Medical Device Daily

VIENNA — The world of information technology is moving ever closer to the patient, bringing into sharp focus a concern among hands-on nurses and doctors about the integrity of the data they see from the devices replacing stethoscopes, thermometers and simple observation.

In other words, if the lines on the monitor screen in the intensive care nursing station are supposed to represent grandfather’s heart rate, is that really grandfather we are looking at? And is the reading accurate?

The answers aren’t as obvious as the questions. And the situtation becomes even more complex as the number of connected computer-driven medical devices and medical decision-support equipment increase, not only across organizations but also across institutional boundaries and national borders.

Moving beyond the exhibits promoting new medical equipment from hardware and software vendors at the World of Healthcare IT (WHIT) here last week, a visitor found at the back of the show a demonstration area set up by the international organization Integrating the Healthcare Enterprise (IHE), featuring an unexpected collection of competitors.

The diverse devices from different vendors in the Interoperability Showcase were interconnected to simulate continuity-of-care for a German man suffering acute chest pains while on vacation in France. The demonstration was a world premiere performance for interoperability across borders for personal care devices (PCD), the newest area of focus for IHE, which to this point has focused on validating behind-the-walls hospital information systems.

Development of this new PCD domain for IHE is sponsored by the American College of Clinical Engineering (Hartford, Connecticut) and the Healthcare Information and Management Systems Society (HIMSS; Chicago).

The well-established IHE methodologies for public review of vendor claims for interoperability were first applied to bedside PCD applications during an IHE Connectathon in New Orleans last February.

A second “plugfest,” where engineers from different companies prove their equipment can push or pull data from the products of other manufacturers, was held during the IHE-Europe Connectathon held in Berlin in late April (Medical Device Daily; May 2, 2007).

This new domain covers 39 defined informatic profiles for radiology, laboratory, cardiology, patient care coordination and IT infrastructure, with profiles currently being developed for pathology and oncology.

WHIT was the first opportunity for IHE to showcase the validated equipment and to fulfill a key goal for the PCD program: “to demonstrate marketable solutions at public trade shows.”

Visitors to the demonstrations area were registered as patients and an ad hoc electronic health record (EHR) was created to track a specific visitor through the continuum of care from an emergency department in France back to a cardiologist in Germany and then to intensive care at a German hospital.

The back-end operations for patient records and hospital administration were handled by diverse systems from eight vendors, reflecting buying decisions made by different care providers.

These included Alert EDIS from Alert Life Sciences Computing (Oporto, Portugal), for creating the admission/discharge transfer file; Hexalis from Agfa Healthcare (Mortsel, Belgium), to upload lab results to the infrastructure; HIE Registry and the HIE repository from IBM (Armonk, New York), to simulate the infrastructure; Professional Gate from InterComponentWare (Waldorf, Germany), as an interfacing infrastructure; forIndex, forView and forConnect from Forecare (Zeist, the Netherlands), to show X-ray orders and accessibility to documents generated in France for diagnosis; Carestream PACS and Carestream IMS from Carestream Health (Hemel Hempstead, UK), to show image capture and storage; and the Inititate Identity Hub from Inititate Systems (Reading, UK), for patient identity management.

Moving from the back-office to the bedside, the demonstration included three systems for patient care, one in emergency then two in intensive care. All patient data tracked was automatically fed as real-time updates into the patient’s EHR.

A patient-specific chart at the simulated German hospital was aggregated and displayed through the Intellivue Clinical Information Portfolio from Royal Philips Electronics (Amsterdam, the Netherlands), destined to operate in “the first 10 feet of care” by gathering data from multiple sources and assembling it in an interface that borrows the familiar structure of a paper chart, organizing sections into tabs and automatically fulfilling regulatory requirements.

The patient scheduled to undergo surgery was received in the emergency department of the hospital, where the Connex data management system from Welch Allyn (Skaneateles Falls, New York) served as the master unit for vital signs monitoring.

The Connex unit captured data from a range of stand-alone and computer-linked devices measuring, for example, blood pressure, temperature, heart rate, oxygen levels, and included the Welch Allyn Spot Vital Signs LXi allowing nurses to identify patients using an attached barcode scanner.

The demonstration showed how these procedures — which traditionally take several minutes for a hypertensive patient such as the fictional German, then require manual input of data — took only 15 to 30 seconds in this case. Visitors to the demonstration were welcomed to challenge this claim and have the procedures performed.

The advantages of gurney-side computer assistance, equally true with equipment demonstrated at the French emergency department back where the German’s journey home began, is that transcription errors are reduced and the patient chart is available to anyone on the system anywhere, meaning the referring cardiologist can monitor the situation from another wing of the hospital, or remotely at his office.

Adverse drug/drug interactions are reduced, as well as unnecessary studies and duplicate treatments, two significant factors measured for quality and cost.

The configurations of data capture and treatment can conform to different workflows or regulatory requirements used in either the French and German hospitals without rendering the core data inaccessible from one hospital to another.

As the patient moved to intensive care, the acute point-of-care system Innovian Solution Suite from Draeger Medical (Telford, Pennsylvania) took over the monitoring tasks.

Previewed as a new product in New Orleans earlier this year, the complete Draeger suite includes a distributed, client-based anesthesia information management system for the operating room; but in Vienna a slimmed-down version was demonstrated for the critical perioperative care.

The Innovian demonstration showed electronic patient charting, flowsheet, scoring and printed reports that continued work by competitive machines and provide the bedside interface for direct access by clinicians checking on the patient’s status

The second monitor demonstrated for critical care was the Intellivue from Philips that offers a touch-screen and three independent displays on a flexible screen configuration that recognizes different clinicians will access the bedside display, including surgeons, perfusionists and anesthetists.

The screen displays mask a high-performance central processing unit receiving multiple leads from sensors and enabling complex functions to prioritize physiologic measurements, monitoring information and alarm notifications. Displays can be set from a menu of clinical measurements with choices for numerical formats or graphical displays from waveforms to data labels.