• Updating regulations in recognition of changing technology
     31 MAY 2011, HHS.gov/Open: Records & Reports
 
FDA’s Bar Code Rule

FDA has been considering which economically significant rule to subject to a cost-benefit reassessment and has tentatively concluded that the “Bar Code Rule” is the best candidate for this review.  The Bar Code Rule dates from February 2004 and requires certain human drug and biological products to have on their labels a linear bar code that contains, at a minimum, the drug's NDC number.  The rule also requires the use of machine-readable information on blood and blood component labels.

Bar codes on drugs allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.  FDA estimated that the bar-code rule, when fully implemented, would help prevent nearly 500,000 adverse events and transfusion errors over 20 years.  FDA estimates the economic benefit of avoiding these adverse events to be $93 billion over the same period.

The goal to the review will be to assess the costs and benefits and to determine if the rule should be modified to take into account changes in technology that have occurred since the rule went into effect.

The comment period closes June 30, 2011, after which HHS will finalize its Plan.  Read more: click here

• 2012 GTIN Sunrise and GTIN Allocation Rules for Healthcare
   MAR 2011, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
The Global Trade Item Number is the fundamental product identification key in the GS1 System. Uniqueness at every level of packaging is essential…and soon.

We hear a lot these days about sunrise dates in the global GS1 System of product identification and related supply-chain standards. A sunrise date is a date in the future, agreed to and typically announced years in advance, at which point an industry or market sector is expected to be prepared to implement a specific technology.

It started with “Sunrise 2005,” the GS1 US initiative to have North American retailers update their point-of-sale (POS) systems to accept EAN-13 data structures in addition to the familiar UPC-12. Trading partners were also reminded that UPC-12 and EAN-13 are, essentially, shortened representations of what is fundamentally a 14-digit data structure. For this reason it was recommended that all supply-chain data processing systems (including POS) be updated to handle the Global Trade Item Number (GTIN)-14 identifier, not just 12 or 13 digits. Read more: Article Text   In-Print

• Pharmaceutical & Medical Packaging News: 2010's Top Stories
     30 DEC 2010, PMPNews.com Daily
 
 #2 Most-Viewed Article in 2010: GS1 DataMatrix: FNC1 versus GS as the Variable-Length Field Separator Character
 
In this article, George Wright IV from PIPS explains that the GS1 General Specification requires the use of FNC1 but the transmitted data are the same if GS (Group Separator) is encoded instead. Does it really matter?
 
To read all PMP News 2010 Top Stories click here

• Webcast: Establishing a State of Readiness: Mass Serialization as a Business Strategy
     DEC 2010, Pharmaceutical & Medical Packaging News, Author: Daphne Allen
 
Companies need to assemble cross-functional teams and develop serialization requirements and specifications to be able to meet pending mandates
 
In October, Joseph Ringwood, COO, Systech International joined PMP News Editor Daphne Allen to discuss the global serialization landscape in a live Webcast. Earlier this year, Allen interviewed Ringwood along with Systech's customers to prepare the white paper, "Establishing a State of Readiness: Mass Serialization as a Business Strategy." Systech International has more than 150 lines serialized and is involved in 90'% of all serialization deployments.  Read more: In-Print

• Printing Accuracy: Hitting the Mark
     NOV 2010, Pharmaceutical & Medical Packaging News, Author: Marie Redding (Freelance Writer)

Pharmaceutical & Medical Packaging News received a question from a reader asking, “Is there a printing machine that is able to ensure 100% in-line printing accuracy?”  Suppliers readily responded. “The question sounds simple, yet the answer is complex,” says William Cuniff, sales manager, Uhlmann VisioTec (Towaco, NJ).  George Wright IV, vice president, Product Identification & Processing Systems Inc. (New York City), responds with a similar reply. “A printing device combined with an inspection system and the appropriate software is necessary,” he says. “No matter which type of printing system is used, it must contain components that are designed to inspect, verify, and validate. Even a simple printing process that uses a traditional in-line flexographic printer with a printing plate requires at least some amount of statistical process control,” advises Wright. “In digital, variable-data printing, such as with a track and trace or pedigree application, 100% automated inspection, including data validation and bar code print quality verification in accordance with ISO/IEC standards is essential," he adds. Read more: Article Text  In-Print

