Medical and Information

CLINICAL ENGINEERING
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 As clinical and information technologies have converged,

I collect, process, store, and communicate clinical data.

Healthcare institutions have adapted standards-based data
communication technologies that allow easy implementa-
tion of communications infrastructure. As clinical and infor-
mation technologies have converged, two trends have
two trends have emerged: 1) the widespread use of commercial
off-the-shelf (COTS) hardware and software and 2) the wide-
spread use of standards-based communication technologies that
have interconnected the medical office, healthcare enterprise,
the community, and the world (e.g., wired and wireless
emerged: the widespread use of commercial off-the-shelf Ethernet). COTS technology significantly reduces medical
hardware and software and the use of standards-based commu- device manufacturing costs and improves manufacturer time to
nication technologies. Technical support for these complex market for new products. These technologies allow many of
systems requires an integrated, “end-to-end” view and staff the major medical systems that are sold today to multitask as
who are knowledgeable of both clinical and computer tech- both a client computer system and a medical device. The mod-
nologies. In this article, examples of new computerized med- ern hospital can interconnect these “medical devices” using
ical devices are discussed as well as the support and support standard data ports in patient care areas and standard wiring,
staff implications of the ever-growing influence of IT on clini- hubs, switches, and routers in data closets. These systems allow
cal systems. the integration of information and clinical technology.
Systems using personal computers (PCs) as medical devices
Healthcare IT Trends are currently in use in a wide variety of inpatient and outpa-
IT offers medical science tools to rapidly collect, process, ana- tient settings and include many different diagnostic and thera-
lyze, store, report, and move clinical data. Since the invention peutic devices and systems (e.g., clinical laboratory,
of the microprocessor in the late 1970s, medical products have physiological monitors, infusion pumps, and medical imaging
become more and more dependent on computer-based tech- systems). With the use of PCs as the medical device platform,
nology. In fact, some clinical technologies [e.g., magnetic res- modern medical system development is now focused on over-
onance imaging (MRI) scanners] do not work without all system design, transducers, interfaces, and software devel-
computers. Microprocessors have become ubiquitous in med- opment. For some systems little hardware work, other than an
ical devices and are used in many different systems including occasional interface circuit, is required. However, for some
“smart” camera pills that are swallowed and image the diges- other microcomputer-based medical devices, such as the artifi-
tive track, sophisticated orthopedic implants that can sense cial ventilator, considerable additional hardware design work
when they are coming loose and need medical attention, and is still required. The artificial ventilator also has additional
remote monitoring devices that collect clinically relevant data design challenges in order to meet critical life-support require-
and transmit it back to the care provider. Today, many medical ments, such as assuring that internal processor and system
systems not only contain embedded microprocessors that are reboot times are of a very short duration.
the “brains” of the medical device but also communicate that The use of COTS and modern data communication tech-
medical data over standards-based communication networks to nologies allow many of these integrated medical and informa-
various clinical information systems and care providers. tion systems to provide new and robust features, including
IT in healthcare has evolved from primarily business-related automatic data collection, analysis, reporting, data communi-
applications (e.g., billing) to a large variety of clinically relevant cation, dynamic reconfiguration for differing applications
information systems such as integrated electronic medical (e.g., pediatric or adult configurations), and remote software
records (EMR) and picture archiving communication systems version upgrading.
(PACS). IT in healthcare has adapted standards-based data com- Another trend is the use of computers, both general purpose
munication technologies that have allowed the relatively easy and specialty, to access multiple information systems. With
installation and implementation of standardized communica- the large number of computer information systems in a health-
tions infrastructure throughout the modern healthcare facility. care facility, it is not practical to deploy a client PC for each

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE 0739-5175/04/$20.00©2004IEEE MAY/JUNE 2004 59

