Applying Risk Management to Mobile Wireless Medical Devices. AAMI Town Hall Meeting January 11, 2012 Rick Hampton Stuart Higgins

Transcription

1 Applying Risk Management to Mobile Wireless Medical Devices AAMI Town Hall Meeting January 11, 2012 Rick Hampton Stuart Higgins

2 Stuart Higgins Stuart Higgins, CCIE #3194 Cisco, Healthcare Enterprise Architect Contact Information Twitter Stuart_Higgins Blog blogs.cisco.com/healthcare Stuart Higgins is Cisco's healthcare industry solution architect in the Cisco EMM - Industry Solutions Engineering team. In this role, his primary focus is creation of healthcare related solution architectures, medical device partner integration and healthcare focused standards bodies work. He has previously led the ISE engineering team in the validation of a number of healthcare solutions which Cisco has brought to market. Stuart joined Cisco as an application solution architect, responsible for the clinical application architecture in support of Cisco's healthcare solutions. Previously he spent 17 years at Shared Medical Systems and Siemens Medical. During this time he designed numerous new campus, data center, and wireless networks for Siemens Medical's customers, and often provides specific healthcare consulting experience to Cisco s customers and healthcare partners. Stuart has more than 23 years of healthcare IT experience and a wide breath of knowledge related to the convergence of Healthcare IT and Biomedical systems.

3 Rick Hampton Rick Hampton Partners HealthCare, Wireless Communications Manager Contact Information One Constitution Center Suite 100 Charlestown, MA Rick Hampton is a member of the Association for the Advancement of Medical Instrumentation, American College of Clinical Engineering, Institute of Electrical and Electronics Engineers, and the Healthcare Information and Management Systems Society. Rick was the recipient of ACCE s 2011 Professional Achievement in Technology Award/Professional Development Award for his efforts in advancing the understanding of radio spectrum and wireless device management in healthcare. Rick is also a member in the IEEE Engineering in Medicine and Biology Society and Communications Society. He has serves on several AAMI committees as well as the IEEE Technical Committees for Wireless Communications for Medical Devices, and is Co-Chair for the Wireless Subcommittee for the IEC Risk Management standard. Mr. Hampton advises numerous medical device companies and regulatory agencies, and presents at numerous conferences and workshops each year. Mr. Hampton currently serves as Wireless Communications Manager for Partners HealthCare System, Boston, MA, where he is responsible for the overall coordination of activities relating to the safe and effective use of wireless communications technologies at Partners Healthcare and its affiliates.

4 Agenda Growth of connected Medical Devices (Wired and Wireless) Increased use of wireless consumer devices Real world examples of why it s important Vendor approaches to problem correction QoS and Roaming recommendations Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

5 Why are we here? In the past, networked medical devices required their own separate network. The HITECH Act and other business drivers are pushing healthcare institutions to converge the medical device network and the HIT network. Does converging medical devices safely require more than simply connecting the medical devices to the HIT network? What methodology do you use to address patient safety, continued efficacy of the medical device, and system security? Are there potential regulatory and legal responsibilities? How will your facility or company deal with the HIT network becoming a critical part of a regulated medical device?

6 Agenda Increased use of wireless consumer devices Real world examples of why it s important Vendor approaches to problem correction QoS and Roaming recommendations Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

7 Courtesy Jan Wittenber, Philips/IEEE 11073

8 Wireless Management The materials were loaded at a nearby Home Depot where the store manager made the customer sign a waiver before loading the vehicle. On the roof are many 2X4s, 4X4s and OSL sheets of lumber. In addition to the lumber on the roof, the back seat contains ten 80-pound bags of concrete! Home Depot estimated the load weight at 3000 lbs. Do you use the VW Jetta Management Method?

9 Agenda Real world examples of why it s important Vendor approaches to problem correction QoS and Roaming recommendations Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

10 The Joint Commission Sentinel Event Alert 42 ( ) Title Safely implementing health information and converging technologies As health information technology (HIT) and converging technologies the interrelationship between medical devices and HIT are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technologyrelated adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. This Alert focuses on how to safely implement HIT and converging health technologies.

