Bar Code Label Requirements for Bar Code Label Requirements for Human Drug ProductsHuman Drug Products

Bruce WrayBruce Wray

Computype, Inc.Computype, Inc.

About ComputypeAbout Computype

Bar code label, scanner, printer, software, and Bar code label, scanner, printer, software, and systems integration companysystems integration company

Serving the blood bank & plasma communities Serving the blood bank & plasma communities since 1975since 1975

Actively involved in original Codabar Uniform Actively involved in original Codabar Uniform Labeling GuidelinesLabeling Guidelines

Made the original suggestion to switch to Code Made the original suggestion to switch to Code 128 at ISBT Working Party meeting in 1989 in 128 at ISBT Working Party meeting in 1989 in the Netherlandsthe Netherlands

FDA says:FDA says:

““Errors related to dispensing and Errors related to dispensing and administration can be minimized through administration can be minimized through the use of bar codes.”the use of bar codes.”

(If bar codes were used) “. . .the health (If bar codes were used) “. . .the health professional would be able to verify that the professional would be able to verify that the right patientright patient is receiving the is receiving the right drugright drug, in , in the the right doseright dose, and at the , and at the right timeright time.”.”

Lessons learned throughLessons learned through ISBT 128ISBT 128 standardization efforts standardization efforts

““If you build it, they will come”--NO; if the If you build it, they will come”--NO; if the law requires it, they will come; or, if they law requires it, they will come; or, if they can’t compete without it, they will comecan’t compete without it, they will come

Technology advances faster than most Technology advances faster than most formal groups can make decisionsformal groups can make decisions

Automating a bad system with bar codes Automating a bad system with bar codes simply enables more efficient mistakes simply enables more efficient mistakes

Lessons learned through Lessons learned through ISBT 128ISBT 128 standardization efforts standardization efforts

Bar codes reduce errors (blood bank study in Bar codes reduce errors (blood bank study in early 90s showed 0.00007% error rate)early 90s showed 0.00007% error rate)

Universal compliance to a uniform standard Universal compliance to a uniform standard benefits the entire industrybenefits the entire industry

Standardized data structures are more Standardized data structures are more important than a standard symbologyimportant than a standard symbology

The importance of software to handle new The importance of software to handle new data structures cannot be overstateddata structures cannot be overstated

More lessons learnedMore lessons learned

The more stakeholders are involved, the longer The more stakeholders are involved, the longer standardization takes. Europe is way ahead of standardization takes. Europe is way ahead of US in US in ISBTISBT 128128 implementation because of a implementation because of a simpler system for collection and transfusionsimpler system for collection and transfusion

Cooperation among label/printer suppliers, Cooperation among label/printer suppliers, instrument vendors, software firms, end-users, instrument vendors, software firms, end-users, and the FDA is a mustand the FDA is a must

Everything takes longer than expectedEverything takes longer than expected

What options do we have today?What options do we have today?

Automatic identification (“Auto ID”)Automatic identification (“Auto ID”)--Level 1 (linear bar code)--Level 1 (linear bar code)

--Level 1A (stacked bar code)--Level 1A (stacked bar code)--Level 2 (2-D bar code)--Level 2 (2-D bar code)

--Level 3 (RFID)--Level 3 (RFID)

Automatic identification--Level 1Automatic identification--Level 1

Linear bar codeLinear bar code: : Easy to print, easy to Easy to print, easy to scan, bi-directional, scan, bi-directional, self-checking and self-checking and check digits available; check digits available; extremely accurate; extremely accurate; limited data limited data encodation based on encodation based on space availablespace available

Auto ID--Level 1AAuto ID--Level 1A

Stacked bar codeStacked bar code A A series of linear bar series of linear bar codes stacked directly codes stacked directly on top of one another on top of one another to form a continuous to form a continuous message; read by message; read by conventional laser conventional laser scanners; printed scanners; printed similarly to linear; similarly to linear; read-onlyread-only

Auto ID--Level 2Auto ID--Level 2

2-D Symbol2-D Symbol: : Extended data capacity, Extended data capacity, error-correction error-correction capabilities, can be capabilities, can be concatenated and concatenated and truncated; requires truncated; requires more expensive more expensive scanners, still may need scanners, still may need eye-readable eye-readable interpretation of datainterpretation of data

