Implementing Wireless in the Hospital Enterprise: Medical Device Considerations

and an Update on IEC 80001

Olivia Hecht, Philips Healthcare, olivia.hecht@philips.comPhil Raymond, Philips Healthcare, phillip.raymond@philips.com

Rick Hampton, Partners Healthcare, RHAMPTON@PARTNERS.ORG

Olivia Hecht, Philips Healthcare, olivia.hecht@philips.com

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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

Cisco 7925Room 202

V-TACH

ConfidentialDivison, MMMM dd, yyyy, Reference

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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