2D Barcode History and Progress

Elizabeth Sobczyk, MPH, MSW 

Manager, Immunization Initiatives 

Division of Pediatric Practice 

American Academy of Pediatrics 

7 "Reviewed November 2014"
 

 

Outline 

• AAP vision 

• History of barcoding at AAP 

• Guidance issued 

• Next steps for AAP 

• Q&A 
 

 

 

 

AAP Vision: Immunizations 

•	 Pediatricians provide a majority of immunizations in the US 

•	 The AAP formed a Task Force on Immunizations in 2005, making 

immunization delivery a priority for the Academy. Both vaccine safety and 

financing issues have been a focus. 

•	 The work of the Task Force continues today through the Committee on 

Practice and Ambulatory Medicine, which deals with practice implementation 

issues including those related to immunizations. 

•	 The AAP would like every child to be safely and effectively immunized, while 

providing pediatricians the resources needed to do so. 
 

History of Barcoding at the AAP 

•	 Several pediatricians in practice and AAP leadership were interested in the 

idea 

•	 Primary drivers: 

• Rapid uptake of technology 

• Vaccine safety and reporting of adverse events 

• Increased need for office efficiency 

•	 AAP started to investigate feasibility 
 

 

 

 

History of Barcoding at the AAP 

• Discuss history with CDC and manufacturers 

• Gather previous process successes 

• Identify why desired outcome was not achieved 

• Learn from past leaders, create contacts with key movers and shakers 

• Identify partners 
 

 

 

 

 

History of Barcoding at the AAP 

Pulled together stakeholders to discuss feasibility and barriers (January 2009) 

• Info needed: manufacturer information, lot number, expiration date on 

barcode
 

• 2D barcodes were identified as a solution 

• Focus was on the primary unit of use (vial, syringe), not packaging 

(secondary) level because of concurrent serialization efforts
 
 

 

 

 

 

History of Barcoding at the AAP 

•	 Needed permission from FDA - guidance dictated the use of linear barcodes 

•	 AAP, manufacturers, and GS1 met with FDA in February 2010 to discuss 

allowing 2D codes on the unit dose of vaccines 

•	 With no major objections, FDA issued updated guidance in September 2010 

•	 Guidance was finalized 11 months later and new stakeholders were identified 
 

 

 

 

 

 

 

 

Guidance Issued
 

• Guidance for clinicians and manufacturers was created 

•	 Clinician Guidance: Includes information on 

getting your office ready and choosing a scanner 

•	 Manufacturer Guidance: This guideline provides 

sufficient information and technical detail to 

implement GS1 DataMatrix technology 

•	 AAP Immunization page with these resources: 

http://www2.aap.org/immunization/pediatricians/ 

barcoding.html 

•	 Sanofi Pasteur was the first to begin rolling out product with six 2D barcoded 

products currently in distribution; GSK has rolled out one and committed to 

changing all of their product lines; we expect others to follow 

•	 The AAP has stayed in contact with CDC and the pilot team throughout the 

process 
 

 

 

 

 

Opportunities and Benefits 

Patient Safety 

• Accurate information is in the record in case of recall or adverse event 

reporting 

• Decision support can identify wrong doses before they are given 

• Reduces rate of vaccine duplication 

Office Efficiency 

• Saves time spent hand writing records 

• Not insignificant when considering how many vaccines are delivered every 

day in a practice 
 

 

Next Steps 

• Workflow scan vaccines after or prior to administration? 

• Refine guidance with lessons learned 

• Request removal of linear barcodes when 2D codes are present 

• Complete integration with registries 

• Full roll out 
 

Conclusion
 

Emily - 1 year old , Jack - 3 years old
 
 

 

 

 

Contact Information 

Elizabeth Sobczyk 

Manager, Immunization Initiatives 

American Academy of Pediatrics 

esobczyk@aap.org 

Special thanks to Jon Almquist, MD, FAAP; Kathy Cain, MD, FAAP; and Edward 

Zissman, MD, FAAP 
Questions?