BBI Contributing Writer

PHILADELPHIA, Pennsylvania — In response to the tragic events of Sept. 11, the annual meeting of the American College of Chest Physicians (ACCP; Northbrook, Illinois) in early November featured several presentations on disaster preparation, understanding the clinical manifestations of chemical and biological agents, and the management of patients who present with these maladies. Several presenters who were at ground zero in New York also detailed their personal experiences.The 67th annual scientific assembly also highlighted presentations on the increased incidence of sepsis, the impending workforce shortage in critical care and the descriptive differences in the top-performing intensive care units (ICUs). The exhibit hall featured about 140 exhibitors who showed a number of new products. The meeting was attended by some 3,600 pulmonary physicians, respiratory therapists and critical care nurses.

As can be expected, the presentations on disaster preparation were and among the most popular on the conference program. Mark Rosen, MD, of Beth Israel Medical Center (New York) chaired a panel discussion of physicians that discussed the differences between natural disasters and terrorist attacks. Panelists noted that in natural disasters, there often is a warning that allows loss of life to be minimized even though large areas may be destroyed. Hospital disaster plans work well to prepare hospitals to respond to those types of events. With terrorist attacks, however, there is no warning, the initial damage is localized, the number of casualties may be high and the psychological impact continues for a long time.

The panel agreed that most hospitals will have to rewrite their disaster plans to adequately prepare for the threat of biological and chemical attack. Those plans will need to be continuously re-evaluated and updated based upon new information learned. Development of new disaster plans will require an understanding that first responders may be at risk. External decontamination centers and triage areas will be needed, as well as the ability to handle a large number of casualties. Staff members and first responders will need to be taught to recognize chemical and biological symptoms, because point-of-care testing will be too slow.

World Trade Center experience

David Plezant, MD, who survived the collapse of the World Trade Center, described his personal experience and provided an insight into the current and future medical needs of the firefighters and other rescue workers who responded to this national tragedy. Plezant is the deputy chief medical officer of the New York Fire Department, a professor of medicine at Albert Einstein College of Medicine and a pulmonary disease specialist at Montefiore Medical Center. Plezant described the collapse of the WTC as "the largest particulate-matter exposure in the U.S." He said that when the buildings collapsed, the rescue workers were exposed to "pulverized dust, glass, cement and other materials in immeasurable proportions." Amazingly, 60% of the rescue workers have not developed any symptoms from inhaling all of this particulate matter. However, 40% have developed a chronic cough, nasal problems and/or gastrointestinal reflux from inhaling the particulate matter. Plezant was the first physician to describe an irritated or sore throat, shortness of breath and wheezing as "World Trade Center cough."

Several emergency response lessons were learned from the tragedy, Plezant said. One was that the rescue workers needed respirators immediately upon reaching the site of the disaster but they were not available in the quantities required. Another lesson learned was that the respirators that were available worked well but were uncomfortable for the rescue workers to wear for extended periods of time. These lessons have implications for medical device manufacturers. Another lesson learned was the need for an early treatment intervention such as Plezant began with inhaled steroids for rescue workers who exhibited WTC cough. In addition, he has started an ongoing medical monitoring program for all first responders hopefully to avoid the onset of future respiratory problems.

Sepsis an emerging problem

One of the more interesting papers that was presented at the meeting was by Greg Martin, MD, of Emory University School of Medicine and the Centers for Disease Control and Prevention (both Atlanta, Georgia). Using data extracted from the National Hospital Discharge Survey in 1988 and 1998, representing 36 million hospital discharges, Martin described how sepsis is changing in the U.S. Since 1988, sepsis has increased 23.3% among hospitalized patients, to 684,035 reported cases per year. Racial and gender differences exist, Martin said, since it is more common in men than women and in African Americans than Caucasians. Since 1998, the most common causes of sepsis were gram-positive bacteria (52.9%) as opposed to gram-negative bacteria (41.6%), anaerobic (1.4%) and fungal (4.1%).

From 1988 to 1998, the overall mortality rate of sepsis decreased from 20.6% to 17.4%. Despite this 3.2% decrease in the number of sepsis patients who die, the absolute number of deaths related to sepsis has continued to markedly increase. In the U.S., sepsis is estimated to consume more than $15 billion annually, Martin said, and it is the 11th-leading cause of death. Sepsis presents many opportunities for new pharmacologic therapies.

