1. Copyright © 2005 ECRI. All Rights Reserved. Clinical Alarms ECRI Perspectives James P. Keller, Jr., M.S. Director, Health Devices Group, ECRI 5200 Butler Pike Plymouth Meeting PA 19462 USA www.ecri.org ACCE Teleconference Series – June 2005

2. Copyright © 2005 ECRI. All Rights Reserved. 2 Background ECRI’s thirty-plus year history investigating alarm-related incidents and evaluating alarm-based medical technology “Back in the day” alarms were simple because devices were simple Technology has evolved and improved, but has become more complex – The same can be said for clinical alarms

3. Copyright © 2005 ECRI. All Rights Reserved. 3 Today’s Environment Many different types of devices and systems with alarms Use in many different clinical applications Variety of user types (e.g., doctor, nurse, patient, caregiver, etc.) Environmental factors contribute to complexity Lack of clarity for many alarm signals

4. Copyright © 2005 ECRI. All Rights Reserved. 4 Some Promising New Trends High-profile attention per JCAHO and others Alarm-based paging systems Alarm enhancement systems for ventilators Alarm integration systems (e.g., Emergin) Integration of device functionality and alarms (e.g., dose error reduction systems for infusion pumps) Remote monitoring services (e.g., VISICU)

5. Copyright © 2005 ECRI. All Rights Reserved. 5 However… Problems Still Exist Breathing circuit disconnections Monitoring devices accidentally put in standby Inappropriate alarm settings for specific clinical situations or settings Miscommunication of alarm-based paging system Occlusion of tracheostomy tubes

6. Copyright © 2005 ECRI. All Rights Reserved. 6 Other Examples Alarm volume set too low Central station speakers facing upside down Wrong priority used for “leads-off” alarms General misunderstanding of how monitors function during alarm conditions Disabled arrhythmia detection alarms Undetected venous line needle dislodgment during hemodialysis

7. Copyright © 2005 ECRI. All Rights Reserved. 7 ECRI Perspectives HTF and other alarm-related research will be a a tremendous help IHE and plug-and-play efforts are huge ECRI will continue its efforts to drive the market and will support ongoing work by HTF Technology and process improvements are keys to success down-the-line

8. Copyright © 2005 ECRI. All Rights Reserved. 8 Something to Think About For Today In an ECRI survey conducted in coordination with the American Association of Critical Care Nurses, we found that 35% of hospitals had not provided clinical training in monitor use for nurses in general care areas where monitors were being used. Nearly 29% of hospitals reported that nurses had not been trained in protocols covering alarm awareness and response. Pelczarski, K. Continuum of Care Monitoring-It’s Time has come. ECRI 1998 Jan.

9. Copyright © 2005 ECRI. All Rights Reserved. 9 Our Job For Today Evaluate how alarms are used and set in your institution – Establish clear protocols for alarm setting and use Know your devices and systems and communicate your knowledge to clinical staff – Include the cost of staff training when budgeting for medical devices acquisitions Evaluate environmental factors that can affect alarm performance and response – Identify immediate technology and process solutions

10. Copyright © 2005 ECRI. All Rights Reserved. 10 Our Job Going Forward Routine feedback to manufacturers, regulatory agencies, ECRI Participate in standards-related efforts (e.g., IEEE, AAMI, IHE) Provide ongoing education of clinical staff Publish and speak on your alarms-related successes and lessons learned Actively participate in technology planning and procurement at your institutions

11. Copyright © 2005 ECRI. All Rights Reserved. 11 Wrapping Up Clinical alarm management is and should continue to be a high profile issue Clinical engineers are uniquely qualified to improve things right away and contribute to the technology and systematic improvements needed going forward ACCE, HTF, and ECRI are here to help!

12. Copyright © 2005 ECRI. All Rights Reserved. 12 Questions or Comments?

13. Copyright © 2005 ECRI. All Rights Reserved. 13 Thank You! James P. Keller, Jr., M.S. Director Health Devices Group ECRI 5200 Butler Pike Plymouth Meeting, PA 19426 (610) 825-6000, ext. 5279 jkeller@ecri.org