philips implementing wireless in the hospital enterprise: medical device considerations and an...
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Philips Implementing Wireless in the Hospital Enterprise: Medical Device Considerations and an Update on IEC 80001TRANSCRIPT
Implementing Wireless in the Hospital Enterprise: Medical Device Considerations
and an Update on IEC 80001
Olivia Hecht, Philips Healthcare, [email protected] Raymond, Philips Healthcare, [email protected]
Rick Hampton, Partners Healthcare, [email protected]
Olivia Hecht, Philips Healthcare, [email protected]
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• 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
Agenda
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Wireless Applications in Healthcare
Applications• Location based services
– Asset tracking
• Voice over IP over Wi-Fi• Paging• WoWs• Bedside charting• Wireless spot check monitoring• Wireless sensing and control for lighting
and HVAC systems• Short range connectivity between body
sensors and monitoring devices
• Communication enhancements– Event management
(e.g. Secondary alerting)– Push to talk communicators
• Workflow enhancements– Spot checks with a direct feed out HL7– Remote data viewing for improved
consultation– Temperature sensors eliminating
clipboards
• Improved resource utilization and productivity
– Community hospitals leveraging intensivists at remote sites
– Electronic data feeds for EMR/EHR– Asset location
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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
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• 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
Distributed Antenna Systems in Healthcare
InnerWireless Horizon DAS
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• 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
WMTS Technology Considerations
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• 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
Short Range Wireless Technologies
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Major Challenges• Use of unlicensed spectrum & non deterministic device accessRecommendations• 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
Wi-Fi and 802.11: Challenges and Recommendations
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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
Step-by-Step Wireless LAN Design
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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 process11. Read and follow IEC 80001-1 & 80001-2-x Wireless Guidance
Technical Report
Step-by-Step Wireless LAN Design
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• 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?
Questions to ask the Wireless Network Manager
• 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…
ISO/IEC 80001-1 Overview
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14
SC62a TC215
IEC ISO
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
IEC 80001-1 Standards Model
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
• Approved final draft International Standard FDIS
• Publication stage International Standard ISO/IEC
Sept 2010
Late 2010
• Executive Mgmt or C-level• Establish policies
– Change/event management• Assigns resources
– Appoints Risk Manager• Creates accountability
– Multi-organization interaction• Documentation
– Defines responsibility agreement
IEC 80001-1 Responsible Organization
Policies for
• RISK MANAGEMENT PROCESS • RISK acceptability criteria • Balancing the three KEY PROPERITIES with the
mission of the RESPONSIBLE ORGANIZATION
Resources
• Provision of adequate resources • Assignment of qualified personnel • Appointment of the MEDICAL IT-NETWORK RISK
MANAGER • Enforcement of RESPONSIBILITY AGREEMENTS
RISK MANAGEMENT PROCESS
• Clear connection to other PROCESSES • Ensuring continuing suitability and
effectiveness • Reviewing results at defined intervals
RESPONSIBLE ORGANIZATION TOP MANAGEMENT responsibilities
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• Reports to RO Mgmt• Establishes and manages Risk
Management file• Engages and works with CE,
Biomed, IT/IS, HIT vendors, MDM, Network vendors
• Assists in establishing processes, policies and procedures
• Event management coordination and documentation
IEC Risk Manager: Front and Center
TOP MANAGEMENT
Biomedical Engineering
area of expertise
IT area of expertise
Clinical Area of expertise
Other...
Residual Risk
Risk Management
File
MEDICAL IT-NETWORK RISK MANAGEMENT
FILE
Sub-contractorMedical
device manufacturer or provider of
other IT technology
B
ProceduresProcesses
Policies
Medical device
manufacturer or provider of
other IT technology
A
MEDICAL IT-NETWORK
RISK MANAGER
Supervises creation of
Approv
es
Prov
ides
inpu
t to
Pro
vide
s in
put t
o Provides input to
AppointsGuide activities of
Prov
ides
expe
rts to
Prov
ides
expe
rts to
Provides
experts to
Providesexperts to
The RESPONSIBLE ORGANIZATION
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• 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.)
IEC Risk Management Documentation
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• Network & Component capabilities
• Design & Configurations
• Medical device networking performance specifications
• Clinical functionality• medical device
configuration• Medical device maintenance
• Network design & Expertise
• Network processes, policies and maintenance
IT/IS CE/Biomed
Network Vendor
MDM
Biomedical & IT Convergence
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)
CE IT
• 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
IEC 80001-2-x Wireless Guidance Index
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Estimate Risk
Loss or impairment of Wireless connectivity
Residual Risk Evaluation
Involves wireless network planning & design, deployment, management and monitoring; Policies and processes
Pre-GoLive testing
Risk Mgmt Report
Identify Hazard
Identify Cause & hazardous sit’n
Identify Risk Mitigations
Implement Risk Mitigations
Verify Mitigations
Wireless Guidance TR FocusRisk
Management(not addressed in
Wireless TR)
Overview Example
Residual Risk Evaluation
IEC 80001-1 Risk Mgmt Process
• Map a risk management process into clinical terminology
Hazard Cause Hazardous Situation
Risk Analysis
Patient Harm
Risk Mitigations
IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Clinical Hazard
Network Failure Cause
HazardousSituation
Severity & Probability
Est.Harm ImpactMitigations
Missed Treatment(Sentinel Event) Ex. AP Outage Loss of Alarm
Catastrophic & Med. Probability
Patient Injury
Add RF Redundancy
IEC 80001-2-x Wireless Guidance
• Example applying risk management wireless networking
Clinical Hazard
Network Failure Cause
HazardousSituation
Severity & Probability
Est.Harm ImpactMitigations
Missed Treatment(Sentinel Event) Ex. AP Outage Loss of Alarm
Patient Injury Catastrophic & Low Probability
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Vendor Specific
Wi-Fi Knowledge
Wireless Guidance TR
IEC 80001-1 HDO Risk Management Process
Wireless Technology & Risk Mgmt Convergence
Wi-Fi Specific Healthcare Guidance
Site Specific Guidance
Medical IT-Network Wi-Fi Strategy