BBI Contributing Editor
NEW ORLEANS, Louisiana – Several monitoring companies used the occasion of this year's American Society of Anesthesiologists (ASA; Park Ridge, Illinois) meeting here in October to introduce new or improved vital signs monitors and also important inputs to any anesthesia information management (AIM) perioperative solution.
Siemens (Danvers, Massachusetts) was showing its new Explorer bedside/CPR architecture, still as a work in progress while it waits for final FDA market clearance. It consists of a medical, reduced-size 3“ x 8“ x 8“ version of a PC-compatible computer, which hosts not only the patient vital signs monitoring, but also a series of other medical applications and data interfaces. The system includes two separate flat panel, color 19" LCD displays which can be configured to simultaneously display various combinations of applications. For example, a conventional bedside with up to 12 waveforms on the left and a diagnostic quality, full-resolution PACS (picturing archiving and communications system) image on the right. Alternately, a real-time display of up to four other displays from patient bedsides, and a full 12-lead ECG display from the local bed are transparently integrated using a keyboard and point-and-touch interface. Explorer leap-frogs Spacelabs' (Redmond, Washington) Universal Clinical Workstation, providing integrated cardiac data, lab data, full-resolution radiology images, pharmacy information, patient history and real-time vital signs. Philips Medical Systems (Andover, Massachusetts) also is talking about such approaches, and can offer two displays per bedside, but the architecture is very different, with the bedside monitor dedicated to one screen and a remote gateway dedicated to driving the other.
Siemens' computerized patient record partner, Picis (Arlington, Virginia), provides a fully-integrated, bedside computerized capability, and if the customer is not interested in Picis, the Siemens system can interface to most other vendors' systems. Price-wise, Explorer adds only about $12,000 to the cost of whatever bedside "pick-and-go" monitor is selected for vital signs, which includes Pentium-processing power, making it about 50% of the cost of an AIM product implemented on most competitive platforms.
There was more good news for the innovative Siemens portable monitoring system. For example, it now has a portable, wireless networking option to keep it in touch while it is going from place to place, and not just sitting at one bedside in its docking station. The system now has a full, IEEE-802.11b Cisco (San Jose, California) wireless local area network capability, which gives these already portable monitors the flexibility of wireless networking. This will certainly make them more competitive with wireless monitors already available from Datascope (Paramus, New Jersey), MDE/Viosys (Arleta, California), Fukuda Denshi (Irvine, California) and others that implemented wireless networked monitors some time ago. It will put pressure on portable companies like Welch Allyn/Protocol (Beaverton, Oregon), which will announce wireless networking on its Propaq bedside monitors this month.
Siemens also was showing the new Micro2 Plus motion-tolerant, pulse oximeter, with newly integrated Masimo (Irvine, California) electronics and using Masimo sensors. This small, battery-operated package, about the size of a patient-worn transmitter, provides full trends and alarm processing at a cost of around $1,200. Limited outputs, limited networking, limited other functionality means this is a good portable oximeter that is accurate and motion tolerant – but that's all it is.
Siemens also was showing an enhanced version of the KION anesthesiology workstation, including several unique features such as a 360-degree rotating vaporizer magazine able to support up to three anesthetic agents simultaneously and an electronic ventilation system. Siemens is trying to gain a real market share in a U.S. anesthesiology market dominated by two competitors – Datex-Ohmeda (Louisville, Colorado) and Drager (Telford, Pennsylvania).
In spite of Siemens' new enhancements, gaining any market share in this crowded space is going to be difficult. Drager, having lost some market share over the last three years to Datex-Ohmeda, has introduced a new anesthesiology workstation, the Fernius GP, also a fully-electronic anesthesiology workstation, complete with integrated automated anesthesia charting capabilities. Datex-Ohmeda also was showing improvements to its popular Astiva series, complete with its own anesthesia charting capabilities. Meanwhile, Spacelabs is aggressively marketing its own anesthesia workstations and several smaller European companies are looking for opportunities to enter the U.S. market. This makes anesthesia workstations one of the most crowded and fiercely contended market niches domestically. With all this activity, who will succeed? From what we saw on the ASA exhibit floor, each vendor's machine had some advantages, but the new Drager unit has the best feature/design mix and most aggressive pricing, so it may regain some of the market share it has lost over the last couple of years. Siemens also may gain some small market share, particularly in those hospitals that standardize on Siemens products wherever they apply.
GE Medical Systems (Waukesha, Wisconsin), now perceived by its U.S. competitors as the 800-pound gorilla in the temporary void created by the second acquisition (by Philips Medical Systems) of the former Hewlett-Packard monitoring division in the last two years, was showing its new Centricity family of point-of-care, computerized patient records systems for perinatal, perioperative, PACS, radiology systems, ICU and emergency department. The perioperative system was of course the focus at ASA, and the system GE Medical showed was well thought out, comprehensive in its coverage of preop, clinical, patient holding, operative and post-operative capabilities. Its unique approach to charting by exception, using a column for prior evaluations, one for "within normal limits" and a third for "new conditions," makes for a screen that is able to display the pertinent exceptions rather than filling the display with lots of normal values. This is particularly useful when it is not the first encounter with the patient and previous data already exists in the system. By grouping functions such as History, Current Assessment, Cardiovascular, Pulmonary, GI, Endocrinology, Physical Exam and Assessment Plan as vertical areas rather than separate tabbed displays, Centricity provides a well-organized summary of pertinent information, including all exceptions, in a single, integrated display on one screen.
