1. © 2013 ECRI Institute Dealing with the Safety Implications of Innovative and Disruptive Technologies James P. Keller, M.S. Vice President, Health Technology Evaluation and Safety jkeller@ecri.org (610) 825-6000, ext. 5279 June 1, 2013 – Clinical Engineering Symposium AAMI Annual Conference

2. © 2013 ECRI Institute 2 Walk Down Memory Lane … Argon Beam Coagulator

3. © 2013 ECRI Institute New York Times and Radiation Therapy “The Times found that while this new technology allows doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error — through software flaws, faulty programming, poor safety procedures or inadequate staffing and training. When those errors occur, they can be crippling. “Linear accelerators and treatment planning are enormously more complex than 20 years ago,” said Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York. But hospitals, he said, are often too trusting of the new computer systems and software, relying on them as if they had been tested over time, when in fact they have not.” * * Radiation Offers New Cures, and Ways to Do Harm. W. Bogdanich. New York Times, February 2010. http://www.nytimes.com/2010/01/24/health/24radiation.html?pagewanted=all&_r=0 http://www.nytimes.com/2010/01/24/health/24radiation.html?pagewanted=all&_r=0 3

4. © 2013 ECRI Institute 4 Source: Health Devices Alerts Special Report S0209, March 2011

5. © 2013 ECRI Institute 5 Additional Examples  Intraoperative MRI Introducing an MR to an surgical environment brings the need for MR safe practices to an entire department from surgeons, nurses, and other ancillary staff (surgical assistants, supply chain, cleaning, transport). Without a comprehensive plan to ensure that only MR safe materials enter into the Gauss field, safety can be compromised.  Hybrid ORs and iCT The increased use of ionizing radiation outside of the traditional radiology and cardiology departments requires radiation dose safety training and measures in departments that are not as experienced in radiation safety practices.

6. © 2013 ECRI Institute 6 Additional Examples …  Alarm Integration Systems ECRI Institute worked with a hospital where the BME department verified that the physiologic monitoring system was appropriately sending alarms to the new alarm integration system. At the same time, the IT department was verifying that the alarm management system was appropriately operating. Unfortunately, no one confirmed that the monitoring system’s alarms were getting to the nurses. As a results, several patient deaths were attributed to this disconnect.

7. © 2013 ECRI Institute 7 Software-Based Hazards and Recalls  ECRI Institute’s Health Devices Alerts database contains hazard and recall information since 1982  Searched “active” & “completed” action items  Search parameter = *software*  Past 15-year trend

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10. 10 Widespread Exposure

11. © 2013 ECRI Institute 11 Who’s that Guy? Top Ten Hazard Video

12. © 2013 ECRI Institute Disruptive Innovation “A disruptive innovation is a technology that brings a much more affordable product or service that is much simpler to use into a market. It allows a whole new population of consumers to afford to own and have the skill to use a product or service, whereas historically, the ability to access was limited to people who have a lot of money or a lot of skill.” * * Will Disruptive Innovation Commoditize Medical Devices? Mobile Health - Reinventing Medical Devices. J.P. Boyle & Associates White Paper, http://www.boyle-associates.com/di/Disruptive-Innovation.pdfhttp://www.boyle-associates.com/di/Disruptive-Innovation.pdf 12

13. © 2013 ECRI Institute http://www.mckinsey.com/insights/business_technology/disruptive_technologies 13

14. © 2013 ECRI Institute Hazard Number 9: Caregiver Distractions from Smartphones  Risk Factors Patient Care Interruption ― Clinical messages ― Personal use Interruption of Clinical Data Entry  Prevention Mobile Device Policy Awareness 14

15. © 2013 ECRI Institute 15 The use of mobile and wireless devices to improve health outcomes, healthcare services, and health research * mHealth – The New Buzzword 2011 NIH Consensus Group Statement, http://www.hrsa.gov/healthit/mhealth.htmlhttp://www.hrsa.gov/healthit/mhealth.html

16. © 2013 ECRI Institute 16 Reproduced with Permission from AAMI. Source can be found at http://www.aami.org/publications/summits/2012_Wireless_Workshop_publication.pdf http://www.aami.org/publications/summits/2012_Wireless_Workshop_publication.pdf

17. © 2013 ECRI Institute ECRI Institute Survey 17 Source – Health Devices, April 2013

18. © 2013 ECRI Institute ECRI Institute Survey Data 18 Source – Health Devices, April 2013

19. © 2013 ECRI Institute 19 Examples of Smart/Cell Phone Risks and Concerns  Security breaches  Digital distractions affecting patient care  Display limitations  Increased traffic on the Wi-Fi network  Threats from computer viruses and other malware  Cross contamination  Limitations of text messaging

20. © 2013 ECRI Institute Alerts Search on Wireless (2012 – Present)  Wireless EEG amplifiers: may overheat near on/off button  Mobile X-Ray systems: Use of wireless remote control may cause additional radiation exposure EMI a possible contributing factor  Wireless digital radiography detector lithium-ion batteries may overheat causing plastic battery casing to melt  Wireless patient monitor reboots resulting in temporary loss of patient monitoring (including alarms) for approximately Problem may be introduced with changes to the hospital wireless LAN hardware or firmware 20

21. © 2013 ECRI Institute Risk Management  Emerging technologies often require placement on the corporate network increasing risk potential  ANSI/AAMI/IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices—Part 1: Roles, responsibilities and activities  Main target audience is the healthcare facility  Risk management is required for the life cycle of the medical IT- network 21

22. © 2013 ECRI Institute HIT Risk Assessment under IEC 80001-1 22

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24. © 2013 ECRI Institute 24 Recall Management  Everything inventoried and named correctly  Source material identified (e.g., what if it’s not regulated)  Responsible individuals  Communication plan in place  Contingency considerations  Follow-through and closing the loop  Good documentation

25. © 2013 ECRI Institute Telemedicine – New Technology Crossing State Lines 25

26. © 2013 ECRI Institute Wrapping Up Perspectives – For Planning  Know your technology – and where will be used  Analysis of risks – before adoption Published studies (i.e., and evidence review) Watch the front page Phone a friend  Be prepared to address and justify Technical and clinical challenges/risks Process, infrastructure, and workflow changes Regulatory issues and actions Training and credentialing 26

27. © 2013 ECRI Institute 27 Wrapping up Perspectives – For Operations  Monitoring for performance Have predicted gains been achieved?  Process for reporting of problems  Recall management  Ongoing training covered?  Scope creep (e.g., with robotics)  Who’s in charge?

28. © 2013 ECRI Institute 28 Wrapping up Perspectives – For Operations  Monitoring for performance Have predicted gains been achieved?  Process for reporting of problems  Recall management  Ongoing training covered?  Scope creep (e.g., with robotics)  Who’s in charge?

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30. © 2013 ECRI Institute 30 Remember the New Frontier  Homecare  Mobile emergency response hospitals  Telemedicine systems in physician offices  Shopping centers  Office buildings  24x7 “wearable” devices Closed loop infusion pumps?

31. © 2013 ECRI Institute My Look into the Future Heads up display 31

32. © 2013 ECRI Institute 32 When will we get there? I’ll take a spin to check it out!

33. © 2013 ECRI Institute Thank You