RTKL HEALTHCARE TECHNOLOGIES

Transcription

1 RTKL HEALTHCARE TECHNOLOGIES For the HAM Operator A Healthcare Primer Steven W. Juett, PE

2 Introduction Licensed Biomedical Engineer Practiced Clinical Engineering RTKL, Healthcare Technologies Medical Technology Planning and Consulting Member ACCE (American College of Clinical Engineers) CE IT initiative, Patient Care Domain (PCD) AAMI (Association for the Advancement of Medical Instruments) ASHE (American Society for Healthcare Engineering) HIMSS (Health Information Management Systems Society) IHE (Integrating the Healthcare Enterprise) FMDIC (FDA Medical Device Industry Coalition) Interests: Operating Rooms and Clinical Systems Integration The great outdoors

3 Forward HIMSS Interoperability Showcase 2015 PCD Introduction History and Empirical Experience Moving Forward

4 History What does healthcare have in Common with HAM Environment Wireless Transmitting Devices Medical and Other Devices

5 Medical Devices Lifestyle in our living environment Implantable devices Pacemakers, Intra Cardiac Defibrillators (ICD) Cochlear Hearing Blood Sugar management Blood test Insulin pump Wearable devices Hearing aid Remote monitoring Activity Tracker

6 Medical Devices Diagnostic devices Wireless imaging communication CT, MRI, PET, NM, DXA Wireless laboratory communication Electro Cardio Gram ECG(heart) Electro Encephalo Gram EEG(brain) Wireless Temperature monitoring Medical Telemetry Life and Critical Care monitoring

7 Medical Devices Therapy and Treatment devices RF Ablation and Electro Surgery (cutting in surgery) Ultrasonic fracturing (Impulse Impact) Ultrasonic Separation (Vibration lens tissue and teeth cleaning) Physical Therapy (Heat) Radiation (Cancer) Robotic Minimally Invasive Surgery (MIS)

8 Other Devices Communication devices Telecommunications Basic Cell Phones Radios o Emergency Responders o Facilities, Security, Logistics Information Systems Wireless Networks Tablets, Laptops Personnel with clinical applications (PDA) MDs, RNs, Technicians

9 History What does healthcare have in Common with HAM Environment Electromagnetic Interference (EMI) Medical and Wireless Transmitting Device Other Devices Compatibility?

10 EMI Testing Example Study (Pre 2000 data) Critical Patient Care Equipment (Impacts patient care outcome) Controlled and safe study Excess of 200 medical devices Tracked Separation distance Effect Impact Changes Diagnosis Changes Therapy Transient Recoverable. OR NOT! o Requires Intervention o Self clearing after event

11 EMI Test Observations (sampling) (FT) Effect Diag. Chg Therapy Chg Transient Recoverable 7 Display distortion within 79 in. N N Y Y None Elevated Baseline within 79 in. N Unknown Y Y Spikes on EKG waveform within 6 in., Sync on spikes within 2 in. Displ. Deflection within 24 in. Y Y Y Y 2 15 Distortion of displ. Waveform and HR chg within 180 in. Y N Y Y 10 Distortion of displ. Waveform within 118 in. Y N Y Y 4 Distortion of displ. Waveform within 39 in. Y N Y Y 5 Change in function/delivered therapy with alarm within 60 in. Unknown Y Y Y 1 BPM incr. And unit alarms within 10 in. Unknown Y Y Y 0 Airway Temp 0 in. N Unknown Y Y 5 Change in function/delivered therapy without alarm within 60 in. Unknown Y Y Y 1 Analog meter displ. Chg within 10 in. Unknown Y Y Y 1 Display malfunction within 10 in. N N Y Y 1 Incr. In breaths per minute/audible alarm within 10 in. Unknown Y Y Y 1 Displayed value change within 10 in. Unknown Unknown Y Y 1 "ECG in use", "ECG lost" alarm within 1 in. HR incr. within 1 in. Y N N w/intervention 1 Device gives error code within 2 in. and stops monitoring Y N N w/intervention CO2 waveform distortion and displ. Value chg, Breath reject message, analyzer locks up within 2 in. Y N N w/intervention 1 0 Error code alert when transmitting directly over keypad. N Y N w/intervention 1 Overtemp alrm within 4 in., displ. temp chg within 1 in, shuts down at 0 in. N Y N w/intervention 1 Displ. Temp chg within 2 in., Overtemp alrm and pump stops within 1.5 in. N Y N w/intervention 1 "Vent fail 4" and "6" and "Vol Sensor Fail" alarms within 1/2 in. N Y N w/intervention 1 Will not take temp within 3 in., higher temp reading within 2 in. Y N Y w/intervention 1 Screen dims/brightens within 2 in. BP chg within 1 in. Y N N Y 2 NIBP meas. Chg. Within 22 in., Signal lost/defl. Fail alarms within 10 in. Y N N Y 0 Ceases to function and resets itself at 0 in. N Y N Y 1 Occlusion alarm within 3 in. N Y N Y 0 Display blinks off/on when BB directly over rear comm port. N N Y Y 1 Displ. Deflection within 1 in. N N Y Y 1 Waveform defl. Within 12 in. of CRT N N Y Y 1 Deflection of pressure waveform within 4.5 in. N N Y Y 1 Display and Audio artifact within 1 in. N N Y Y 1 Displ. Defl. Within 8 in. N N Y Y 6 "Clicking" heard within 69 in. Unknown N Y Y

