BBI Contributing Writer

ORLANDO, Florida – As more data relating to hospital infection rates as well as the undesirable effects of procedures such as central line placement becomes more evident, clinicians are waking to the need for the development of minimally invasive and noninvasive technology. That was the message of Max Harry Weil, MD, one of the founding members of the Society of Critical Care Medicine (SCCM) and currently a member of the organization's board of directors. During his presentation at this year's SCCM annual meeting here in February, Weil emphasized that the more invasive the technology required to obtain patient data, the more adverse complications were likely to be associated with the measurement. This translates into more events, longer hospital stays and added expense, and does not necessarily signify improved outcomes. Weil stressed the need to become less invasive, but noted that as measurements moved outside of the body, the quality of the signal declined and frequently became lost in noise and artifact.

Weil made his observations and his challenge for the vendor industry to progress even more rapidly in this direction at the SCCM's Technology Meeting. To underscore the society's appeal for less-invasive methods of obtaining information, Weil presented the organization's first-ever Award for Significant Technical Achievement to Joe Kiani, president of Masimo (Irvine, California). Weil pointed to the achievements of Kiani and his company in helping to extract patient signals and to allow reliable noninvasive monitoring of pulse oximetry. In his acceptance of the award, Kiani thanked the clinical members of the society for their encouragement and openness in evaluating and supporting the company's signal extraction technology (SET), noting that without such support, the technology would be gathering dust in a corner somewhere, rather than improving patient care.

The exhibit floor at this year's conference echoed the noninvasive theme. In spite of the traditionally small attendance of this conference (slightly over 3,000 of the 9,500 or so SCCM members), Mallinckrodt (St. Louis, Missouri) had a full-sized booth, but was showing only the new N395 pulse oximeters from its Nellcor Puritan Bennett unit (Pleasanton, California). The N395 is a nicely packaged, traditional, portable oximeter. Mainstream in design and concept, the new oximeter line is doing well for Mallinckrodt.

Masimo also had a large booth where it was introducing the new Radical oximeter, interfaced to five companies' bedside monitors. Radical, as the name implies, breaks some marketing rules, and is truly a guerrilla oximetry product. It is a chameleon device. First, it is a hand-held oximeter with full display of pulse rate and SpO2, as well as trends and alarms, and is very portable compared to competitors' oximeters. However, snap Radical into its docking station and it becomes a transportable or stand-alone oximeter, complete with communications. Yet, you can also cable the docking station into a patient monitor, which allows Radical to provide Masimo's SET capabilities right into the monitor, displaying the waveform on the screen, as well as the saturation and alarms on the monitor's display.

While Radical "came out" at SCCM, it was shown privately as a work in progress to some members of the press and prospects at last October's American Society of Anesthesiologists' meeting. Since then, these private showings have resulted in the build-up of a large backlog of orders that will be shipped beginning this month.

Masimo and Nellcor weren't the only companies showing new oximetry at the SCCM gathering. Agilent Technologies (formerly Hewlett-Packard) was showing enhanced SpO2 algorithms in its Merlin SpO2 monitors for the first time. This technology first appeared in the company's M3 portable, which was shown at ASA last fall. Agilent claims that this algorithm is as good as the Masimo SET. Siemens (Iselin, New Jersey) also was talking about its low noise oximetry, again claiming to be as good as SET.

However, oximetry wasn't the only new technology to be seen on the SCCM exhibit floor. Bispectral Index (BIS) monitoring from Aspect Medical (Natick, Massachusetts) was present and interest was strong. BIS is a well-executed technology that is well on its way to becoming a new standard of care in anesthesia. Aspect is showing its BIS technology not only for perioperative applications, but is now cautiously expanding into the conscious sedation markets for ICU and imaging. Interest in this technology is intense and Aspect's stock, which went public earlier this year, has risen from the IPO price of $15 per share to as high as $66, although it was at $45.50 as this issue went to press.

ICU sedation also was the subject of a new pamphlet from Roche Pharmaceuticals (Nutley, New Jersey). Entitled "Building Sedation Care Competency in the Intensive Care Unit," it is an excellent primer for providers seeking to expand their ICU sedation awareness and skills. The SCCM also provided educational sessions on BIS, with a session titled "Advances in Sedation Assessment."

Novametrix Medical Systems (Wallingford, Connecticut) was showing enhancements to its new Fick non-invasive cardiac output device (niCO) that allowed determination of CO in patients experiencing "mixed" breathing on a ventilator. The device features an adjustable rebreathing loop that connects to the patient circuit ahead of the ventilator, and uses an in-line Capnostat CO2 sensor and a rebreathing valve to calculate CO every couple of minutes without staff assistance. It is suitable for adolescent and adult patients, but has too much dead space for small pediatric or neonatal patients. FDA studies are now completed, and this device is ready for prime time.

Not all of the interesting technology at the conference was in the exhibitors' booths; some was "walking around" the exhibit floor. For example, InMedica (Salt Lake City, Utah) was showing a niBP product that was able to perform real-time hematocrit (HCT) measurements. InMedica announced its product in December 1999. This interesting technology is useful for identifying and tracking body fluid shifts in a variety of acute situations and is based upon the principle that, if the patient isn't bleeding, the number of red cells circulating per unit volume of blood is constant. Consequently, as the hematocrit (HCT) rises and falls, it is tracking fluid shifts into and out of the circulating volume. This could signal, for example, fluid being third-spaced. HCT is a component of standard blood tests, with more than 240 million tests being performed annually. It also is reimbursable under Medicaid for testing of pregnant women seeking nutritional support under government assistance programs. This niche alone represents 30 million HCT tests per year, and the InMedica device performs these noninvasively.

The most interesting and useful application of this technology will be in the emergency department, surgery, recovery, and ICU settings, where patients need to be monitored in order to determine their true circulating volume, as well as where any fluid shift has occurred. The technology is based on known science; however, recent U.S. patents covering the application of the technology include nos. 5,526,808 and 5,642,734. As providers realize the usefulness of continuous HCT, and begin to adjust their patient management protocols to incorporate it, HCT will become an important monitored parameter, making conventional niBP alone obsolete.

There also were some new or improved ventilator (and related) technologies at the conference. Dynavox, a division of Sunrise Medical (Pittsburgh, Pennsylvania), was showing its VitalVoice devices that enable speech-impaired patients (those with tracheotomies, head trauma, strokes, or who are being ventilated) to express themselves using a computer-generated voice. The device is a small, bedrail-mounted symbolic keypad that enunciates the patient's need in response to touch. While the voice sounds like a first-generation computer, it nevertheless allows communication. However, at $6,000 per bed, this technology is still too expensive, even with the integration of TV and bed control functions. At $1,200, the device would be interesting and cost-effective, but since it has no disposable component to generate revenues, it can't be essentially given away in exchange for a disposables contract, as can many other technologies. Consequently, Dynavox will need to make a significant price reduction before the technology becomes mainstream.

Hamilton Medical (Reno, Nevada) showed its newest Galileo ventilator. This advanced design now supports both adult and neonatal ventilation, placing it in competition with the Bird Life Design (Dallas, Texas) VIP and the Drager (Telford, Pennsylvania) Babylog. It supports many ventilation modes and costs around $28,000 in the U.S. It has a battery option to provide from 25 to 90 minutes of operations in the event of power failures or for short, intrahospital transports. Its simple, differential pressure transducer is highly accurate. On the other hand, the Galileo is not as advanced in its communications. Providing only RS-232 outputs (using its own, proprietary, published protocol), Galileo lacks the HL-7 or XML support that would allow it to communicate with hospital information systems directly or via the Internet. The unit does offer relay contacts for turning room status door lights on, or activating the RN call system.

