Surgical monitors keep tabs on far more than vital signs - Operating Room

Today's surgical patients are surrounded by a dizzying array of sophisticated equipment designed to constantly monitor heart rate and rhythm, breathing, blood pressure, body temperature, body fluid balance; and levels of unconsciousness. Anesthetists and other surgical personnel charged with monitoring those devices move frenetically to a symphony of waveforms, beeps, and alarms, assimilating information on the fly while making critical life-and-death decisions.

In recent years, technological advances have put powerful tools in the hands of O.R. staff that not only provide relief from some of the grueling mental data processing work, but also supply a wealth of clinical information never before possible in healthcare.

To the general public, the technology is so much Star Wars gizmos and gadgets. But the reality is quite apart from fiction. Consider the following examples:

* In December 2002, the Indiana Heart Hospital in Indianapolis opened as the nation's' first all-digital heart hospital, built from the ground up to deliver a new level of care for cardiovascular disease by eliminating paper and film-based medical records. The $60 million, 210,000-square-foot facility's four O.R. suites feature the latest heart care monitoring, diagnostic, and imaging technologies. The facility's all-digital work flow was designed through a partnership between hospital staff and Milwaukee-based GE Medical Systems and features the GE Centricity Information System, an enterprise clinical information system that integrates patient information, including images, monitoring data and medical history, from every care area of the hospital into a single electronic record spanning a patient's entire lifetime. With specialized modules for the emergency room, intensive care unit, the operating rooms, recovery rooms, general care floors, and physician order entry systems, Centricity manages the patient en counter end-to-end. "Now, at the stroke of a key, I ... am able to review not just reports but actual images of echocardiograms, of EKGs, of cardiac catheterization films. It will make me and all my peers better physicians," said Michael C. Venturini, M.D., cardiologist and chief medical officer.

* Earlier this year, St. Vincent's Hospital in Birmingham, AL, implemented a wireless network, the largest such network in healthcare in the Southeast, that allows caregivers to access lab results, medication orders and surgery notes through wireless notebook computers or Pocket PCs that are synchronized with hospital systems for up-to-the-minute accuracy.

* Care Group Health System in Boston setup wireless local area networks in its operating rooms, intensive care, and emergency department to improve patient care by eliminating errors caused by hard-to-read handwritten treatment orders and bringing full patient records -- including X-rays, CT scans and more -- to doctors anywhere in the hospital. Dell laptops with Cisco Systems' Aironet WLAN adapters connect to a Bluesocket wireless gateway, which bridges the wireless traffic to the backend, wired local area network.

* Several years ago, the U.S. Department of Veterans Affairs began requiring embedded medical information bus (MIB) interfaces in any new physiological monitoring equipment it acquires for the more than 150 hospitals it operates. The MIB, which is a standard today, automatically captures numeric and wave form data generated by monitoring devices and routes it to a central controller. The Veterans Affairs system cited the standard's open architecture and the resulting ability to plug and play monitoring devices into hospital information systems as the key reasons for adopting MIB.

Later this summer, Staten Island (NY) University Hospital will become the first in the world to treat its patients with BrainSUITE, a completely packaged neurosurgical operating room that fully integrates all relevant surgical and diagnostic tools, including intraoperative, high-field magnetic resonance imaging (iMRI) and surgical patient monitoring equipment -- even O.R lighting -- to treat complicated neurosurgical cases in a workflow-optimized and efficient way.

While these examples may be more the exception than the rule, they illustrate many of the important trends shaping patient monitoring in today's O.R. -- from portability and integration to technological innovations designed to help a shrinking clinical workforce deal with an aging population and its higher level of acuity.

Market overview

According to Frost & Sullivan's recent report, "2003 Outlook of the Patient Monitoring Industry," patient monitoring revenue growth in general has been healthy and is expected to continue to do well over the next three years. In 2002, the total U.S. patient monitoring industry generated $6.5 billion in revenues, translating into an 11 percent compound annual growth rate for the 2000-2005 time frame.

In fact, growth in the multiparameter monitors, the most popular type of patient monitors, is expected to be relatively flat, according to Frost & Sullivan. The combined U.S. hospital and alternate care multiparameter patient monitoring market is expected to grow at a compound annual rate of only 2.1 percent through 2008. Frost attributes that to the commodity--like state" the market has reached. "Commoditization has resulted in little if any differentiation between similar types of multiparameter patient monitors, offering no technological or market advantage for vendors," the market research firm notes in another of its reports, "U.S. Multiparameter Patient Monitoring Equipment."

As a result, the firm notes, the multiparameter market has reached the maturity stage, and has become highly price-sensitive. Prices have slowly but continuously dropped and end-users are increasingly demanding lower cost products. "Such a scenario dictates that all value-add will most likely come from services or ancillary products related to these commoditized multiparameter patient monitors," Frost & Sullivan notes. "Therefore, one of the challenges facing the industry is to shift toward complementary opportunities underlying in the market."

