PHYSICIAN'S EAR BME:09 FEBRUARY 21ST, 2018 STAGE-GATING 4 TAYLOR - - PowerPoint PPT Presentation

PHYSICIAN'S EAR – BME:09

FEBRUARY 21ST, 2018 – STAGE-GATING 4 TAYLOR COMBS, MEGAN HOLMBERG, SEIVER JORGENSEN, & SAM KULTGEN

Problem Statement

Free-field audibly medical alarms are loud and

• uninformative. The alarms

cause sleep deprivation for patients and alarm fatigue for clinicians.

Patient Needs Assessment

• Must not infringe on patient confidence in provider
• Safety for Patient
• Must have informative alarms to improve positive predictive value
• Must not interfere with conversation and normal sounds
• Must include alert for low battery and system malfunction

Provider Needs Assessment

• Interface
• Should have volume control
• Should have haptic feedback control
• Should have button to acknowledge receipt of

alarm

• Safety for Wearer
• Must be insulated to prevent shock and excessive

heating

• Must be sweatproof, waterproof
• Provider Efficacy
• Should be available in multiple sizes
• Must be comfortable to wear all day
• Must stay in ear easily
• Transmitted alarms must not overbearing
• Should have a haptic component to alarm signal
• Must be sterilizable
• Must have long battery life
• Should not receive unnecessary alarms to prevent

alarm fatigue

• Must be wireless with stable connection to

central hub

System Needs Assessment

• Cost Efficacy
• Must be able to be purchased in bulk by hospitals or clinics
• Should have long shelf life and capability to be activated as

needed

• Less than $500 per unit
• Central Control
• Must be able to selectively add patients to individual device
• Must be able to direct signal to alert physician and/or nurse by

need

• Must improve positive predictability of medical alarms.

PROTOCOL

SSRT AND GRAPHIC USER INTERFACE

AfterShokz TREKZ Titanium Bone Conductor Headphones Lofelt Basslet Haptuator

PATENT SEARCH

• No history of similar devices
• Class 381 Audio Signal Processing System and Device
• Crossover with other medical devices
• Acquires information from them
• Wireless connection methods
• LG Electronics Inc. Patent application number

20170295455

• Mesh network of Bluetooth devices over a wireless

signal

• Alarm sounds
• Novel or licensed

REGULATORY PATHWAY

• Related regulatory pathways
• Blood Pressure Alarm: Class 2
• Medical Device Information Transfer: Class 1
• The sounds we are working with would be Class 2
• The device we are proposing would be Class 1

REIMBURSEMENT & MANUFACTURING COSTS

• Not reimbursable
• Paid for by Hospital or Medical Center
• Suggested maximum unit cost of $500
• Current Estimation: $300
• Similar headsets sell for ~ $125
• Haptuator ankle band sells for ~$150

POTENTIAL MARKET

• Hospital Systems
• 5,512 acute care hospitals (2015)
• 5.3% growth in health care expenditures (2005-2015)
• 3.2% GDP growth (2005-2015)

NEXT STEPS

• Finalize communication method between headphones,

haptuator, and computer

• Build additional soundscapes
• Establish sound communication through Matlab
• Build GUI in Matlab for communication with participant

BIBLIOGRAPHY

lirezaee, Parisa, et al. “Did You Feel That? Developing Novel Multimodal Alarms for High Consequence Clinical Environments.” Proceedings of the 23rd International Conference on Auditory Display ICAD 2017, 2017, doi:10.21785/icad2017.066. Edworthy, J. “Alarms and Human Behaviour: Implications for Medical Alarms.” British Journal of Anaesthesia, vol. 97, no. 1, 2006, pp. 12–17., doi:10.1093/bja/ael114. Edworthy, J. “Fewer but Better Auditory Alarms Will Improve Patient Safety.” Quality and Safety in Health Care, vol. 14, no. 3, Jan. 2005, pp. 212–215., doi:10.1136/qshc.2004.013052. Edworthy, J. “Medical Audible Alarms: a Review.” Journal of the American Medical Informatics Association, vol. 20, no. 3, Jan. 2013, pp. 584–589., doi:10.1136/amiajnl-2012-001061. Edworthy, Judy Reed, et al. “Classifying Alarms: Seeking Durability, Credibility, Consistency, and Simplicity.” Biomedical Instrumentation & Technology, vol. 51, no. s2, 2017, pp. 50–57., doi:10.2345/0899-8205-51.s2.50. Edworthy, Judy, et al. “Improving Auditory Warning Design: Relationship between Warning Sound Parameters and Perceived Urgency.” Human Factors: The Journal of the Human Factors and Ergonomics Society, vol. 33, no. 2, 1991, pp. 205–231., doi:10.1177/001872089103300206 Hasanain, Bassam, et al. “A Formal Approach to Discovering Simultaneous Additive Masking between Auditory Medical Alarms.” Applied Ergonomics, vol. 58, 2017, pp. 500–514., doi:10.1016/j.apergo.2016.07.008. Knox, Richard. “Silencing Many Hospital Alarms Leads To Better Health Care.” NPR, National Public Radio, 27 Jan. 2014, www.npr.org/sections/health-shots/2014/01/24/265702152/silencing- many-hospital-alarms-leads-to-better-health-care. Ruskin, Keith J., and Dirk Hueske-Kraus. "Alarm fatigue: impacts on patient safety." Current Opinion in Anesthesiology 28.6 (2015): 685-690. Schlesinger, Joseph J., et al. “Frequency-Selective Silencing Device for Digital Filtering of Audible Medical Alarm Sounds to Enhance ICU Patient Recovery.” Proceedings of the 23rd International Conference on Auditory Display - ICAD 2017, 2017, doi:10.21785/icad2017.062. White, Jess. “New for 2016: Joint Commission Updates Alarm Guidelines.” Healthcare News & Insights, Joint Commission, 30 Dec. 2015, www.healthcarebusinesstech.com/alarms-2016/.