BBI Contributing Writer

SAN ANTONIO, Texas The American Association of Critical-Care Nurses (AACN; Aliso Viejo, California) held its 30th annual National Teaching Institute (NTI) for the first time ever in San Antonio in mid-May. In light of continued national security advisories and travel hassles, the AACN was concerned that attendance would be down but was pleased that there were some 6,000 attendees. The focus on the previously acknowledged nursing shortage was evident throughout the event. According to a March 2000 study conducted by the Department of Health and Human Services, there are 403,527 nurses in the U.S. who care for critically ill patients in a hospital setting. Of this number, 201,833 work at least half time in an intensive care unit, while 70,241 work at least half time in a step-down or transitional care unit, 94,912 work at least half time in an emergency department and 36,541 work at least half time in post-operative recovery units (Table 4). Critical-care nurses comprise about 31% of the total number of nurses working in a hospital setting.

There have been some reported changing numbers concerning the looming nursing shortage, but the bottom line is nonetheless ominous. In her opening speech, AACN President Connie Barden, estimated a 400,000-nurse deficit in the U.S. by the year 2020 as compared to the figure referred to by others of a 750,000 nurse shortage by 2020. The shortage is being touted as particularly acute in specialty areas of nursing. No hard specialty numbers are cited as yet, but the AACN released figures that indicate a skyrocketing rise in requests for temporary and traveling critical care nurses to fill staffing gaps in every part of the U.S. The AACN says that the number of these requests has jumped 45% for adult critical care units, 50% for pediatric ICUs/neonatal ICUs and 140% for emergency departments. On the exhibit floor of the NTI, well over half of the 400 vendors were either hospital recruitment- or travel nurse-focused.

Coupled with this growing shortage of qualified critical care clinicians is the reality that the patients who do enter a critical-care unit are sicker than patients who were cared for even five years ago. Many of the patients who were cared for in critical care units in the past are being cared for either at home or on a medical unit. Because of this trend, some experts are predicting that hospitals of the future will be large critical care units and that lesser acuity patients will be cared for in separate locations. Meanwhile, technology is advancing rapidly, and new skills need to be learned constantly by those nurses who remain in the critical care area.

Medication delivery systems

One of the areas in critical care that is changing rapidly is the method of delivering medication to patients. Ever since the 1999 report by the Institute of Medicine (IOM; Washington) stating that medical errors kill between 44,000 and 98,000 people each year, companies have been introducing evolving equipment and software intended to assist in decreasing this number. Adverse drug events cause more than 770,000 injuries and deaths each year and cost up to $5.6 million per hospital, according to a 2001 report by the Agency for Healthcare Research and Quality (Rockville, Maryland). The same report highlighted the fact that patients who suffered unintended drug events remained in the hospital an average of eight to 12 days longer than patients who did not experience such mistakes, with hospital stays costing $16,000 to $24,000 more. An analysis from Frost & Sullivan (San Jose, California), "Strategic Analysis of the U.S. Infusion Pumps Market," reveals that this market, which has numerous companies participating, accrued revenues worth $1.67 billion in 2002 and is poised to expand to $2.5 billion by 2008.

Many of the companies offering a medication delivery system have reported increases in revenues, but this market still has plenty of expansion room. Baxter International (Deerfield, Illinois) reported that its medication delivery sales grew 17% to $850 million in the first quarter of 2003. Alaris Medical (San Diego, California) reported that in the first quarter of 2003, it had higher volumes of both drug infusion instruments and disposable administration sets as the primary factors leading to the increase in North America revenues of $10.6 million, or 15%, over the prior year.

Abbott Laboratories (Abbott Park, Illinois), one of the largest infusion companies, and Cerner (Kansas City, Missouri), one of the major pharmacy information system suppliers, announced in April that they had entered into an exclusive agreement to develop and co-market a comprehensive new point-of-care medication management system for infusion therapy. The system will integrate point-of-care infusion and diagnostic medical devices, bar coding, clinical information and knowledge-based decision support tools at the patient's bedside. The goal for the system is to facilitate improved patient safety, clinical outcomes and cost management, as well as caregiver efficiency and effectiveness. At the NTI, Abbott was closed-mouth about new products it was about to introduce.