 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 sys- accelerometer is measured and communicated via teleme-
tem due to cost, infrastructure requirements, and lack of space. try. Those data are then interpreted to indicate if and how
Therefore, access to multiple applications are integrated into much the prosthesis has loosened.
one client computer, allowing almost simultaneous access to ➤ Electrical stimulators: For many years, pacemaker patients
multiple information sources. have had the capability to send data from their pacemaker
From a support standpoint, traditional boundaries separating over the telephone. Newer stimulator and monitoring
IT department responsibilities from clinical engineering (CE) devices have more sophisticated features that include: long-
responsibilities are rapidly blurring. Technical support for these term cardiac event monitoring for syncope (fainting symp-
complex integrated and converged systems requires an integrat- toms), implanted pacemaker/defibrillators, and stimulators
ed, “end-to-end” view and knowledge by staff who are trained used to treat neurological diseases such as Parkinson’s dis-
and familiar with both the clinical and computer technologies. ease and cerebral palsy. Many of these products now
These changes provide challenges and opportunities, both tech- include sophisticated monitoring devices to remotely com-
nical and organizational, for both IT and CE. Clinical engineers, municate clinical data to the care giver as well as make sure
with some IT training and/or experience, are uniquely positioned the implanted device is performing properly.
to take on increased responsibilities in order to help healthcare ➤ Devices for the mobile workforce: Wireless networked per-
administrators optimize their capital and support resources of sonal digital assistants (PDAs) and laptop and tablet com-
which IT systems are taking a larger and larger portion. puters allow mobile clinicians to view clinical data while
moving from one patient location to another. These are cur-
Devices rently using either wireless Ethernet (802.11) or cell phone
New computer-based medical devices are being introduced technology, but the integration of these two technologies
into the market place daily. Some examples are: into single devices will soon allow the seamless roaming
➤ A laptop electrocardiogram (ECG) machine: A small outdoors, and within and between buildings, as long as
device (cigarette-pack sized) converts a laptop computer there is either cell phone or wireless Ethernet coverage.
into an ECG machine. This device serves as the input ➤ Ambulance data communication: Further relying on the
amplifiers and electrical isolation between the patient and cellular network, ambulance defibrillators now have
the ECG machine (i.e., laptop computer). ECG software options for a built-in cellular data communication link [3].
installed on the laptop performs the display and calculation These send data, which are interpreted back at the receiv-
functions. The ECG software can also be integrated into ing Emergency Department, allowing the emergency
EMR workstations in order to easily manage workflow physicians to start treatments earlier and the paramedics to
(e.g., ECG order entry) and ECG results reporting as well obtain additional assistance in the field.
as perform the ECG machine functions [1]. ➤ Surgical robotics: Minimally invasive surgery is becom-
➤ Remote patient monitoring: Various devices are now on ing commonplace, and more and more procedures are
the market that allow patients to measure and report (either being developed that use surgical robots as assistants.
by themselves or with the aid of family or other care- The surgical robot allows the surgeon sitting at a remote
givers) clinically important measurement data in their console to manipulate miniature instruments and make
home. These devices interface to telephone or data net- precise movements of these instruments. This may be the
works (dialup or broadband) and automatically send stored primary surgeon or an assistant. Three of these new
measurement data back to computer systems that monitor robotic-assisted procedures are left-ventricular lead
values and trends and send alert information to caregivers placement for ventricular resynchronization therapy,
when parameter values exceed alert limits. Devices prostate removal, and robotic-assisted laparoscopic sig-
include automated scales that sense small changes in moid colectomy for diverticulitis [4].
weight relevant to the clinical management of congestive ➤ Virtual instrumentation: Virtual instrumentation systems
heart failure, blood glucose levels for diabetics, and provide a set of PC-based hardware and software engineer-
spirometry and pulse oximetry for patients with chronic ing, simulation, and development tools that facilitate the
obstructive pulmonary disease or asthma. design of real-time and quasi-real-time applications.
➤ Prosthesis monitors: Devices are under development that Several of these applications are moving from the research
can detect early loosening of implanted prosthesis (e.g., lab into modern healthcare. Examples include systems that
artificial hip implants). One device [2] consists of an test the vision of infants [5], automate DNA sequencing
implanted accelerometer interfaced to a digital microcon- [5], assist hospitals with optimal patient bed placement [6],
troller and microtelemetry system. External vibrations are and display “dashboards” of relevant healthcare manage-
mechanically induced, and the response from the ment data [6].

60 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004

 From a support standpoint, traditional boundaries
separating IT department responsibilities from CE
responsibilities are rapidly blurring.

