Philips Implementing Wireless in the Hospital Enterprise: Medical Device Considerations and an Update on IEC 80001

1. Implementing Wireless in the Hospital
Enterprise: Medical Device Considerations
and an Update on IEC 80001
Olivia Hecht, Philips Healthcare, olivia.hecht@philips.com
Olivia Hecht, Philips Healthcare, olivia.hecht@philips.com
Phil Raymond, Philips Healthcare, phillip.raymond@philips.com
Rick Hampton, Partners Healthcare, RHAMPTON@PARTNERS.ORG

2. Agenda
• Common Wireless Applications in Use Today
• The Need to Define a Wireless Strategy
• Wireless Technologies Overview
– DAS for infrastructure
– WMTS
– 802.15 Short Range Radio
– 802.11 Wi-Fi
• Medical WLAN High Level Design Steps
• How IT and CE departments can support wireless technology
• IEC 80001: An Update
• IEC 80001-2-x Wireless Guidance Technical Report Overview
– Medical IT-Network Wireless Strategy Overview
• Q&A
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3. Wireless Applications in Healthcare
Applications • Communication enhancements
• Location based services – Event management
– Asset tracking (e.g. Secondary alerting)
– Push to talk communicators
• Voice over IP over Wi-Fi
• Workflow enhancements
• Paging Room
Cisco 7925
202 – Spot checks with a direct feed out HL7
• WoWs V-TACH
– Remote data viewing for improved
• Bedside charting consultation
• Wireless spot check monitoring – Temperature sensors eliminating
• Wireless sensing and control for lighting clipboards
and HVAC systems • Improved resource utilization and
• Short range connectivity between body productivity
sensors and monitoring devices – Community hospitals leveraging
intensivists at remote sites
– Electronic data feeds for EMR/EHR
– Asset location
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4. What’s the Hospital’s Wireless Strategy?
• Mapped out plan in concert with IT, RF Manager (if applicable)
• Consider things such as:
– What systems and spectrum will the hospital deploy?
– Is the facility providing staff with cell phones?
– Capacity required (across the spectrum) and coverage necessary, now and
down the road for all systems
– Number of services expecting to support; potential for conflicts
– System scalability
– Total cost of ownership
– Who is maintaining life critical network? Discrete system vs. integrated into
a DAS?
– Repair/maintenance strategies, vendor support and risk management
Confidential 4
Divison, MMMM dd, yyyy, Reference

