Uploaded by zm.lai

Medical and Information

advertisement
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.
Download