Auto ID--Level 3Auto ID--Level 3

Radio Frequency ID Radio Frequency ID Can read data from tags Can read data from tags not visible to the not visible to the system; large storage system; large storage capacity; can be read/ capacity; can be read/ write or read-only; can write or read-only; can be protected from be protected from environment by form environment by form factor; fairly costly factor; fairly costly technologytechnology

Passive Tag ExamplePassive Tag Example

The chip is activated by a reader with a The chip is activated by a reader with a pre-set frequency and sends a signal in pre-set frequency and sends a signal in

responseresponse

Epoxysupport

antenna

Chip protected by resin

RFID Offers:RFID Offers:

Long-range, automatic identification that is Long-range, automatic identification that is robust, error-free, and reliablerobust, error-free, and reliable

A unique, unalterable identification codeA unique, unalterable identification code Ability to store variable information Ability to store variable information Effective performance at extremes of Effective performance at extremes of

temperature and humiditytemperature and humidity Does not require line-of-sight for operationDoes not require line-of-sight for operation

What will it cost?What will it cost?

Contact wand: $240Contact wand: $240 CCD: $420CCD: $420 Linear imager: $570Linear imager: $570 Moving-beam laser scanner: $890 Moving-beam laser scanner: $890 2-D image reader: $9852-D image reader: $985 PDA with scanner: $700 - $2500PDA with scanner: $700 - $2500

What hardware is available?What hardware is available?

PDA (Personal Digital PDA (Personal Digital Assistant) with Assistant) with integrated bar code integrated bar code scannerscanner

Equipped with wire-Equipped with wire-less communications less communications capabilitiescapabilities

Scan ID for real-time Scan ID for real-time host access/response host access/response

HardwareHardware

PDAs use either Palm- PDAs use either Palm- or Pocket PC-based or Pocket PC-based (Windows) operating (Windows) operating systemsystem

Doctors typically are Doctors typically are already Palm usersalready Palm users

Can display prompts--Can display prompts--scan blood bag, scan scan blood bag, scan recipient, etc.recipient, etc.

Networking options-WiredNetworking options-Wired

PDAs without wireless PDAs without wireless capability must be capability must be inserted in docking inserted in docking station for data station for data downloads to hostdownloads to host

Eliminates cost of RF Eliminates cost of RF access pointsaccess points

Data is not available in Data is not available in “real time”“real time”

Networking options-WirelessNetworking options-Wireless

Wireless PDAs require Wireless PDAs require “access points” for “access points” for their RF signals (2.4 their RF signals (2.4 GHz) to be picked up GHz) to be picked up and transmitted to hostand transmitted to host

Additional hardware Additional hardware expenseexpense

Application runs in Application runs in “real-time”“real-time”

Wireless network overviewWireless network overview

Scan patient on 7th floorScan patient on 7th floor Access point on 7th floor Access point on 7th floor

picks up signalpicks up signal Transmits data via Transmits data via

Ethernet to host some-Ethernet to host some-where in the building where in the building

Each device has its own Each device has its own IP address; no confusionIP address; no confusion

Bar code-equipped PDAs in use Bar code-equipped PDAs in use in healthcare:in healthcare:

Positive patient IDPositive patient ID Specimen collectionSpecimen collection Medication Medication

administrationadministration Pharmacy ordersPharmacy orders Taking vital signsTaking vital signs

Nursing ordersNursing orders Charge captureCharge capture Supply managementSupply management Medical record Medical record

trackingtracking X-ray trackingX-ray tracking

Recommendations (1)Recommendations (1)

The FDA should require the use of machine-readable symbols on all human drug and biologic products

Eye-readable representation of significant information should always accompany the machine-readable symbol(s)

Recommendations (2)Recommendations (2)

Rather than require a specific bar code symbology (language), the FDA should mandate that an agreed-upon data structure be encoded for machine reading

Recommendations (3)Recommendations (3)

Guidelines should be provided to each stakeholder industry group by the FDA which outline the minimum information content of their symbol(s), and the timeline for implementation

Recommendations (4)Recommendations (4)

An Auto ID Coordinating Council should be appointed to help resolve implementation issues, made up of volunteers from the disciplines involved, bar code suppliers, and the FDA, and should be tasked with ensuring minimum data requirements are met, that the best technology available is used, and that costs are minimized