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


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

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

  1. 1. Implementing Wireless in the HospitalEnterprise: Medical Device Considerations and an Update on IEC 80001Olivia Hecht, Philips Healthcare, Olivia Hecht, Philips Healthcare, Phil Raymond, Philips Healthcare, Rick Hampton, Partners Healthcare, RHAMPTON@PARTNERS.ORG
  2. 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 2
  3. 3. Wireless Applications in HealthcareApplications • 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 3
  4. 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 managementConfidential 4 Divison, MMMM dd, yyyy, Reference
  5. 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 5
  6. 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 6
  7. 7. Short Range Wireless Technologies• 802.15.x family of PHY & MAC layer architectures – Info: – 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 7
  8. 8. Wi-Fi and 802.11:Challenges and RecommendationsMajor 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 8
  9. 9. Step-by-Step Wireless LAN Design1. 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 incompatibilities4. Define the clinical functionality in the use and support of the medical devices5. Create the clinical SLA by mapping the clinical functionality to the network design 9
  10. 10. Step-by-Step Wireless LAN Design6. 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 process7. 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 SLA9. 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 10
  11. 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? 11
  12. 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. 13. IEC 80001-1 Standards Model IEC ISO SC62a TC215 JWG7 80001-1 80001-2-x 80001-2-xxHigh reference to:•ISO14971: Medical device Mfr Risk Management process•IEC 60601-1: Medical device basic safety and essential performance 14
  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/CDVSept 2010 • Approved final draft International Standard FDISLate 2010 • Publication stage International Standard ISO/IEC
  15. 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 16
  16. 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 Appoint rts s pe de to ex rovi Biomed, IT/IS, HIT vendors, MDM, Biomedical Gu P s id Engineering ea Policies es area of ctiv ov pr itie Network vendors expertise ert s Ap s to exp vide so Processes Pro f Procedures s IT area of ide to expertise ov• Assists in establishing processes, Sup erv ises cre MEDICAL IT-NETWORK RISK Pr erts e xp atio no policies and procedures MEDICAL IT- NETWORK RISK Risk f MANAGER Provides experts to Other... MANAGEMENT Management FILE• Event management coordination to File Provides input to put Pro s in vide Residual Risk vide s and documentation inpu Pro t to Sub- Medical Medical contractor device device manufacturer manufacturer or provider of or provider of other IT other IT technology technology A B 17
  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.) 18
  18. 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) 19
  19. 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 20
  20. 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 EvaluationRisk Mgmt Report 21
  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. 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. 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. 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 25