FDA Home Page | CDRH Home Page | Search | A-Z Index

FDA > CDRH > Unique Device Identification > October 25, 2006 Public Meeting > In K. Mun Presentation

Medical Device Marking with RFID & Barcode

Medical Device Marking with RFID & Barcode

In K. Mun, Ph.D.
VP, Research & Technology, NFD, HCA
T: 305-582-722, E: ikm1@mit.edu / ikm1@aol.com

IOM Report in 1999

To Err is Human: Building A Safer Health System

• One million patients in hospitals daily
  • 770,000 injuries caused by medication errors per year
    • 39% physician ordering
    • 38% drug administration
    • 11% drug dispensing
  • 44,000 – 98,000 preventable deaths per year
  • 5% of patients acquire an infection from a hospital

Barcoding “is an effective remedy” for medication errors, “a simple way to ensure that … all of the steps in the dispensing and administration processes are checked for timeliness and accuracy.”

Barcode For Healthcare

• 1983 – The Health Industry Business Communication Council (HIBCC)
• 1985 – First published account of medication bar-coding
• 1985 – Medication dispensing
• 1985 – Hokanson JA, et al, Am J Hosp Pharm
• 1985 – Nold EG & Williams TC, Am J Hosp Pharm
• 1987 – Smith JE & Meyer GE, Am J Health Syst Pharm.
• 1989 – Medication administration
• 1989 – Barry GA et al, Am J Hosp Pharm
• 1991 – Lefkowitz S et al, Hosp Pharm
• 1992 – Abdoo YM, Comput Nurs
• 1999 – IOM report: discussed barcode to improve patient safety
• 1999 – 1.1% of hospitals (60) using barcode
• 2001 – FDA announces intent to propose a bar code rule
• 2002 – 1.5% of hospitals (90) using barcode
• 2004 – JCAHO make a proposal and drops mandate
• 2005 – 9.4% of hospitals (560) using barcode

Identification Technology

• Linear Barcode
• Well known technology
• Lower cost, easy to copy / print
• Manual process
• Local data poor / remote data rich



 

 

• RFID

• Promising new technology
• High cost, difficult to copy
• Automation possible
• Local data poor / remote data rich
• 2D Barcode
• Reasonably known technology
• Low cost, easy to copy / print
• Item level management
• Local data rich / remote data rich

Steps Taken For BPOC

• Patient safety initiative to reduce medication error
  • “Improving Medication Practices” started in Feb 2000.
• Expect for facilities to implement from 2001 to 2010.
  • Non-HCA facility cost: $400K to $1M per facility
• Implementation was accelerated
  • By end of 2005, all 171 facilities implemented BPOC.

BPOC Experience

Lessons From BPOC

• Fewer medication administration errors
• More complete documentation
• Patient & staff perception of improved safety

Linear barcode does reduce errors, but

• Everybody must be engaged
• Work around is possible

Identification Technology

• Linear Barcode
• Well known technology
• Lower cost, easy to copy / print
• Manual process
• Local data poor / remote data rich
• RFID
• Promising new technology
• High cost, difficult to copy
• Automation possible
• Local data poor / remote data rich
• 2D Barcode
• Reasonably known technology
• Low cost, easy to copy / print
• Item level management
• Local data rich / remote data rich

Asset Management

• Managing infants
• Managing medical device, consumables
• Theft prevention, location, storage, readiness
• Bio-Medical service, repair, PM
• Rental equipment management
• Managing Patients
• Managing nurses, technologists and physicians

Why Device Management?

• National average utilization of mobile equipment is 45% - Universal Hospital Services
• Hospitals can lose nearly $1 million a year in medical equipment thefts alone - HCPro Healthcare Marketplace
• Five to fifteen percent of hospital inventory is written off each year since it can no longer be located or more importantly serviced - Frost & Sullivan
• “Equipment moving from patient to patient without going through decontamination in between has become a significant issue to JCAHO in regard to infection control in hospitals” - JCAHO Sentinel Alert
• To build an infrastructure for future patient safety improvements

Steps Taken

• Reviewing available technologies starting 2000
• Linear Barcode
• Passive RFID
• Active RFID
• Selected active RFID technology in 2003
• Reliability
• Automation
• Selected a vendor out of nine vendors in 2004
• Battery life
• Size of tag
• Resolution
• Experience
• Implemented a pilot system in 2005
• A 120 bed hospital
• Hospital-wide implementation

Pilot Configuration

• Device tracking, PM, rental management
• 433 Mhz active tag
• Small tags to maximize number of items to track
• Real-time tracking (broadcast few times per minute)
• Variable resolution: bed, room, department,..
• Manage high density of tags in a room
• Minimum additional network traffic
• Clean installation: invisible readers
• Web applications: support PDA, laptop, …
• Experience with several large hospital installations
• Less than three years for ROI
• To develop additional applications

Infusion Pump Utilization

• April1 through May 30, 2006
• Single and Multi-Channel Infusion Pumps
• Excludes rentals

Savings by an Early Adopter

• Realized Net Savings to Date: Over $1.5 Million
• Excludes “cost avoidance” and “soft” savings

Current Status

• Installation & staff training done
• Few hiccups & push backs
• Interfaced to bio-medical service database
• Interesting information
• Some items not moving
• Relationship among unexpected items (rental / discharge
• Designing new workflows to improve operations
• To increase ER throughput
• Surgical tool tracking in OR
• To improve workflow in ICU
• New interface to physician PDA
• Less than three years for ROI based on hard benefits

Business Processes

Lessons

• Medical Device / Asset Management using active RFID can be cost effective.
• Additional developments are needed:
• What happens when I lose an active RFID tag?
• How do I manage database?
• What do I do with surgical tools?
• How can I keep the cost down?
• Backup information?
• Do we have physics problem?
• What happens when I lose connectivity?
• How can I have information-rich local environment?
• Reduce errors further
• Katrina factor

Database Entries

Common name used by nurses: Arjo Lift
Common name used by industry: Lift/Patient
The device name: Patient Lift

Identification Technology

• Linear Barcode
• Well known technology
• Lower cost, easy to copy / print
• Manual process
• Local data poor / remote data rich
• RFID
• Promising new technology
• High cost, difficult to copy
• Automation possible
• Local data poor / remote data rich
• 2D Barcode
• Reasonably known technology
• Low cost, easy to copy / print
• Item level management
• Local data rich / remote data rich

2D Barcode?

• Minimum change in workflow
• Reasonable cost for infrastructure
• Less physics issues
• Solution for item level issues
• Data rich local environment
• More info available to reduce additional errors
• Katrina factor

Information Content

• Cost effective unifying standard
• Staff badges
• Patient wristband / patient identification
• Non-IV medication
• IV-medication / smart infusion pumps
• Medical device identification
• Blood products

• Documents of interests
• Positive identification for patient medication safety from Partners Healthcare Systems
• Working documents from ISBT-RFID Task Force.
• Documents for HIBCC standards

Comments

• Medical device marking for active RFID asset management system appears to work better when supplemented with a locally data rich 2D barcode.

• Medical device marking with limited information (pointer or unique number) using RFID tag or barcode may not be able to address certain clinical problems effectively.

• Many clinically critical problems may be best solved when the local environment is data rich.

Thank You!

Updated November 8, 2006

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH