With all the focus on medical device integration for EMRs and middleware vendors like Emergin, many of the hospital’s looking for solutions today know little about how connectivity has evolved. So, we were talking at Capsule the other day and here is a timeline we came up with. This surely isn’t a complete list, and we’re sure there are other significant efforts that should be included. We tried to keep it focused on successful implementations in a production environment of a system extracting data from a medical device into a clinical information system. So let us know what you think is missing!
1970’s and 1980’s
Early systems evolved from research work performed in some of the large university teaching hospitals. For more background – see this link. Eventually the market evolved from patient management systems (for example the HP Patient Data Management System or PDMS.) which were the first commercially available systems to provide any type of automated data capture between a medical device and a computerized system.
Standalone or independent connectivity solutions — Early efforts started in 1992 with Hewlett-Packard’s CareVue (now Philips) using the HP CIS Gateway. Early ventilator interfaces were implemented with custom serial cabling pulled to each bedside to connect ventilators via serial home-run cables back to wiring closets. The HP CIS Gateway was the data consolidation point and an early version of HL7 (2.1) was used to interface to the CIS. Other vendors such as EMTEK, Clinicom, and CliniComp also developed similar capabilities in this timeframe. There were a handful of drivers written for only the most common mainstream ventilators. In the peri-operative market, most surgical/peri-operative CIS vendors leveraged the local PC platform for serial connections directly to a multiplexor card.
Patient monitoring-based solutions – In parallel to the standalone connectivity solutions, key patient monitoring vendors including HP, Marquette, SpaceLabs, and Siemens developed monitoring-centric connectivity. These early products were proprietary “plug-in” modules that connected the medical device serial ports to the patient monitor. In these deployments, the patient monitor became the central “hub” for data consolidation. Here is primary purpose of the interface was to display non-monitoring data such as ventilation parameters and waveforms in a correlated display along with the physiological monitoring data. Alarms are also processed via these types of connections and sent to the monitoring central station. However, these types of interfaces have somewhat diminished in value over time – mainly because ventilator devices now have very advanced graphical user interfaces (less of a clinical need to correlate device data on the monitoring display) and alarm management and directed notification systems (i.e. Emergin) are now mainstream products.
Marquette Medical (now GE) released Octacomm (see original press release here) and Hewlett-Packard released HP DeviceLink and. Both of these products were based on an 8-port terminal server and this was the first instance of converting serial data to network (TCP/IP). Serial cabling included an identification module that provided the device type so that the correct device driver could be invoked. These solutions included a data aggregation server with an HL7 interface to the CIS application server. In this timeframe, McKesson DAS and others started to become popular but most of these solutions were still based on serial cabling end-to-end (and in some instances short haul modems). Around this same time, Capsule was founded in Paris, France.
As CIS applications started to become more pervasive, many vendors entered this market with various point solutions for medical device connectivity. But the two main methods continued to be either patient-monitor-centric or standalone solutions that leverage a terminal server/concentrator at the patient’s bedside. During this timeframe, products such as DeviceLink and Octacomm evolved into Philips DeviceLink II (link here) and GE Unity ID (link here). One notable change in the market during this period was the earliest release of intelligent IV pumps or Smart Pumps as they are referred to today. Smart IV pump devices are the result of pioneering work done by Nat Sims, MD and others at Mass General back in the 1987-1992 timeframe (see link here). Alaris Medical was the first commercial vendor to use this “smart” technology. As these devices started to gain traction in the market, interfacing to CIS/EMR’s started to become a core requirement. This requirement started to challenge the strategies of the large incumbent vendors – mainly the patient monitoring companies. The main challenge to their strategy became a question of how to best connect the smart pumps to the CIS/EMR. Connecting IV pumps to the monitor did not make any sense either clinically or from a cost/complexity perspective.
As markets typically evolve, in this timeframe some vendors disappeared or merged into larger companies and new companies entered this market. Wireless (802.11/WiFi) and mobility have created new challenges. The market started to realize that serial cabling is messy and cumbersome from both an aesthetics and clinical workflow perspective. In addition, location-based “tagging” of the data is starting to become more problematic. Mapping data to a bed label or room number worked when the medical devices remained fixed and hardwired – but more and more devices are now enabled with WiFi and as a result are very mobile.
New challenges (and opportunities) are: (1) in the area of eliminating all serial cabling via wireless enablement or via the device vendor providing an embedded wireless feature and (2) in associating the devices to a verified patient identifier (see link here).