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Vision on Medical Device Plug-and-Play Qixin Wang Assistant Professor, Dept. of Computing, The Hong Vision on Medical Device Plug-and-Play Qixin Wang Assistant Professor, Dept. of Computing, The Hong Kong Polytechnic University June 21, 2009

Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit academic use 2

Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit academic use 3

Why do we want Medical Device Plug-and-Play (MDPn. P)? (and why wireless MDPn. P? Why do we want Medical Device Plug-and-Play (MDPn. P)? (and why wireless MDPn. P? ) Flexibility and expanded medication capability Safety Convenience and Efficiency Independence from device vendors June 21, 2009 Qixin Wang, for non-profit academic use 4

Hundreds of thousands of medical devices exist in nowadays hospitals, but are mostly designed Hundreds of thousands of medical devices exist in nowadays hospitals, but are mostly designed for isolated use (proprietary) Figure Credit: P. Carleton, RN June 21, 2009 Qixin Wang, for non-profit academic use 5

Flexible composition of medical devices expands medication capability by enabling new methods/apps Patient Controlled Flexible composition of medical devices expands medication capability by enabling new methods/apps Patient Controlled Anesthesia (PCA) Nurse Pain Button Patient June 21, 2009 Qixin Wang, for non-profit academic use 6

Flexible composition of medical devices expands medication capability by enabling new methods/apps Patient Controlled Flexible composition of medical devices expands medication capability by enabling new methods/apps Patient Controlled Anesthesia (PCA) Computer Infusion Pump Pain Button Std. Vital Sign Monitor Patient Special Vital Sign Monitor June 21, 2009 Qixin Wang, for non-profit academic use 7

We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring 47/74 Correct June We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring 47/74 Correct June 21, 2009 Qixin Wang, for non-profit academic use 8

We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring 49/59 Error: too We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring 49/59 Error: too low June 21, 2009 Qixin Wang, for non-profit academic use 9

We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring Proposal: MDPn. P We need interconnected/interlocked medical devices to provide safety Blood Pressure Measuring Proposal: MDPn. P interlocked Bed and BP meter 49/59 47/74 Offset Corrected June 21, 2009 Qixin Wang, for non-profit academic use 10

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Correct Procedure: Qixin Wang, for non-profit academic use 11

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Correct Procedure: Qixin Wang, for non-profit academic use 12

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Correct Procedure: Qixin Wang, for non-profit academic use 13

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Absent Minded Procedure: Qixin Wang, for non-profit academic use 14

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Absent Minded Procedure: Qixin Wang, for non-profit academic use 15

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine June 21, 2009 Ventilator Absent Minded Procedure: Qixin Wang, for non-profit academic use 16

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine Ventilator Absent Minded Procedure: “. . . In the second case, the anesthesiologist forgot to resume ventilation after separation from cardiopulmonary bypass. The delayed detection of apnea was attributed to the fact that the audible alarms for the pulse oximeter and capnograph had been disabled during bypass and had not been reactivated. Both patients sustained permanent brain damage. ” Anesthesiology. 87(4): 741 -748, October 1997 June 21, 2009 Qixin Wang, for non-profit academic use 17

We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident We need interconnected/interlocked medical devices to provide safety Cardiopulmonary Bypass v. s. Ventilator Accident Heart Lung Machine Ventilator Proposal: MDPn. P Interlocked Architecture MDPn. P Control Computer Oximeter June 21, 2009 Capnograph Qixin Wang, for non-profit academic use 18

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 19

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident Blurry We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident Blurry Image June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 20

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 21

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 22

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 23

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident “A We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident “A 32 -year-old woman was having a laparoscopic cholecystectomy performed under general anesthesia. . At some point, the anesthesiologist glanced at the EKG and noticed severe bradycardia. He realized he had never restarted the ventilator … The patient ultimatedly died. ” APSF Newsletter, Winter, 2005. June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 24

We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident Proposal: We need interconnected/interlocked medical devices to provide safety X-Ray v. s. Ventilator Accident Proposal: MDPn. P interlock of X-Ray and Ventilator June 21, 2009 Qixin Wang, for non-profit academic use Picture provided by Mu Sun 25