The instrument that seemed to steal the SCCM show was the Drager Evita ventilator (Dura 2 and 4), with its anatomic tube compensation, which reduces work of breathing. The Evita has a mode that allows the ventilator to sense the lowest peak airway pressure necessary to obtain the prescribed tidal volume, coupled with a mode that allows the patient to take spontaneous breaths without fighting the ventilator. Drager has seen its market share in the adult ICU segment rise rapidly over the last three years, from around 5% to around 18%, particularly in the last year due to the acceptance of the new Evita models.

Zoll Medical (Burlington, Massachusetts) was showing its popular M-Series defibrillators, now with biphasic waveforms, 12-lead ECG and analysis (OEM'd from GE Medical), and other enhancements. The M-series sales pushed Zoll's 4Q99 sales up by 300% over 1998 levels, as shipments to EMS customers grew by more than 150% in the same period. Accordingly, the M-series is receiving a warm welcome in both pre-hospital and ED inpatient settings. With its integrated Masimo SET pulse oximetry technology and FDA-pending etCO2 capabilities, the M-series is creating many smiles around Zoll.

One key to gaining rapid market acceptance is getting the cost/value relationship right, and this cost-value equation is a nagging problem for some new technologies. Somanetics (Troy, Michigan) has struggled with this for several years with its older Invos 4100, as well as in its newest Invos 5100 cerebral oximeters. While these devices have wide application in thoracic, carotid, and other major surgeries, the $17,000 (Invos 4100) to $25,000 (Invos 5100) price tags give would-be buyers pause. However, the sensor, at $40, provides a means of "giving away" the devices in exchange for a sensor contract. This is becoming a common means of funding such technologies; however, the per-sensor increment necessary to amortize a $25,000 instrument in a reasonable period is still an issue to most hospitals. The Invos 5100 has an additional FDA-pending application to pediatric patients, contrasted to the older Invos 4100, which was qualified primarily for adults only. Some industry watchers think Somanetics would do better to get this product down to a module and convince someone to integrate it into their monitoring system, in order to reach a more realistic cost/value relationship and promote much wider acceptance of this stalled technology.

The packaging issue is also a problem with the HemoSonic 100 non-invasive hemodynamic monitor offered by Arrow International (Reading, Pennsylvania). This device uses an esophageal probe to determine cardiac output. Since it must be placed in the esophagus, it is best described as minimally invasive, and probably applicable only to intubated or unconscious (sedated) patients. While the technology works, the engineering is almost ancient. Its monochrome CRT display, on-screen alphanumerics, and user interface in a Radio Shack enclosure need to be reduced in volume and price. Some feel this product should simply be a circuit board or module in someone else's monitor, or at least use VueLink or some other back door to display the HemoSonic data on an existing patient monitor. This would avoid the size, weight, and styling issues of the current device. If it must be a stand-alone, a flat-panel, color display would do wonders for its appeal and display capabilities. Teamed up with another parameter, such as bioimpedance CO, the device might have broader appeal, being useful for a wider continuum of care on patients that are awake as well as sedated.

Another product with a packaging design from the past is the SiteRite 3 from Bard Access Systems (Salt Lake City, Utah). This pole-mounted monitor helps the clinician visualize the underlying veins of a patient, and then guides the needle into the vein to assist in successful catheterization for difficult patients (with collapsed veins, for example). The device uses 7.5 MHz and 9 MHz ultrasonic probes to locate the veins, and works well. However, its $13,400 price tag makes it a hard sell to cost-conscious health care systems. As a result, the company has placed only about 1,700 of these units in the U.S. market. Given the 5,015 short-stay hospitals, along with their emergency departments, ORs, cath labs, and other units where such assistance would be helpful, this is minimal penetration of the market. Making the device hand-held, using a color display, and getting its price down to the $2,000-to-$3,000 range would mushroom its sales potential overnight.