• AIM, Inc., the Association for Automatic Identification and Mobility –  www.aimglobal.org – Comments on Bar Code Label Requirements—Questions and Answers (Question 12 Update)
   08 NOV 2010, AIM, Inc.; Document ID: FDA-2010-D-0426-0015

AIM is the international trade association representing automatic identification and mobility technology solution providers. AIM is also the worldwide authority on linear bar code and 2- dimensional symbologies. AIM members are providers and users of technologies, systems, and services that capture, manage, and integrate accurate data into larger information systems that improve processes enterprise-wide. Serving members in 43 countries for 35 years, the Association has developed key technical specifications and guidelines that support the use of auto ID and mobile IT solutions. Industries that participate in our standards development process include aerospace, automotive, consumer goods, healthcare, government, high-tech, and transportation and logistics.

Support for the Use of Two-Dimensional Symbologies on Vaccines

Consistent with our submission of 12 June 2003 in response to FDA’s request for comment on the original proposed rule for "Bar Code Label Requirements for Human Drug Products and Biological Products" (Docket Number 02N-0204), AIM supports the move by FDA to broaden the application of the GS1 System (formerly EAN/UCC) General Specifications and relevant GS1 System application guidelines to permit the use by prescription drug (and certain OTC drug) labelers of two-dimensional bar code symbologies specified by the GS1 System as an alternative to the linear symbologies to which they are currently restricted under "Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule" (69 FR 9120)...

AIM recommends that the FDA accept and give industry guidance on the use of ISO/IEC 16022:2006 DataMatrix ECC 200 as the preferred 2-dimensional symbology for vaccine labeling.


Recommended Future Guidance on the Use of Two-dimensional Symbologies on Drugs

However, AIM would urge FDA to go beyond a narrow exception for vaccines and, after issuing final guidance on this question concerning vaccines, to establish a sunrise date when manufacturers of all drug and biological products covered by the rule (21 CFR Parts 201, 606, et al.) would be permitted to use a 2-dimensional symbol specified under the GS1 System (or, consistent with the rule, the HIBCC and ISBT128 systems) instead of a linear bar code to which they are now limited. Setting an appropriate future date (at least two years after issuance of the revised FDA guidance) for the optional use of 2-dimensional symbols (in lieu of the current linear requirement) will allow hospitals and other enterprises sufficient time to ensure that their scanning equipment is capable of reading the 2-dimensional symbols.

This would also require the FDA removing the restriction on 2-dimensional symbols under the "Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule", whether though a revision to the regulation itself or revised guidance that provides for permissive use. Again, because it supports all the recommended drug serialization systems, AIM recommends that the FDA provide industry guidance that ISO/IEC 16022 DataMatrix ECC 200 be the preferred 2-dimensional symbology, particularly on unit-dose and unit-of-use packaging.  Read more:  Download PDF

• Bar Code Label Requirements—Questions and Answers (Question 12 Update)
   07 SEP 2010, FDA Guidance for Industry - Draft Guidance; Docket No. FDA-2010-D-0426

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update)” dated August 2010. This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the “Bar Code Label Requirements—Questions and Answers” guidance dated October 2006 (Bar Code Guidance), to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. When this guidance is finalized, we intend to incorporate the revised response to Q12 into the Bar Code Guidance, but otherwise continue with our recommendations for bar code label requirements as currently provided in the Bar Code Guidance. Read more:  View PDF   Download PDF