Telemedicine used to process, analyze, store, and communicate it to a vari-

Telemedicine, the use of technology to practice medicine from ety of information systems.
a distance, is used for the evaluation of patients at remote rural Modern telecommunication standards and technology have
locations and other isolated areas (e.g., prisons). Traditional allowed the monitoring of entire intensive care units (ICUs) to
telemedicine uses analog video conferencing and multimedia be moved to a location remote from the hospital. For example,
communication technologies and can reduce the costs, time, the VISICU products [7] allow hospitals to monitor ICU
and logistics of specialist clinician and patient travel. patients in multiple ICU locations using video, audio, and
Telemedicine applications are in use in both real-time consul- clinical data communicated to a remote location making more
tations (e.g., emergency, post-surgery, psychiatry) and store efficient use of specially trained ICU physicians (intensivists),
and forward applications (e.g., images from radiology, pathol- who are in very short supply.
ogy, and dermatology). Patient examinations are conducted
using various examining cameras and other instruments (e.g., Quality Control and Reliability
stethoscopes). Integrated systems provide the medical device manufacturer
New computer technologies have made telemedicine appli- with the challenge of assuring quality at a level required for a
cations much easier and less expensive to deploy. Digital medical device while at the same time using COTS operating
cameras have increased the resolution of video imaging pro- system software and COTS hardware that may not have origi-
ducing digital images with increased fidelity, resulting in nally been put through the rigorous quality control protocols
improvements in remote diagnosis. As speed improvements required for medical devices. In the United States, the Food
have occurred with COTS computer and digital communica- and Drug Administration (FDA) regulates medical device
tion technologies, telemedicine applications are moving away manufacturers and mandates that various quality control mea-
from the plain old telephone service and leased analog sures be in place. According to an FDA document [8], the
telecommunication lines (e.g., T1, T3) toward newer tech- medical device manufacturer who uses off-the-shelf software
nologies such as ISDN, DSL, and video over Internet protocol “still bears the responsibility for the continued safe and effec-
(IP). These newer digital technologies tend to have lower tive performance of the medical device.” Like any medical
telecommunication costs but offer other challenges, particular- device, the level of validation and verification required for
ly for real-time applications, in bandwidth, quality of service, software-based medical systems is based on risk and the
security and availability in the rural areas where telemedicine severity of the potential hazards to the patient, operators, and
is most needed. Additional challenges for digital telemedicine bystanders should there be a system failure, regardless of the
technologies include the lack of video standards for interoper- failure cause (e.g., hardware or software).
ability (i.e., there are a variety of standards for digital video, However, software is very difficult to exhaustively test.
streaming video, and video teleconferencing encoding). Operating systems may contain millions of lines of code.
Although software does not fatigue or break down in the same
Systems Integration way as a mechanical device or an electronic component, soft-
Various medical data communication standards (e.g., ware problems occur regularly. These problems can range
DICOM, HL-7), wired communication standards (e.g., wired from applications that do not perform as designed and are
Ethernet), and wireless communication standards (e.g., restartable with minimal problems, to operating systems stop-
802.11a/b/g, CDMA) play a critical role in the increased inte- pages that require reboots that may be catastrophic on a life-
gration of systems. DICOM is used to connect medical imag- support system. Even when exhaustive testing has been
ing equipment to PACS. HL-7 is the key standard for performed, systems can still experience software failures due
demographic and clinical data in a text format. Wireless to memory problems that develop over long periods of time
Ethernet (IEEE 802.11) and various cellular phone standards (e.g., so called memory leaks), user or operator error (e.g.,
are the key standards for wireless communication and are inappropriate system recovery from erroneous keystroke
being used more and more to transmit medical data. sequences), lack of internal computer resources, and problems
As the various examples in this article describe, systems are caused by foreign applications, viruses, or malicious intru-
being integrated using a large variety of common commercial sions. For example, medical device manufacturers sometimes
computer and communication technology along with contin- deliver their Microsoft Windows-based applications with a
ued refinement of specialized medical technology. There will built-in Web server—Internet information services—installed,
always be a need for the special materials and miniaturization even when the medical device does not use a Web-server
of implants, new sensors, and specialized medical software. application. This is an extraneous application that can be an
However, once the signal is digitized and external from the added security risk and should not be installed when not need-
body, common computer and communication systems will be ed. Another example is the recent case of a physiological

