Vol. 15 •Issue 2 • Page 47
What Lies Ahead for Blood Gas Analyzers
Ten most wanted analyzer features revealed.
PsychiC John Edward made hundreds of bold predictions on his popular TV program “Crossing Over” in 2001. Among them, he accurately forecast that his rival’s series, “Beyond With James Van Praagh,” would be cancelled before the end of the season. To date, it’s Edward’s only correct premonition.
Edward’s stunning inability to accurately predict the future is hardly unique. Prognosticating is difficult stuff, and I’m no fortuneteller. However, I believe that a careful examination of the medical and economic factors that influence diagnostic testing will provide a reasonable perspective for what lies ahead in the evolution of blood gas analyzers.
As with almost all in-vitro diagnostic products, two primary forces will undoubtedly shape new blood gas devices: what users and managers need to meet the demands of their facilities’ testing services, and what vendors can produce that will meet these needs while providing an opportunity to make an acceptable profit.
ABG wish list
Customers and vendors must consider what sought-after features will make blood gas analyzers of the future a reality.
Based on hundreds of conversations with people who perform blood gas testing, I’ve confirmed that health care professionals involved with blood gas testing want analyzers that provide results rapidly and are cost-effective, accurate and reliable. Beyond these obvious attributes, here are the 10 most wanted analyzer features commonly cited by those responsible for performing arterial blood gases:
Automated quality control (QC). As the trend toward decentralization of blood gas testing continues, the desire to have analyzers perform QC automatically has grown by leaps and bounds. QC is required for all analyzers, and it ensures that an analyzer’s results are accurate and reliable. QC is required daily, and in many instances up to three times per day (once per shift).
Unfortunately, the process of running QC can be complicated and cumbersome, and nurses and other non-laboratory personnel may shy away from performing this task. If systems are designed to perform QC automatically and shut down if not running within specifications, a lab manager or point-of-care coordinator may be less concerned about placing analyzers outside of the lab for testing.
Broad test menu. There’s substantial interest in the ability to test for multiple analytes when performing ABGs. Customers are seeking expanded testing capabilities for a broad spectrum of compounds and parameters, including creatinine, bilirubin, blood urea nitrogen (BUN) and lactate.
Creatinine is a waste product produced in the muscles from the breakdown of a compound called creatine. Creatine is part of the cycle that produces energy needed to contract muscles and is produced at a constant rate. Almost all creatinine is excreted by the kidneys, so blood gases are a good measure of a patient’s kidney function.
Bilirubin tests are used to monitor liver disorders. When bilirubin levels are high, jaundice occurs, and further testing is required to determine the cause. Accurate testing for bilirubin levels can determine if the body is producing too much bilirubin, or if the liver is incapable of adequately removing it in a timely manner.
BUN tests measure the amount of urea nitrogen — a breakdown product of nitrogen — in the blood. Blood gases also can test lactate levels. Lactate levels help detect hypoxia and other conditions that cause excess production or insufficient clearing of lactate in the blood.
Compact design. Characteristically, adequate space is at a premium in hospitals, both in lab settings and on the floors. Analyzers with small footprints are overwhelmingly preferred. Hand-held analyzers have appeal but also may cause concerns regarding their likelihood of being easily misplaced or stolen, as well as how accurately their results correlate with lab-based systems.
Connectivity. Connectivity is the process by which vital data are extracted from the analyzer and electronically recorded in a database. The ability to transfer patient, operator and analyzer information to a laboratory or hospital information system is of escalating importance to administrators. The capability to record and easily retrieve this data also is a priority.
Lab managers are seeking an automatic, wireless downloading of data after every test is run. These functions should involve little or no operator involvement or unique computer programming. However, if security isn’t adequate, connectivity problems could lead to potential problems complying with the Health Insurance Portability and Accountability Act.
Ease of use. With laboratory and medical technicians in dwindling supply, it’s increasingly important that future blood gas analyzers be straightforward and intuitive to operate, offering simplified data entry and built-in usage instruction. Bar code scanners that automatically enter data and on-board instructional videos for user training and updates are helpful for operators.
Additionally, customizable, easy-to-navigate menus and self-diagnostics will improve workflow during testing.
Minimum maintenance. With the advent of point-of-care testing, greater numbers of non-laboratory-trained personnel have been asked to operate blood gas analyzers. Many of these people aren’t familiar with the maintenance for these systems. Future generations of analyzers will require simplified, minimal maintenance.