Alaris Medical showed the Medley Medication Safety System, which is a modular point-of-care computer that integrates infusion, patient monitoring and clinical best practice guidelines in one platform. The company's Guardrails Safety Software helps protect against entry errors by checking the accuracy of the input before the information is transferred to the infusion system. Clinicians are alerted if a programming error is made. Alaris was featuring a new syringe delivery module especially appropriate for neonatal patients.This soon-to-be-released Alaris module can accommodate syringes from 1 cc to 60 cc and has a sensor located in the top of the unit that determines the size of the syringe. Once the syringe is in place, the clinician needs to enter the syringe manufacturer's name into the unit as each company's syringe holds varying true amounts (a 20 cc syringe may actually hold only 18.8 ccs), an important factor for neonates. The syringe is to be used with special tubing that has a sensing disc that fills with fluid as line pressure builds which minimizes air in the tubing and enables the medication to be administered immediately. Again, this is important with small doses that need to be started quickly on neonates or pediatric patients. Alaris will announce the release of an etCO2 module for its system in the fall.

B. Braun Medical (Bethlehem, Pennsylvania) exhibited its medication safety product, Horizon Outlook IV Electronic Pump Safety System. The Braun system provides automated programming of infusion data via bar-coded labels. Once the pharmacy fills a prescription, a bar code is placed on the IV bag, which is then delivered to the critical care bedside. The nurse scans an ID badge (provided by the hospital) across the Horizon Outlook scanner to verify authorization. The nurse then scans the patient's ID to identify the correct patient. The bar code on the IV bag also is scanned to confirm the match and to program the infusion device. Having confirmed that the displayed information is correct, the nurse initiates infusion by pressing a run button. In spite of the fact that Braun has had its system for only a couple of years now, it has reached a milestone in having been chosen by Premier (San Diego, California), the nationwide alliance of hospitals and health systems group purchasing organization, for a new contract category for medication management infusion systems.

Baxter Healthcare (Round Lake, Illinois) was showing a different and cutting-edge medical safety (and beyond) system. In November 2001, Baxter acquired Autros Healthcare Solutions (Toronto, Ontario), a manufacturer of wireless, Internet-enabled patient information and medication management systems that linked healthcare professionals involved in patient care with the decision-support needed to safely and correctly administer medication. At this year's NTI, Baxter showed a system that included a PDA device that clinicians would carry that offered real time information at the point of care. As soon as information is entered into the medication system (at any point), it is available to all caregivers. For example, if a nurse is hanging a medication at 9 a.m., but the physician decides to discontinue the med at 9:01 a.m., the nurse will know immediately to stop the infusion. This happens because the system communicates wirelessly on the 802.11 band and therefore, the pharmacy, the physician and the bedside nurse are connected in real time. Baxter indicated that if the hospital chose to include billing and the laboratory, for instance, then billing became automatic as the medication was scanned, and real-time lab values also would be available. This is a step toward true patient safety especially in critical-care areas, as patient laboratory values can change by the minute and therefore medications to be delivered may change. A wireless system would be invaluable for nurses with ever-increasing patient care loads. Baxter currently has the system installed only at Northwest Medical Center (St. Albans, Vermont).

Wireless ECG monitoring

On another wireless note, a new company, GMP Wireless Medicine (Fort Lauderdale, Florida) was showing a wireless ECG monitoring system that it hopes will receive FDA approval by this month. The system uses 802.11 Bluetooth technology to enable the transmission of ECG and respiration data to standard ECG monitoring units. The unit interfaces with all of the monitoring companies, including Philips, GE, Siemens, Datascope, Spacelabs, Datex-Ohmeda, Welch Allyn and others. This technology is intended for continuous ECG monitoring, 12-lead ECG and stress testing. Because it is wireless technology, the patient is "untethered" and freer to move about. As patients are encouraged to ambulate more quickly in their hospital stay to prevent complications, this may be a real advantage. This marketing approach is similar to Masimo's (Irvine, California) effort with its pulse oximetry technology, which it has interfaced with numerous vendors. However, it would seem that the major vendors could hop on this untethered bandwagon rapidly, if they chose to do so.

