CLINICAL ENGINEERING Medical and Information Technologies Converge The Impact on Clinical Engineering Background & technician: ©1999 PhotoDisc. Inc. Inset photo: ©1997 Digital Stock BY TED COHEN nformation technology (IT) offers medical science tools to collect, process, store, and communicate clinical data. Healthcare institutions have adapted standards-based data communication technologies that allow easy implementation of communications infrastructure. As clinical and information technologies have converged, two trends have emerged: the widespread use of commercial off-the-shelf hardware and software and the use of standards-based communication technologies. Technical support for these complex systems requires an integrated, “end-to-end” view and staff who are knowledgeable of both clinical and computer technologies. In this article, examples of new computerized medical devices are discussed as well as the support and support staff implications of the ever-growing influence of IT on clinical systems. I Healthcare IT Trends IT offers medical science tools to rapidly collect, process, analyze, store, report, and move clinical data. Since the invention of the microprocessor in the late 1970s, medical products have become more and more dependent on computer-based technology. In fact, some clinical technologies [e.g., magnetic resonance imaging (MRI) scanners] do not work without computers. Microprocessors have become ubiquitous in medical devices and are used in many different systems including “smart” camera pills that are swallowed and image the digestive track, sophisticated orthopedic implants that can sense when they are coming loose and need medical attention, and remote monitoring devices that collect clinically relevant data and transmit it back to the care provider. Today, many medical systems not only contain embedded microprocessors that are the “brains” of the medical device but also communicate that medical data over standards-based communication networks to various clinical information systems and care providers. IT in healthcare has evolved from primarily business-related applications (e.g., billing) to a large variety of clinically relevant information systems such as integrated electronic medical records (EMR) and picture archiving communication systems (PACS). IT in healthcare has adapted standards-based data communication technologies that have allowed the relatively easy installation and implementation of standardized communications infrastructure throughout the modern healthcare facility. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE As clinical and information technologies have converged, two trends have emerged: 1) the widespread use of commercial off-the-shelf (COTS) hardware and software and 2) the widespread use of standards-based communication technologies that have interconnected the medical office, healthcare enterprise, the community, and the world (e.g., wired and wireless Ethernet). COTS technology significantly reduces medical device manufacturing costs and improves manufacturer time to market for new products. These technologies allow many of the major medical systems that are sold today to multitask as both a client computer system and a medical device. The modern hospital can interconnect these “medical devices” using standard data ports in patient care areas and standard wiring, hubs, switches, and routers in data closets. These systems allow the integration of information and clinical technology. Systems using personal computers (PCs) as medical devices are currently in use in a wide variety of inpatient and outpatient settings and include many different diagnostic and therapeutic devices and systems (e.g., clinical laboratory, physiological monitors, infusion pumps, and medical imaging systems). With the use of PCs as the medical device platform, modern medical system development is now focused on overall system design, transducers, interfaces, and software development. For some systems little hardware work, other than an occasional interface circuit, is required. However, for some other microcomputer-based medical devices, such as the artificial ventilator, considerable additional hardware design work is still required. The artificial ventilator also has additional design challenges in order to meet critical life-support requirements, such as assuring that internal processor and system reboot times are of a very short duration. The use of COTS and modern data communication technologies allow many of these integrated medical and information systems to provide new and robust features, including automatic data collection, analysis, reporting, data communication, dynamic reconfiguration for differing applications (e.g., pediatric or adult configurations), and remote software version upgrading. Another trend is the use of computers, both general purpose and specialty, to access multiple information systems. With the large number of computer information systems in a healthcare facility, it is not practical to deploy a client PC for each 0739-5175/04/$20.00©2004IEEE MAY/JUNE 2004 59 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. With the use of PCs as the medical device platform, modern medical system development is now focused on overall system design, transducers, interfaces, and software development. clinical location for each separate specialty information system due to cost, infrastructure requirements, and lack of space. Therefore, access to multiple applications are integrated into one client computer, allowing almost simultaneous access to multiple information sources. From a support standpoint, traditional boundaries separating IT department responsibilities from clinical engineering (CE) responsibilities are rapidly blurring. Technical support for these complex integrated and converged systems