5. Distributed Antenna Systems in Healthcare
• Good for bringing wireless WAN (e.g. cellular)
into buildings
• Differences in compatibility with discrete Wi-Fi
architectures
• Active vs. Passive
• Scalability potential issue for future
capacity/BW expansion
InnerWireless Horizon DAS
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6. WMTS Technology Considerations
• Frequency and physical separation
with use of protected spectrum
• Integration of WMTS wireless
network into existing wired
infrastructure
• Can be compatible with some DAS
systems
• 608 MHz band with migration to 1.4
GHz band
• ASHE registration required
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7. Short Range Wireless Technologies
• 802.15.x family of PHY & MAC layer architectures
– Info: http://ieee802.org/15/index.html
– 802.15.1 Bluetooth (WiBree)
– 802.15.4 ZigBee focus
– 802.15.6 Body Area Networks
• Applications include sensor networks, Bedside wireless ecosystem,
Health & Well-Being
• Spectrum usage varies (unlicensed but MBAN potential)
• Most implementation, configuration and management is built-in
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8. Wi-Fi and 802.11:
Challenges and Recommendations
Major Challenges
• Use of unlicensed spectrum & non deterministic device access
Recommendations
• Use WMM (QoS)
– Segregate traffic based on priority access
• Utilize both bands of spectrum (2.4 & 5 GHz)
• Take advantage of networking vendor capabilities
– Visibility into, and monitor the network health & usage
• Be aware of network vendor proprietary extensions
– Are your devices compatible with proprietary functions
• Read and follow IEC 80001-1 & 80001-2-x Wireless Guidance TR
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9. Step-by-Step Wireless LAN Design
1. Determine the networking capabilities of the medical device
– Wireless technology, spectrum usage, QoS, etc.
2. What are the networking performance requirements of the medical
device?
– Protocols used, latency, signal strengths, etc.
3. Match the wireless networking performance requirements of the
Medical Devices and Systems to the existing capabilities of the
general purpose IT network and identify gaps or incompatibilities
4. Define the clinical functionality in the use and support of the medical
devices
5. Create the clinical SLA by mapping the clinical functionality to the
network design
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10. Step-by-Step Wireless LAN Design
6. Identify and implement risk mitigations. Many risk mitigations are very
much like ‘best design practices’, but are documented, applied, and
verified as part of the risk management process
7. Design and configure the network(s) to match the most stringent SLAs
of all devices (medical and non medical)
8. Perform pre-GoLive and live network testing to verify that all devices
properly coexist while maintaining their particular SLA
9. Use operational measures to monitor and manage the network such
that SLAs are continuously being met.
10. Policy and procedure implementation; e.g. change control process
11. Read and follow IEC 80001-1 & 80001-2-x Wireless Guidance
Technical Report
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11. Questions to ask the Wireless Network Manager
• What spectrum is being used or planned in the hospital
– E.g. 2.4 GHz ISM, 5 GHz U-NII, Cellular, Protected (WMTS)
• What types of devices are currently on the wireless network
– General purpose, Voice communications, medical devices
• How are the current or proposed devices used
– Mission critical, guest access, life critical
• How are devices and traffic segregated, prioritized & managed
– SSID, security, infrastructure, QoS
• What are the network support response times
– Is there a focus on clinical requirements on response times
• What are the network change control procedures
– Are they documented?
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12. ISO/IEC 80001-1 Overview
• A voluntary, international standard applying a risk management process for IT
networks incorporating medical devices (a Medical IT-Network)
– Spanning operational phases from planning to decommissioning
– Sibling documents called “Technical Reports” for further details
• Three “Key Properties” – Safety, Effectiveness, Data & System Security
• Creates a “Responsible Organization” that establishes a “Risk Management
Process” and appoints a Risk Manager that maintains a “Medical IT-Network Risk
Management File”
• Accompanying Technical reports (TR):
– Wireless Guidance TR
– Healthcare Delivery Organization Guidance TR
– Security TR
– Step by Step Risk Management Process TR
– Other… 13

13. IEC 80001-1 Standards Model
IEC ISO
SC62a TC215
JWG7
80001-1 80001-2-x
80001-2-xx
High reference to:
•ISO14971: Medical device Mfr Risk Management process
•IEC 60601-1: Medical device basic safety and essential performance 14

14. IEC 80001-1 – Status
• Preliminary stage Preliminary work item
• Proposal stage New work item proposal
• Preparatory stage Working draft
• Committee stage Committee draft
• Enquiry stage Enquiry draft IEC/CDV
Sept 2010 • Approved final draft International Standard FDIS
Late 2010 • Publication stage International Standard ISO/IEC

15. IEC 80001-1 Responsible Organization
RESPONSIBLE ORGANIZATION
TOP MANAGEMENT responsibilities
• Executive Mgmt or C-level
Policies for
• Establish policies • RISK MANAGEMENT PROCESS
• RISK acceptability criteria
– Change/event management • Balancing the three KEY PROPERITIES with the
mission of the RESPONSIBLE ORGANIZATION
• Assigns resources
– Appoints Risk Manager
Resources
• Creates accountability
• Provision of adequate resources
– Multi-organization interaction • Assignment of qualified personnel
• Appointment of the MEDICAL IT-NETWORK RISK
• Documentation MANAGER
• Enforcement of RESPONSIBILITY AGREEMENTS
– Defines responsibility agreement
RISK MANAGEMENT PROCESS
• Clear connection to other PROCESSES
• Ensuring continuing suitability and
effectiveness
• Reviewing results at defined intervals
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16. IEC Risk Manager: Front and Center
• Reports to RO Mgmt
The RESPONSIBLE ORGANIZATION
• Establishes and manages Risk
Management file TOP MANAGEMENT
Clinical Area
• Engages and works with CE, of expertise
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A B
17