Remote access/control. Given the proliferation of ABGs performed outside of central testing locations, administrators are fervently seeking the ability to monitor, access and control these systems remotely. In particular, remote lock-out capabilities are desired.
Many new blood gas systems offer these features. They eliminate the need for a point-of-care coordinator or blood gas administrator to travel to every site in the hospital to check on individual analyzers. Supervisors can monitor all analyzers from their office and make adjustments, including remotely shutting down the instrument if needed.
Small sample capability. Obtaining sufficient quantities of blood from patients can be problematic, especially when dealing with children or infants. Many administrators want to move from milliliter to microliter-sized samples for performing blood gas analysis with the thinking that the smaller the sample required, the better.
Standardization. Hospital administrators are increasingly concerned about the correlation of test results from diverse analyzers in different locations, which often is accompanied by lack of common workflow procedures and quality control methodologies. Consequently, ABG administrators are seeking greater standardization in blood gas devices.
Versatility. Users seek flexibility in how they can modify the many features of their blood gas analyzers to their individual testing circumstances. They want to be able to customize and select specific menus, and pay for only those analytes required in a given situation. So, when using cartridge-based systems, managers want a choice of many test volume options to minimize waste and maximize convenience.
What the vendors say
Before implementing plans to address customers’ future needs, blood gas analyzer manufacturers must consider several factors affecting how they can apply their resources. The state of the blood gas analyzer market and budget constraints are only the beginning.
The number of hospitals in developed nations is declining, and while the volume of ABG testing will likely grow in proportion to an aging population, this doesn’t necessarily translate into more analyzers. The blood gas market has grown 3 percent to 5 percent during the past several years.
Although the volume of testing is expected to continue growing modestly, facilities aren’t replacing blood gas analyzers as quickly as in the past. This is partly due to hospitals lacking the funds to upgrade as often, as well as the reliability of newer technology. The average life span of a typical blood gas analyzer device has increased from 4.5 to 5 years, to 6 to 6.5 years.
The fact that many facilities don’t have to upgrade as often has its drawbacks for vendors. Manufacturers are faced with increasing expenses for research and development operations, which have to be weighed against potential financial returns. Higher labor costs, rising costs for raw materials, and more point-of-care testing translate into the need for more automated and technically complex systems. If consumers are purchasing fewer devices, then the analyzer manufacturers may have less funding to support the creation of these new devices.
In the near future, manufacturers may be more likely to weigh investing in blood gas testing in comparison to other product opportunities, potentially diminishing the attractiveness of future investment in enhanced blood gas analyzers.
Vendors also encounter technological limitations. Currently, there appear to be no new and improved technologies available for analyte sensors. Thus, the near-term future market for blood gas analyzers may be restrained by the capabilities and cost considerations of electrochemical sensors. However, users don’t necessarily want new technology; they want current technology to run faster and more reliably, which the vendors are now able to give them.
So, do these factors mean that the future of blood gas testing is bleak? Absolutely not. They simply indicate that improvements in blood gas analyzers may be more incremental than revolutionary.
In the pipeline
Some blood gas analyzer manufacturers are working on special features, and consumers may see these upgrades sooner than later.
Biometrics will become a popular method for user identification and device access. Currently, passwords control access to each ABG device, but these can be easily circumnavigated. Through voice, retinal or thumb print identification, biometrics offers several options that provide more robust security and will probably be incorporated in upcoming systems.
Along the same lines, bar coding improved sample identification, but radio frequency identification (RFID) takes the security process another step forward. RFID is a generic term for technologies that use radio waves to automatically identify objects or people. For blood gas testing, a set of unique RFID tags will be used to uniquely identify a patient’s samples. Each ABG device will be able to read these tags.
Future analyzers also will likely have built-in Internet connectivity. Web-linked communications allow vendors to send automatic updates for system software, remotely monitor reagent levels and automatically reorder supplies. Advanced connectivity will allow users to accept test orders via portable, computer-like devices, as well as send test results directly to laboratory and hospital information systems.
With the continuing input of those responsible for performing and managing blood gas testing, and the ongoing efforts of vendors to develop innovative systems, the future of blood gas analyzers is exciting and promising.
Edward L. Weiner is the founder and president of The Emmes Group, a health care strategy consultancy based in Boston and San Francisco.
