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Health Care Industry

Patient management options are expanding with new technologies in critical care arena

BBI Newsletter, The, July, 1996

Over the past 15 years, numerous companies in the medical device and diagnostics industry - including Abbott Laboratories (Abbott Park, Illinois), Pfizer Inc. (New York), Puritan-Bennett Corp. (now part of Nellcor Puritan Bennett, Pleasanton, California), Cardiovascular Devices/3M Corp. (Tustin, California), LightSense (Santa Monica, California), Optex Biomedical (The Woodlands, Texas) and others - have pursued major programs to develop continuous in-dwelling sensors to monitor blood gases in the critical care setting.

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Not only has the development of accurate and reliable technology for in vivo blood gas monitoring proven extremely challenging, but in addition the increasing cost-consciousness of hospitals has hindered acceptance of the limited number of systems that have been introduced. Only one system, the Pfizer Biomedical Sensors Paratrend 7 continuous in vivo blood gas monitor, employing a Clark electrode sensor for p[O.sub.2] measurement and optical absorbance sensors for pC[O.sub.2] and pH, continues to be marketed in the U.S.

The demand for more rapid availability of blood gas results at the bedside in the critical care setting has not abated, however, and in fact, as clinicians seek to improve the efficiency of patient management and to transfer patients out of intensive care beds to less expensive medical/surgical beds as quickly as possible, an increased need has arisen for more timely information on patient status, including both immediate and trend information on blood gas levels. To meet that need, a new generation of devices has emerged for in vitro measurement of blood gas at the bedside, and two new systems have been launched for paracorporeal blood gas monitoring.

New technologies for blood gas monitoring

The 1996 annual meeting of the American Association of Critical-Care Nurses (AACN), held in May in Anaheim, California, provided a forum for the introduction of new sensor-based blood gas monitoring systems. Ex vivo, or paracorporeal monitoring systems, were exhibited by Optical Sensors Inc. (Minneapolis, Minnesota), in partnership with Marquette Electronics (Milwaukee, Wisconsin), and by Via Medical Inc. (San Diego, California). In addition, SenDx Medical Inc. (Carlsbad, California) launched the SenDx 100 pH, Blood Gas and Electrolyte Analyzer for in vitro testing at the bedside; and Hewlett-Packard (Andover, Massachusetts) displayed a conceptual model of a new module for the HP Merlin patient monitoring system that accepts blood gas/electrolyte and other test cartridges manufactured by i-STAT Corp. (Princeton, New Jersey). Details regarding those and other products for point-of-care blood gas testing in the hospital critical care setting are shown in Table 1 on page 124.

Products for in vitro bedside blood gas analysis have been available for more than five years. One of the first products to be introduced in the U.S. was the GEM system from Mallinckrodt Sensor Systems (Ann Arbor, Michigan), a portable electrochemical sensor based system using multi-test cartridges, allowing either 150 or 300 tests to be performed before cartridge replacement is required. While that product has proven moderately successful (GEM systems are installed at over 600 hospital locations in over 30 countries), sales have stabilized at between $25 million and $30 million worldwide. Newer products have been launched by i-STAT and Diametrics Medical that have provided attractive alternatives for point-of-care in vitro blood gas/electrolyte analysis, and in the case of the i-STAT system, a broader test menu, including chemistry and other tests. The i-STAT system has been well received by the marketplace, with i-STAT's total sales approximately doubling from $10.7 million in 1994 to $20.1 million in 1995, driven in part by the addition of blood gas tests to the menu in late 1994.

The most recent advance announced by i-STAT is its partnership with Hewlett-Packard to re-configure the hand-held i-STAT instrument as a module with front dimensions of about 3[inches] x 3[inches] that plugs into the HP patient monitoring system. A blood sample drawn from the patient is deposited into the i-STAT cartridge, the cartridge is inserted into the module, and results are displayed on the HP monitor, along with vital signs data, in about two minutes. The test information also is integrated into the vital signs database for the patient and into HP's Clinical Information System charting program. Using the HP Palm-Vue hand-held terminal, physicians at a variety of locations can have immediate access to the bedside data, including vital signs waveforms.

A new alternative for in vitro bedside blood gas analysis, introduced at AACN, is the SenDx 100 blood gas/electrolyte/hematocrit test system. That lightweight monitor employs a 100-test cartridge to perform blood gas/electrolyte/hematocrit measurements on 200 microliters of blood in less than 90 seconds. List price per test is $3.75, making the SenDx 100 one of the lowest-cost bedside blood gas testing systems available.

Health Care Industry

Patient management options are expanding with new technologies in critical care arena

BBI Newsletter, The, July, 1996

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