<July 2008>
doc.: IEEE 802.15-<doc#>
Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)
Submission Title: [A day in the life of wireless medical device network risk management]
Date Submitted: [10 July 2008]
Source: [Rick Hampton] Company [Partners HealthCare System]
Address [Boston, MA]
Voice:[Add telephone number], FAX: [Add FAX number], E-Mail:[RHampton@Partners.org]
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Abstract: [Description of document contents.]
Purpose: [Description of what the author wants P802.15 to do with the information in the document.]
Notice: This document has been prepared to assist the IEEE P802.15. It is offered as a basis for
discussion and is not binding on the contributing individual(s) or organization(s). The material in this
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Submission
Slide 1
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
IEEE 802 Plenary Tutorial Session
"A Day In The Life: Wireless Risks In The
Hospital Environment"
July 15, 2008
Rick Hampton
Wireless Manager
Partners HealthCare
Information Systems
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Agenda
•
•
•
•
•
•
The Current Environment
Uses of Wireless
Some Problems Experienced
Regulatory Concerns
The Challenges
Action Agenda Recommendations
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Uses of Wireless Devices
• Voice devices
– Cellular telephones, wireless VoIP, hand-held radios
• Data devices
– Laptop computers, PDAs, two-way pagers, RFID tags/readers,
wireless LAN access points (APs)
• Integrated devices (RIM Blackberrys®)
• Real-Time Location devices
– Active/passive RFID tags
• Medical Telemetry
– WMTS and wireless LANs
• Accessory devices
– Cordless headsets, keyboards, mice, printers, etc.
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
FCC Services Utilized
•
•
•
ISM (Industrial, Scientific,
Medical)
WMTS (Wireless Medical
Telemetry Service)
PLMRS (Private Land Mobile
Radio Service)
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•
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Public Safety
Bio-medical Telemetry
Industrial/Business
Private Land Mobile Paging
Radiolocation
Paging
MURS (Multi-Use Radio Service)
FRS (Family Radio Service)
GMRS (General Mobile Radio
Service)
MICS (Medical Implant
Communications Service)
Submission
•
Part 15
–
–
–
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Medical Telemetry
RFID
Spread Spectrum
U-NII (Unlicensed National
Information Infrastructure)
– UWB (Ultra WideBand)
• Medical Imaging
•
•
•
•
•
•
Cellular Radio Service
SMRS (Specialized Mobile
Radio)
AWS (3G) - Advanced Wireless
Services Spectrum
PCS (Personal Communications
Service)
Amateur Radio
Private Operational Fixed
Microwave
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Courtesy Jan Wittenber, Philips/IEEE 11073
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Wireless Application Map
Graphics
Long Range
Text
GSM/CDMA
Internet
HiFi
Audio
Streaming
Video
Digital
Video
GPRS/3G
Multi-Channel Video
LMDS/Wi-Max
WAN
Two-way Radio
802.11n
802.11FH
Active
RFID
Bluetooth
Class 1
802.11b
802.11a/g
LAN
WMTS
Short Range
Zigbee
Bluetooth
Class 2
MICS/
MRDCS
Passive
RFID
Low Data Rate
Submission
Bluetooth
Class 3
Ultra WideBand
PAN
High Data Rate
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Summary - The Current and Changing
Environment
• Many wireless/radio systems for many different purposes
• Placed in context as part of the hospital system (collection
of devices and utilities required to care for the sick and
injured) these communications systems are life-critical in
nature. Failure of some could lead to injury, illness, or
death of patients, healthcare staff, and visitors
• IT industry is marketing the unified IT w/LAN as the single
best solution moving forward
• The IT LAN, wired and wireless, must meet high standards
for availability, reliability, and manageability not seen before
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Some Problems Experienced:
• Pre-deployment
– Site survey tools “best guess”… at best!
• Deployment
– Too many ways IT vendors can choose to implement Standards
– EVERY new wireless device is problematic
• Reliability
– “Sell it now, fix it later!” mentality in IT industry
– Too many bugs associated with proprietary work-arounds
– Can’t keep up with code revisions
• Maintainability
– Some automated management tools don’t work
– “Legacy support” – Medical devices have MUCH longer design
cycle and life-span than IT equipment
• 17 floors of 802.11FH still used for medical monitoring
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Regulatory Concerns of Wireless Medical
Devices
• FDA does not yet regulate the IS LAN as a
medical device.
• If connecting a medical device to the IS LAN adds
functionality to the device, the LAN could become
part of the device and additional regulatory
requirements (510k) would likely be required.
• Since the device manufacturer has no control over
the IS LAN, it is prudent for the IS department to
begin assessing and ensuring the extra level of
reliability required by the addition of medical
devices.
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Regulatory Concerns of Wireless Medical
Devices (Cont.)
• IEC 80001 Draft Standard – Title:
Application of risk management for ITnetworks incorporating medical devices
– Expected to be ratified in 2010
– Addresses IT/Medical integration “head on”
– Requires risk analysis and mitigation to be done
on an ongoing basis for networked medical
systems
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Regulatory Concerns of Wireless Medical
Devices (Cont.)
• FDA Medical Device Data System (Proposed) is a device intended to
provide one or more of the following uses:
– The electronic transfer or exchange of medical device data from a
medical device, without altering the function or parameters of any
connected devices.
– The electronic storage and retrieval of medical device data from a
medical device, without altering the function or parameters of
connected devices.
– The electronic display of medical device data from a medical
device, without altering the function or parameters of connected
devices.
– The electronic conversion of medical device data from one format
to another format in accordance with a preset specification.
• Major concern is that automating systems removes transparency of
error generation from end user and over-reliance upon flawed systems
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
The Challenges
(To be more fully addressed by subsequent presenters)
• Current standards address only the most basic
requirements requiring IT vendors to create multiple
proprietary work-arounds
– May not be compatible between vendors
– Need to work with “generic” devices and be transparent
• 802.11 QoS for medical devices (or lack thereof)
• Inability to segregate wireless traffic (not enough SSIDs)
• Some current automated wireless management systems
fail miserably
– Unreliable - Cause dropout of clients
– Present undesirable conditions for every medical device
manufacturer I’ve worked with
– We have 2000+ APs, all managed manually
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
The Challenges (Cont.)
• Wireless systems will need “NOC-level” real-time
spectrum management capabilities
• IT industry goals often do not take into account
clinical/medical goals – conflicts result
– VoIP, RFID, etc., may required different/conflicting
wireless architecture (QoS, deployment, security,
etc.)
• Current wireless standards are implemented for
consumer environments, not enterprise healthcare
– Bluetooth Version 1.0 – notorious interferer
– 802.11n, Zigbee, Wibree, and other “standards”
coming and not all may be useful in hospitals
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Overlapping wireless technologies in the
2450 MHz ISM band
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Action Agenda Recommendations
• Understand and acknowledge that 802.11
committees have an important role in improving
healthcare in hospitals, in homes, in life in general
• Establish formal link with IEEE 11073 and other
medical device standards committees
• Take a leadership position in rectifying issues
outlined by this group of presenters through the
creation of meaningful standards for medical
devices
Submission
<Rick Hampton>, <Partners Healthcare, Boston>
doc.: IEEE 802.15-<doc#>
Contact Information
Rick Hampton
Wireless Communications Manager
Partners HealthCare System
One Constitution Center, OCC210
Charlestown, MA 02129
Office: 617-726-6633
Cell: 617-968-2262
RHampton@Partners.org
Submission
<Rick Hampton>, <Partners Healthcare, Boston>