12 Take Away Observation Results Greater than 30% of Critical Medical Equipment impacted Function Power Distance Frequency Immunity (shielding) Actions Taken Reported to FDA (subsequently shared with FCC) Reported to AAMI Medical Device manufacturing standards updated 2003 Management approach change and implementation

13 History What does healthcare have in Common with HAM Environment Spectrum Allocation and Management Medical and Wireless Transmitting Device Other Devices Compatibility Management feet Function of: Power, Distance, Frequency and Shielding

14 Ham Operator Club 2000 Command Center, 2 meter band MHz, Jonsson Admitting, 2 meter handitalkies ProNet Paging System 175,000 Wadley tower Telemetry, FM-FM analog 5 3J, 4J, 13R -- Marquette ECG telemetry Telemetry, coherent digital 5 5J, 10R -- Marquette ECG telemetry Telemetry, SpO2 5 6T(E&W), 7J, 12R -- Novametrix Model 1010 SpO2 telemetry system Medical Implant and/or Programmer Private Land Mobile Radio Service (PLMRS) Medical Telemetry Television ch Medical Telemetry 25 microwatts EIRP is 18.2 mv/meter MICS TV Primary Telemetry Secondary Baylor beepers (7970 pages) 200,000 Quintron, Roberts roof Spectrum - Site Specific Example Frequency Power (MHz) RF Generator (mw) Comment IMPACT.wf pagers at 3J IMPACT.wf pagers at 5J IMPACT.wf pagers at 4J IMPACT.wf pagers at 10R IMPACT.wf pagers at 13R PLMRS have primary status - licensed: 50Khz, 25 KHz channel separation Telemetry - secondary, have 12.5KHz channel 2,000 Marquette waveform pagers Data Critical holds nationwide licenses for protected frequencies on the LMCC low power channel plan. Data Critical believes the refarming actions will have no negative impact on customers using our products Telemetry, digital? Landry, Cardiac Rehab 24 channels -- Channel 20 ( ) has had interference problems apparently due to the Engineering Walky-talky system. Current workaround is not to use this channel Two-Way Radio 2,000 Unknown Two-Way Radio 2,000 Central Supply Two-Way Radio 500 Biomedical Engineering project/ installation use MHz Two-Way Radio 500 SCN, ICN, LD Talkabout 250 handheld Radio Two-Way Radio 500 BCRC (Y2K) Two-Way Radio 2,000 Nutrician Services, Basement of Truett

15 Spectrum Allocation and Management MedRadio is a group of radio frequencies set aside to allow shortrange wireless communication between an implant or patient worn therapy device and a control unit. (Several bands ~ MHZ) Part 95, subpart I, Licensed by rule secondary Medical Micropower Networks (MMNs): wireless medical devices that can be used to restore functions to paralyzed limbs (Several bands ~ MHZ) Medical Body Area Network (MBAN) is intended to replace the wires connecting a patient to his or her bedside. It s low power network of sensors controlled by a hub, designed primarily for in room use connecting to health care provider. ( MHz)

16 Spectrum Allocation and Management Wireless Medical Telemetry Service is for a short distance data communication service for transmitting patient medical information to a central monitoring location in a medical facility. Part 95, subpart H ( MHz, MHz, & MHz) Medical devices may also operate under the rules for unlicensed devices under Part 15 in any frequency band available under that Part.