Balloon pumping developments

Intra-aortic balloon pumps (IABPs) are a subset of the cardiac assist market, a market segment that has grown as an increasing number of community hospitals without cardiac surgery continue to add interventional facilities. Following American Heart Association (Dallas, Texas) guidelines, hospitals that set up interventional facilities also add balloon pumps and catheters. About half of all patients who suffer heart attacks enter the system at a community hospital. Hospitals that have IABPs are able to intervene early in the course of treatment for patients who suffer cardiogenic shock and/or who then need to be stabilized and transported to a larger hospital setting for treatment.

It is interesting to note that even patients with an IABP in place are being encouraged to faster ambulation in spite of having the device in place. Historically, patients with an IABP not only were bedbound, but could turn only side to side at 20 degrees because the timing mechanism in an IABP is critical not only to ensure effectiveness but also so that the pump does not damage the patient it is intended to help. Now these catheters are placed through areas above a patient's waist so that patients can ambulate from a mechanical point of view, but there is still the problem of timing. There are two main intra-aortic balloon pump companies Datascope (Montvale, New Jersey) and Arrow International (Reading, Pennsylvania).

Datascope introduced a new large pressure lumen IABP catheter called Fidelity in the third quarter of 2002 that transmits a clearer arterial waveform that assists in the timing of their pump, even for patients that are increasingly more mobile. The company's 2002 sales of cardiac assist devices were $112.5 million, 5% below its 2001 sales. Cardiac assist product sales increased 14% to $31.6 million in the third quarter of 2003, reflecting strong worldwide sales of intra-aortic balloon pumps and the higher international sales of IABP catheters. Sales of Datascope's Fidelity IABP catheter continued to grow, accounting for 51% of the company's total IABP catheter sales in the third quarter.

Arrow International is the second intra-aortic balloon pump company. At the NTI, Arrow was demonstrating its new fiber optic arterial pressure technology in its intra-aortic balloon catheter. This catheter held a stable waveform even in the presence of severe movement. And Arrow's Autocat2 Wave IABP system automatically selected the best heartbeat from which to time the inflation of the balloon pump. The system costs $50,000 per unit and each catheter is priced at $750, about the same price of non-fiber optic catheters.

Arrow also offers what the company described as a "destination treatment for congestive heart failure [CHF]" in the form of its LionHeart left ventricular assist device (LVAD). This device is intended for end-stage CHF patients who for whatever reason are not candidates for other therapy or for a heart transplant. The LionHeart is a pulsatile LVAD implanted within a patient's chest that uses a wireless power transmitter, which means that the patient has a battery inside of his or her body. This allows the patient to be completely disconnected from the external battery pack for as long as 20 minutes long enough to take a shower or a short swim or whatever he or she would enjoy. There also is an external power source in the form of a pair of battery packs worn on a belt. At a cost of $60,000 to $75,000, the device is not cheap, but because it keeps patients out of critical care units and reduces drug needs and the amount of close monitoring required by expensive medical staffers, using an LVAD can be less costly than having no device. The break-even point is about 45 to 50 days after implant.

Sedation in the ICU

Another rapidly changing critical care topic is that of sedation at the critical care bedside. Level of sedation is an obvious need in the operating room (OR), but the need is not as intuitive in the ICU. In the OR, Aspect Medical's (Newton, Massachusetts) BIS monitor has been used to measure level of consciousness quite successfully, but now Aspect is making a compelling case for a much broader use for BIS in the critical-care areas.