Another market trend of note: sales of surgical patient monitors are brisk in the outpatient arena. According to the American Society of Anesthesiologists, more than 8 million patients will receive anesthesia for surgical procedures in doctors' offices this year alone. Surgeon and patient preference are touted as the main driving forces, according to a survey conducted by the Medical Society of New York. New developments in anesthesia techniques and surgical technology have made office-based surgery and anesthesia more comfortable for patients.

One inescapable trend affecting the monitoring market is simply our aging population. According to Frost & Sullivan, the number of older Americans is expected to more than double to 70 million by 2030, meaning one in every five Americans will be 65 years or older by then. As the population ages, the incidence of chronic and degenerative diseases and disabilities, such as heart disease, cancer, and arthritis, will increase.

"An aging population means more higher acuity patients needing monitoring," said Jane Flenner, patient monitoring product manager for Irving, TX-based Novation, the group purchasing arm of VHA. "Monitoring will be needed across all levels of care -- from surgery, to post-op and intermediate care -- to allow clinicians to continue monitoring the critical issues of the patient."

Adds David Russell, global marketing director, patient monitoring, cardiac and monitoring Systems, for Philips Medical Systems, "Without exception, the market is driven by the need to safely deliver care to an aging population and its attendant higher acuity of diseases."

A drive for efficiency

One of the more disturbing trends driving innovation in patient monitoring in surgery is the growing shortage of clinicians in hospitals. The means fewer caregivers watching more and more monitors.

It has become common knowledge that the nursing profession has been suffering a severe shortage, one expected to spiral even further by 2020. But nurses aren't the only profession showing a decline in numbers. An April 2002 survey by the American College of Emergency Physicians (ACEP) attributed workforce shortages as the main culprit behind 90 percent of large hospitals operating "at" or "over" capacity for treating patients. The ACEP also found that current medical training programs will fail to create a number of qualified physicians sufficient to meet projected demand from the growth of the 65 and older population.

Even more alarming is the shortage of anesthesiologists, who supervise patient monitoring during surgery. Contributing heavily to the shortage are anesthesiologists' malpractice insurance premiums, which jumped more than 33 percent last year, according to the American Society of Anesthesiologists.

The shortage is placing more demands and stresses on these stressed caregivers, making them more susceptible to making medical errors. For example, a recent report on sentinel event reporting by the joint Commission on Accreditation of Healthcare Organizations (JCAHO) identified inconsistent post-operative monitoring procedures as one of eight root causes of needless complications before, during, and following surgery. Slightly more than half of those complications occurred during the post-operative procedure period, 23 percent during intraoperative procedures, 13 percent during post-anesthesia recovery, and 6 percent during anesthesia induction, according to JCAHO.

Monitoring manufacturers are keen to these kinds of statistics. "For the first time in history, there are more openings for surgical residents than there are physicians to fill them," said Gary Earl, senior marketing manager of clinical systems for GE Medical Systems Information Technologies. "What this means is we need systems that allow nurses, technicians and physicians to become more productive and efficient."

Add to these pressures are those that are placed on busy O.R.s to turn surgical cases around as quickly as possible. "At a very high level, people are looking to increase efficiendes of O.R. suites, and that means improving patient throughput," said Mark Kolnsberg, vice president, marketing, patient care systems, electromedical division, Siemens AG, Mountain View, CA. "This is a key issue driving product innovation in surgical patient monitoring." Kolnsberg said the pressure is no different in post anesthesia care units (PACUs), where monitoring is critical in moving patients to lower acuity settings.

According to Frost & Sullivan, the need to lower the workload of remaining nursing staff to at least keep experienced nurses satisfied and productive are forcing a large number of hospitals to acquire low-cost, high-performance multiparameter patient monitors with enhanced measurements, such as motion tolerant SpO2 and accurate CO2. In addition, the firm notes, monitoring systems with inerconnectability with clinical information systems are increasingly preferred over those lacking such capability.

Portability

In commenting on Joint Commission findings regarding medical errors and post-operative monitoring, Mark Malangoni, M.D, of the American College of Surgeons, issued a statement that defines yet another key trend shaping innovation in patient monitoring, namely, portability. "The monitoring of patients should be predicated on patient needs, not on locations," Malangoni said.

More and more hospitals today are demanding monitors that travel with the patient as he goes from the emergency room, the O.R, and other hospital treatment areas. And virtually every monitoring manufacturer addresses this feature in their product lines.