We need interconnected/interlocked medical devices to provide safety Laser v. s. Oxigen Concentration Accident We need interconnected/interlocked medical devices to provide safety Laser v. s. Oxigen Concentration Accident June 21, 2009 Qixin Wang, for non-profit academic use 26

We need interconnected/interlocked medical devices to provide safety Laser v. s. Oxigen Concentration Accident We need interconnected/interlocked medical devices to provide safety Laser v. s. Oxigen Concentration Accident Proposal: MDPn. P interlock of Laser and O 2 Monitor No airway laser allowed when O 2 > 30% June 21, 2009 Qixin Wang, for non-profit academic use 27

We need interconnected/interlocked medical devices to provide safety Contangeous patient calls nurse for help We need interconnected/interlocked medical devices to provide safety Contangeous patient calls nurse for help June 21, 2009 Qixin Wang, for non-profit academic use 28

We need interconnected/interlocked medical devices to provide safety Contangeous patient calls nurse for help We need interconnected/interlocked medical devices to provide safety Contangeous patient calls nurse for help Contageous, must wear mask! June 21, 2009 Qixin Wang, for non-profit academic use 29

We need interconnected/interlocked medical devices to provide safety Proposal: Contangeous patient calls nurse for We need interconnected/interlocked medical devices to provide safety Proposal: Contangeous patient calls nurse for help MDPn. P connection of EMR DB, Nurse Station, and Vital Sign Monitors Contageous, must wear mask! EMR DB Nurse Station June 21, 2009 Qixin Wang, for non-profit academic use 30

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Messed Up Operation Room MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Messed Up Operation Room June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 31

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Messed Up OR v. MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Messed Up OR v. s. Vital Sign Bulletin Board June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 32

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Live. Data OR Dashboard MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Live. Data OR Dashboard Messed Up OR v. s. Vital Sign Bulletin Board June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 33

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency The Operation Room Spider MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency The Operation Room Spider Web June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 34

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency The Operation Room Spider MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency The Operation Room Spider Web, after MDPn. P safety interlocks June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 35

MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Spider Web OR v. MDPn. P, particularly wireless MDPn. P, improves convenience and efficiency Spider Web OR v. s. Wireless OR June 21, 2009 Qixin Wang, for non-profit academic use Picture quoted from www. mdpnp. org 36

Independence: hospitals need hundreds of thousands of types of medical devices; don't want to Independence: hospitals need hundreds of thousands of types of medical devices; don't want to be controlled by one vendor. Figure Credit: P. Carleton, RN June 21, 2009 Qixin Wang, for non-profit academic use 37

Why do we want Medical Device Plug-and-Play (MDPn. P)? (and why wireless MDPn. P? Why do we want Medical Device Plug-and-Play (MDPn. P)? (and why wireless MDPn. P? ) Flexibility and expanded medication capability Safety Convenience and Efficiency Independence from device vendors June 21, 2009 Qixin Wang, for non-profit academic use 38

MDPn. P benefits whom? Hospitals: independence, medication capability, safety Doctors: medication capability, safety, convenience MDPn. P benefits whom? Hospitals: independence, medication capability, safety Doctors: medication capability, safety, convenience Patient: medication capability, safety, cost Government: tracktability, cost Vendors: larger market Academia: systems June 21, 2009 typical case of cyber-physical Qixin Wang, for non-profit academic use 39

Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit academic use 40

IEEE 1073 Committee IEEE 1073 (5/1996): overall network/middleware architecture ISO/IEEE 11073 -10101 (6/2004): nomenclature IEEE 1073 Committee IEEE 1073 (5/1996): overall network/middleware architecture ISO/IEEE 11073 -10101 (6/2004): nomenclature ISO/IEEE 11073 -20601 (9/2008): middleware group management and communication protocol guideline ISO/IEEE 11073 -30200 (1/2000): cable PHY ~ transportation layer ISO/IEEE 11073 -10441 (1/2009): device spec. – cardiovascular fitness and activity monitor June 21, 2009 Qixin Wang, for non-profit academic use 41