11 The Joint Commission Sentinel Event Alert 42 Leadership standards LD.4.20 (LD *) and LD.4.40 (LD *) address designing new processes and establishing a safety program. In addition, since technology is prevalent in health care from patient admission to the surgical suite to the ordering and administration of medication and the use of equipment and medical devices any Joint Commission standard could potentially be tied to technology. Users should consider the use of any technology in relation to the standards and be aware of potential dangers to patients, as in any clinical situation. Environment of Care standards EC , EC , and EC address product recalls, selection, testing, and maintenance of medical equipment, and contingencies when equipment fails.

12 ECRI Institute - Top 10 Health Technology Hazards For 2011 Alarm Hazards ranked #2 Alarm-related adverse incidents typically involve, alarms not being properly relayed to ancillary notification systems (e.g., paging system, wireless phones), potentially leading to a failure to notify relevant staff. Data Loss, System Incompatibilities, and Other Health IT Complications ranked #5 The convergence of medical technology and health information technology (HIT) is no longer a new phenomenon or purely a specialized concern. Technologies like medication management systems and processes like the incorporation of medical data from devices such as physiologic monitors and ventilators into electronic health records are just a few examples of how convergence is becoming more commonplace.

13 ECRI Institute Top 10 Technology Hazards For 2011 Data Loss, System Incompatibilities, and Other Health IT Complications ranked #5 While convergence presents many benefits, including improved standards of care and operational efficiencies, it also presents many risks. Ineffective convergence can adversely affect patient care in a wide variety of ways. It can, for example, lead to data being lost (e.g., overwritten, unsuccessfully transmitted) or being associated with the wrong patient, which in turn can lead to misdiagnosis, inappropriate treatment, or the need for repeat testing. To prevent hazards associated with convergence of medical technology and HIT, ECRI Institute recommends, [employing] good project management, change management, and risk management processes. To aid in this effort, hospitals should consider applying the International Electrotechnical Commission s new IEC standard, Application of Risk Management for IT- Networks Incorporating Medical Devices Part 1: Roles, Responsibilities and Activities.3

14 Agenda Vendor approaches to problem correction QoS and Roaming recommendations Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

15 Addressing the wireless challenges and trends Leading Technology Unified Policy and Network Management CleanAir Bandselect ClientLink Interference Protection Detect, classify, locate and mitigate interference Improving network reliability and performance IEC conformance Automatic band steering for 5GHz 5GHz capable clients are automatically moved to cleaner 5GHz spectrum move critical devices band reserved for medical devices Improved Client Performance Beam forming = more bars everywhere and a superior user quality of experience improvements for one = improvements for all Identity Services Engine (ISE) Who? What? When? Where? How? VideoStream Superior Video Quality Reliable multicast, stream prioritization, and resource reservation Cisco Prime NCS BioMed NAC Network Access Control for Biomed Devices Automatic wireless/wired network provisioning

16 Detect and Classify Uniquely identify and track multiple interferers Assess unique impact to Wi-Fi performance Monitor AirQuality 35 Cisco CleanAir High-resolution interference detection and classification logic built-in to Cisco s n Wi-Fi chip design. Inline operation with no CPU or performance impact.

17 Locate WCS, MSE Mitigate Wireless LAN Controller Classification processed on Access Point Interference impact and data sent to WLC for realtime action WCS and MSE store data for location, history, and troubleshooting Visualize and Troubleshoot POOR GOOD Maintain Air Quality CH 1 CH 11 Cisco CleanAir Cisco CleanAir Technology integrates interference information from the AP into the entire system.

18 Access Point Assisted 5 GHz Band Selection Challenge Dual-Band clients persistently connect to 2.4 GHz 2.4GHz may have b/g clients causing contention 2.4GHz is prone to interference and is a plethora of consumer devices Solution BandSelect directs clients to 5 GHz optimizing RF usage Better usage of the higher capacity 5GHz band Frees up 2.4 GHz for single band clients Dual-Band Client Radio 2.4/5GHz n Discovery Probes Looking for AP Discovery Response 5 Optimized RF Utilization by Moving 5 GHz Capable Client Out of the Congested 2.4 GHz Channels

