According to the GE Healthcare website, GE Healthcare is “a leading provider of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare enables precision health in diagnostics, therapeutics and monitoring through intelligent devices, data analytics, applications and services. With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, the company helps improve outcomes more efficiently for patients, healthcare providers, researchers and life sciences companies around the world.”

PPAHS asked GE Healthcare to answer the questions that we posed to manufacturers of continuous monitoring devices. PPAHS questions are in blue.

GE Healthcare’s answers are below in green (provided March 29, 2018). These answers have been prepared by GE Healthcare medical affairs.

All links were accessed July 18, 2018.

Parameters Monitored

What physiologic parameters of the patient does your device monitor for?

The CARESCAPE™ Bx50 Patient Monitoring platform provides multi-parameter monitoring, which includes monitoring of hemodynamic parameters including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, respiratory (impedance respiration), airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and neurophysiological status including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission.

What evidence is there that your device provides a reliable and early indicator of deterioration of the patient’s condition or decline?

The GE CARESCAPE Patient Monitors are cleared for use as multi-parameter high acuity patient monitors intended for use in multiple areas within a professional healthcare facility. We have numerous white papers, abstracts and reference lists available on our Clinical View Website.

Best Clinical Usage

What is the target population for your equipment?

The CARESCAPE Monitor Bx50 platform is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Is there a patient condition, clinical unit, or area that you believe that your device provides an earlier indication of patient deterioration vs. your competitors?

GE has a strong heritage of clinical excellence and deep expertise in each major physiological areas, allowing us to offer one of the most comprehensive sets of clinical measurements available. As an example, GE’s patient monitors offer advanced arrhythmia monitoring based on our EK-Pro Multi-lead algorithm. Please reference our EK-Pro Whitepaper available on our clinical view website (www.clinicalview.gehealthcare.com) for information on the benefits of multi-lead arrhythmia analysis.

Reducing Adverse Events and Patient Deaths

Have your customers experienced a reduction in serious adverse events (“near misses”) or patient deaths using your device?

Our physiologic continuous monitoring devices are intended to detect, alert/inform and provide feedback to clinicians to make patient treatment decisions, which can help them reduce adverse events and patient deaths.

Patient Satisfaction

How is your device connected to the patient?

Our acquisition devices are connected to the patient via industry standard connections, cables, accessories and sensors (electrodes, finger wraps, etc.)

What patient feedback have you had regarding use of your device? Have there been any patient recommendations for improvement? Have these recommendations been included in your device design.

We collect patient and clinician feedback regarding the reliability and usability of our devices as part of our design and development process. We also maintain a database to collect ongoing feedback once the product is in use. Feedback is often focused on ergonomics for both the patient and the clinician and the ability to support advanced clinical workflows designed for quieter patient care environments.

Alarm Fatigue

Does the monitor alarm at the bedside only or is it centrally monitored?

Our devices can be used both in standalone or in centrally monitored settings. Central monitoring for our devices is supported both at a nurse station (in unit, on floor) or a “war room” setting.

Have clinicians using your device experienced an increase in the number of alarms sounding? Identify the number or percentage of alarms in terms of criticality.

Alarm fatigue is recognized as an industry wide challenge and we understand that providers are always managing a balance between patient vigilance through patient monitoring and insuring that alarms are actionable. GE Healthcare’s approach to alarm management includes not only advanced algorithms and features but also a consulting approach to help hospital systems optimize the GE monitoring settings to support their care delivery models and minimize non actionable alarms. GE also offers advanced training to our users so that clinicians are equipped to tailor the monitor settings to their individual patient needs. Finally, GE offers analytics solutions (Alarm Spotlight) that enable care teams to obtain alarm burden information from GE patient monitors and telemetry systems to tailor workflow alarm threshold limit settings. Clinicians may use Alarm Spotlight information, current patient monitoring data and their clinical judgment to help adjust monitoring settings with a goal to reduce non- actionable alarms and alarm burden.

What advice do you provide your customers to help distinguish between actionable and non-actionable alarms?

We advise clinicians to leverage their knowledge of their patient population and their institutions protocols and configure their devices in an optimal way to reduce non-actionable alarms. We provide a number of tools to allow configuration by care area, patient profile as well as individual physiological condition. In addition, we provide the option of changing individual alarm priorities (high, medium, low) and to set alarms to informational level when appropriate. We also provide safeguarding features to ensure that our devices provide an alarm when there is actionable event.

Interoperability – Does your device interface with other technologies, such as EHR or other monitoring devices?

GE Healthcare offers various solutions to enable device interoperability in the patient monitoring system. The GE patient monitoring products interface engine, the CARESCAPE Gateway, provides a single interface or “data bridge” transferring information between patient monitoring devices residing on GE’s CARESCAPE Network and a hospital’s enterprise network with a resident Clinical Information System (CIS), Hospital Information System (HIS), and Electronic Medical Record (EMR).