American Society for Testing and Materials (ASTM), International Standardization Draft ASTM TC F 29. American Society for Testing and Materials (ASTM), International Standardization Draft ASTM TC F 29. 21 N 21 (2008): Medical Devices and Medical Systems – Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) – Part 1: General requirements and conceptual architecture June 21, 2009 Qixin Wang, for non-profit academic use 42

US Government Efforts FDA: Draft Guidance for Industry and FDA Staff: Radio-Frequency Wireless Technology US Government Efforts FDA: Draft Guidance for Industry and FDA Staff: Radio-Frequency Wireless Technology in Medical Devices, draft released for comment on Jan 3, 2007 June 21, 2009 Qixin Wang, for non-profit academic use 43

US Government Efforts President's Council of Advisors on Sci. & Tech. (PCAST): 2007 Report US Government Efforts President's Council of Advisors on Sci. & Tech. (PCAST): 2007 Report on Federal Networking and Information Technology R&D list Cyber-Physical Systems as the top of the eight priorities for federal research investments. June 21, 2009 Qixin Wang, for non-profit academic use 44

US Government Efforts NSF: Call for Proposals: Cyber-Physical Systems (CPS), solicitation 08 -611, deadline: US Government Efforts NSF: Call for Proposals: Cyber-Physical Systems (CPS), solicitation 08 -611, deadline: Feb. , 2010. “. . . Research advances in cyber-physical systems promise to … enhance societal wellbeing (e. g. , assistive technologies and ubiquitous healthcare monitoring and delivery) … NSF … are spear-heading the Cyber-Physical Systems (CPS) program becaues of its … impact … critical to U. S. Security and competitiveness, including … healthcare. . . ” June 21, 2009 Qixin Wang, for non-profit academic use 45

US Government Efforts National Coordination Office for Networking and Information Technology Research and Development US Government Efforts National Coordination Office for Networking and Information Technology Research and Development Program (NCO/NIRTD): High-Confidence Medical Devices: Cyber-Physical Systems for 21 st Century Health Care, Feb. , 2009 June 21, 2009 Qixin Wang, for non-profit academic use 46

Industry and Academia Efforts MDPn. P: http: //www. mdpnp. org, initiators: June 21, 2009 Industry and Academia Efforts MDPn. P: http: //www. mdpnp. org, initiators: June 21, 2009 Qixin Wang, for non-profit academic use Source: www. mdpnp. org 47

Industry and Academia Efforts MDPn. P: http: //www. mdpnp. org, initiators: June 21, 2009 Industry and Academia Efforts MDPn. P: http: //www. mdpnp. org, initiators: June 21, 2009 Qixin Wang, for non-profit academic use Source: www. mdpnp. org 48

Industry and Academia Efforts CIMIT: http: //www. cimit. org Center for Integration of Medicine Industry and Academia Efforts CIMIT: http: //www. cimit. org Center for Integration of Medicine & Innovative Technology, a non -profit consortium initiated by 12 institutes, including Mass. Gen. Hospital, Harvard Medical School, MIT, VA Boston Healthcare System etc. More than 40 industry partners. June 21, 2009 Qixin Wang, for non-profit academic use 49

Industry and Academia Efforts IEEE Computer: Insup Lee, George J. Pappas, Rance Cleaveland, John Industry and Academia Efforts IEEE Computer: Insup Lee, George J. Pappas, Rance Cleaveland, John Hatcliff, Bruce H. Krogh, Peter Lee, Harvey Rubin, Lui Sha: High-Confidence Medical Device Software and Systems. IEEE Computer 39(4): 33 -38 (2006) CPS Week: since 2008 (NSF CPS Summit), involving RTAS, IPSN, HSCC CPS Track: since 2007, IEEE RTSS June 21, 2009 Qixin Wang, for non-profit academic use 50

Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit Contents Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit academic use 51

Healthcare CPS can involve and stimulate the growth of nearly every CS area. Telemedicine Healthcare CPS can involve and stimulate the growth of nearly every CS area. Telemedicine Medical Information Systems Medical Device Systems (MDPn. P) June 21, 2009 Qixin Wang, for non-profit academic use 52

Thank You! Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for Thank You! Demand Existing Efforts Vision and Roadmap June 21, 2009 Qixin Wang, for non-profit academic use 53