Of the computerized patient record (CPR) suppliers, only Picis (Arlington, Virginia) and Clinicomp (San Diego, California) were present. Picis was showing its newest software enhancements in its booth, publicizing its recent selection by the VHA group as its preferred perioperative partner. The company continues to expand and integrate the software applications it has available. Picis is partnered with Siemens in Europe, and has some large orders there. The company is likely to maintain its market momentum, and is involved in discussions with a number of potential CPR market partners. The company could be acquiring some compatible technology, or be the subject of an acquisition by another company or one of its existing partners in the near future.

Apache Medical Systems (McLean, Virginia) was demonstrating its new, web-enabled system, allowing providers to take advantage of the Internet to access the Apache database. Apache is increasingly using CPR vendors' front ends, such as Agilent Technologies' Carevue, to gather data and populate the 27 physiologic variables that are part of the Apache database. This allows products like Acute Care Voyager+ to provide outcome predictions to clinical providers, and to track outcomes. This product is one of several recognized by JCAHO for outcomes reporting.

A newcomer with a slightly different approach was IC USA (Baltimore, Maryland), the brainchild of practitioners from Johns Hopkins Medical Center (also Baltimore), who wanted to reduce medical errors and provide remote expertise in real-time via the Internet. This 18-month-old company is one of several offering a remote doc-in-a-box (room) to watch over the patients at smaller or remote hospitals that may not have the staff or qualified practitioners to monitor patients continuously. IC USA will compete with companies like Vitalcom (Arleta, California), which offers the infrastructure for such services but not the qualified practitioners to populate the remote-surveillance, mission-control centers they create. First pilot installations of the IC USA technology went live at Sentara Health (Norfolk, Virginia), but installations that are more interesting will go live later this year at Vanderbilt University (Nashville, Tennessee). The system provides video and direct interface to HP/Agilent, GE, and SpaceLabs bedside monitors. IC USA estimates that using its real-time services reduces the costs of caring for "outlier" patients by half, and reduces ICU costs per networked bed by 30% or $150,000 a year. Vanderbilt will be an interesting test of validation of these numbers. Questions about staff responsibility and patient liability during "missed" events, however, remain as real issues. Who is responsible and liable for an event that has an adverse outcome missed by both the local hospital and the remote surveillance team? What if the net goes down, or storms or other interruptions disrupt communication between the hospital and remote center? How does the local hospital upgrade qualified staff to cover such incidents?

Considering new technologies in general, along with the rapid consolidation of the medical device industry, we wonder how inventors of a single, new technology will continue to find commercialization for their products. With rare exceptions (such as BIS monitoring), single-parameter technologies and devices will find it increasingly difficult to distribute their products, once they reach the proof of concept stage. Who will sell them and what distribution channels will be accessed are the missing elements in most of these small company business plans. Small companies need to get together in order to partner their technologies, rather than to go it alone and attempt to market their products in a vacuum.

In contrast to the activity at some of the booths, notably Masimo and Mallinckrodt/Nellcor, some exhibits at the side of the convention floor had such minimal activity that sales persons were giving yo-yo (rather than product) demonstrations. SCCM has never been a busy show, and as a result, a number of important vendors no longer bother with it. Absent were companies like Invivo Research (whose offices are in Orlando), Protocol Systems, MDE, Nihon-Kohden, GE Marquette Medical Systems, and many others. For whatever reason, SCCM doesn't seem to know how to promote itself either to vendors or to the trade press. Each year the number of vendors at this show seems to remain the same, at best. Coverage of this event by the press is also limited.

Many of the educational seminars, including the "Year in Review" presentations, discuss research performed by other groups, some of which was five years old – hardly cutting-edge stuff for a group that talks about how intensivists are the ones who will make a difference in outcomes and cost-control in the ICU. Perhaps the SCCM should encourage its members to do more original research of their own, which would establish the society as a more significant force in medicine. Even the SCCM sessions that dealt with original research were attended by only a handful of clinicians. It is sad to see SCCM meeting and vendor attendance stagnate and probably ultimately decline, to the detriment of the society and its worthy mission.

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