During the ACCP meeting, Eli Lilly and Co. (Indianapolis, Indiana) had a prominent display in its exhibit that showed the network of cascading clinical events that occur when sepsis ensues. Lilly's message was that pharmacologic therapies targeting a wide range of mechanisms may be required to treat a disease process that is as complex and multifactorial as sepsis. The FDA approved Lilly's Xigris in late November but only for use with sepsis patients who are not expected to survive. When given to these types of patients, the drug can reduce the chances of death by 13%.

Top-performing ICUs

Jack Zimmerman, MD, of George Washington University (Washington) presented a study on "Top Performing ICUs: Their Policies and Practices." This presentation was especially interesting since there is an impending shortage of critical care physicians and nurses. The study found that the best ICUs were more efficient and had an equal or better patient survival. The best hospitals had a 20% to 25% better average length-of-stay and the worst hospitals had a 15% to 30% worse length-of-stay. All of the best hospitals had intermediate or step-down units in their hospital.

Each of the best hospitals frequently transferred patients to specialty hospitals. Since ICU patients are usually amongst the sickest and most costly patients for a hospital to provide care for, prompt patient transfer to a specialty hospital could be the single most important factor leading to their success. This could bode well for specialty hospital providers Select Medical (Mechanicsburg, Pennsylvania) and Kindred Care (Louisville, Kentucky). All of the best hospitals had a specific mechanism to facilitate prompt patient transfer to a lower level or alternative level of care. In other words, they carefully controlled the usage of their costly ICU beds.

Critical care work force shortage looming

The ACCP also used this meeting to form a coalition with the American Association of Critical Care Nurses (Aliso Viejo, California), American Thoracic Society (New York) and the Society of Critical Care Medicine (Woodbury, New Jersey) relative to the acute workforce shortage in critical care medicine. That shortage was first described and published in the Journal of the American Medical Association in December 2000, but has largely gone unnoticed by the clinical community and federal government. This impending workforce shortage is particularly frightening in light of the threat of chemical and biological warfare by terrorists and the subsequent preparedness of U.S. hospitals. Critical care specialists (physicians and nurses) are essential in times of national or local disaster. When there is a deluge of critically ill or injured patients due to accident or illness, these patients must be immediately triaged and treated. If specialists are not available, the system fails.

The coalition said that there are insufficient numbers of trained physicians and nurses to provide specialized care in ICUs for critically ill patients. This crisis is expected to intensify as the population ages and requires more intensive services. Today, about 600 physicians are in training to provide critical care services in the U.S. Because federal policy establishes the number of critical care fellowship training positions, this number will remain constant unless funding is increased by the federal government. By 2007 a shortage of trained critical care physicians will be evident. After 2007, demand for clinical services will continue to grow rapidly while the supply of critical care physicians will remain constant. By 2020 their will be a 22% shortfall and if left unabated, a shortfall of 35% in 2035.

The story is not much better for critical-care nurses. There are an estimated 400,000 critical care nurses in the U.S. today. Their average age is 45, and 61% are between the ages of 40 and 60. Only 9% are between the ages of 22 and 29. This means that the number of critical care nurses entering the specialty is minimal and mirrors the declining enrollment in nursing schools. A large number of experienced critical care nurses are nearing retirement just as the population ages and will be more in need of such care.

This impending personnel shortage has profound implications for medical device companies, which can develop products to reduce labor costs and allow decisions to be made faster. One company that has recognized this is Siemens Medical Systems (Danvers, Massachusetts). At the ACCP meeting, it showed several interesting products that can be purchased separately or integrated into a system. The SC7000 and SC9000XL Patient Monitors can measure up to 30 different clinical parameters. The SC7000 has a 10.4" screen and the SC900XL a 12.1" screen. These monitors have a cable management solution that uses one cable to provide for multiple clinical parameters instead of multiple cables. Both are "plug and go," meaning they can be easily moved with the patient during transport. The clinician does not need to look for a special monitor and then download all of the patient's clinical information into it before the patient can be moved. And both units have infinite modularity. Software can be added in the monitor or the docking station to automatically configure the parameter needs to the acuity level of the patient. Siemens will compete in this segment with GE Marquette Medical (Milwaukee, Wisconsin), Phillips/Agilent (Andover, Massachusetts) and Spacelabs (Redmond, Washington), along with Datascope (Montvale, New Jersey), Welch Allyn/Protocol (Beaverton, Oregon), Mennen Medical (Clarence, New York), Nihon Kohden (Foothill Ranch, California) and Datex-Ohmeda (Madison, Wisconsin).

