Point-of-Care Bedside Bar Code Verification SystemAlex Stramel2, Talbot Hansum1,2, Nicholas Ryan1, Jason Whaylen², Vanessa Luckman1,2

Advisors: Paul King, Ph.D.1, Patrick Harris 3

1 Department of Biomedical Engineering, Vanderbilt University, Nashville, TN2 Department of Electrical and Computer Engineering, Vanderbilt University, Nashville, TN

3 PharmaSys Hospital Solutions, Cary, NC

Problem Statement

Hardware and Software Design System DesignDesign Goals

Product Description (eMEDS)

Existing Products and Cost

Hardware Data Flow

Handheld PDA

Host Computer, Router, and Barcode Label Printer

Software and Databases

Graphical User Interface

Possible Software Modifications

Conclusions and Future Direction

Acknowledgements

Potential Market Growth

PDA Requirements:- Alphanumeric Keypad- Barcode Scanning Capabilities- Windows OS- WLAN Capabilities- Multicolor Display- Speakers

PDA Considerations:- Size of Display- Weight and Size- Processor and Memory- Environmental Sealing- Durability/Drop Specs- Battery Life- Cost

Host Computer Requirements:- Windows based for synchronization with PDA- Adequate memory to hold prototype databasesHost Computer Choice: HP Laptop

Symbol MC50 Specifications:- Dimensions: 5.35 x 2.95 x .94 in.-Weight: 6.77 oz-Touch Panel Display: 4 x 3 in., TFT-LCD- QWERTY 37 button keypad- 1D Linear CMOS Scanner- CPU: Intel®XScale 520 Mhz processor- Memory: 64MB RAM/ 64MB ROM- Operating System: Windows Mobile 2003- WLAN: IEEE 802.11b- Battery: Rechargeable Lithium Ion 3.7V- Includes: Speakers, Microphone, SDIO Slot- Approximately $1200

Handheld PDA Choice:Symbol MC50

PDA: mobile device capable of barcode scanning at the point-of-care

Wireless Router: creates WLAN for communication between PDA and host computer

Host Computer: acts as database server as well as barcode printing station

Barcode Printer: creates labels with barcodes and other needed information

Wireless Router Requirements:Capable of creating WLAN for PDAWireless Router Choice: Linksys Router

Barcode Printer Requirements:Produces quality barcode labels

Barcode Printer Choice:Intermec EasyCoder PC4

Software Description:- PDA program developed with Visual Studio and Visual Studio Emulator- Written in C# to be compatible with Windows CE .NET operating system of the PDA- Alternate version written in C++ using GUI layout software QT for use with windows based PCsSoftware Process Flow:

Databases: - Currently using Microsoft SQL server to hold drug, patient, and staff databases- PDA application must use SQL server because of limitations of C#, however PC version can integrate with multiple types of servers

Drug Event (PADE) is a common medical error that occurs during medication administration. The FDA has strongly recommended a bar code system to reduce this error using NDC (National Drug Code) bar codes on unit doses of medicine. We worked with PharmaSys Hospital Solutions to develop a product to address this need.

We created a system called eMEDS that works by scanning the nurse’s bar code on his/her identification badge, the bar code on the wrist band of the patient, and the bar code of the medication.   If there is a conflict, the system will visually alert the nurse and drug administration will not be allowed. If all three scans check out, the system will save the following information:

-Date/Time- Size and # of Units- Nurse’s Name- Dose # of Total

Example:

“Please administer drug” “Mismatch: No drug administration”Objectives:- Reflect the needs and constraints of the current hospital environment and consider pharmacists, nurses, and hospital IT professionals when making design decisions - Include software, hardware and other digitized apparatus to develop and execute the bar code system - Adapt to a number of hospital settings and interface with an organization’s existing software and IT architecture - Be HIPAA compliant and consider network security issues - Easily adapted and intuitive for end-users

Competitors: Omnicell, CareFusion, Baxter Healthcare, McKesson, Cerner Bridge Medical, Intellidot CorporationCost Example:- St. Clair Hospital (Pittsburgh, PA), using Veriscan- 15646 annual hospital admissions- 0.63 PADEs in 100 admissions; 98.57 PADEs per year- Average $6400 per prevention

Savings: $630,000/year

Market Considerations: - 2.4 million registered nurses in 7,000 hospitals in the United States- Largest Annual Growth Rate (5.12%) in medium hospitals which have 50-250 beds- Market goal: To find one potential customer at a medium hospital to implement systemOur System Advantage:

We offer a user-friendly interface and have an organizational flow that will decrease the amount of time that a nurse spends filling out forms and enhances patient safety. In addition, the FDA mandate for drug validation will ensure the need for these sorts of systems in hospitals.

- Incorporate patient photographs into the patient record- Color changes to the program’s background when medication errors are detected- Automatic updates to the eMAR (electronic medication administration record)- Compatibility with RFID technology- Notification of drug administration method (i.e. pill, IV bag, syringe)- Compatibility with multiple types of servers (Oracle, DB/2, etc.) and databases (MS Access, SAP DB, etc.)

Our team has succeeded in the creation of a system that deters medication administration errors at the patient bedside. With our fully functional prototype, the next logical step is to pilot eMEDS in a small or medium-sized hospital. Hospitals are not the only option, however. Pharmacies, nursing homes, and small clinics would also benefit from our system. On an even simpler level, school systems might be interested in eMEDS for ensuring student safety when medications are administered by school nurses.

PharmaSys Hospital Solutions plans on piloting our prototype system and expanding the functionality for hospital use. With an estimated savings of $630,000 per year and a market growth of 5.12%, piloting eMEDS in a medium-sized hospital yields the greatest return. Future business plans include hiring employees with software engineering and marketing experience to take over the product and continue working on new developments for the pilot. These plans are currently in work and will continue into the summer and next year. Overall, our prototype of eMEDS has created a solid foundation for future design and development considerations.

We would not have succeeded without the patience, consideration and assistance of the following individuals:

• Charles Lankford, CEO, PharmaSys• Patrick Harris, eMEDS Product Manager, PharmaSys Hospital Solutions• Paul King, Ph.D., Vanderbilt University School of Engineering • Mark Roberts, Computer Science, Vanderbilt University• David Cochran, Manager Health Systems Network, Vanderbilt University

PDAPersonnel

Query

PDAPatientQuery

PDADruglQuery

PersonnelDatabase

PatientDatabase

DrugDatabase

PDAData

Buffer

AdministrationApproval orRejection

Record ofAdministration

Record ofRejection

HandheldPDA

SQLServer

StaffDatabase

DrugDatabase

PatientDatabase

Barcode Printer

Host Computer

WirelessRouter

In recent years, preventing medical errors has been a major initiative of the Food and Drug Administration (FDA). According to a study conducted by the Institute of Medicine, medical errors affect an estimated 1.5 million people annually, costing $1.5 billion and killing several thousands in the United States alone. A Preventable Adverse