Skaneateles Falls, NY-based Welch Allyn, for example, bases its entire patient monitoring product line on the premise of enhancing the interaction between patient and caregiver at the point-of-care. The company makes several monitors for conscious sedation, IV anesthesia monitoring, and surgical procedures. Its Propaq models allow hospitals to use a single monitor from transport to surgical procedure. A monitor can be attached to the patient during pre-op and the patient can receive constant surveillance during surgery and the PACU without having to switch monitors, according to the company.

Experts say that emerging wireless technologies will join a growing number of conventional patient monitors that have been enhanced with transmitters and receivers that allow wireless links to hospital information systems. Siemens' Mark Kolnsberg noted that many hospitals today don't yet realize the potential for wireless monitoring, even in surgery "Our products can go from hardwired to wireless on demand," he said. "When the patient leaves the O.R, you can take the monitor off the docking station and roll the patient into PACU and re-dock the monitor and from there, undock the monitor and take the patient to the ICU."

One of the most important applications of wireless monitoring has involved telemetry devices, which were initially developed to transmit the ECG data of patients recovering from cardiac surgery However, the early discharge of patients (cardiac and non-cardiac) from the intensive care units of the hospital has increased the acuity level of patients on subacute floors of the hospital, rendering ECG-only telemetry devices inadequate to meet the needs of the patients, according to Frost & Sullivan. Consequently, the demand for devices that monitor other parameters, such as SpO2, NIBP, and derived 12-lead ECG, has increased.

Need for portability spawns further innovation

Newton, MA-based Aspect Medical's Bispectral Index System (BIS) employs a sensor placed on a surgical patient's forehead, translating information from the electroencephalogram (EEG) into a single number that represents each patient's level of consciousness. The technology directly measures the effects of anesthetics and sedatives on the brain, enabling clinicians to customize the type and amount of medication they administer to meet their patient's individual needs. According to the company, the technology has made the monitoring of level of consciousness a reality through the non-invasive monitoring and processing of EEGs, or brainwaves, during surgery. More than half of the largest 100 U.S. hospitals, and49 percent of teaching hospitals use BIS technology, whose benefits include reduced anesthesia drug costs and shorter PACU stays, according to Aspect Medical figures.

Another twist? Implantable monitors. Ypsilanti, MI-based Integrated Sensing Systems was recently awarded a $1.98 million grant from the National Institute of Standards and Technology's Advanced Technology Program to develop wireless, batteryless, microfabricated pressure sensors that can be implanted in the body for direct and continuous monitoring of biologic fluid pressures. The two specific targets of this project are sensors for patients affected by hydrocephalus and glaucoma, according to the company.

Connectivity hurdles

Connectivity has become one the biggest challenges for monitor manufacturers--and one of the biggest headaches for hospital IT managers and purchasing agents. As sophisticated as they are, monitors in some instances don't share critical data easily. Essentially, this defeats one of the most important needs for hospitals, unless they standardize on all of their monitors.

"The biggest challenge and opportunity in hospitals today with patient monitoring is the lack of common connectivity standards," said Rick Davis, vice president, patient monitoring, for Welch Allyn. "Large companies in the market see that as an opportunity for standardization, That's a great story, but not necessarily great for purchasing." Davis added that instead of standardizing on monitoring equipment, hospitals should look for open architecture monitoring systems that will allow integration with clinical information systems. Welch Allyn later this year plans to introduce an "Acuity connectivity server" that will allow hospital clinical information systems to share data with disparate monitors, he added.

"If a hospital has an upgradable monitoring system, it's just a software issue. But some hospitals have to acquire new systems altogether [because of connectivity issues]," said Jay Matthaei, senior director, capital equipment and business services, for Novation. "If a supplier has a monitor with open architecture, multiple vendor monitoring systems easily interface."

Leading monitoring firms such as Philips, GE Medical Systems, Siemens and Welch Allyn, all promote their systems' open architecture. But that wasn't always the case.

"For the first time, manufacturers are realizing that we can't be all things to all people," said GE Medical's Gary Earl. "We all understand that we have to be very open. Information has to flow. In the past, there have been isolated pools of information. We need to be able to move at the speed of care."

Earl said GEMS and its competitors "are continuing to drive toward open architecture. The medical information bus was a big step in that direction." The MIB offers providers the ability to buy equipment from any vendor and have it interoperate and then use MIB data to create clinical pathways that help patients heal faster, thus reducing costs while improving care.

Several years ago, leading vendors fanned a consortium to promote open architecture in patient monitoring systems. Many subscribe to standards promulgated by the Institute of Electrical and Electronics Engineers (IEEE), a non-profit professional association that is the leading authority in technical areas ranging from computer engineering, biomedical technology and telecommunications, to electric power, aerospace and consumer electronics.