requires an integrated, “end-to-end” view and knowledge by staff who are trained and familiar with both the clinical and computer technologies. These changes provide challenges and opportunities, both technical and organizational, for both IT and CE. Clinical engineers, with some IT training and/or experience, are uniquely positioned to take on increased responsibilities in order to help healthcare administrators optimize their capital and support resources of which IT systems are taking a larger and larger portion. ➤ ➤ Devices New computer-based medical devices are being introduced into the market place daily. Some examples are: ➤ A laptop electrocardiogram (ECG) machine: A small device (cigarette-pack sized) converts a laptop computer into an ECG machine. This device serves as the input amplifiers and electrical isolation between the patient and the ECG machine (i.e., laptop computer). ECG software installed on the laptop performs the display and calculation functions. The ECG software can also be integrated into EMR workstations in order to easily manage workflow (e.g., ECG order entry) and ECG results reporting as well as perform the ECG machine functions [1]. ➤ Remote patient monitoring: Various devices are now on the market that allow patients to measure and report (either by themselves or with the aid of family or other caregivers) clinically important measurement data in their home. These devices interface to telephone or data networks (dialup or broadband) and automatically send stored measurement data back to computer systems that monitor values and trends and send alert information to caregivers when parameter values exceed alert limits. Devices include automated scales that sense small changes in weight relevant to the clinical management of congestive heart failure, blood glucose levels for diabetics, and spirometry and pulse oximetry for patients with chronic obstructive pulmonary disease or asthma. ➤ Prosthesis monitors: Devices are under development that can detect early loosening of implanted prosthesis (e.g., artificial hip implants). One device [2] consists of an implanted accelerometer interfaced to a digital microcontroller and microtelemetry system. External vibrations are mechanically induced, and the response from the 60 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE ➤ ➤ ➤ accelerometer is measured and communicated via telemetry. Those data are then interpreted to indicate if and how much the prosthesis has loosened. Electrical stimulators: For many years, pacemaker patients have had the capability to send data from their pacemaker over the telephone. Newer stimulator and monitoring devices have more sophisticated features that include: longterm cardiac event monitoring for syncope (fainting symptoms), implanted pacemaker/defibrillators, and stimulators used to treat neurological diseases such as Parkinson’s disease and cerebral palsy. Many of these products now include sophisticated monitoring devices to remotely communicate clinical data to the care giver as well as make sure the implanted device is performing properly. Devices for the mobile workforce: Wireless networked personal digital assistants (PDAs) and laptop and tablet computers allow mobile clinicians to view clinical data while moving from one patient location to another. These are currently using either wireless Ethernet (802.11) or cell phone technology, but the integration of these two technologies into single devices will soon allow the seamless roaming outdoors, and within and between buildings, as long as there is either cell phone or wireless Ethernet coverage. Ambulance data communication: Further relying on the cellular network, ambulance defibrillators now have options for a built-in cellular data communication link [3]. These send data, which are interpreted back at the receiving Emergency Department, allowing the emergency physicians to start treatments earlier and the paramedics to obtain additional assistance in the field. Surgical robotics: Minimally invasive surgery is becoming commonplace, and more and more procedures are being developed that use surgical robots as assistants. The surgical robot allows the surgeon sitting at a remote console to manipulate miniature instruments and make precise movements of these instruments. This may be the primary surgeon or an assistant. Three of these new robotic-assisted procedures are left-ventricular lead placement for ventricular resynchronization therapy, prostate removal, and robotic-assisted laparoscopic sigmoid colectomy for diverticulitis [4]. Virtual instrumentation: Virtual instrumentation systems provide a set of PC-based hardware and software engineering, simulation, and development tools that facilitate the design of real-time and quasi-real-time applications. Several of these applications are moving from the research lab into modern healthcare. Examples include systems that test the vision of infants [5], automate DNA sequencing [5], assist hospitals with optimal patient bed placement [6], and display “dashboards” of relevant healthcare management data [6]. MAY/JUNE 2004 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. From a support standpoint, traditional boundaries separating IT department responsibilities from CE responsibilities are rapidly blurring. Telemedicine Telemedicine, the use of technology to practice medicine from a distance, is used for the evaluation of patients at remote rural locations and other isolated areas (e.g., prisons). Traditional telemedicine uses analog video conferencing and multimedia communication technologies and can reduce the costs, time, and logistics of specialist clinician and patient travel. Telemedicine applications are in use in both real-time consultations (e.g., emergency, post-surgery, psychiatry) and store and forward applications (e.g., images