• In a Windows World DOS Comes to the Rescue
   JUL 2010, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
Things are not always what they seem. Many bar code application standards require non-printing “control” characters to be encoded in the symbol, but these characters do not show up on the screen when the encoded message is scanned into most PC programs. But that doesn’t mean the control characters aren’t encoded. This “invisibility” can be disconcerting to someone casually checking symbol encodation with a scanner connected to a PC instead of a bar code verifier. Read more: Article Text   In-Print

• GS1 to Sunset Application Identifier AI(22) Data Structure for Secondary Attributes 
   APR 2010, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
Introduced more than 15 years ago to provide a convenient migration path for companies converting from the Health Industry Bar Code (HIBC) Supplier Labeling Standard to the global GS1 System of product identification and bar code marking standards, Application Identifier AI(22), “Secondary Data for Specific Health Industry Products,” is now slated for withdrawal effective January 1, 2013. Read more: Article Text   In-Print

• Is your verifier telling you the truth?
   APR 2010, Pharmaceutical & Medical Packaging News, PIPS Ad
 
Even the best verifier needs to be regularly challenged for conformance
 
IT'S A FACT: Not all bar code verifiers are created equal and until now there has been no way to check their accuracy. Now there is. GS1•US Data Matrix test card symbols are precisely engineered to challenge 2D verifiers for conformance with ISO/IEC 16022, 15415 and 15426-2. Each card is certified by the GS•US 2D Judge(TM) – the ultimate authority on 2D symbol quality. This is the only official test card specifically for 2D verifier conformance testing. Read more: View PDF   In-Print

• Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
   26 MAR 2010, FDA Guidance for Industry - Final Guidance
 
This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain. Read more:  View PDF   Download PDF

• Symbology-based self-configuring verifier
   16 FEB 2010, U.S. Patent No. 7,661,596 Issued
 
Abstract - A self-configuring verifier for performing standardized evaluation and verification of the print quality of a data carrying graphical symbol is structured with a plurality of illumination sources and at least one imaging device. The verifier is capable of automatically determining the symbology of the graphical symbol to be evaluated, and establish a pre-defined illumination pattern and possibly other settings, as required, to satisfy pre-defined evaluation standards. Once the illumination pattern is established and setup is complete, the verifier may fully evaluate and report on the quality of at least one data carrying graphical symbol imaged by the imaging device of the verifier. Read more: Full Text   PDF of Front Page

• Verifying the Bar Code Verifier
   JAN 2010, Pharmaceutical & Medical Packaging News, "News"
 
For years, users of linear bar codes have been able to do something 2-D bar codes users haven’t—confirm the accuracy of bar code verification systems through the use of a Calibrated Conformance Standard Test Card (CCSTC). These cards can be used for verifier calibration but are principally designed as a tool to test a verifier for conformance as per ISO/IEC specifications. In December, however, GS1 US announced the availability of the ISO/IEC Data Matrix and GS1 DataMatrix CCSTC, featuring 2-D bar code symbols of exact dimensional and reflectance values. Read more: Article Text  In-Print

• Here Comes The Judge…The 2D Judge™
   27 NOV 2009, SCAN: The DATA CAPTURE Report
 
PIPS, Inc. selected by GS1 US to produce Data Matrix conformance test cards and operate the 2D Judge™ high-resolution metrology instrument. Read more: PDF Reprint

• GS1 DataMatrix: FNC1 vs GS as the Variable-Length Field Separator Character
   NOV 2009, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
The GS1 General Specification requires the use of FNC1 but the transmitted data are the same if GS (Group Separator) is encoded instead. Does it really matter? Read more: Article Text   In-Print

• PACKAGE PRINTING AND CODING: Digital Bar Code Basics: Split Hairs, Not Pixels
   MAY 2008, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
As digital printing becomes more common in pharmaceutical and medical or surgical packaging, the incidence of poor-quality linear bar codes with low decodability grades could occur if digital printing equipment manufacturers, purchasers, and users do not become better acquainted with the resolution-dependent limitations of these systems. Read more: Article Text   In-Print