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004 61

 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 include authorized users making errors (e.g., accidental data
became infected with the “Blaster” worm [9]. Medical device deletion) and common software bugs (i.e., erroneous and/or
manufacturers must design systems as reliable as possible and incompletely tested software code). Malicious attacks include
design them so that failures are “soft” and do not negatively unauthorized users, authorized users maliciously viewing or
impact the patient. As operating systems continue to evolve, altering data, authorized users knowing or unknowingly giving
their real-time functionality and reliability are improving, and away passwords, malicious code unknowingly placed on the
more and more critical applications and devices are using computer (e.g., viruses, worms, trap doors), denial of service
COTS-based systems. attacks, or unauthorized electronic interception of data and
In order to assure that medical systems based on COTS unauthorized physical access to data or systems.
operate reliably, the entire system (transducer, interface, Good system security design can preclude some of the mali-
COTS hardware, COTS software, application software) must cious as well as unintentional security problems. Examples of
operate together and reliably. COTS hardware can be measures that can decrease security risks include:
extremely reliable. Typically, one of the weakest points from ➤ Systems should force periodic password changes as well as
a reliability standpoint is the operating system (OS). For eight (or more) digit passwords that include both numbers,
example, Windows NT 4.0 has a reported reliability of letters (upper and lower case), and special characters. These
99.0% uptime (for a continuous OS this is about 80 h/year of “harder” passwords are far more difficult to crack than sim-
downtime) and Windows 2000 99.95% (5 min/year of pler (e.g., three-digit numeric) passwords. Where additional
unscheduled downtime). Older versions of Windows (Win authentication security is required, biometrics such as reti-
95, Win 98) were far less reliable [10]. nal scans, fingerprints, or handprints should be considered.
Further quantitative comparison of the reliability of various ➤ Systems should have automatic logouts implemented and
OSs (e.g., UNIX versus Windows 2000) is controversial and users should not leave systems logged in and unattended.
not yet well documented because there are no real standards ➤ Physical security must be managed. Data closets and serv-
for software reliability measurement comparisons. Some com- er rooms should have controlled access.
panies have attempted to measure reboots per time period but ➤ Backups should be performed routinely and backup media
even that is suspect because different OSs have differing should be stored in a separate location from its computer
scheduled needs for reboots such as the reboot requirements system, preferably in a fire-proof safe.
that occur when new applications are installed in older ver- ➤ Manufacturers of networked medical systems should
sions of Windows. Newer versions of Windows (e.g., include, or at least approve for installation, COTS virus
Windows 2000, Windows XP-Pro) are known to be more reli- scanners that run simultaneously with, and don’t interfere
able and require far fewer reboots than the older versions of with, the medical applications.
Windows. UNIX and its variants are generally more reliable ➤ System administrators need to implement software update
than the older versions of Windows. It remains to be seen if and version control (both OS and application program). A
the newer versions of Windows can match UNIX reliability. process needs to be in place to test and approve the instal-
lation of security-related OS patches as these are periodi-
Information System Security cally released by the OS maker (e.g., Microsoft).
A computer system or network can be considered secure only ➤ For further network protection, a firewall and/or virtual
when its resources are available solely to authorized users and private network (VPN) can be installed to control access
when use of those resources produces trusted results. A system into and out of specific locations via domain, IP, and other
compromised by an intruder cannot be trusted. However, soft- network-access control methodologies. Firewalls can be
ware bugs, user errors, or malfunctioning sprinkler systems programmed to control all access in and out of a local or
are also computer systems security threats. Designing security wide-area network (WAN). A VPN can be implemented
into medical information systems is important and should using encapsulated and encrypted data over the public net-
include network connectivity authentication, user name and work (i.e., Internet) where it is necessary to “tunnel”
password management, and update and version control, as through the firewall to connect from the “outside” into a
well as physical security for the computer hardware. Also, corporate or institutional WAN.
both human and engineering controls need to be in place in ➤ Where additional security is required, it can be provided
order to maintain medical information confidentiality, as man- by various encryption techniques. For wireless systems, a
dated in the United States by the Federal Health Insurance common encryption standard is wired encryption privacy
Portability and Accountability Act regulations. (WEP). However, WEP is known for its weak encryption
Computer security threats can be divided into errors of use and newer, stronger wireless encryption standards, such as
and design and malicious attacks. Errors of use and design extensible authentication protocol, are under development.

62 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004

➤ 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 signif- failure. 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, “high-
turn are also connected to a WAN. The premise for this secu- availability” 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 “mir-
more security is required and the more difficult it is to provide rors” the operation of the primary system and takes over opera-
that 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 man-
layer 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 addi- the 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 chal-
information systems for troubleshooting and upgrades is a lenges include the rapid obsolescence of many computer com-
more 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 sim- A 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
firewall or other authorization methods. INTERNET Zone 2: Firewall
Installing VPN equipment provides a Web Information
much more secure method as it uses Servers Systems
EMR General
public infrastructure but provides IP Zone 1:
Specialty Purpose
Medical
address access control and encapsulates Device Medical Workstations
Work-
and encrypts the data. Of course, with Connected
stations
to the Patient
all these external access methods, user
name and password management are Firewall HIS, PACS, LIS,
also very important. Leaving a persis- Cardiology, IS, etc.
tent 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 Notes:
1) Security requirements (and risk) increase as you move toward inner shell.
not working properly, automatically
2) Local configuration, anti-virus, and update control ability decrease as you move
“phone home” and report problems to toward inner circle (i.e., inner circle more dependent on vendors).
their support system. Many vendors 3) Communication between layers increases risk. Penetration of multiple layers
(e.g., imaging equipment companies) (more than 1) should be restricted with certain controlled exceptions
use remote access to continuously moni- (e.g., use of VPN, access control lists).
tor the status of these multimillion-dol- 4) Virtual private network (VPN) tunnel through firewall, should be required for access
from outside wide area network (WAN) into any inner zone.
lar systems (e.g, MRI, CT scanners)
looking for small problems (e.g., tem-
perature increases, low MRI cryogen Fig. 1. A security model for networked medical devices.

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004 63

 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., Documentation

printers, displays), which increase the support costs for the The CE literature contains many discussions regarding
medical system (if you can get the parts) and ultimately, this required service documentation for medical instrumentation.
phenomena decreases the average life. However, little is written about how to document complex,
computer-based medical systems, particularly networked com-
Infrastructure puterized information systems. One approach is to require the
IT standards-based medical systems allow communication via following: 1) as-built drawings, including all network and
TCP/IP and other standards that hasten interconnectivity. other interconnects; 2) operator manuals and specifications for
Systems based on standards also allow common data infra- each component; 3) service manuals and troubleshooting
structure to be installed during construction and prior to know- information for critical components; and 4) software tools to
ing which vendor’s specific clinical system will be purchased aid in troubleshooting.
(e.g., category 5 cabling). Other advantages include installing As-built drawings provide a way to document the system
computer hardware in the data closet and saving space in the after it is installed showing all wiring, hubs, switches, routers,
clinical location. Challenges include building the data closets servers, access points, and workstations. Computerized as-
large enough to house more—and more sensitive—equipment built drawings based on Adobe Acrobat’s pdf files are one
and color coding (or otherwise identifying) cables and other way to develop and distribute as-built drawings. These net-
closet hardware, particularly for real-time medical systems, in work drawings can include “hot” links to printer and other
order to separate them from office and other noncritical appli- peripheral information and also include information regarding
cations. Uninterruptible power supplies or emergency power the equipment’s physical location, model, data communication
need to be provided to these data closet components in case of paths, IP addresses, modem phone numbers, and more.
power failure and to assure continuous operation during emer- Traditional user manuals including configuration informa-
gency generator tests. Access to the data closet needs to be tion are required and typically supplied. Service manuals are
controlled, yet medical systems support staff need to be sometimes difficult to obtain but critical for all systems and
allowed access. components that are not “off-the-shelf” and, therefore, may be
Several wireless technologies have penetrated the health- difficult and/or expensive to replace. Any software trou-
care market, including IEEE 802.11 in clinical telemetry bleshooting tools that the vendor will make available to the
applications, “in-building” cellular phone systems, mobile customer should also be obtained and appropriate documenta-
wireless computers, PDAs for medical staff, and more. Both tion provided in order to operate these tools.
frequency-management and access-point (antenna) location
management is required in order to avoid interference Impact on CE
between all the varieties of wireless technologies currently What is the overall impact on CE of the information and med-
vying for the healthcare market, ceiling space, and airways. ical technology convergence? Can CE and IT departments
In order to reduce wireless infrastructure, standardization of continue to function the way they have previously functioned?
the various wireless technologies is important but currently Can the cultures merge as well as the technologies? There is
very difficult due to the large number of different wireless no answer to these questions—yet. Some proactive healthcare
standards in use. (e.g., IEEE 802.11a, b, g, FH). Battery organizations are restructuring in order to better manage tech-
management is also a challenge as more and more mobile nology; others maintain the status quo. Several mergers of CE
devices are used and recharge “opportunities” need to be and IT departments have occurred, with the CE department
planned and available. reporting to the chief information officer. In others, a third and
separate department, sometimes named Clinical Information
Training and Education Systems, has been implemented. Regardless of the organiza-
IT, CE, and biomedical equipment technician (BMET) pro- tional structure, there are significant differences between the
fessionals supporting these integrated medical and informa- CE and IT communities, and in some of those communities
tion systems have new training needs, with the IT staff these differences are resulting in cultural conflicts due to per-
needing more clinical knowledge and the biomedical/CE ceived differing needs. In others, there is an awareness that
community requiring additional computer and IT training. technology is changing and merging and that the institutions’
CE and BMET training needs to include fundamental com- needs outweigh historical cultural differences, and positive
puter technologies (e.g., Microsoft Windows and UNIX changes are occurring in both the CE and IT departments.
OSs, databases, applications, wired and wireless Ethernet) Regardless of organizational structure, the following are
and other new computer technologies plus clinical informa- some of the changes that need to take place within CE depart-
tion system education. ments in order to better manage IT-based medical technology:

