1. The document discusses a new support model called Integrated Systems Management (ISM) for networked medical devices that incorporates processes from asset management, risk management, systems management, and project management. 2. ISM and a software tool called CE-IT Live are presented as a way to help hospitals better manage the growing number of networked medical devices by automating identification, documentation, and remote support capabilities. 3. The adoption of integrated medical systems and networks is changing how medical device support needs to be provided, and a new collaborative model between clinical engineering and IT departments using ISM and tools like CE-IT Live is presented as an effective way to address these new challenges.

1. A Renovo White Paper
IMPLEMENTING A NEW SUPPORT
MODEL FOR NETWORKED MEDICAL
DEVICES / SYSTEMS
EXECUTIVE SUMMARY Management (ISM). ISM is a new support
model that incorporates processes that
With the increased use of personal improve performance, lower lifecycle costs
computer technology in the design of and reduce risks. These processes include
Medical Devices, manufacturers have ‘best practices’ from:
greatly enhanced the opportunity to » Asset Management
integrate standalone devices into systems » Risk Management
that can share real-time patient information. » Systems Management
This integration has improved productivity » Project Management.
for direct patient care staff and made
patient information widely accessible to All four disciplines combine to form a
remote care providers. cohesive management model, producing
synergistic, effective outcomes.
The resulting changes in workflow
and documentation create new To tackle the challenges of implementing
interdependencies and risks that previously integrated systems support, Renovo
did not exist. Component failures and Solutions has created a software tool called
limitations within the enterprise network CE-IT Live that enables hospital leadership
infrastructure have a major impact on an and support staff to take control of
organization’s ability to deliver patient care. undocumented and unprotected networked
medical devices. Through a standard web
In addition to system failures, a significant portal, CE-IT Live assists medical IT network
risk comes from security threats inherent maintainers in the following ways:
on common Information Technology » Expands the asset management
networks. Since modifications to these data set to include configuration
medical devices/systems are regulated information needed from networked
under Food and Drug Administration device devices, and automates the collection
classification requirements, care must of this data.
be taken in establishing documentation » Provides remote device and software
and tracking protocols that share the service monitoring and failure
information among responsible parties. notification.
Joint responsibility often leads to confusion » Provides complete documentation of
in systems security management and risk incidents, problems, change requests,
mitigation efforts undertaken by technical project tasks and risk mitigation efforts
support staff. Efforts may be delayed or all from a single service event.
ineffective, resulting in an increase of overall » Provides internal remote connectivity
risk for the health-care provider. tools that enable support staff to
determine device status immediately,
Renovo Solutions has redefined the or provide user assistance from the
traditional Medical Equipment Management same service portal.
Plan by incorporating best practices from » Leverages the data collected to create
the Manufacturing and IT industries within an accessible knowledge base to assist
a new management framework. We refer facilities in improving service quality.
to our approach as Integrated Systems Renovo Solutions’ Integrated Systems

2. IMPLEMENTING A NEW SUPPORT MODEL FOR NETWORKED MEDICAL DEVICES / SYSTEMS
Management model, in conjunction with are enabling true collaboration between
CE-IT Live, ties the needed pieces of an vendors. In recent published market
effective program together in a package research, it is estimated that as many as 61
that is economical and easily adopted percent of the electronic medical devices
across the enterprise. Most importantly, in a typical health-care organization today
Renovo Solutions’ methodology enables are networked in some way. [2]
collaboration and compliance, while
reducing the overall cost of Medical INTEGRATED SYSTEMS
Equipment Management. The increased use of personal computer
technology has driven the adoption
of standard communication protocols
THE SHIFTING PARADIGM between various devices. As they have
OF MEDICAL TECHNOLOGY found their way into medical device
MANAGEMENT design, manufacturers now produce many
In the American Recovery and Reinvestment instruments with the ability to be interfaced.