• Generating Quality Digital Bar Code Masters
   MAY 2007, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
Not every digital bar code image is a bar code “master,” that is, a high-quality, first-generation bar code image (digital or otherwise) suitable for producing printing mats or plates and, ultimately, an accurate and reliably readable printed symbol. Because bar codes are nothing more than a series of varying-width bars or lines, it is critical that these bars be produced with precise widths and spacing. Read more: Article Text  In-Print

• Code Blue
   APR 2007, Pharmaceutical & Medical Packaging News, Author: John Conroy
 
Pharmaceutical firms are complying with FDA’s 2006 rule requiring standardized bar codes for drugs distributed in hospitals. However, some equipment suppliers worry that poor bar code quality could undercut the new regulation’s intent to lower hospital error rates. Read more: Article Text   In-Print

• GS1 Renames Reduced Space Symbology as GS1 DataBar
   APR 2007, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
In a move that caught many automatic identification and data capture (AIDC) industry professionals by surprise, GS1 announced on February 14 at its annual meeting of national member organizations (such as GS1 US, GS1 Canada, GS1 UK, etc.), that it was changing the name of Reduced Space Symbology, often referred to as RSS, to GS1 DataBar. Read more: Article Text   In-Print

• Garment with embedded data
   27 MAR 2007, U. S. Patent 7,195,165 Issued
 
Abstract - A system and method are provided for using machine-readable technology to uniquely identify garments and to associate the garments with particular users, wherein the machine-readable technology is designed to withstand the various environments that are imposed upon a garment during its lifetime. The machine-readable technology includes identification tracking markers such as bar codes, magnetic tags, and other identification tracking markers that withstand laundering, mending, sterilizing and other processing. Read more: Full Text   PDF of Front Page

• Facing a Bar Code Deadline
   APR 2006, Pharmaceutical & Medical Packaging News, Author: David Vaczek
 
Firms look to meet FDA mandate for quality bar coding with a spectrum of printing options. Read more: Article Text

• Fundamentals of ANSI/ISO Bar Code Print Quality Verification – Part I
   MAR 2004, Pharmaceutical & Medical Packaging News, Author: George Wright IV
 
Whatever the bar coding application, standardized bar code print quality verification is essential.
 
Healthcare bar code application guidelines from EAN.UCC and HIBCC require a minimum overall symbol print quality grade of C. This is the equivalent of 1.5 on the 0.0-4.0 numeric scale. The grade is determined according to the globally accepted standard for calculating bar code print quality: ISO/IEC 15416, Information technology–Automatic identification and data capture techniques–Bar code print quality test specification–Linear symbols. This ISO standard supersedes ANSI X3.182-1990.

Here are some important points to consider when selecting a verifier and developing a bar code print quality verification protocol. Scanning is not verification. A bar code scanner is a data collection tool. Its purpose is to decode or read the data encoded in the symbol and to pass this information on to a computer system. Ideally, it should do this easily and quickly, even on poorer quality bar codes. A bar code print quality verifier is a quality assessment instrument. It is intended to evaluate, measure, and report with accuracy and repeatability specific physical characteristics of a bar code to quantify the likelihood that it will be readily decoded. A verifier should perform in strict accordance with globally accepted ISO specifications. Read more: Article Text

• Method and apparatus for U.P.C./EAN symbology ambiguous character compensation by localized thermal energy dot adjustment
   29 DEC 1998, U.S. Patent 5,853,252 Issued (Continuation of U.S. Patent 5,676,473)
 
Abstract - A method and apparatus is disclosed that can be used to print the U.P.C./EAN symbology in a way that does not suffer poor print quality over a range of ink spread conditions by applying appropriately more or less thermal energy to at least one row of dots on the internal edges of the ambiguous characters. The resultant characters have identical edge-to-edge measurements to those without the compensation; but, the sum of the widths of the bars are beneficially adjusted. The resulting print quality grades and scanning performance are enhanced on thermal printer platforms of moderate to high resolution. Read more: Full Text   PDF of Front Page

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