19 Improve Reliability and Coverage Challenge Legacy clients may have poor receiver sensitivity aka poor reception and slow speed selected Increased density of wireless devices requires higher data rates to reduce channel contention Advantage Client Link uses Beam Forming to Direct Signal to Improve Performance and Coverage for a/g Devices a/g Without ClientLink and Beam Forming a/g With ClientLink and Beam Forming Existing n Solutions Beam Strength Not Directed to Client Up to 65% Increase in Throughput Up to 27% Improvement in Channel Capacity Increases Overall Wireless System Capacity in Mixed Client Environment

20 Video Impact Choppy, Unreliable Video Data Rates b/g Technical Challenges Multicast packets (UDP) are sent as broadcast packets over the air per standard Broadcast packets do not use error correction: fire and forget Broadcast packets are sent at Lowest supported mandatory data rate: 1 MB for B/G (400K actual) 6 MB for A (2.7 MB actual) Video Stream does not utilize n High Throughput data rates Heavy utilization of channel due to high rate of very slow packets Video delivery is not reliable causing poor Quality of Experience M0 M1... M14 M15 n AP 1140 Default b/g mandatory data rates Video Server

21 Video Impact Smooth, Reliable Video delivered to multiple clients Quality of Video protected in varying channel load conditions Prevents video flooding Prioritizes Business Video over other video Data Rates b/g Technical Solution IGMP state monitored for each client. Only send video to clients requesting Multicast packets replicated at AP and sent to individual clients at their data rate Resource Reservation Control (RRC) used to prevent channel oversubscription. Works in conjunction with Voice CAC Stream Prioritization ensures important videos take precedence over others SAP/SNMP error message created when Channel Subscription violated M0 Intelligence in the AP Video Server M1... M14 M15 n AP 1140 Default b/g mandatory data rates QoS Marked on CAPWAP From WLC

22 Challenge Advantage Cisco VideoStream Technology Delivering high quality multicast video on mobile devices at scale Provides HD multicast video by protecting QoS of all streams with Prioritization and RRC Primary n Components Stream Prioritization Resource Reservation Control MULTICAST STREAM AP UNICAST STREAMS In room patient surveillance Physical Security Feed Live OR Video Training Live Video Entertainment AP VIDEO NOT AVAILABLE WLC AP Efficiently Scales Enterprise-Class Video Collaboration on Mobile Devices

23 Agenda QoS and Roaming recommendations Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

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25 Enabling WMM is not automatically bi-directional, wireless application must mark traffic accordingly An end-to-end QoS Policy is required

26 Intra-Controller Roaming Inter-Controller Roaming Client A: MAC, IP Addr, AP, QoS, Security Client A: MAC, IP Addr, AP, QoS, Security Client A: MAC, IP Addr, AP, QoS, Security IP Subnet Controller Client DB Controller 1 Client DB IP Subnet Controller 2 Client DB CAPWAP CAPWAP CAPWAP CAPWAP AP1 AP2 AP1 AP2 Re-Authentication Client roams from AP1 to AP2 Pre-Roam Traffic Path Post-Roam Traffic Path Client roams from AP1 to AP2 Pre-Roam Traffic Path Post-Roam Traffic Path

27 Mobility Group Inter-Controller Roaming IP Subnet Client A: MAC, IP Addr, AP, QoS, Security Client A: MAC, IP Addr, AP, QoS, Security Controller 1 Client DB Mobility Msg Exch Controller 2 Client DB CAPWAP CAPWAP AP1 AP2 Pre-Roam Traffic Path Post-Roam Traffic Path Client roams from AP1 to AP2

28 Mobility Groups Mobility Groups Wireless LAN Controller(s)

29 Third-Party Integration to LBS (Nurse Call, BioMed, EMR) Wireless Management PC Browser Based Cisco Catalyst 3750G Integrated Wireless LAN Controller NAC MSE ACS WCS Wireless LAN Controller (WLC) Cisco Catalyst 6500 Wireless Services Module (WiSM) MGN 2.0 Campus Cisco ISR Wireless LAN Controller Module Voice & QoS Enabled Access Switches SSC

30 In use at some healthcare facilities Wireless LAN Controller (WLC) Cisco Catalyst 6500 Wireless Services Module (WiSM) Voice & QoS Enabled Access Switches Dedicated Biomed Switch Fabric Local Biomed WLAN Controller(s) SSC