Siemens also showed the Multi-View Workstation, a traditional central station device that includes a unique ventilator viewer offering the clinician a variety of ventilator settings and waveforms for up to 72 hours. Each workstation sells for $20,000-$40,000, according to the number of ICU beds that will be monitored. Siemens' Infinity Explorer is awaiting FDA approval. This unit will tie multiple information systems (such as clinical information, hospital information, DICOM imaging or any web-enabled system) together at the patient bedside to improve workflow and enhance employee productivity. The clinician goes to a single portal of information and can access and input data through multiple systems through a few simple clicks of a mouse. The anticipated list price will be $20,000 to $25,000 per bed, depending on product configuration. Siemens will compete in this market with GE Marquette, Phillips/ Agilent and SpaceLabs.

Other vendor announcements

Respironics (Pittsburgh, Pennsylvania) introduced the Image 3 Full Face Mask, which is only available as a disposable and will compete with the recently released ResMed (Poway, California) Mirage full-face mask and Respironics Spectrum masks (both available in disposable and reusable versions). All of these masks are designed for use with the Respironics STD-30 and Vision noninvasive ventilators or any other commercially available ventilator that allows noninvasive ventilation. Respironics also showed its Palm 111C interface for hospital sleep lab use. This device has a remote connection that allows Respironics' BIPAP Synchrony unit to be remotely controlled by the polysomnographer while a patient is undergoing a sleep study. The device will be marketed as a Lab Titration System and will include the BIPAP Synchrony, Palm 111C and an analog output module.

Southmedic (Barrie, Ontario) showed its new OxyArm device. This is a comfortable new way to deliver variable amounts of oxygen by adjustment of the flow rate. The device is uniquely designed, much like a telephone operator's headset. The patient wears the headset and receives oxygen through a baffled cup delivery system located on the end of the arm near the mouth. The device appears to be more comfortable to wear than conventional nasal cannulas or Venturi masks. It is easy to use and requires no facial contact due to its ergonomic design. This device allows the patient to talk, eat and drink in an unencumbered fashion. The success or failure of this product in the U.S. will depend upon clinical studies that document its superiority or equality to Venturi Masks and nasal cannulas in hypoxic patients, and its end-user cost. The company is trying to set up distribution into the home care and hospital markets now.

Salter Labs (Arvin, California) introduced a pneumatic oxygen-conserving device called the O₂Xpress. Demand oxygen conserving devices are designed to provide for the maximum utilization of cylinder contents. They typically come in two variations: pneumatic or electronic. Pneumatic devices operate from gas pressure while electronic devices require battery operation. The key feature of the O₂Xpress is its compact size and "pressure to regulate to bolus volume." The unit uses a patented dual-lumen cannula. One side of the cannula is for oxygen delivery while the other is for sensing of the patient's inspiratory effort. Its use is expected to reduce the time lag from the beginning of the patient's inspiratory effort and the time when the bolus of oxygen is delivered to the patient, thus enhancing oxygenation. Other manufacturers of pneumatic demand oxygen-conserving devices include Nellcor Puritan Bennett (Pleasanton, California), Victor Medical (St. Louis, Missouri) and Western Medica (St. Louis, Missouri). Major manufacturers of electronic demand oxygen-conserving devices include Chad Therapeutics (Chatsworth, California), Transtracheal Systems (Denver, Colorado), Sunrise Medical/Devilbiss (Longmount, Colorado), Air-Sep (Buffalo, New York), InvaCare (Elyria, Ohio) and Western Medica.

Fujinon Endoscopic Systems (Wayne, New Jersey) introduced its ultra-high-resolution Model 485 colonoscopes and gastroscopes for use with the Sigma 400 System. The scopes feature the highest resolution available, with850,000 pixels. This allows the physician to see unprecedented detail and true tissue color. The device also has an optical adjustable close-focus feature that allows the physician to get within 1 mm of the wall of the stomach or colon with perfect clarity. The system can be configured to meet users' clinical demands. Options include an image management computer system, processor light source, monitor, printer and type of scope. The Sigma 400 system also allows multi-tasking with a full range of gastrointestinal, pulmonary and surgical scopes. Competitors in this segment are Olympus America (Seattle, Washington) and Pentax Medical (Hamburg, Germany).