from radiology, pathology, and dermatology). Patient examinations are conducted using various examining cameras and other instruments (e.g., stethoscopes). New computer technologies have made telemedicine applications much easier and less expensive to deploy. Digital cameras have increased the resolution of video imaging producing digital images with increased fidelity, resulting in improvements in remote diagnosis. As speed improvements have occurred with COTS computer and digital communication technologies, telemedicine applications are moving away from the plain old telephone service and leased analog telecommunication lines (e.g., T1, T3) toward newer technologies such as ISDN, DSL, and video over Internet protocol (IP). These newer digital technologies tend to have lower telecommunication costs but offer other challenges, particularly for real-time applications, in bandwidth, quality of service, security and availability in the rural areas where telemedicine is most needed. Additional challenges for digital telemedicine technologies include the lack of video standards for interoperability (i.e., there are a variety of standards for digital video, streaming video, and video teleconferencing encoding). Systems Integration Various medical data communication standards (e.g., DICOM, HL-7), wired communication standards (e.g., wired Ethernet), and wireless communication standards (e.g., 802.11a/b/g, CDMA) play a critical role in the increased integration of systems. DICOM is used to connect medical imaging equipment to PACS. HL-7 is the key standard for demographic and clinical data in a text format. Wireless Ethernet (IEEE 802.11) and various cellular phone standards are the key standards for wireless communication and are being used more and more to transmit medical data. As the various examples in this article describe, systems are being integrated using a large variety of common commercial computer and communication technology along with continued refinement of specialized medical technology. There will always be a need for the special materials and miniaturization of implants, new sensors, and specialized medical software. However, once the signal is digitized and external from the body, common computer and communication systems will be IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE used to process, analyze, store, and communicate it to a variety of information systems. Modern telecommunication standards and technology have allowed the monitoring of entire intensive care units (ICUs) to be moved to a location remote from the hospital. For example, the VISICU products [7] allow hospitals to monitor ICU patients in multiple ICU locations using video, audio, and clinical data communicated to a remote location making more efficient use of specially trained ICU physicians (intensivists), who are in very short supply. Quality Control and Reliability Integrated systems provide the medical device manufacturer with the challenge of assuring quality at a level required for a medical device while at the same time using COTS operating system software and COTS hardware that may not have originally been put through the rigorous quality control protocols required for medical devices. In the United States, the Food and Drug Administration (FDA) regulates medical device manufacturers and mandates that various quality control measures be in place. According to an FDA document [8], the medical device manufacturer who uses off-the-shelf software “still bears the responsibility for the continued safe and effective performance of the medical device.” Like any medical device, the level of validation and verification required for software-based medical systems is based on risk and the severity of the potential hazards to the patient, operators, and bystanders should there be a system failure, regardless of the failure cause (e.g., hardware or software). However, software is very difficult to exhaustively test. Operating systems may contain millions of lines of code. Although software does not fatigue or break down in the same way as a mechanical device or an electronic component, software problems occur regularly. These problems can range from applications that do not perform as designed and are restartable with minimal problems, to operating systems stoppages that require reboots that may be catastrophic on a lifesupport system. Even when exhaustive testing has been performed, systems can still experience software failures due to memory problems that develop over long periods of time (e.g., so called memory leaks), user or operator error (e.g., inappropriate system recovery from erroneous keystroke sequences), lack of internal computer resources, and problems caused by foreign applications, viruses, or malicious intrusions. For example, medical device manufacturers sometimes deliver their Microsoft Windows-based applications with a built-in Web server—Internet information services—installed, even when the medical device does not use a Web-server application. This is an extraneous application that can be an added security risk and should not be installed when not needed. Another example is the recent case of a physiological MAY/JUNE 2004 61 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. Once the signal is digitized and external from the body, common computer and communication systems will be used to process, analyze, store, and communicate it to a variety of information systems. monitoring system for the cardiac catheterization lab that became infected with the “Blaster” worm [9]. Medical device manufacturers must design systems as reliable as possible and design them so that failures are “soft” and do not negatively impact the patient. As operating systems continue to evolve, their real-time functionality and reliability are improving, and more and