In the past, critical care nurses assessed level of consciousness using subjective guidelines based upon patient vital signs, amount and type of movement and sedation/agitation scales. The difficulty is that clinicians interpret these signs using different values and based upon varying levels of experience. Also, some of the signs of possible under-sedation could indicate an increased pain level or decreased level of oxygen available to the brain or other factors. A study published in the February 2000 issue of Critical Care Nurse found that 15.4% of ICU patients were undersedated in the course of their care, while 30.6% were properly sedated. Interestingly, 54% of these patients were oversedated. Oversedation would seemingly tend toward patients being kept comfortable during their ICU treatment, but oversedation also translates to increased ICU and hospital lengths of stay, increased need to perform tests, delayed weaning from ventilators and therefore increased overall costs. Undersedation has been demonstrated to increase anxiety/agitation as well as causing more adverse incidents.

For patients requiring intravenous sedation in an ICU, Aspect cites a study performed at Spectrum Health (Grand Rapids, Michigan) that demonstrated a 58% savings in average monthly cost of sedatives alone (from $10,837 pre-BIS to $4,537 with BIS). Added to these savings would be the lowered length of stay, fewer complications and less testing required when precise consciousness levels are tracked. The two ICU conditions for which BIS monitoring is routinely used are for neuromuscular blockade (used for patients who have various respiratory difficulties and/or organ failure, etc.) and barbiturate coma (used for patients with severe head injuries, seizures and other conditions). Other expanding uses of BIS are for patients who are having substance abuse issues, for obese patients following lengthy operations (due to the fact that these people tend to store anesthetics in their excess fat tissue and then have the anesthetic agent released erratically), for general post-anesthesia recovery monitoring and for some end of life patients. The ICU market (especially through increased sensor sales) is essential to help Aspect grow revenues required to reach a break-even point.

It is interesting that research presented at the American Society of Anesthesiologists' (ASA; Park Ridge, Illinois) annual meeting last October showed that even short periods of deep sedation (BIS below 40) had an adverse impact on one-year mortality. Given this research, it is important to consider how longer periods of deep sedation that occur in the ICU setting might affect patients. If Aspect ever proves a connection conclusively, sales of its BIS monitors and sensors will skyrocket and the BIS will become a standard of care.

New brain tissue oxygen monitoring system

Integra NeuroSciences (Plainsboro, New Jersey) was showing its Licox brain tissue monitoring system at the NTI. This is technology that was obtained by NeuroSciences from a German manufacturer in April 2001 and appears to have increasing use in neurosurgical units across the U.S. The Licox system includes a probe inserted into a patient's brain (with the procedure being performed at the bedside). Aggressive treatment to prevent secondary brain damage in patients with severe brain injury increases the chance of good neurological outcome. The main advantage of using this system is that it provides early warning when the patient's brain is not receiving adequate oxygen in real time, when changes can be made early in the patient's condition.

According to the company, 60 hospitals are using the Licox system across the U.S. The cost of the monitor is $12,000, and each probe costs $500. Annually within the U.S. there are about 2 million emergency room visits for head injury, roughly 300,000 admissions for head trauma, nearly 52,000 deaths and approximately 80,000-90,000 cases of severe long-term disability. Integra NeuroSciences is conducting studies to complement the numerous studies that have documented the cost and patient benefits using the Licox system in Europe.

It is apparent each year at the NTI that the technology required to safely care for patients in a critical care unit continues to improve. This year the vendors seemed to have heeded the dire nursing shortage numbers and are beginning to incorporate that reality into their new products. Not only are the companies selling to the nursing reality with claims that focus on saving nursing time and improving efficiency, but they also are looking toward real future changes to reduce the labor intensity of nursing.

Many of the companies are looking to become wireless, leveraging off of hospitals already in place 802.11 wireless infrastructure. When companies finally integrate their systems into one PDA or other mobile communication/monitoring device, nurses will truly benefit. For now, the evolution is unfolding, and it will be interesting to see at next year's National Teaching Institute just how far many of these companies have progressed.