Data integrity is assured with both a back-collection option for up to eight hours of data if monitoring devices go off- line and a store-and-forward option for up to 12 hours should the CIC/HIS/EMR system go off-line (e.g. server upgrades). Furthermore, the CARESCAPE Gateway uses a hardened Linux® operating system to mitigate the threat of viruses and other malware from being transmitted to the hospital’s network and patient monitoring devices.

In addition, GE recently released CARESCAPE Connect, a solution that enables a solution that includes all the benefits of the CARESCAPE Gateway but also supports third party device integration. CARESCAPE Connect synchronizes, aggregates and normalizes multi-source data into standardized outputs based on IHE Patient Care Device (PCD) integrations profiles:

  • [DEC] Device Enterprise Communication
  • [ACM] Alert Communication Management
  • [WCM] Waveform Communication Management

These standardized outputs can help support various applications including EMR integration, visualization tools, secondary alarm notification, analytics, data storage and research tools.

Engineering/Design – Did the design of your device include input from human factors engineers, clinicians, or hospital biomedical department? If so, what was that input and how did it affect the marketed version of your device?

GE Healthcare’s philosophical approach and commitment to research and development is to stay on the cutting edge of technology and provide users with a product that meets their clinical information system needs today as well as their needs of tomorrow. The development and clinical support teams along with management determine product enhancements based on requests and suggestions submitted by our customer base, new technological advances in computer systems and software, new clinical trends, and responses to competitive developments.

Recalls – Have there been product recalls of this equipment? If yes, when, what were the key safety issues, and what was the resolution?

Information on FDA FD alerts, actions, warning letters and other communications are public information and subject to the Freedom of Information Act. Such information can be obtained at any time, directly through the FDA, via their website.

Training – What training, on-going staff education, equipment troubleshooting, and other assistance do you provide your customers to ensure their use of your device is kept up-to-date and state of the art in terms of high quality patient care delivery?

Education and training programs from GE Healthcare include offerings from initial installation training, to a broad range of Clinical Applications, Healthcare IT, Clinical Best Practice, Technical and Continuing Education Classes. All are structured to help our customer’s staff get the most out of the equipment and technology features purchased. Our programs help users stay on top of the latest technologies and therapies, to deliver better care, increase patient safety, and ultimately reduces costs.

We can design specific training programs to meet our customer’s needs. Whether a customer has clinicians requiring instruction on advanced use or healthcare IT professionals needing to understand how to work across platforms, GEHC offers the detailed, focused curriculums with qualified instructors to fit those needs. Also, many of our clinical programs provide Continuing Education Units (CEUs).

Install Base – In North America, approximately how many patients are monitored each day using your monitoring equipment?

GE Healthcare is one of the leading monitoring systems in the United States. Market Share reports can be found through third party sources such as Frost & Sullivan.

Equipment Usage – Approximately what are the percentages that your equipment is being used in:

  1. ICU
  2. PACU
  3. Med-surg
  4. Pediatrics
  5. General care floor
  6. Telemetry or step down units
  7. During conscious sedation or MAC (Monitored Anesthesia Care)
  8. In healthcare facilities other than at a hospital hospital (e.g. ambulatory surgical settings, surgi centers, outpatient clinics that provide endoscopy capabilities)
  9. ______ (pls provide details)

GE Healthcare’s CARESCAPE patient monitors are widely used across the entire enterprise including ICU, PACU, Med-surg, pediatrics, general floor care, during conscious sedation or MAC as well as in healthcare facilities other than at a hospital. We offer comprehensive telemetry solutions for telemetry and step-down units.

Equipment Costs (approximates are acceptable)

What is the cost per patient per day to monitor with your equipment? Is there a specific ICD 10 code or bundled payment code which applies to your device?

Have your customers seen a return on their investment? (please specify parameters for measuring ROI)

CARESCAPE modular monitors are designed to adapt to ever-changing patient needs across care areas, helping healthcare providers improve patient flow, better manage staff workload, and deliver consistent quality care across beds and units. Patient monitoring can help support the care plans for patients across multiple ICD 10 codes or bundled payment codes as they provide physiological measurements and alerts that help clinicians asses patient status.

Our patient monitoring system is designed to protect our customers’ investment. Recognizing the need to leverage current investments, many of our products include backwards compatibility, helping to protect existing assets while allowing customers to keep pace with innovation and reducing both the time and financial cost of integrating new equipment—minimizing disruptions to crucial ongoing operations. The design of the monitoring system allows new monitors at different revision levels to be added to the system without requiring a full upgrade of every monitor and other component of the system. In addition, GE practice has been to offer attractive upgrade options to its installed base when monitoring system components reach end of useful life.