Act of 2009, $20 billion has been This has allowed more flexibility in system
appropriated for health-care providers to design through the integration of individual
encourage device integration and stimulate devices. These devices can share real-time
the adoption of the Electronic Health patient data, and provide a cost-effective
Record in the U.S. health-care system [1]. replacement to what had been elaborate
Though the health-care industry has been and costly manufacturer-specific systems. In
slow to adopt EHR technology, recent addition to creating more comprehensive
developments in communication standards data to drive patient care, deployment
are improving the interoperability between of industry-standard communication
medical devices, while reducing the protocols allows information generated by
proprietary development strategy most medical devices to be shared with that of
vendors were accustomed to following. other enterprise systems. As one example,
These standards are not only increasing previously standalone devices such as EKG,
interoperability between equipment and EEG and Ultrasound machines can now
information system platforms, but they be connected into clusters, providing data
Figure 1: Sample Integrated Network
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3. to central repositories where clinicians can also are on the verge of new regulations
assess and manipulate it using custom and standards development that will
software packages. The resulting picture require further transformation of medical
provides greater context for treatment equipment management programs.
decisions, and is readily available to ISO/IEC 80001: Application of risk
patient care professionals at remote management for IT Networks incorporating
locations. System-to-system communication medical devices is expected to be
further allows for more efficient billing finalized and presented for acceptance
and administrative review throughout the in the summer of 2010 [3]. This process
organization (Figure 1). standard covers activities, particularly
risk management, required of both the
System integration has enabled health-care organization and equipment
productivity enhancements for patient manufacturer when medical devices are
care staff, while improving availability integrated into a network, or when such
of patient information wherever and integrations are changed (see Figure 2).
whenever needed. Workflow changes
and documentation requirements create According to the ISO subcommittee, this
new interdependencies and risks. Failure standard also will cover the handover of
of individual components unrelated to information from the manufacturer to the
bedside care may now pose problems in responsible organization, sufficient to allow
both the business operations, as well as in the health-care organization to manage
patient care arenas. risk. This information includes a technical
instruction manual aimed specifically at the
A significant and challenging risk person who integrates a medical device
comes from security threats inherent on into a network. In addition, the standard
common IT networks. Since modifications will require the health-care organization
to networked medical devices are to appoint individuals to certain roles with
regulated under FDA device classification clearly defined responsibilities.
requirements, health-care providers
must assure problem identification and Due to the underlying technology platform
resolution is accomplished effectively, and infrastructure resources required,
documented properly and complies with hospital administrators will most likely look
all promulgated standards. This implies to their IT leadership for the development
redefining the boundaries of technical and management of a support program
support for medical devices, and has for networked medical devices that meets
blurred the lines of responsibility between these requirements. For years now, hospital
biomedical engineering and IT support. IT departments have been implementing
physical, technical and administrative
In addition to the drive towards electronic controls to protect their enterprise
health records influenced through the information systems. They often have
recent government stimulus funding, we faced resistance when implementing the
IEC 80001 (Committee Draft)
“There remain a number of potential problems associated with the integration of medical devices to
IT-networks, including: Insufficient support from manufacturers for integration of their medical devices into networks,
for example the non-availability or inadequacy of information provided by the manufacturer to the operator of the
IT-network.
» Mixing of medical devices and non-medical devices on the same network;
» Mixing of medical device software and non-medical software in the same network;
» Conflict between the need for strict change control of medical devices and the
need for rapid response to an attack by a malware.
When these problems manifest themselves it frequently leads to unintended consequences.” (From the IEC 80001 Introduction)
Figure 2
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4. IMPLEMENTING A NEW SUPPORT MODEL FOR NETWORKED MEDICAL DEVICES / SYSTEMS
same controls within their medical device and meet the coming requirements for
networks. It is not uncommon for most IT documentation and tracking.