17. IEC Risk Management Documentation
• Risk Management file is for documenting the process and results
– Risk Management Process or Plan
– IT network documentation
– Risk analysis & associated measures
– Medical device or software assets
• Responsibility Agreement
– Defines responsibilities and interdependencies
– Involves Medical device manufacturer, networking vendor, hospital
admin
– A contract (e.g. may start with RFP, etc.)
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18. Biomedical & IT Convergence
• Network design & • Clinical functionality
Expertise • medical device
• Network processes, configuration
policies and maintenance • Medical device maintenance
IT/IS CE/Biomed
CE
IT
Network
MDM
Vendor
• Medical device • Network & Component
networking performance capabilities
specifications • Design & Configurations
 Engages and works with Clinicians, Biomed, IT/IS, HIT vendors, MDM, Network vendors, etc.
 Opportunity for converged skill-set – Biomedical, HIT, networking (wired and wireless)
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19. IEC 80001-2-x Wireless Guidance Index
• 1 Introduction
• 1.1 Organization of the technical report 3
• 1.2 Clinical Functionality and Use Case 4
• 1.3 Wireless Guidance and Risk Management 4
• 4 Wireless Medical IT-Network: An Introduction 7
• 4.1 MEDICAL DEVICE Networking Traffic Profile 7
• 4.2 Enterprise MEDICAL IT-NETWORK 7
• 4.3 Wide Area MEDICAL IT-NETWORK9
• 4.4 Distributed Antenna Systems 10
• 5 Wireless MEDICAL IT-NETWORKS: Planning and Design
• 6 Wireless MEDICAL IT-NETWORKS: Deployment and Configuration
• 7 Wireless MEDICAL IT-NETWORKS: Management & Support
• 8 General RISK MITIGATIONS
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20. Wireless Guidance
Overview Example
Risk TR Focus
Management Identify Hazard
(not addressed in Loss or impairment of
Wireless TR) Wireless connectivity
Identify Cause &
hazardous sit’n
Estimate Risk
Involves wireless network
Identify Risk
Mitigations planning & design,
deployment, management
Residual Risk
Evaluation and monitoring;
Policies and processes
Implement Risk
Mitigations
Pre-GoLive testing
Verify Mitigations
Residual Risk
Evaluation
Risk Mgmt Report
21

21. IEC 80001-1 Risk Mgmt Process
• Map a risk management process into clinical terminology
Hazardous
Hazard Cause
Situation
Risk Patient Risk
Mitigations Harm Analysis

22. IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Missed Treatment
(Sentinel Event) Ex. AP Outage Loss of Alarm
Network
Clinical Hazardous
Failure
Hazard Situation
Cause
Severity &
Mitigations Harm Impact Probability
Est.
Patient Injury Catastrophic &
Med. Probability

23. IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Missed Treatment
(Sentinel Event) Ex. AP Outage Loss of Alarm
Network
Clinical Hazardous
Failure
Hazard Situation
Cause
Severity &
Mitigations Harm Impact Probability
Est.
Patient Injury Catastrophic &
Low Probability
Add RF Redundancy

24. Medical IT-Network Wi-Fi Strategy
Vendor Site Specific Guidance
Specific
Wi-Fi Wi-Fi Specific Healthcare
Knowledge Guidance
Wireless Wireless Technology &
Guidance TR Risk Mgmt Convergence
HDO Risk
IEC 80001-1 Management Process
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