more critical applications and devices are using COTS-based systems. In order to assure that medical systems based on COTS operate reliably, the entire system (transducer, interface, COTS hardware, COTS software, application software) must operate together and reliably. COTS hardware can be extremely reliable. Typically, one of the weakest points from a reliability standpoint is the operating system (OS). For example, Windows NT 4.0 has a reported reliability of 99.0% uptime (for a continuous OS this is about 80 h/year of downtime) and Windows 2000 99.95% (5 min/year of unscheduled downtime). Older versions of Windows (Win 95, Win 98) were far less reliable [10]. Further quantitative comparison of the reliability of various OSs (e.g., UNIX versus Windows 2000) is controversial and not yet well documented because there are no real standards for software reliability measurement comparisons. Some companies have attempted to measure reboots per time period but even that is suspect because different OSs have differing scheduled needs for reboots such as the reboot requirements that occur when new applications are installed in older versions of Windows. Newer versions of Windows (e.g., Windows 2000, Windows XP-Pro) are known to be more reliable and require far fewer reboots than the older versions of Windows. UNIX and its variants are generally more reliable than the older versions of Windows. It remains to be seen if the newer versions of Windows can match UNIX reliability. Information System Security A computer system or network can be considered secure only when its resources are available solely to authorized users and when use of those resources produces trusted results. A system compromised by an intruder cannot be trusted. However, software bugs, user errors, or malfunctioning sprinkler systems are also computer systems security threats. Designing security into medical information systems is important and should include network connectivity authentication, user name and password management, and update and version control, as well as physical security for the computer hardware. Also, both human and engineering controls need to be in place in order to maintain medical information confidentiality, as mandated in the United States by the Federal Health Insurance Portability and Accountability Act regulations. Computer security threats can be divided into errors of use and design and malicious attacks. Errors of use and design 62 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE include authorized users making errors (e.g., accidental data deletion) and common software bugs (i.e., erroneous and/or incompletely tested software code). Malicious attacks include unauthorized users, authorized users maliciously viewing or altering data, authorized users knowing or unknowingly giving away passwords, malicious code unknowingly placed on the computer (e.g., viruses, worms, trap doors), denial of service attacks, or unauthorized electronic interception of data and unauthorized physical access to data or systems. Good system security design can preclude some of the malicious as well as unintentional security problems. Examples of measures that can decrease security risks include: ➤ Systems should force periodic password changes as well as eight (or more) digit passwords that include both numbers, letters (upper and lower case), and special characters. These “harder” passwords are far more difficult to crack than simpler (e.g., three-digit numeric) passwords. Where additional authentication security is required, biometrics such as retinal scans, fingerprints, or handprints should be considered. ➤ Systems should have automatic logouts implemented and users should not leave systems logged in and unattended. ➤ Physical security must be managed. Data closets and server rooms should have controlled access. ➤ Backups should be performed routinely and backup media should be stored in a separate location from its computer system, preferably in a fire-proof safe. ➤ Manufacturers of networked medical systems should include, or at least approve for installation, COTS virus scanners that run simultaneously with, and don’t interfere with, the medical applications. ➤ System administrators need to implement software update and version control (both OS and application program). A process needs to be in place to test and approve the installation of security-related OS patches as these are periodically released by the OS maker (e.g., Microsoft). ➤ For further network protection, a firewall and/or virtual private network (VPN) can be installed to control access into and out of specific locations via domain, IP, and other network-access control methodologies. Firewalls can be programmed to control all access in and out of a local or wide-area network (WAN). A VPN can be implemented using encapsulated and encrypted data over the public network (i.e., Internet) where it is necessary to “tunnel” through the firewall to connect from the “outside” into a corporate or institutional WAN. ➤ Where additional security is required, it can be provided by various encryption techniques. For wireless systems, a common encryption standard is wired encryption privacy (WEP). However, WEP is known for its weak encryption and newer, stronger wireless encryption standards, such as extensible authentication protocol, are under development. MAY/JUNE 2004 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. ➤ Logging all server administrator accesses, possible intru- levels) before they become large problems that result in system sion attempts (e.g., failed login attempts), and other signiffailure. For software issues, these systems can also provide icant events and then auditing the logs is another security remote updates, patches, and software “repairs.” For hardware measure. and facility problems, they