1. Extracorporeal Counter-Irritation Device Jessica Brisbin Alexandra Jefferds Nichole McPherson Nicholas Werner University of Pittsburgh Senior Design – BioE 1160-1161

2. Overview Needles are used in many common medical procedures: Immunizations Administration of drugs Starting IVs and catheters Fear of needles (6-22% US population)

3. Overview An Extracorporeal Counter-Irritation Alleviates the pain, anxiety, and discomfort associated with needle sticks. Provides auditory, visual, and tactile stimuli.

4. Project Objectives For the child: Significantly reduce or eliminate anxiety and pain during needle sticks For the doctor, nurse, or technician: Allow him/her to focus on the medical procedure Not interfere or hinder in his/her ability to perform the medical procedure

5. Competitive Analysis Hypnosis Causes patient to be deeply calm, however it can wear off unexpectedly. Tactile Therapy Shown to work in most case, however draws extra attention to the site. Diversion Therapy Distracts the patient and lowers anxiety, but does nothing to prevent pain. Local/Topical Anesthesia Only affects top two-three layers of skin, which is not deep enough for most needle sticks.

6. Design Alternatives Alternatives “Simon” game Device administers injection Choice of lights/music/vibration Relatively simple Not too distracting (no motion of patient) Product remains non-invasive

7. Features & Benefits 3x2x1″ box (fits on small arms) Appealing color scheme (friendly to kids) Large on/off switch (easy for clinicians to use) Lights, music (distraction) Vibration (counter- irritation)

8. Engineering technologies/methodologies Materials Standard electronics parts Music chip Xbox controller motor (high resistance) Fabrication Circuit board Loose wires & solder Paint (kid-friendly)

9. Description Improvements needed More streamlined case (animal shaped) All off-the-shelf parts Durable parts (music chip) Biocompatible strap Marketing Clients purchase for $30 Patient base: 20 million children under age 5 (US Census Bureau, 2000 data) Market base: 7,569 hospitals (2005 data)

10. Risk Analyses Initial Hazards Analysis Case breaks → Electrical Shock Remote, Severity III Flashing Lights → Seizure Improbable, Severity I FMEA Part failure → Device failure → Patient pain Occasional, Severity IV Human Factors Analysis Rough handling exposes electrical components Occasional, Severity III Severity I …….....…Severity IV

11. Obstacles to Market IRB Testing on children FDA ECI Device Low Risk → Class I Device Registration & Listing (21 CFR 807.20) General Systems (21 CFR 820) 510k EndoTwinn Class 1 Device Applies heat and vibration to tip of dental instrument (Root Canals)

12. Project management Most tasks were group effort Chief Responsibilities: Jessica: Obtained parts Alexandra: Built ECI device Nichole: Solidworks, manager Nick: Testing, Verification & Validation

13. Redesign Ideas Animal Shaped Case Enhance distraction, kid-friendly, dangling legs Cleat-like bumps on bottom of device Enhance effects of vibration Use disposable tourniquet Have decorative screen which clips onto the device between the patient and the procedure

14. Experimental design Awaiting IRB approval Clinical pediatric trials upon approval Children’s Hospital Ages 5-8 Receiving stick on back of the hand Color Analog Scale (CAS)

15. Color Analog Scale

16. Preliminary Testing Randomized set of trials on group members Controlled factors With/without device Arm used Time between trials Hardness of “snap”

17. Results n=2

18. Verification and Validation Verification Housing (< 6 in 2 ) Weight (< 8 oz) Working components Reduction of pain/anxiety Validation Focus Group → Approved Clinical Testing

19. Acknowledgements Sources of funding Generous gift of Drs. Hal Wrigley and Linda Baker Department of Bioengineering James J. Menegazzi, PhD Dr. Daniel Thomas

20. Questions?