31 Two adjacent 20-MHz channels are bonded together (courtesy Rick Hampton Partners Healthcare)

32 Agenda Brief mention of MDDS Mobile Medical Applications, regulation on the horizon. 20 Minutes Q&A

33 FDA Initiatives: MDDS, MMA, etc. February 14, 2011: Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well.

34 Medical Device Data Systems Final Rule [21 CFR] Medical device data system. (a) Identification. (1) A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) The electronic transfer of medical device data; (ii) The electronic storage of medical device data; (iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) The electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in

35 Important MDDS Caveats A device data system that facilitates clinical assessments or monitoring, such as alarm or alert functionality based on preset clinical parameters (including low priority physiological conditions) is not an MDDS. We have modified the rule to include the word active to represent any device that is intended to be relied upon in deciding to take immediate clinical action. A device intended to be used for active patient monitoring (or decision support) is not an MDDS. There are existing classifications for patient monitoring devices.* Any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action or that is to be used for continuous monitoring by a health care professional, user, or the patient is not an MDDS. Such devices are generally accessories to other devices. [Note: Current FDA regulations define components of and accessories to medical devices as medical devices themselves.] * See, e.g., 21 CFR part 880, subpart C (general hospital and personal use monitoring devices); 21 CFR part 868, subpart C (anesthesiology monitoring devices); 21 CFR part 884, subpart C (obstetrical and gynecological monitoring devices); and 21 CFR part 870, subpart C (cardiovascular monitoring devices).

36 What is IEC 80001? IEC Ed.1: Application of risk management for it-networks incorporating medical devices Part 1: Roles, responsibilities and activities It is an international standard It is a voluntary standard unless formally adopted by regulatory authorities Specifically aimed at healthcare facilities of all sizes It is a process standard describing the risk management process Does not provide a checklist, but informs users how to create a program suitable for their facility

37 Future Documents Technical Reports (guidance documents) to be published soon: Guidance for Healthcare Delivery Organizations An implementation guide for HDOs of all sizes Step by Step Risk Management Still not a bullet-list of steps to accomplish, but rather a simple explanation of concepts from ISO and how they might be adopted by Responsible Organizations Security Use of Wireless Technologies With more to come

38 Origins of Core ideas drawn from: ISO Application of risk management to medical devices Applies ONLY to medical device manufacturers ISO IT Service Management Standards ITIL IT Infrastructure Library

39 The Key Properties defines three Key Properties to be managed. They are, in this order of priority: Safety (freedom from unacceptable risk of physical injury or damage to the health of people or damage to property or the environment) Effectiveness (ability to produce the intended result for the patient and the Responsible Organization) Data and System Security (an operational state of a Medical IT- Network in which information assets (data and systems) are reasonably protected from degradation of confidentiality, integrity, and availability) does not specify acceptable risk levels.

40 Role Relationships Medical Device Manufacturer Providers of Other Information Technology Responsible Organization Top Management Medical IT-Network Risk Manager

41 Next Steps Create a multi-disciplinary group to evaluate and take preliminary steps towards meeting new regulatory and risk management requirements Obtain, read, and apply the following documents: FDA MDDS Announcement with link to Final Rule: ouncements/ucm htm IEC Risk Management Standard:

42 Other References ISO/IEC : 2005 Medical Electrical Equipment requires manufactures to include some information in accompanying documents if medical equipment is to be connected to an IT network ISO/IEC 14971:2007 Application of risk management to medical devices ISO/IEC : 2010 Application of risk management for IT-networks incorporating medical devices Part 1: Roles, responsibilities & activities ISO/IEC :2005 IT Service Management System Information Technology Infrastructure Library (ITIL v3) HIMSS/NEMA HN Manufacturer s Disclosure Statement for Medical Device Security (MDS2) MIL-STD-882E DOD s Standard Practice for System Safety, ACCE ECRI Security Guide for Biomedical Technology, Systems Engineering Guide for Systems of Systems, Version 1.0, Office of the Deputy Under Secretary of Defense for Acquisition and Technology, Systems and Software Engineering. Washington, DC: ODUSD(A&T)SSE, DOD, Aug 2008 National Institute of Standards and Technology (NIST) standards (

43 Final Thoughts In flying I have learned that carelessness and overconfidence are usually far more dangerous than deliberately accepted risks. Wilbur Wright in a letter to his father, September 1900