64 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004

➤ as stated above, an end-to-end view of the IT-based clini- in healthcare technology leadership and organization are
cal system required for managing integrated clinical and IT. Differing meth-
➤ CE involvement in IT technology decisions including ods, including new responsibilities, new departments (e.g.,
needs assessments, infrastructure and applications specifi- C.I.S), and departmental mergers and reorganizations, will be
cations, and technology product selection decisions used to organize IT and clinical technology support organiza-
➤ frequency and RF spectrum management tions. CE and IT departments both need to evolve in order to
➤ CE involvement with vendors on product keep pace with the technology and provide healthcare institution
development and implementation issues such as operating leadership with the knowledge required to make optimal tech-
system selection decisions; improved configuration; instal- nology-related decisions. With blurry, ever-changing boundaries
lation and initial testing procedures; and improved revi- it is imperative that CE and IT staff work together as a team to
sion tracking, control, and upgrade management support this complex environment and to provide the best tech-
➤ CE, vendor, and IT collaboration on improved security nology possible for our ultimate customers, the patients.
processes.
Overall, CE will have to become more technologically Ted Cohen received his B.S. in electronics
proactive across a broader range of technologies, including IT engineering from U.C.L.A. and his M.S. in
and telecommunications. Of course, the IT departments will biomedical engineering from California
also have to change, but that is outside the scope of this article. State University, Sacramento. He is cur-
rently manager of clinical engineering at
Conclusion the University of California Davis Medical
IT is changing extremely rapidly, and medical technology, Center in Sacramento, California, where he
although changing not as quickly, is rapidly evolving. Today, has been a clinical engineer for 25 years.
emerging medical technologies that are based on IT include: Prior to his employment at UC Davis, Mr. Cohen worked as
new wireless products that will decrease the cable tangle at the a civilian electronics engineer (computer systems) for the
bedside using Bluetooth for short-range communication [11], United States Air Force. Mr. Cohen is a member of the
surgical robotics with tactile sensors, “smart” artificial limbs, board of directors of the American College of Clinical
advanced speech recognition, voice-over IP telephones, video- Engineering and the Association for the Advancement of
over IP, digital broadcast quality video at reasonable cost, and Medical Instrumentation (AAMI) and a prior board member
many, many others. of the California Medical Instrumentation Association. Mr.
Standards-based information and medical technology inte- Cohen is the author of a variety of clinical engineering-relat-
gration will easily allow workstations to communicate with ed publications, including the AAMI-published book
multiple systems without special integration testing and con- Computerized Maintenance Management Systems for
cern over critical performance problems. New standards- Clinical Engineering and several articles on benchmarking
based efforts, such as the Integrating the Healthcare Enterprise medical equipment repair and maintenance services and the
Project, are making progress in developing manufacturer- ever-increasing impact of IT on medical systems and the
agreed-upon implementation “profiles” that add to, interpret, clinical engineering profession.
and make more practical common standards (e.g., DICOM,
HL-7), so that true “plug-and-play” interface compatibility Address for Correspondence: Ted Cohen, Clinical
can occur between multivendor—and often competing ven- Engineering Department, University of California Davis
dor—software [12]. Medical Center, 2315 Stockton Blvd., Sacramento, CA 95817
Data transmission rates will continue to increase with cost USA. E-mail: [email protected].
continuing to decrease (e.g., gigabit Ethernet, faster DSL). Data
and voice infrastructure will merge; data outlets will become as References
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IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE MAY/JUNE 2004 65