departments to have little to no information
on the networked medical devices/systems Successful support requires a combination
in use within their organizations. of the medical device management
experience found within Clinical
Engineering, with the tools and skill
A NEW SUPPORT MODEL - sets traditionally available from the
INTEGRATED SYSTEMS IT department. Since most enterprise
IT networks, devices and software
MANAGMENT applications have been standardized to
By now, most Clinical Engineering leaders minimize acquisition and support costs,
should have alerted their organizations to most IT departments find it difficult, if not
the paradigm shift occurring within medical impossible, to provide support for the
device design and connectivity, and the varied configurations of hardware and
attendant need to redefine current Medical software present in most medical devices
Equipment Management Plans. If you and systems. Individualized support
have not begun to implement changes to requirements and service response levels
your CE support infrastructure, you may are dictated by the intended function of
be overlooking areas of growing risk that devices and systems in accordance with
could compromise the environment of care. the patient care need. This poses another
While change is difficult, the opportunity challenge for IT staff who may not be
exists to reshape the support team for accustomed to individualizing service
networked medical systems in an effective and support protocols based on so many
way, reducing the chance that such change factors (Figure 3).
will be forced upon you in response to an
untoward patient outcome. In response to these challenges, some
organizations have already developed
Traditionally, CE has focused its asset collaborative relationships, or have formally
management and technical support joined the CE and IT departments. However,
functions on discrete and independent successful collaboration, both formally
medical devices. Managing effective or informally, requires a mutual cultural
maintenance and performance assurance change in both CE and IT staff in order
throughout the device inventory rightly to be effective. Common language and
remain primary concerns. However, most support models must be developed, position
CE management plans do not address the descriptions modified and task assignments
unique challenges of managing systems rethought. Even this oversimplification
with a clear process. Similarly, most implies that support and guidance from
Computerized Maintenance Management senior management is critical to making
Systems do not provide the tools required such a change successful.
to effectively address the collection of
appropriate configuration information
IT SUPPORTED SYSTEMS VENDOR PROVIDED SYSTEMS
» Homogeneous hardware/software single » Non-homogeneous hardware/software -
vendor (Facility Standards) Dell/HP/unbranded
» Support scaled out – e.g. mass » Support requirements are individualized
operations divided by function » Systems are FDA-classified Medical Devices
» Business class devices/networks that are » Life critical impact with patient driven
organizationally defined response timelines
» Business critical impact with business-
driven timeline
Figure 3
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5. INTEGRATED SYSTEMS REQUIRE IMPLEMENTING A
INTEGRATED SUPPORT
MANAGEMENT TOOL
To adequately manage the challenges
presented by exposing medical devices to The four disciplines used in the
a network environment or integrating them Integrated Systems Management
into a larger system, new management model provide “data rich” monitoring
processes and tools must be implemented. tools. Many commercially available
computer software applications provide
By examining the best practices found similar project, systems, risk and asset
within the manufacturing and IT industries, management tools; however, they are not
several elements quickly emerge as customized for the Medical Equipment
common to both CE and IT missions. The Management function. Using them
management processes presented within individually would simply increase the
Integrated Systems Management are burden of documentation on limited staff
not new or unique; however, they extend resources, without realizing the intended
across the dividing line of traditional CE benefits.
and IT support, and often are missing from
traditional medical equipment management To tackle the challenges with Integrated
programs (Figure 4). Systems Management, Renovo Solutions
has created a management framework
The ISM model includes processes that (ISM) and a software tool (CE-IT Live)
improve performance, lower lifecycle that enable hospital leadership and
costs and reduce the risks of networked support staff to take control of the
systems. Since Risk, Systems and Project growing number of undocumented and
Management are all engineering unprotected networked medical devices.
disciplines, they can be effectively CE-IT Live is a software tool that builds
combined into a synergistic support model upon the foundation of existing CMMS
that ensures positive results. applications. Most equipment support
staff already utilize CMMS systems daily,
This new framework incorporates the best but need such systems to clearly identify
practices of management engineering to individual devices and the network(s) they
shift the focus from managing individual form, as well as to provide them with the
components to supporting “the system.” tools to maintain them effectively.
Systems Management Risk Management Asset Management
Risk Assessment
Configuration Planning & Acquisition
Management Risk Mitigation
Risk Control
Inventory Control
Incident
Management
Maintenance
Management
Problem
Availability & Utilization
Management
Project Management Safety Monitoring
Change
Management Project Development
Financial Management
Project Deployment
Security Project Monitoring
Management Disposal Management
Project Documentation
Figure 4: ISM Model
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6. CE-IT Live provides a single-portal configuration information and provide
system that: effective and timely support.