17 Wireless Management About AAMI s Wireless Strategy Task Force AAMI s Wireless Strategy Task Force (WSTF) which is composed of manufacturers, regulators, users of technology, and other interested parties is developing educational resources and tools and sharing best practices to address wireless challenges in healthcare. For more information about the WSTF, visit The biggest mistake a healthcare delivery organization can make with wireless is failing to create a strategic plan on how to use and implement wireless technologies.

18 Wireless Management IEC and ISO Both are International consensus standards which outline how to identify, assess, and manage risks associated with medical devices. ISO focuses on manufacturers and the manufacturing processes IEC focuses on healthcare delivery organizations (HDO)

19 Management - HTM and IT IT should manage the vast majority of wireless networking, since it is primarily used for nonmedical, administrative, and public communication. IT will have access and networking expertise, but rarely has patient safety and risk management expertise. Healthcare Technology Management (HTM) provides that vital patient safety priority. In the hospital, direct patient support must have the highest priority. Wireless networks used for patient care should be built and operated to IEC standards IEC If any of the network is used medically, such as for patient monitoring, radiologic image transfer, infusion pump management, etc., then both HTM and IT must jointly manage the wireless network.

20 Wireless Design and Planning

21 Design Wireless Expertise Understand your environment before designing Do Master Planning Site Survey Only good the day it was done

22 Distributed Antenna System (DAS) Separate spectrum services Power KW vs. W vs. mw Function Public vs. Business vs. Clinical

23 Testing Public Workshop FCC/ FDA Joint Workshop on Wireless Medical Device Test Beds, March 31, s/workshopsconferences/ucm htm#date Connect2HealthFCC Task Force FCC website dsunmedicalproductsafetynetwork/ucm htm

24 Public Workshop FCC/ FDA Joint Workshop Washington, D.C. On Tuesday, March 31, 2015, the Federal Communications Commission and the Food and Drug Administration will host a public workshop on the role of wireless medical test beds and their influence on the development of converged medical technology for clinical and non clinical settings. A wireless test bed is an environment where devices can be evaluated across a range of interference scenarios. The workshop is another step in the ongoing FDA/FCC collaboration and leadership in promoting innovative medical technologies and is being organized by the Connect2HealthFCC Task Force, the FCC Office of Engineering and Technology, and the FDA Center for Devices and Radiological Health. Topics may include the need for and scope of wireless medical device test beds, an overview of current public and private test bed programs and initiatives, a discussion of ideal features, functions and gaps of such programs, and how best to drive innovation and safe coexistence of wireless medical technologies. The FCC and FDA encourage the participation of a broad range of stakeholders, including device manufacturers, health care facilities and clinicians, test labs, standard setting bodies, innovators, patient safety groups, researchers, and entrepreneurs, among others. The agencies also seek public input regarding questions for workshop participants

25 Summary: Healthcare has in Common We have only one shared RF airspace Responsibility to use it wisely Creative Interest and Energy to Research and Develop Collaboration is a must Healthcare loves their HAM

26 OUR SERVICES MEDICAL EQUIPMENT PLANNING Capital Equipment Strategic Planning Medical Equipment Technology Planning BIM/REVIT 3D Modeling Construction Administration CLINICAL SYSTEMS PLANNING Integrated OR systems PACS systems integration Point of care testing Physiological monitoring Connected Medical Equipment DATA CENTER PLANNING + DESIGN Situational Assessment Reliability Planning IT Master Plan Financial analysis & cost of ownership Facility design, engineering & commissioning PROCUREMENT Strategic Sourcing Medical Equipment, FFE and Technology Installation and move-in management FACILITY TRANSITIONING Occupancy planning Personnel Preparedness Move Management TECHNOLOGY SYSTEMS DESIGN Structured cabling design Clinical communications Security systems Audio/visual systems and cabling Wireless systems Network design IT equipment coordination OPERATIONAL MODELING + SIMULATION Computer simulation of clinical operations Model Operational Effectiveness

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