can automatically dispatch service Figure 1 shows a model for network security for medical personnel as well as contact the facility to let them know of the devices that are connected to information systems, which in problem. Other advantages include on-line, fail-safe, “highturn are also connected to a WAN. The premise for this secuavailability” systems that include a constantly running second rity model is that the closer to the center of the model, the disk drive, power supply, or even a second computer that “mirmore security is required and the more difficult it is to provide rors” the operation of the primary system and takes over operathat security. In order to provide more security as the systems tion if a problem occurs on the primary system. move closer to the center, access is restricted from any one System support challenges include software version manlayer to only one other layer toward the center and only one agement, tracking and control, and upgrade management (e.g., other layer outward. Exceptions are only allowed when addithe problem of upgrading 500 network-connected infusion tional security measures are taken, such as a VPN. pumps to a new software revision level when all the pumps Remote access for vendors providing support to medical always need to be at the same revision level). Other chalinformation systems for troubleshooting and upgrades is a lenges include the rapid obsolescence of many computer commore and more common feature but also presents security ponents resulting in brand-new medical products being challenges. Common vendor access methods include dial-up provided with obsolete components and decreased lifecycle of modems, network (i.e., WAN) access, and access via a VPN. Where staff are always present, modems provide a simA Four-Zone Network Security Model ple connectivity method and allow the end users to disconnect the modem when not in use. However, when the information system is in a secure or remote location, or a location that is not staffed, then it is not practical to turn the modem on and off, and always-on Zone 3 modems become security risks. WAN Intranet access is simple but also can be very insecure unless access is controlled by a INTERNET firewall or other authorization methods. Zone 2: Firewall Information Installing VPN equipment provides a Web Systems much more secure method as it uses Servers General EMR Zone 1: public infrastructure but provides IP Purpose Specialty Medical address access control and encapsulates Medical Workstations Device WorkConnected and encrypts the data. Of course, with stations to the Patient all these external access methods, user name and password management are Firewall HIS, PACS, LIS, Cardiology, IS, etc. also very important. Leaving a persistent Internet connection (non-VPN) open 24 h/day, seven days/week with a VPN generic user name and no password is Citrix an invitation to an unwanted intrusion. System Support Computerized medical systems offer several support advantages for both the manufacturer and the end user. Built-in system self-tests allow devices to test themselves on start-up and, periodically, during operation. Some networked devices can self-test and, when they are not working properly, automatically “phone home” and report problems to their support system. Many vendors (e.g., imaging equipment companies) use remote access to continuously monitor the status of these multimillion-dollar systems (e.g, MRI, CT scanners) looking for small problems (e.g., temperature increases, low MRI cryogen Notes: 1) Security requirements (and risk) increase as you move toward inner shell. 2) Local configuration, anti-virus, and update control ability decrease as you move toward inner circle (i.e., inner circle more dependent on vendors). 3) Communication between layers increases risk. Penetration of multiple layers (more than 1) should be restricted with certain controlled exceptions (e.g., use of VPN, access control lists). 4) Virtual private network (VPN) tunnel through firewall, should be required for access from outside wide area network (WAN) into any inner zone. Fig. 1. A security model for networked medical devices. IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004 63 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. Both frequency-management and access-point (antenna) location management is required in order to avoid interference between all the varieties of wireless technologies currently vying for the healthcare market, ceiling space, and airways. components (e.g., microprocessors) and peripherals (e.g., printers, displays), which increase the support costs for the medical system (if you can get the parts) and ultimately, this phenomena decreases the average life. Infrastructure IT standards-based medical systems allow communication via TCP/IP and other standards that hasten interconnectivity. Systems based on standards also allow common data infrastructure to be installed during construction and prior to knowing which vendor’s specific clinical system will be purchased (e.g., category 5 cabling). Other advantages include installing computer hardware in the data closet and saving space in the clinical location. Challenges include building the data closets large enough to house more—and more sensitive—equipment and color coding (or otherwise identifying) cables and other closet hardware, particularly for real-time medical systems, in order to separate them from office and other noncritical applications. Uninterruptible power supplies or emergency power need to be provided to these data closet components in case of power failure and to assure continuous operation during emergency generator tests. Access to the data closet needs to be controlled, yet medical systems support staff need to be allowed access. Several wireless technologies have penetrated