treatments and to communicate efficiently among one another. 

• PatientHub allows a patient to transmit treatment data from the cycler or dialysis machine, along with additional clinical information like blood pressure and other data, to the patient’s nurse. PatientHub also supports messaging with nurses, access to laboratory data and other medical information, ordering of dialysis supplies, and education and support materials. 
• CareTeamHub provides a mechanism for remote patient monitoring of treatments. It proactively flags exceptions in treatments (including device alarms) and alerts issues to nurses (and soon to other care team members including social workers and dietitians). It allows nurses to respond quickly and proactively to any issues identified and to document any interventions undertaken, giving home patients more confidence and individualized timely support.
• ProviderHub delivers real-time access to the electronic medical record (and documented treatments) to physicians and advanced practitioners. ProviderHub is available on multiple mobile device platforms and supports smartphones and tablets, as well as laptops and desktops. It is designed to support easy access to patient information and clinical documentation during provider rounds or while responding to issues outside of scheduled rounds or visits. 

FMCNA has demonstrated significant patient benefits from theHub and its underlying technologies: 

• 20 percent reduction in hospitalization for patients who submit five or more flowsheets per week via PatientHub compared to patients who do not submit flowsheets¹ 
• 2.4 percent monthly increase in time on therapy for patients using the modem that connects the Liberty cycler to theHub² 
• 30 percent reduction in home therapy modality drop rate for patients using Nx2Me³

In recognition of this potential, FMCNA is continually working to enhance connected health. 

TECHNOLOGY ADVANCES IN HOME THERAPIES 

Beyond treatment monitoring, FMCNA is actively exploring a broad range of sensing technologies to empower healthcare providers to track patient well-being in the home environment. For example, FMCNA has invested in BioIntelliSense to create a strategic partnership focused on continuous patient monitoring. BioIntelliSense has developed the first FDA-cleared single-use device for up to 30 days of continuous vital signs monitoring, including activity, body position, sleep status, gait, and more. And FMCNA is exploring other wearable technologies that monitor patients outside the clinic to improve their care and outcomes. All of these initiatives are intended to provide more granular data that can support predictive analytics and clinical insights to improve patient outcomes. 

Closely allied to the IoMT are advances in machine learning and artificial intelligence. Current FMCNA devices, like those described above as well as the FMCNA family of 2008T and 2008T Bluestar hemodialysis machines, have the capacity to collect important quantities of patient and machine data. Dialysis providers such as FKC use these data from its patients for medical reporting, prediction of at-risk patients, and development of clinical algorithms. With new and emerging sensing technology, opportunities open dramatically. 

One area of active investigation at FMCNA is the use of sensing data and artificial intelligence to predict or anticipate intradialytic hypotension. Another area of investigation relates to the use of data from the Crit-Line 4® or the CLiC™ device to track changes in patient hematocrit (which correlate with changes in intravascular volume). Combining this data with machine learning algorithms may result in the identification of new ways to improve volume management. The combination of sensing and analytics, in general, creates many exciting possibilities to anticipate problems, avoid adverse patient events, and improve patient outcomes. 

The IoMT is not limited to patient data. FMCNA has piloted acoustic sensing technology in its dialysis clinics to identify clinics that are at risk. Specific sounds create acoustic fingerprints that can signal what is happening in an environment. Using these fingerprints and a machine learning algorithm, FMCNA data scientists have converted sound into non-discernible numerical data that can potentially be used to classify clinic-level quality outcomes. 

Device monitoring may also be used by biomedical technicians to predict when a device (such as a dialysis machine) should be preemptively assessed before machine alarms and before delays in the clinic’s operational activities and patient therapy are triggered. In addition, the 2008T Bluestar and NxStage System One currently collect machine performance and maintenance data. This information can be used to identify possible enhancements, including improved technical reporting, machine efficiencies, and workflow. 

Beyond home-based dialysis and traditional in-center dialysis, FMCNA is expanding the IoMT it manufactures into acute and critical care environments as well. The NxStage System One is being deployed in critical care departments for continuous renal replacement therapy or prolonged intermittent renal replacement therapy. It offers capabilities to capture treatment data that can be transmitted and analyzed to provide quality metrics for oversight of acute therapy programs.

NOVALUNG: TREATING CARDIAC AND RESPIRATORY FAILURE 

In early 2020, FMCNA further extended its IoMT into the critical care settings with the introduction of Novalung, the first FDAcleared extracorporeal life support device for long-term (>6 hours) respiratory and cardiopulmonary support. Novalung provides this life support—for adults with acute respiratory or cardiopulmonary failure—with one device, something not previously available on the market for long-term use. 

With the incidence of acute respiratory distress syndrome and complications related to periodic epidemics such as COVID-19, veno-venous extracorporeal membrane oxygenation (ECMO) can provide a modality for critically ill patients beyond conventional mechanical ventilation. 

A common clinical feature of severe chronic obstructive lung disease is the accumulation of carbon dioxide, which often requires management with conventional mechanical ventilation. This is an emerging area of interest for veno-venous ECMO. Carbon dioxide levels can be reduced in the system through extracorporeal carbon dioxide removal (ECCO2R). This has led to the exploration of ECCO2R as an alternative to conventional ventilation. Early studies suggest this approach may offer the potential for symptomatic relief and a reduced need for, or possible avoidance of, invasive mechanical ventilation.⁴

Additionally, patients with cardiogenic shock or witnessed cardiac arrest may benefit from early support with veno-arterial ECMO. This would allow for bridging investigations or intervention to be performed, affording greater chance of meaningful recovery, through evaluation and treatment with cardiac assist devices or cardiac transplantation.⁵ Currently, Novalung supports venoarterial ECMO with continuous flow. FMCNA is evaluating ways to provide synchronization with cardiac rhythm and whether it can be used to create a more natural pulsatile flow for these types of patients, with possible use of assisting devices and support. 

Data integration is at the forefront of many conversations surrounding IoMT. FMCNA is developing real-time connected technologies for devices, such as Novalung, to facilitate management of critically ill patients and timely interventions in the intensive care setting. 

In summary, healthcare has crossed the threshold of a very exciting decade. In ways never before possible, information is becoming actionable in real time as data flows ever more readily from simple devices and more complex life-sustaining machines through the internet of medical things. Data can be presented to healthcare providers in a direct, raw form or synthesized into actionable insights for clinicians that are derived from carefully constructed analytic engines and decision support algorithms. The principal beneficiaries, of course, are patients, whose outcomes are improved. Additional benefit accrues to clinicians who can provide care more efficiently and to healthcare systems that are moving from volume-based care models to value-based care models. 

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References

1. Associations between use of patient portal with hospitalization rates and modality failure in peritoneal dialysis patients. Research abstract submitted to American Society of Nephrology, 2018.
2. RTG study on FKC patients with Liberty Modems. Fresenius Kidney Care internal study, 2018.
3. Nx2Me study on FKC patients. Fresenius Kidney Care, 2017.
4. Braune S, Sieweke A, Brettner F, et al. The feasibility and safety of extracorporeal carbon dioxide removal to avoid intubation in patients with COPD unresponsive to noninvasive ventilation for acute hypercapnic respiratory failure (ECLAIR study): multicentre case—control study. Intensive Care Med 2016 Sep;42(9):1437-44.
5. Rao P, Khalpey Z, Smith R, et al. Venoarterial extracorporeal membrane oxygenation for cardiogenic shock and cardiac arrest. Circ Heart Fail 2018 Sep;11(9):e004905.