IEEE 802.15 <subject>

1
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 VoiceAdd telephone number, FAX Add FAX
number, E-MailRHampton_at_Partners.org Re If
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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

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Agenda

• The Current Environment
• Uses of Wireless
• Some Problems Experienced
• Regulatory Concerns
• The Challenges
• Action Agenda Recommendations

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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.

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FCC Services Utilized

• Part 15
• 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

• ISM (Industrial, Scientific, Medical)
• WMTS (Wireless Medical Telemetry Service)
• PLMRS (Private Land Mobile Radio Service)
• 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)

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Courtesy Jan Wittenber, Philips/IEEE 11073
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Wireless Application Map
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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

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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
• Cant keep up with code revisions
• Maintainability
• Some automated management tools dont 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

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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.

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Regulatory Concerns of Wireless Medical Devices
(Cont.)

• IEC 80001 Draft Standard Title Application of
  risk management for IT-networks 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

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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

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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 Ive worked with
• We have 2000 APs, all managed manually

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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/conflicti
  ng 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

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Overlapping wireless technologies in the 2450 MHz
ISM band
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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

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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_at_Partners.org