Bar Code Requirements for Blood Banks

(PDF - 196 KB)

 

Bar Code Requirements

Diane Maloney
Associate Director for Policy
CBER
January 20, 2006

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Bar Code Rule

• Blood -Before the Bar Code Rule
• Bar Code rule
  • Background
  • Blood and blood components
  • Other biological products

 

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Before the Bar Code Rule

• Re: Blood and blood components
• Old regulation said:
• The container label may bear encoded information in the form of machine readable symbols approved for use by the Director, CBER
• In 1985, FDA recognized the use of Codabar
• In 2000, FDA accepted the use of one version of ISBT 128

 

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Bar Code Rule

• For blood and blood components- machine readable information mandatory
• Required bar codes on most Rx drugs and some OTC drugs
• Not applicable to devices

 

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Bar Code Rule

• Finalized: February 26, 2004
• Effective Date: April 26, 2004
• Products approved after effective date must comply within 60 days of approval
• Products approved before the effective date must comply within 2 years of effective date

 

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Products covered by rule

• Most prescription drugs (including biological drugs)
• Certain over-the-counter drugs
• Blood and blood components

 

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How bar coding can prevent medication errors

• Patient gets bar-coded ID bracelet
• Hospital uses scanner linked to the hospital's medical records
• Healthcare worker scans bracelet and drug
• Computer compares medical record to drug
• If no match- error message

 

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Types of Errors Detected

• Wrong patient
• Wrong dose of drug
• Wrong drug
• Wrong time to administer drug
• Patient chart updated and prescribed medicine has changed

 

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What blood components must bear bar codes?

• All blood and blood components for transfusion -including splits units, pooled units, pedi-packs and syringes
• Bottom line: If it's a blood or a blood component and it goes to the patient's bedside it must bear machine readable information.

 

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Blood Establishments Must Comply

• Blood Establishments that:
  • Manufacture, process, repackage, or relabel blood and blood components
  • Intended for transfusion
  • And regulated under the FDC or PHS Act
  • Are subject to the rule

 

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Blood and blood components

• At a minimum, the label must contain:
• Unique facility identifier(e.g. registration #)
• Lot number relating to the donor
• Product code
• Blood type (ABO) and Rh of the donor

 

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Blood and blood components

• Label must be unique to the product
• Info must be surrounded by sufficient blank space so can be scanned correctly
• Info must remain intact under normal conditions

 

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What blood components do not have to bear machine readable information

• Blood collected from a patient intraoperatively and transfused to that patient in the operating or the recovery room
• Autologous preparations of fibrin sealants or platelet sealants manufactured and used during surgery
• Drainage collected in the ER or operating room as part of trauma care for that patient

 

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Requirements for other blood products

• Source Plasma used to manufacture plasma-derived therapies -SP not intended for transfusion - so does not need to bear machine readable information. However, the resulting products would be subject to the bar code rule
• Plasma derivatives (e.g. IGIV) are subject to the bar code requirements for drug products (see 21 CFR 610.67 and 201.25)

 

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What about devices?

• E.g.
• filters and apheresis kits
• Rule DOES NOT apply to devices
• Devices present different regulatory issues and challenges
• Unlike drugs, devices don't have a standardized unique ID system like NDC
• FDA will continue to consider issue

 

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What about "Tissues"?

• Human cells, tissues, and cellular and tissue based products subject to premarket approval (351 products) are subject to the bar code rule
• HCTPs regulated only under 361 of the PHS Act are not subject to the bar code rule

 

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Exemptions from the bar code requirement

• FDA may exempt a product from the bar code requirements
• Factors:
  • Compliance would adversely affect safety, effectiveness, purity or potency or not technologically feasible
  • Alternative regulatory program renders bar code unnecessary for patient safety

 

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Thank You.