The system we saw, however, was not ready for clinical use – it simply was too much of a demonstrator and had too many painfully obvious, serious flaws. It allowed clearly erroneous, indeed impossible patient vital signs, to be easily entered and accepted without any warning. We typed in a blood pressure of 88 systolic over 98 diastolic, which Centricity gladly accepted and entered on the chart. There is clearly no default checking of entered data for medical rationality, or if there is, it will require tedious user customization to implement. Since this is unlikely to get done, GE Medical might better rename the system "Eccentricity" until the company provides such rudimentary logic checking on patient vital signs data. Once accepted, such data would cause serious miscalculations and all sorts of derived parameters that depend on blood pressure, and could be a legal issue in any litigation if patient outcome was less than expected.
Vendors often wonder why the majority of anesthesiologists don't want to fiddle with anesthesia information management systems, and this is a perfect example – it allows the charting of "garbage" data. If this was real clinical software, as was asserted at the GE Medical booth, it has serious problems for general medical use, and if it was not real clinical software, why was it shown there, misleading those who tried it into believing that all the functionality being demonstrated was actually available for installation in their practice?
While Centricity's perioperative CPR/management system was clearly one of the best and most comprehensive operating room management and AIM systems we saw at ASA, such non-functionality and vaporware issues should not be present in systems demonstrated by the U.S. market leader. The industry needs to show products that can at least work well during demos if participating companies want to convince doctors that they should invest $25,000 per OR in systems that will work well in clinical practice. No matter what the other features of the AIM system may be, the sale is lost because more than they want such products, doctors don't want to buy systems that could cause them to err in clinical settings.
GE also was showing its newest Dinamap Pro 1000 monitor, capable of both fast oral and rectal temperatures, noninvasive blood pressure, respiration, Nellcor (Pleasanton, California) "gold standard" pulse oximetry, and GE Marquette Medical's (Milwaukee, Wisconsin) ECG Pro analysis processing. It has two traces on a generous 10" color screen and the very popular "trim knob" user interface that Marquette developed and patented before its acquisition by GE Medical. A bed rail hook pulls out from the back, and the monitor includes both an ethernet and serial output for cabled networking. Presumably, these same outputs could drive one of the new, WMTS bidirectional wireless transceivers just acquired from Data Critical (Bothell, Washington), but the booth personnel were not talking about that, presumably because the Dinamap's internal software set was not yet programmed to be Data Critical/ WMTS-aware. The unit weighs in at a competitive 12 pounds and can operate on its internal batteries about two hours before requiring rapid recharging. The Dinamap Pro 1000 is priced under $9,000 without recorder, which is about a $400 option. It is intended for subacute settings being converted to monitoring, such as gastrointestinal labs, outpatient surgery or recovery areas, and other diagnostic areas. The Dinamap Pro is scheduled for a Masimo SET (Signal Extraction Technology) oximetry option in early 2002, so that customers who feel that SET works better than any other oximeters can get the unit with this motion-tolerant oximetry.
Philips Medical (formerly HP), now the non-U.S. market leader, had an interesting new portable, low-cost, 2-D color ultrasound scanner, about the size of a laptop computer. This box is priced at around $13,000, and is ideal for fast obstetrical or cardiology screening in both the inpatient and alternate site settings. Indeed, it may even open up some new screening type applications. For example, a quick scan will show effusions into the pericardial sac, a condition that represents a patient emergency. Just keep a scanner on your SICU or thoracic ICU. No calling radiology for a stat test. No need for a $70,000 to $150,000 cart-based, high-end ultrasound scanner. Just apply to the patient's chest and visualize the cardiac function. This same, inexpensive ultrasound scanner would be equally affordable for a school district's medical department, and could be used at high schools around a district to screen high school athletes for cardiac thickening and other markers that indicate defects that have resulted in sudden death of apparently healthy athletes. The ability of the scanner to store and annotate many tests makes it possible to collect the data and then take it back to the district where all students could be reviewed by one district-level medical consultant. Cost per test can be as low as $10.
Philips also was showing its now FDA-cleared Pulsion OEM invasive CO module. This module provides a much less risky and less nursing-labor intensive method of acquiring serial CO measurements. It avoids the higher costs of expensive Swan-Ganz PA catheters, or the expense of stand-alone computers such as Edwards Lifesciences' (Irvine, California) Vigilant CCO device. The technology provides continuous CO by pulse contour, as well as stroke volume and systemic vascular resistance.
Also on display was the new Philips implementation of the Aspect Medical (Newton, Massachusetts) Bispectral (BIS) module, which fits nicely in and on Philips' bedside module rack. This brings BIS measurements directly into the family of available Philips bedside modules, making BIS more affordable and convenient in both the perioperative and ICU consciousness sedation settings. This is an implementation of the latest XP technology and sensors that Aspect Medical was simultaneously introducing in its stand-alone monitor configuration at its own booth. This offers improved tolerance to artifacts cause by electrocautery/electrosurgical units, reducing BIS measurement blocking during surgery by up to 68% over its original technology.
Philips also was showing enhancements to its recently acquired compu-record perioperative charting and scheduling system. Indeed, these systems were everywhere. The sudden emergence of such systems is probably an attempt by all major monitoring companies to take advantage of the recent announced recommendations from the American Patient Safety Foundation (APSF) that hospitals adopt electronic anesthesia charting (AIMS) systems within the next 10 years, announced in their Summer 2001 Newsletter. Literally, every vendor was looking to alert anesthesiologists that it had an AIMS product worth taking a look at.