» Expands the asset management This saves tremendous time over manual
data set to include information from approaches that require on-site presence
networked devices, and automates its of the support engineer. The thought
collection. of accomplishing these management
» Provides remote device and software objectives without an automated tool
service monitoring and failure may be a major reason most equipment
notification. support managers have not moved faster
» Provides complete documentation of in adopting new approaches.
incidents, problems, change requests,
project tasks and risk mitigation efforts, In addition to configuration information,
all from a single service event. CE-IT Live can be used to monitor device
» Provides internal remote connectivity status and interface activity. Notifications
tools that enable support staff to can be sent to engineers if a device or
determine device status immediately, service should unexpectedly shut down.
or provide user assistance from the This notification often occurs before users
same service portal. are even aware that there is a problem.
» Leverages the data collected to create
a knowledge base among facilities that CONCLUSION
improve service quality. The adoption of technology in health-care
through advanced medical devices has
CE-IT Live provides additional functionality vastly improved the quality of patient care
found in many IT management systems and changed the landscape for Medical
that can cost well over $100,000. Equipment Management. The drivers of
The primary task of identifying and this change will continue to come from
documenting medical devices connected to medical research, technology development
IT networks has been automated by CE-IT and economic concerns. Integrated systems
Live. With no more than the device address have created opportunities, risks and
and appropriate access credentials, responsibilities that must be thoughtfully
engineers can remotely identify devices addressed through comprehensive
within a network, retrieve the relevant organizational efforts. Through the adoption
Figure 5
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7. of best practices, standards, knowledge System Security
and tools, hospitals can ensure a safe
General / Administrative
and effective environment of care, while Security Information
safeguarding patient information and Management
meeting regulatory compliance. Network Information and
Network Appliances
System Change Change Configuration
Health-care providers who are not actively Events
Management Management System Devices /
planning to re-engineer their equipment Interfaces /
Applications
support programs to adapt to these
changes may be putting themselves and
their patients in a precarious position.
Renovo Solutions has responded to this Incident Problem
need by creating the Integrated Systems Management Management
Management model. Used in conjunction
with CE-IT Live, it ties together effective Service Events Financial System Problems
elements of systems support into a single, Management
economical package. This ‘systems
management’ approach is intuitive and can
be deployed across the enterprise, fostering System Financials
collaborative effort, and enabling regulatory
compliance while reducing risk and cost.
Medical Equipment Management is
entering a “Brave New World” – we can
procrastinate and hope to survive, or we
can embrace the opportunity and flourish!
REFERENCES
[1] Ellis, Hirotaka, Morey, Timothy and Ni Riain, Tina. Expand and Enhance Health IT Capabilities
While Reducing Health-Care Operating Costs with Medical Devices Using Intel® Active Management
Technology. Product Strategy & Architecture Practice (PSA) March 2009, Sponsored by: Intel Corporation
Copyright © Wipro Ltd. 2009.
[2] Ness, D., and Lambie, B. Raising the Performance Bar: Gauging Asset Management Improvement in
a Government. Proceedings from “Clients Driving Innovation International Conference,” (2004).
[3] Wenzler, I. Development of an Asset Management Strategy for a Network Utility Company: Lessons
from a Dynamic Business Simulation Approach, Simulation & Gaming, Vol.36 No.1, 75-90. March 2005.
[4] Woodhouse, J. (2000). Finding the Right Mix of Costs, Risks and Performance. Retrieved April 2007
from http://www.plant-maintenance.com/articles/Costriskop.pdf
[5] HHS. (2010, 4 22). Recovery. Retrieved 4 22, 2010, from HHS.Gov: http://www.hhs.gov/recovery/
[6] ISO/IEC 80001
[7] Y, David. Advanced Clinical Engineering Workshop Proceedings, Havana, Cuba, June 2001.
[8] “Equipment Acquisition: How Clinical Engineering Can Help” Bioinstrumentation & Technology
Journal March/April, 2007.
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