the healthcare market, including IEEE 802.11 in clinical telemetry applications, “in-building” cellular phone systems, mobile wireless computers, PDAs for medical staff, and more. Both frequency-management and access-point (antenna) location management is required in order to avoid interference between all the varieties of wireless technologies currently vying for the healthcare market, ceiling space, and airways. In order to reduce wireless infrastructure, standardization of the various wireless technologies is important but currently very difficult due to the large number of different wireless standards in use. (e.g., IEEE 802.11a, b, g, FH). Battery management is also a challenge as more and more mobile devices are used and recharge “opportunities” need to be planned and available. Training and Education IT, CE, and biomedical equipment technician (BMET) professionals supporting these integrated medical and information systems have new training needs, with the IT staff needing more clinical knowledge and the biomedical/CE community requiring additional computer and IT training. CE and BMET training needs to include fundamental computer technologies (e.g., Microsoft Windows and UNIX OSs, databases, applications, wired and wireless Ethernet) and other new computer technologies plus clinical information system education. 64 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE Documentation The CE literature contains many discussions regarding required service documentation for medical instrumentation. However, little is written about how to document complex, computer-based medical systems, particularly networked computerized information systems. One approach is to require the following: 1) as-built drawings, including all network and other interconnects; 2) operator manuals and specifications for each component; 3) service manuals and troubleshooting information for critical components; and 4) software tools to aid in troubleshooting. As-built drawings provide a way to document the system after it is installed showing all wiring, hubs, switches, routers, servers, access points, and workstations. Computerized asbuilt drawings based on Adobe Acrobat’s pdf files are one way to develop and distribute as-built drawings. These network drawings can include “hot” links to printer and other peripheral information and also include information regarding the equipment’s physical location, model, data communication paths, IP addresses, modem phone numbers, and more. Traditional user manuals including configuration information are required and typically supplied. Service manuals are sometimes difficult to obtain but critical for all systems and components that are not “off-the-shelf” and, therefore, may be difficult and/or expensive to replace. Any software troubleshooting tools that the vendor will make available to the customer should also be obtained and appropriate documentation provided in order to operate these tools. Impact on CE What is the overall impact on CE of the information and medical technology convergence? Can CE and IT departments continue to function the way they have previously functioned? Can the cultures merge as well as the technologies? There is no answer to these questions—yet. Some proactive healthcare organizations are restructuring in order to better manage technology; others maintain the status quo. Several mergers of CE and IT departments have occurred, with the CE department reporting to the chief information officer. In others, a third and separate department, sometimes named Clinical Information Systems, has been implemented. Regardless of the organizational structure, there are significant differences between the CE and IT communities, and in some of those communities these differences are resulting in cultural conflicts due to perceived differing needs. In others, there is an awareness that technology is changing and merging and that the institutions’ needs outweigh historical cultural differences, and positive changes are occurring in both the CE and IT departments. Regardless of organizational structure, the following are some of the changes that need to take place within CE departments in order to better manage IT-based medical technology: MAY/JUNE 2004 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply. ➤ as stated above, an end-to-end view of the IT-based clini- cal system ➤ CE involvement in IT technology decisions including needs assessments, infrastructure and applications specifications, and technology product selection decisions ➤ frequency and RF spectrum management ➤ CE involvement with vendors on product development and implementation issues such as operating system selection decisions; improved configuration; installation and initial testing procedures; and improved revision tracking, control, and upgrade management ➤ CE, vendor, and IT collaboration on improved security processes. Overall, CE will have to become more technologically proactive across a broader range of technologies, including IT and telecommunications. Of course, the IT departments will also have to change, but that is outside the scope of this article. Conclusion IT is changing extremely rapidly, and medical technology, although changing not as quickly, is rapidly evolving. Today, emerging medical technologies that are based on IT include: new wireless products that will decrease the cable tangle at the bedside using Bluetooth for short-range communication [11], surgical robotics with tactile sensors, “smart” artificial limbs, advanced speech recognition, voice-over IP telephones, videoover IP, digital broadcast quality video at reasonable cost, and many, many others. Standards-based information and medical technology integration will easily allow workstations to communicate with multiple systems without special integration testing and concern