To overcome connectivity challenges, among other things, monitoring equipment manufacturers have resorted to a number of strategies, including targeting niche markets and forming strategic alliances, either through joint ventures, distribution agreements, or in the case of GE Medical Systems and other large players such as Philips, mergers and acquisitions.

One of the most significant such developments destined to have far-reaching impact is GE Medical Systems' pending acquisition of Instrumentarium Corp., a Finnish-based technology giant, for approximately $2 billion in cash. The acquisition will give GE offerings in anesthesia machines, ventilators and patient monitoring devices by virtue of Instrumentarium's children - Datex-Ohmeda, Andover MA, an anesthesia equipment powerhouse, and Spacelabs Medical, Issaquah, WA, a critical care monitor maker.

One observer who asked to remain anonymous called the pending acquisition "a smart move for GE" because it gives the company core expertise and the broadest possible product line in virtually every aspect of patient monitoring.

Integration is the key

Monitoring vendors are confident they will eventually overcome connectivity hurdles. The key selling point today with hospital O.R.s and other departments is integration - the ability of monitoring systems to place as much captured data from multiple monitors, as well as patient records, test results - even X-ray, ultrasound and MRI results - at the fingertips of clinicians.

The integration trend is so pervasive that leading monitoring manufacturers are looking less and less like device makers. Observes Novation's Jay Matthaei, "Patient monitoring manufacturers are very entrenched in software development. In fact, many are even referring to themselves today as solutions providers or information companies."

Market observers also believe that the trend toward digitization and integration will reap incredible benefits for the healthcare industry. "Integrated solutions help generate revenues and reduce operational costs. [They] also help end-users to be compliant with various regulatory impositions," said Meltem Buyukonat, industry manager for Frost & Sullivan's patient monitoring group. Moreover, he added, the continuous integration of monitors with enhanced built-in connections and linkage capability with information systems will address integrated healthcare delivery networks' need to form interdisciplinary, interoperable and outcomes-focused clinical information systems.

Here is a brief look at several examples of such integration:

* Philips' Intelli Vue Patient Monitoring System, which features "portal technology," enables interaction with monitoring and clinical applications on one patient monitor screen without the need for a separate network connection. The system prioritizes the real-time monitoring information, avoiding any conflicts between real-time monitoring information and archived clinical data, so clinicians can access the most critical data at any given time.

* "We have technology today that allows surgeons and anesthesiologists to view lab results real time during surgery. This is a huge advantage that allows better on-the-spot decisions to be made during surgery," said Siemens' Kolnsberg. Siemens' Infinity Explorer is a critical care monitor and workstation used in the O.R that allows clinicians to view information from monitors, ventilators, medical imaging archives and hospital information systems, and then organize it to fit their clinical information requirements. The system allows the user to download X-ray, ultrasound, CAT scan and other DICOM images, and comparative case information from the Web.

* Datex-Ohmeda's new System 5 is a family of products designed to simplify the anesthesia and critical care environments by offering the benefits of integration across the company's range of products and services.

* Munich-based BrainLab is taking monitoring integration in the O.R to the extreme with its latest venture called BrainSuite - a completely packaged, fully equipped neurosurgical operating room suite that includes everything, including an MBI. Originating in 1986 as a software developer of neurosurgical applications, BrainLab integrates all of the necessary surgical patient monitoring applications - from vital signs to MR spectroscopy-into BrainSuite. Interoperative MRI, one of the hottest trends in brain surgery, allows the surgeon to monitor patient outcome on the fly. A typical neurosurgical suite includes 40-50 items, and Brain Lab assumes all of the equipment risks and guarantees installation, performing due diligence, design and negotiating, said Doug Garrabrant, North American sales manager. In addition to its appeal to surgeons, BrainSuite has a great appeal to materials management. "Purchasing people like defined installation timelines and costs, and BrainSuite offers that," Garrabrant said. "Instead of having 40-50 purchase orders to execute, you only have two or three. A purchasing agent told us that it would take more than a year to get 40-50 vendors together on a neuro suite."

* Wakefield, MA-based Picis is another software company taking its expertise into the surgical suite. Picis maintains that its healthcare information technology solution called PeriopSuite automates the clinical documentation and business practices of the operating room, surgical, PACU and critical care environments. The company claims that it has installed platforms at more than 600 of the leading medical centers throughout the world. Chesapeake (VA) Health System contracted with Picis to automate the hospital's operating rooms and anesthesia locations with the company's software solution. The hospital plans to implement the Picis system in the main facility, automating more than 16,000 inpatient surgical procedures annually, as well as all clinical and business processes of the perioperative department. Chesapeake projects that it will start saving as much as $900,000 per year within 18 months. HPN

John Hall is a former senior editor of Healthcare Purchasing News and a Chicago-based freelance writer specializing in healthcare.

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