over critical performance problems. New standardsbased efforts, such as the Integrating the Healthcare Enterprise Project, are making progress in developing manufactureragreed-upon implementation “profiles” that add to, interpret, and make more practical common standards (e.g., DICOM, HL-7), so that true “plug-and-play” interface compatibility can occur between multivendor—and often competing vendor—software [12]. Data transmission rates will continue to increase with cost continuing to decrease (e.g., gigabit Ethernet, faster DSL). Data and voice infrastructure will merge; data outlets will become as ubiquitous as electrical power outlets, although the design and location needs of both will change as more and more data transmission moves to wireless. Data closets and data infrastructure will continue to grow in size and complexity as the rate of equipment that moves from clinical spaces into the data closets increases faster than the size reduction of the equipment. For critical patients, point-of-care testing and indwelling sensors will become more commonplace, whereas in the general acute care areas of the hospital, more and more laboratory tests will be performed via very automated, robotics-based, off-site laboratories. Nursing unit central stations will become less clinically important as physiological monitor alarms, “nurse-call” requests, and other critical information are communicated directly to the assigned care givers, although the care givers’ primary communication tool has not yet been well defined. The acuity level of the inpatient will continue to increase, and more and more technology will be moved to the inpatient’s room, rather than moving the patient to the technology. Continuing education of all CE and support staff is required in order to keep up with this changing technology. New paradigms IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE in healthcare technology leadership and organization are required for managing integrated clinical and IT. Differing methods, including new responsibilities, new departments (e.g., C.I.S), and departmental mergers and reorganizations, will be used to organize IT and clinical technology support organizations. CE and IT departments both need to evolve in order to keep pace with the technology and provide healthcare institution leadership with the knowledge required to make optimal technology-related decisions. With blurry, ever-changing boundaries it is imperative that CE and IT staff work together as a team to support this complex environment and to provide the best technology possible for our ultimate customers, the patients. Ted Cohen received his B.S. in electronics engineering from U.C.L.A. and his M.S. in biomedical engineering from California State University, Sacramento. He is currently manager of clinical engineering at the University of California Davis Medical Center in Sacramento, California, where he has been a clinical engineer for 25 years. Prior to his employment at UC Davis, Mr. Cohen worked as a civilian electronics engineer (computer systems) for the United States Air Force. Mr. Cohen is a member of the board of directors of the American College of Clinical Engineering and the Association for the Advancement of Medical Instrumentation (AAMI) and a prior board member of the California Medical Instrumentation Association. Mr. Cohen is the author of a variety of clinical engineering-related publications, including the AAMI-published book Computerized Maintenance Management Systems for Clinical Engineering and several articles on benchmarking medical equipment repair and maintenance services and the ever-increasing impact of IT on medical systems and the clinical engineering profession. Address for Correspondence: Ted Cohen, Clinical Engineering Department, University of California Davis Medical Center, 2315 Stockton Blvd., Sacramento, CA 95817 USA. E-mail: theodore.cohen@ucdmc.ucdavis.edu. References [1] Midmark/Brentwood [Online]. Available: http://midmarkdiagnostics .com/noflash/literature.html, Digital ECG [2] R. Puers, M. Catrysse, G. Vandevoorde, R.J. Collier, E. Louridas, F. Burny, M. Donkerwolcke, and F. Moulart, “An implantable system for detecting loosening of a hip prosthesis,” in Proc. 15th Int. Symp. Biotelemetry, Juneau, AK, May 9–14, 1999, pp. 63–64. [3] Schiller, “Automatic defibrillator with built-in GSM communication” [Online]. Avialable: http://www.schiller.ch/products/powerslave,id,11,nodeid ,11,_country,hq,_language,en.html [4] P.A. Weber, S. Merola, A. Wasielewski, and G.H. Ballantyne, “Teleroboticassisted laparoscopic right and sigmod colectomies for benign disease,” Robotic Surgeons Quarterly, no. 4, Summer 2003. [5] National Instruments Inc. [Online]. Available: http://www.ni.com/solutions/ [6] Premise Development Inc. [Online]. Available: http://www.premiseusa.com/ [7] VISICU Inc. [Online]. Available: http://www.visicu.com [8] Food and Drug Administration, Off-The-Shelf Software: Use in Medical Devices. Washington, D.C.: U.S. Department of Health and Human Service, Sept. 9, 1999. [9] “Health devices alerts: GE Medical Systems—Networked systems using Microsoft Windows NT Operating System: May be affected by W32/Blaster Worm,” ECRI, Plymouth Meeting, PA, Accession No. A5274, 2003. [10] “Windows 2000 server family: Delivering the level of reliability you need” [Online]. Available: http://www.microsoft.com/windows2000/server/ evaluation/business/ overview/reliable/default.asp [11] Nonin Medical Inc. [Online]. Available: http://www.nonin.com/Products /pdfs/4100brief.pdf [12] Integrating the Healthcare Enterprise [Online]. Available: http://www.rsna. org/IHE/mission.shtml MAY/JUNE 2004 65 Authorized licensed use limited to: Shanghai Electric Group Co.Ltd. Central Academe. Downloaded on February 21,2020 at 01:56:27 UTC from IEEE Xplore. Restrictions apply.